Catheter assembly tracking

Abstract

A system for an electrophysiology procedure includes a catheter assembly including a plurality of coaxially disposed catheter elements, the plurality of catheter elements being movable relative to one another along a longitudinal axis. The system also includes a controller configured to generate a first position of a first catheter element based on a first electrical signal and a second position of a second catheter element based on a second electrical signal, and in response to detecting longitudinal motion of the second catheter element relative to the first catheter element along the longitudinal axis, apply a historical correction to the first position and the second position based on previously determined first position and second position vectors to obtain an initially corrected first position and second position. The control also generates an anatomical map of the electrophysiology procedure with a visualization of the catheter assembly including the longitudinal adjustment.

Description

[0001] Cross-references to related applications

[0002] This application claims priority and benefit to U.S. Provisional Patent Application No. 63 / 616,270, filed December 29, 2023, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to medical systems and methods for electrophysiological procedures, such as ablation of cardiac tissue, performed in a patient via a catheter assembly. More particularly, this disclosure relates to medical systems and methods for tracking a catheter assembly in a patient during an electrophysiological procedure. Background Technology

[0004] Electrophysiological procedures involve guiding a catheter assembly into the heart and tracking its position relative to the heart. Catheter ablation is a minimally invasive electrophysiological procedure used to treat various heart conditions, such as supraventricular and ventricular arrhythmias. These procedures may involve visualizing the heart, cardiac activity, and the location of the catheter assembly within the heart. Common visualization systems involve the use of fluoroscopy, which exposes patients and clinicians to ionizing radiation. Electroanatomical mapping is an alternative visualization technique that does not involve the use of ionizing radiation. Electroanatomical mapping allows clinicians to accurately pinpoint the location of arrhythmias, define the geometry of the heart in three dimensions, delineate regions of interest for anatomy, and allow for spatial localization of the catheter assembly for positioning and manipulation.

[0005] A catheter assembly comprises multiple catheter elements, such as catheters, sheaths, dilators, guidewires, and needles. For example, a catheter assembly may include both a catheter and a sheath. In electroanatomical mapping systems, navigation-enabled catheter assembly elements (such as navigation-enabled catheters) use magnetic fields to track magnetic sensors within the catheter element with relative accuracy. However, not all catheter elements include magnetic sensors. Impedance-based catheter elements (such as catheter sheaths or catheters) use electric fields to track catheter elements with lower-cost components (such as electrodes), but are generally less accurate than navigation-enabled catheter elements in electroanatomical mapping systems. Regardless of whether the catheter element is navigation-enabled or impedance-based, electroanatomical mapping systems use electrical measurements to determine the catheter orientation, or a three-dimensional curve of the distal portion of the catheter assembly traversed by the electrodes. Due to the inaccuracies of the tracking system, even if a catheter assembly includes one catheter element positioned within another within the patient's body (such as a catheter positioned within a sheath), the different catheter elements within the catheter assembly may appear displaced or separated from each other in visualization. Summary of the Invention

[0006] Example 1 is a system for an electrophysiological procedure. The system includes a catheter assembly comprising a plurality of coaxially arranged catheter elements, including a first catheter element and a second catheter element. The first catheter element forms an elongated lumen defining a longitudinal axis, and the second catheter element is disposed within the lumen. The first and second catheter elements are movable relative to each other along the longitudinal axis. The first catheter element includes a first tracking sensor configured to generate a first electrical signal, and the second catheter element includes a second tracking sensor configured to generate a second electrical signal. A controller is configured to generate a first position of the first catheter element based on the first electrical signal and a second position of the second catheter element based on the second electrical signal. In response to detected longitudinal movement of the second catheter element relative to the first catheter element along the longitudinal axis: historical corrections are applied to the first and second positions based on previously determined first and second position vectors to obtain initially corrected first and second positions; longitudinal adjustments are applied to the initially corrected first and second positions based on constraints imposed on the detected longitudinal movement; and an anatomical diagram of the organ for the electrophysiological procedure is generated, with visualization of the catheter assembly including the longitudinal adjustments.

[0007] Example 2 is the system described in Example 1, wherein the controller is configured to update the previously determined first position vector and second position vector in response to detected longitudinal movement of the second catheter element along the longitudinal axis relative to the first catheter element.

[0008] Example 3 is the system described in Example 2, wherein the updated previously determined first position vector and second position vector are based on a plurality of previously determined first position vectors and second position vectors.

[0009] Example 4 is the system of any one of Examples 2 and 3, wherein the update of the previously determined first and second position vectors is based on the parameters of the electrophysiological program.

[0010] Example 5 is the system of any one of Examples 2-4, wherein the update of the previously determined first and second position vectors is based on a time period of the electrophysiological procedure.

[0011] Example 6 is the system of any one of Examples 2-5, wherein the update of the previously determined first and second position vectors is based on the anatomical location of the electrophysiological procedure.

[0012] Example 7 is the system described in Example 4, wherein the update of the previously determined first and second position vectors is based on multiple parameters of the electrophysiological program.

[0013] Example 8 is a system according to any one of Examples 1-7, wherein the controller is configured to laterally align the first position with the second position based on lateral and rotational displacements determined from the first position and the second position.

[0014] Example 9 is the system described in Example 8, wherein the first conduit position includes a first position and a first tangent in space, and the second conduit position includes a second position and a second tangent in space, and wherein the first position and the first tangent are laterally aligned with the second position and the second tangent based on lateral offset and rotational deflection determined from the first tangent and the second tangent.

[0015] Example 10 is a system as described in any one of Examples 1-9, wherein the controller is configured to track the first catheter element via impedance tracking and the second catheter element via magnetic tracking.

[0016] Example 11 is a system as described in any one of Examples 8-10, wherein the controller is configured to laterally align the second position to the first position.

[0017] Example 12 is a system as described in any one of Examples 1-11, wherein the controller is configured to apply the longitudinal adjustment to the second position relative to the first position.

[0018] Example 13 is a system according to any one of Examples 1-12, wherein the detected longitudinal movement of the second catheter element along the longitudinal axis relative to the first catheter element is based on an independent parameter that detects the relationship between the sheath and the electrodes on the catheter.

[0019] Example 14 is the system of claim 13, wherein the independent parameter includes a sheath detection mechanism.

[0020] Example 15 is the system of any one of Examples 1-13, wherein the first catheter element includes a catheter sheath.

[0021] Example 16 is a system for an electrophysiological procedure. The system includes a catheter assembly comprising a plurality of coaxially arranged catheter elements, including a first catheter element and a second catheter element. The first catheter element forms an elongated lumen defining a longitudinal axis, and the second catheter element is disposed within the lumen. The first and second catheter elements are movable relative to each other along the longitudinal axis. The first catheter element includes a first tracking sensor configured to generate a first electrical signal, and the second catheter element includes a second tracking sensor configured to generate a second electrical signal. A controller is configured to generate a first position of the first catheter element based on the first electrical signal and a second position of the second catheter element based on the second electrical signal. In response to detected longitudinal movement of the second catheter element relative to the first catheter element along the longitudinal axis: historical corrections are applied to the first and second positions based on previously determined first and second position vectors to obtain initially corrected first and second positions; longitudinal adjustments are applied to the initially corrected first and second positions based on constraints imposed on the detected longitudinal movement; and an anatomical map of the organ for the electrophysiological procedure is generated, with visualization of the catheter assembly including the longitudinal adjustments.

[0022] Example 17 is the system described in Example 16, wherein the controller is configured to update the previously determined first position vector and second position vector in response to detected longitudinal movement of the second catheter element along the longitudinal axis relative to the first catheter element.

[0023] Example 18 is the system described in Example 17, wherein the update of the previously determined first position vector and second position vector is based on a plurality of previously determined first position vectors and second position vectors.

[0024] Example 19 is the system described in Example 17, wherein the update of the previously determined first and second position vectors is based on the parameters of the electrophysiological program.

[0025] Example 20 is the system described in Example 17, wherein the update of the previously determined first and second position vectors is based on a time period of the electrophysiological procedure.

[0026] Example 21 is the system described in Example 17, wherein the update of the previously determined first and second position vectors is based on the anatomical location of the electrophysiological procedure.

[0027] Example 22 is the system described in Example 17, wherein the update of the previously determined first and second position vectors is based on multiple parameters of the electrophysiological program.

[0028] Example 23 is the system described in Example 16, wherein the controller is configured to laterally align the first position with the second position based on lateral and rotational displacements determined from the first position and the second position.

[0029] Example 24 is the system described in Example 23, wherein the first conduit position includes a first position and a first tangent in space, and the second conduit position includes a second position and a second tangent in space, and wherein the first position and the first tangent are laterally aligned with the second position and the second tangent based on lateral offset and rotational deflection determined from the first tangent and the second tangent.

[0030] Example 25 is the system described in Example 16, wherein the controller is configured to track the first catheter element via impedance tracking and the second catheter element via magnetic tracking.

[0031] Example 26 is the system described in Example 16, wherein the controller is configured to laterally align the second position to the first position.

[0032] Example 27 is the system described in Example 16, wherein the controller is configured to apply the longitudinal adjustment to the second position relative to the first position.

[0033] Example 28 is the system described in Example 16, wherein the detected longitudinal movement of the second catheter element along the longitudinal axis relative to the first catheter element is based on an independent parameter that detects the relationship between the sheath and the electrodes on the catheter.

[0034] Example 29 is the system of claim 28, wherein the independent parameter includes a sheath detection mechanism.

[0035] Example 30 is the system described in Example 16, wherein the first catheter element includes a catheter sheath.

[0036] Example 31 is the system described in Example 16, wherein the second catheter element includes an ablation catheter.

[0037] Example 32 is a system for an electrophysiological procedure. The system includes a catheter assembly comprising a plurality of coaxially arranged catheter elements, including a first catheter element and a second catheter element. The first catheter element forms an elongated lumen defining a longitudinal axis, and the second catheter element is disposed within the lumen. The first and second catheter elements are movable relative to each other along the longitudinal axis. The first catheter element includes a first tracking sensor configured to generate a first electrical signal, and the second catheter element includes a second tracking sensor configured to generate a second electrical signal. A controller is configured to generate a first position of the first catheter element based on the first electrical signal and a second position of the second catheter element based on the second electrical signal. In response to a detected longitudinal movement of the second catheter element relative to the first catheter element along the longitudinal axis based on sheath detection: historical corrections are applied to the first and second positions based on previously determined first and second position vectors to obtain initially corrected first and second positions; longitudinal adjustments are applied to the initially corrected first and second positions based on constraints imposed on the detected longitudinal movement; and an anatomical map of the organ for the electrophysiological procedure is generated, with visualization of the catheter assembly including the longitudinal adjustments.

[0038] Example 33 is the system described in Example 32, wherein the controller is configured to update the previously determined first position vector and second position vector in response to a detected longitudinal movement of the second catheter element along the longitudinal axis relative to the first catheter element, and wherein the updated previously determined first position vector and second position vector are based on a plurality of previously determined first position vectors and second position vectors.

[0039] Example 34 is a system for an electrophysiological procedure. The system includes a catheter assembly comprising a plurality of coaxially arranged catheter elements, including a first catheter element and a second catheter element. The first catheter element forms an elongated lumen defining a longitudinal axis, and the second catheter element is disposed within the lumen. The first and second catheter elements are movable relative to each other along the longitudinal axis. The first catheter element includes a first tracking sensor configured to generate a first electrical signal, and the second catheter element includes a second tracking sensor configured to generate a second electrical signal. A controller is configured to track the first catheter element via impedance tracking and the second catheter element via magnetic tracking; generate a first position of the first catheter element based on the first electrical signal; and generate a second position of the second catheter element based on the second electrical signal. In response to the detected longitudinal movement of the second catheter element along the longitudinal axis relative to the first catheter element based on sheath detection: historical corrections are applied to the first and second positions based on previously determined first and second position vectors to obtain initial corrected first and second positions; longitudinal adjustments are applied to the initial corrected first and second positions based on constraints imposed on the detected longitudinal movement; and an anatomical map of the organ for generating the electrophysiological program is generated, having visualization of the catheter assembly including the longitudinal adjustments.

[0040] Example 35 is the system described in Example 34, wherein the controller is configured to apply the longitudinal adjustment to the second position relative to the first position.

[0041] While several embodiments have been disclosed, other embodiments of this disclosure will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative embodiments of this disclosure. Therefore, the drawings and detailed description should be considered illustrative in nature and not restrictive. Attached Figure Description

[0042] Figure 1 This is a schematic diagram illustrating an example clinical setting for treating a patient and for treating the patient's heart, which includes an example electrophysiological system.

[0043] Figure 2 It is shown that... Figure 1 A block diagram of an example controller used in an example electrophysiological system.

[0044] Figure 3 It is shown Figure 2 A schematic diagram of an example process for an example controller.

[0045] Figure 4 It is shown that... Figure 1 A schematic diagram of the isolated example section of an example catheter element used in an example electrophysiological system.

[0046] Figure 5A It shows the use Figure 4 Example catheter element implementation Figure 3 A diagram illustrating the context of the process.

[0047] Figure 5B It shows the data from the tracking. Figure 5A A schematic diagram representing an example device model of a conduit element.

[0048] Figure 5C It is shown that... Figure 5B Equipment model implementation Figure 3 A schematic diagram illustrating the characteristics of the process.

[0049] Figure 5D It is shown that... Figure 5C Equipment model implementation Figure 3 A schematic diagram illustrating another characteristic of the process.

[0050] Figures 6A-6F Example catheter elements and illustrations Figure 3 A schematic diagram of the corresponding equipment model for the process characteristics.

[0051] Figure 7 It is shown Figure 3 A flowchart illustrating the process characteristics.

[0052] Figure 8 It is shown Figure 7 The concept of process Figure 5B A schematic diagram representing the device model.

[0053] Figure 9 It is to further demonstrate Figure 8 A perspective view of the spatial mapping concept.

[0054] Figure 10 It is shown Figure 7 A flowchart illustrating the process features.

[0055] While this disclosure is applicable to various modifications and alternatives, specific embodiments have been shown by way of example in the accompanying drawings and described in detail below. However, it is not intended to limit this disclosure to the specific embodiments described. Rather, this disclosure is intended to cover all modifications, equivalents, and alternatives that fall within the scope of this disclosure as defined by the appended claims. Detailed Implementation

[0056] For the purpose of facilitating an understanding of the principles of this disclosure, reference is now made to the examples shown in the accompanying drawings, which are described below. The illustrative examples disclosed herein are not intended to be exhaustive or to limit this disclosure to the precise forms disclosed in the following detailed description. Rather, these exemplary embodiments have been selected and described so that others skilled in the art can apply their teachings. Using multiple (e.g., all) features in the examples throughout all examples does not exceed the scope of this disclosure. Therefore, no single figure should be construed as having any dependency or requirement associated with any individual component or combination of components shown therein. Furthermore, the various components depicted in the figures may be integrated in the examples with various components in other components (or components not shown) depicted therein, all of which are considered to be within the scope of this disclosure.

[0057] This disclosure describes examples of electrophysiological procedures and systems in which an electroanatomical mapping system tracks catheter assemblies, wherein electrophysiological testing and ablation systems are used for illustration. Ablation procedures are used to treat many different conditions in patients. Ablation can be used to treat arrhythmias, benign tumors, cancerous tumors, and to control bleeding during procedures. Typically, ablation is performed using thermal ablation techniques, including radiofrequency (RF) ablation and cryoablation. In RF ablation, a catheter is inserted into the patient, and radiofrequency waves are delivered through the catheter to the surrounding tissue. The RF waves generate heat, which destroys the surrounding tissue and ablates blood vessels. In cryoablation, a hollow needle or cryoprobe is inserted into the patient, and a cold, heat-conducting fluid is circulated through the probe to freeze and kill the surrounding tissue. Another ablation technique uses electroporation. In electroporation, or electroosmosis, an electric field is applied to cells to increase the permeability of the cell membrane. Electroporation can be reversible or irreversible, depending on the waveform or pulse pattern, intensity, and duration of the electric field. If electroporation is reversible, the temporary increase in cell membrane permeability before cell healing and recovery can be used to introduce chemicals, drugs, or deoxyribonucleic acid (DNA) into the cell. Tissue recovery can occur within minutes, hours, or days after ablation. If electroporation is irreversible, the affected cells are killed, such as through some form of cell death, such as programmed cell death, possibly through apoptosis, or traumatic cell death, such as through necrosis. Irreversible electroporation can be used as a non-thermal ablation technique. In irreversible electroporation, a series of short, high-voltage pulses is used to generate a sufficiently strong electric field to kill the cells. In cardiac tissue ablation, irreversible electroporation can serve as a relatively safe and effective alternative to the indiscriminate killing of cells by thermal ablation techniques such as RF ablation and cryoablation. Irreversible electroporation can be used to kill targeted tissue (such as myocardial tissue) by using a selected electric field strength and duration that effectively kills the targeted tissue without effectively and permanently damaging other cells or tissues (such as non-targeted myocardial tissue, erythrocytes, vascular smooth muscle tissue, endothelial tissue, and nerve cells). Irreversible electroporation systems are described in this disclosure for illustrative purposes, but the concept of catheter and component tracking can also be applied to other systems.

[0058] Cardiac ablation and other electrophysiological procedures may involve the use of catheter assemblies. A catheter assembly comprises multiple catheter elements, and these elements may include catheters, sheaths, dilators, guidewires, and needles. As electrophysiological procedures increasingly rely less on fluoroscopy, catheter elements include tracking devices or sensors to facilitate tracking within electroanatomical mapping systems. Typically, the catheter elements within a catheter assembly are tracked individually via a tracking system within the electroanatomical mapping system. Because tracking systems are imprecise and provide approximations of the location of catheter elements within an organ, even if the catheter assembly includes one catheter element positioned within another within the patient, the different catheter elements within the assembly may appear displaced or separated from each other in visualization. It should be expected that the catheter elements are presented in precise locations relative to each other and to the heart for clinical interpretation. For example, when the tracked elements are physically coaxial, it is desirable to use this information to improve the estimation of catheter element location and, for instance, to present the catheter elements as coaxial in visualization. Similarly, for example, when one of the tracked elements has advanced past another, it is desirable that the catheter elements be presented as a single catheter assembly.

[0059] Figure 1 An example clinical setting 10 is shown according to this disclosure for treating a patient 20 (such as the heart 30 of the patient 20) using an electrophysiological system 50. The electrophysiological system 50 includes an electroporation catheter system 60 and an electroanatomical mapping (EAM) system 70. The example electroporation catheter system 60 includes an elongated catheter assembly 100, in this example, including an electroporation catheter 105 and a guide sheath 110; and an electroporation console 130. Furthermore, the electroporation catheter system 60 includes various connecting elements (such as cables) operatively connecting the components of the electroporation catheter system 60 to each other and to components of the EAM system 70. Typically, the EAM system 70 includes a positioning field generator 80, a mapping and navigation controller 90, and a display 92. Additionally, the clinical setting 10 may include additional equipment, such as an imaging device 94 (represented by a C-arm), and various controller elements configured to allow an operator to control various aspects of the electrophysiological system 50, such as a foot pedal controller 96. Clinical environment 10 can have Figure 1 Other components not shown, and their arrangement.

[0060] The electroporation catheter system 60 is configured to deliver electric field energy to targeted tissue in a patient's heart 30 to induce cell death in the tissue, for example, to prevent the tissue from conducting electrical signals. An elongated catheter assembly (such as catheter assembly 100) may include multiple coaxially arranged catheter elements. For example, a catheter element (such as a sheath or catheter) defines a longitudinal axis passing through the centroid of a catheter element's cross-section, such as the centroid of the catheter's axial cross-section or the centroid of the sheath's lumen cross-section. Coaxially arranged catheter elements include catheter elements disposed within another catheter element such that the longitudinal axis of each catheter element generally follows the same three-dimensional curve or path until the furthest point where both exist. A catheter element may include a first catheter element such as an elongated guide sheath 110 and a second catheter element such as an elongated catheter (such as electroporation catheter 105). The first catheter element includes an elongated lumen, and the second catheter element is disposed within the lumen. In this example, catheter 105 is disposed within guide sheath 110. The first and second catheter elements are movable relative to each other along their longitudinal axes. For example, the distal end of catheter 105 can be manipulated to extend from the distal tip of guide sheath 110, or the distal tip of guide sheath 100 can be retracted from the distal end of catheter 105. Furthermore, the distal end of catheter 105 can be retracted from the distal tip of guide sheath 110. The first catheter element includes a first tracking sensor, and the second catheter element includes a second tracking sensor. For example, each of the first and second catheter elements may include one or more tracking sensors. Examples of tracking sensors may include magnetic navigation devices and electrodes.

[0061] The guide sheath 110 is operable to provide a delivery conduit through which the catheter 105 can be deployed to a specific target site within the patient's heart 30. Access to the patient's heart can be obtained through a blood vessel, such as a peripheral artery or vein. Once access to the blood vessel is obtained, the electroporation catheter 105 can be navigated into the patient's heart, such as within a cardiac chamber. In one example, the catheter assembly 100, including the guide sheath 110, is adapted for use with transseptal puncture. The left atrium of the heart is a relatively difficult chamber to access percutaneously, and transseptal puncture allows direct access to the left atrium via the intraatrial septum and the systemic venous system.

[0062] Example catheter 105 includes an elongated catheter shaft and a distal end configured for deployment near target tissue, such as within a chamber of a patient's heart. The distal end may include a basket, balloon, spline, configured tip, or other electrode deployment mechanism to achieve treatment. The electrode deployment mechanism includes an electrode assembly or array. For example, an electrode assembly may include multiple spaced-apart electrodes, multiple sets of spaced-apart electrodes, or multiple groups of spaced-apart electrodes. In some examples, electrodes (such as multiple spaced-apart electrodes) may be deployed on the catheter shaft as a complement or replacement for electrodes on the electrode deployment mechanism. In one example, the multiple electrodes may be formed of a conductive, solid surface, biocompatible material, and spaced apart on an insulator. Each of the multiple electrodes is electrically coupled to a corresponding elongated lead conductor that extends along the shaft to the proximal end of the catheter. In one example, each of the spaced-apart electrodes corresponds to a single, individual lead conductor. In another example, multiple electrodes may be coupled to a single lead conductor. Other configurations are contemplated. The multiple lead conductors may be insulated from each other within an insulating sheath along the catheter shaft, such as using an insulating polymer sheath. Lead conductors can be electrically coupled to a plug in the proximal region of catheter 105, such as a plug configured to be mechanically and electrically coupled to electroporation console 130, for example, directly or via an intermediate electrical conductor (such as a cable). In one example, electroporation console 130 is configured to provide electrical signals, such as multiple concurrent or sequential electrical signals, to the electrically connected catheter 105 along lead conductors of spaced-apart electrodes. In examples of electroporation catheters, the spaced-apart electrodes are configured to generate a selected electric field near the target tissue based on the electrical signals from electroporation console 130 to achieve electroporation.

[0063] Electroporation can be achieved by generating a selected electric field using electrodes. A first electrode or a first set of electrodes can be selected as the anode, and different second electrodes or a second set of electrodes can be selected as the cathode, allowing an electric field to be generated between the anode and cathode based on signals (such as pulses) supplied to the electrodes from the electroporation console 130. The console 130 supplies electrical pulses of varying lengths and amplitudes to the electrodes on the conduit 105. The electrical pulses can be provided as a continuous pulse stream or as multiple separate pulse trains. Pulse parameters of interest include the number of pulses, the duty cycle of the pulses, the spacing of the pulse trains, the voltage or amplitude of the pulses (including the peak voltage), and the duration of the voltage. For example, the console 130 can select two or more electrodes of the electrode assembly and supply pulses to the selected electrodes to generate an electric field between the selected electrodes, thereby providing pulsed field ablation (PFA). For example, PFA can be performed using single-phase and two-phase waveforms. Without being bound by any specific theory, electric field strengths, typically in the range of 200–250 volts per centimeter (V / cm) with microsecond-level pulse durations, have been shown to provide reversible electroporation in cardiac tissue. Electric field strengths of approximately 400 V / cm have been shown to provide irreversible electroporation in cardiac tissues of interest, such as targeted myocardial and endocardial tissues, with demonstrable preservation of erythrocytes, vascular smooth muscle tissue, endothelial tissue, nerves, and other non-targeted adjacent tissues.

[0064] The electroporation console 130 is configured to control various aspects of the electroporation catheter system 60. In embodiments, the electroporation console 130 is configured to provide one or more of the following: modeling an electric field that can be generated by the electroporation catheter 105, which typically includes consideration of the physical characteristics of the electroporation catheter 105, including the electrodes and their spatial relationships on the electroporation catheter 105, and whether the electroporation catheter 105 is in bipolar or unipolar mode; generating a graphical representation of the electric field, which typically includes consideration of the location of the electroporation catheter 105 in the patient 20 and the characteristics of the surrounding tissues; and overlaying the generated graphical representation onto an anatomical diagram on a display 92. In some examples, the electroporation console 130 is configured to generate an anatomical diagram. In some examples, the EAM system 70 is configured to generate an anatomical diagram for display on the display 92.

[0065] The electroporation console 130 includes a controller (such as one or more controllers, processors, or computers) that executes instructions or code (such as processor-executable instructions) from a non-transitory computer-readable medium (such as a storage device or memory) to cause (such as control or execution) various aspects of the electroporation catheter system 60. The memory may be part of one or more controllers, processors, or computers, or it may be part of a memory device accessible through a computer network. Examples of computer networks include local area networks (LANs), wide area networks (WANs), and the Internet.

[0066] The EAM system 70 is operable to track the position of various components of the electroporation catheter system 60 and generate high-fidelity three-dimensional anatomical and electroanatomical mappings of the heart, including parts of the heart such as the chambers of interest or other structures of interest such as the sinoatrial node or atrioventricular node. In an illustrative example, the EAM system 70 may include OPAL, sold by Boston Scientific Corporation. TM HDx calibration system (formerly known as RHYTHMIA) TM HDx mapping system for sale). The mapping and navigation controller 90 of EAM system 70 includes one or more controllers (such as microprocessors or computers) that execute code from memory to control or perform functional aspects of EAM system 70, wherein the memory may be part of one or more controllers, microprocessors, computers, or a memory device accessible via a computer network.

[0067] The EAM system 70 generates a positioning field via a magnetic field generator 80 to define a positioning volume around the heart 30, and position sensors or sensing elements on the tracked device (such as sensors on the electroporation catheter 105) generate outputs that can be processed by the mapping and navigation controller 90 to track the position and orientation of one or more sensors within the positioning volume, and thus track the position and orientation of the corresponding device. In the example shown, device tracking is accomplished using magnetic tracking technology, where the field generator 80 is a magnetic field generator that generates a magnetic field defining the positioning volume, and the position sensors on the tracked device are magnetic field sensors.

[0068] In other examples, impedance tracking methods can be used to track the position of various devices. In these examples, the positioning field is a set of independently oriented and spatially varying electric fields, such as those generated by external field generators (e.g., surface electrodes), in vivo or intracardiac devices (e.g., intracardiac catheters), or both. In these examples, position sensing elements can form electrodes on the tracked devices, generating outputs received and processed by the mapping and navigation controller 90 to track the positions of various position sensing electrodes within the positioning volume. Generally, impedance tracking systems employ field mapping or other mechanisms to correlate the positioning field with spatial positions within the body. As electrode sensors on the impedance tracking device measure the positioning field during tracking, the impedance tracking system estimates the spatial positions of the electrodes. In some systems, the field mapping is calculated using, for example, a mathematical model of the electric field induced in the body by surface electrodes. In other systems, the field mapping is measured using a magnetic tracking device that measures the electric field at a point in space known from magnetic information. Other possibilities are envisioned; for example, the field mapping might be stored on a computer system and read by the impedance tracking system. In one example, component tracking addresses the problem of maintaining consistency between two different tracking methods. The examples shown involve magnetic tracking and impedance tracking methods. However, in general, whenever two (or more) location information sources are used and one location information source is more accurate than the other, the less accurate one is improved by using the more accurate location information source and the knowledge of the physical relationship between the two together.

[0069] The EAM system 70 can be equipped with both magnetic tracking and impedance tracking functions. In this type of example, impedance tracking might be achieved by first creating an electric field map induced in the chamber of interest within the heart cavity using an electric field generator and a probe equipped with a magnetic position sensor, similar to using OPAL HDx. TM The mapping system is the same. An example probe is the INTELLAMAP ORION, sold by Boston Scientific Corporation. TM Mapping catheter.

[0070] Regardless of the tracking method used, the EAM system 70 utilizes location information for various tracked devices, along with cardiac electrical activity acquired by, for example, an electroporation catheter 105 or another catheter or probe equipped with sensing electrodes, to generate detailed three-dimensional geometric anatomy maps or representations of cardiac tissues and spaces (such as cardiac chambers), and electroanatomical maps in which the cardiac electrical activity of interest is superimposed on the geometric anatomy maps, which are then displayed via a display 92. Furthermore, the EAM system 70 can generate graphical representations of various tracked devices within the geometric anatomy maps or electroanatomical maps.

[0071] Example EAM system 70 uses processes known in the art to track the position of catheter elements of catheter assembly 100. In one example of EAM system 70, equations are provided including the position and possible velocities of each electrode. The tracked device, such as the catheter element of catheter assembly 100, is characterized in EAM system 70 as a device model including electrode positions and tangents, among other parameters. In one example presented for illustration, tracking may include the application of external electrodes that generate multiple non-parallel electric fields throughout the body for impedance tracking. Magnetic tracking devices are used to correlate these electric field values, or impedance values, with each location in space determined magnetically. The resulting data structure is presented in the form of an electric field map. In the case of tracking only the impedance device, field measurements are inverted to estimate the position of each electrode. The estimated positions are smoothed, and these processes include various constraints on the shape of the flexible device comprised of all its electrodes. The body is nearly transparent to magnetic fields, but the geometry and electrical properties of body tissues greatly affect the amplitude and shape of the electric field, resulting in lower accuracy for impedance tracking compared to magnetic tracking.

[0072] Figure 2 An example controller 200 is shown that can be used with an example electrophysiology system 50, such as a controller for an example electroporation catheter system 60, which may include a controller for an example EAM system 70 (such as a mapping and navigation controller 90). The controller 200 can be implemented to provide a device model and visualization of the catheter assembly as a single unit within the patient's body, even when the catheter elements of the catheter assembly are tracked independently and in different ways during an electrophysiological procedure. The controller 200 may include a processor 202 and a memory 204. The memory 204 stores processor-executable instructions 206. In one example, the processor-executable instructions may be in the form of a program, such as a computer program or application. The processor 202 can execute the instructions 206, which may be included in configuring the controller 200. In one example, the controller 200 may be implemented to include a computing device, such as a laptop computer, workstation, desktop computer, tablet computer, or smartphone. In such examples, the controller 200 may include additional components such as a display, touchscreen, speaker or other output device, keyboard or other input device, or communication circuitry (such as a computer network adapter). The controller 200 can be implemented in various architectures and components (such as processor 202 and memory 204) and can be distributed in various locations.

[0073] In one example, processor 202 may include multiple main processing cores to run an operating system and perform general-purpose tasks on an integrated circuit. Processor 202 may also include built-in logic or programmable functional units, also residing on the same integrated circuit with a heterogeneous instruction set architecture. In addition to multiple general-purpose main processing cores and application processing units, controller 200 may also include other devices or circuitry (such as graphics processing units or neural network processing units), which may include heterogeneous or homogeneous instruction set architectures with main processing cores. For example, controller 200 may be used to perform other tasks, such as in the case of a computing device including a resonant sound amplification device.

[0074] Memory 204 is an example of a computer storage medium. Computer storage media include RAM, ROM, EEPROM, flash memory or other storage technologies, CD-ROM, digital versatile disc (DVD) or other optical storage, magnetic tape cassettes, magnetic tape, disk storage or other magnetic storage devices, USB flash drives, flash memory cards or other flash memory devices, or other storage media that can be used to store desired information and can be accessed by processor 202. Any such computer storage medium can be part of controller 200 and implemented as memory 204. Memory 204 is a non-transitory, processor-readable memory device. Therefore, the propagation of signals itself does not constitute a storage medium or memory 204.

[0075] Controller 200 can be configured to receive input or information from electrophysiology system 50, such as input from electroporation catheter system 60 and EAM system 70 (including electroporation console 130 and mapping and navigation controller 90), for storage in memory 204 and use by instructions 206. For example, controller 200 can receive input such as a cardiac anatomy diagram representing the heart or cardiac mapping data 208 from EAM system 70, which may include data representing cardiac geometric anatomy and cardiac electroanatomy. Furthermore, cardiac mapping data 208 may include annotations, markings, or user-added tags for the heart, which may include markers or other data for anatomical locations of interest to generate visualizations of interest that clinicians may find during the procedure. Controller 200 can also receive tracking position data 210 for each catheter element of the catheter assembly. Tracking position data may be generated by magnetic tracking, impedance tracking, or other tracking techniques and may be generated via other features of EAM system 70 or electrophysiology system 50. Tracking position data may be received periodically, such as at a sampling rate. In one example, the sampling rate for tracking location data 210 may be 20 Hz. In one example, tracking location data 210 includes information for determining the position of sensors on catheter elements relative to the heart. Furthermore, if the electrophysiological system 50 includes a sheath detection mechanism, tracking location data 210 may include information about how many electrodes in the catheter are exposed below the sheath, such as sheath detection data. In some examples, processor 200 may receive parameter data 212, which includes catheter assembly parameter data and patient physiological parameter data. The catheter assembly parameter data of parameter data 212 may include information about parameters of the catheter elements, such as the number and spacing of electrodes on the catheter elements, the type of tracking method used, and various other parameters, such as mechanical properties and status (e.g., in one embodiment, used to determine the performance of constrained catheter elements). A single catheter assembly parameter data of parameter data 212 may include individual inputs for each catheter element. The patient physiological parameter data of parameter data 212 may include information such as cardiac cycle phase, respiratory cycle phase, temperature data, anatomical location, program elapsed time, and other information associated with the received tracking location data 210, such as parameters associated with each received data sample. Other parameter data may include environmental data, such as the type and amount of ambient electromagnetic noise present in the environment, which can affect the accuracy of the magnetic tracking field or impedance tracking field, and thus the positioning accuracy. In one example, cardiac mapping data 208, tracking position data 210, and parameter data 212 are stored in memory 204 for use by processor 202 executing instructions 206.

[0076] The controller 200 is configured to generate a visualization 220 that may include the location of the identified catheter assembly as a single unit based on received tracking data of the catheter elements and reference to a cardiac anatomy map. In one example, the controller 200 is configured to generate the visualization 220 based on constraints applied to the tracking data 210, catheter parameter data 212, and cardiac mapping data 208.

[0077] Figure 3 A process 300 is illustrated for configuring a controller (such as controller 200) to simultaneously track a catheter assembly having multiple catheter elements, each with a tracking sensor. In the example process 300, the catheter assembly includes multiple coaxially arranged catheter elements, and the catheter elements include a first catheter element and a second catheter element. In this example, the first catheter element forms an elongated lumen, and the second catheter element is coaxially disposed within the lumen. The first and second catheter elements are movable relative to each other along an axis. An example of the first catheter element may be a sheath or dilator / sheath assembly, and an example of the second catheter element may be an ablation catheter disposed within the lumen of a sheath. The first catheter element includes a first tracking sensor, and the second catheter element includes a second tracking sensor. Process 300 can receive parameters regarding the first and second catheter elements via catheter parameter data 212.

[0078] In one example, process 300 may be implemented as a set of processor-executable instructions (such as instruction 206) residing in non-transitory memory (such as memory 204) to be executed by processor 202 to configure controller 200. Instructions implementing process 300 may be configured to receive information, such as retrieving cardiac mapping data 208 and tracking location data 210, as well as parameter data 212, from memory 204. Furthermore, instructions implementing process 300 may be configured to write cardiac mapping data 208 and generate visualizations, such as a graphical representation visualization 220 on a display.

[0079] Process 300 includes configuring controller 200 at 302 to receive electroanatomical mapping data of an organ, such as receiving cardiac mapping data 208. At 304, controller 200 is configured to track a catheter assembly within the heart based on a first electrical signal from a first tracking sensor and a second electrical signal from a second tracking sensor. In this example, the position of the catheter element is typically tracked simultaneously. At 306, controller 200 is configured to generate a first position of the first catheter element based on the first electrical signal and a second position of the second catheter element based on the second electrical signal. For example, controller 200 is configured to generate the position of a magnetic tracking sensor or each electrode on the first catheter element based on a set of magnetic or electrical signals of the first catheter element, and the same applies to the second catheter element. The first and second catheter element positions may each include a dataset of information about the catheter element in space, determined by mapping and navigation controller 90, such as catheter posture or a three-dimensional curve of the distal portion of the catheter with tracking sensors, as included in tracking position data 210. In one example, the first conduit element position includes a first spatial position and a first tangent of the conduit element determined by the EAM system 70, and the second conduit element position includes a second spatial position and a second tangent of the conduit element determined by the EAM system 70. In the example used in this disclosure, two objects are considered coaxial if they are in contact at a point and have the same tangent at that point. At 308, the first position is laterally aligned with the second position based on the lateral displacement of the first conduit element relative to the second conduit element. For example, the first position and the first tangent are laterally aligned with the second position. The second tangent is based on the lateral displacement and rotational displacement determined from the first position and the first tangent, and the second position and the second tangent, respectively. For example, the tangent at this point can be aligned by a rigid body transformation (such as rotation) or by locally modifying the tangent of the other device along a point of one device. At 310, the first position is longitudinally adjusted relative to the second position based on the detection of the second tracking sensor using the first tracking sensor. For example, the first position is longitudinally adjusted relative to the second position based on the detection of the first tracking sensor using the second tracking sensor. At 312, the controller is configured to generate an electroanatomical map of the organ for generating an electrophysiological program, with visualization of a catheter assembly having a device model of a first catheter element constrained by a device model of a second catheter element.

[0080] Lateral alignment at 308 and longitudinal adjustment at 310 can be performed based on various determinations of catheter parameter data from tracking location data 210 and parameter data 212. Lateral alignment at 308 can be applied to correct for deviations or displacements in the device model of the catheter element. In one example, deviations or displacements are addressed by translating or moving a device from one point to another along a vector. Furthermore, lateral alignment at 308 can be applied to correct for deflections or rotations in the device model of the catheter element. In one example, rotation is applied by moving a device by an angle. Longitudinal adjustment at 310 can be applied to correct for protrusions or longitudinal displacements of one catheter element relative to another. The determination of the number of exposed or unsheathed electrodes can inform the longitudinal adjustment at 310. In one example of a tracked catheter and sheath, sheath detection—or a technique for determining whether and how many electrodes are exposed under the sheath—is used to constrain the relative positions of the device models of the catheter and sheath, such as for longitudinal adjustment at 310. Rotational alignment can be applied at the location by rotating one or both objects, or by modifying the local shape of one object to align local tangents. In another example of lateral alignment at 308, the position and orientation of the conduit element can be determined by tracing the conduit element of the conduit assembly, applying a possible curve to the conduit assembly using reduced bending energy determined according to the conduit parameter data 212, and again finding the position and orientation but constraining it to that possible curve. This example process can be repeated.

[0081] One or more catheters in the device model of a catheter element can be aligned and adjusted. The determination of lateral alignment at 308 and longitudinal adjustment at 310 can be based on the confidence level of the tracked catheter element's position in space relative to the heart (as shown in the tracking), assigning weights to each device model of the catheter element. Generally, the confidence level of tracking for both elements can be used to weight the operations applied to each element to influence the desired constraints. For example, magnetic tracking is relatively accurate and closely represents the position of the catheter element relative to the heart in space. When the catheter is configured for magnetic tracking and the sheath is configured for impedance tracking, one approach is to assign a high confidence value to the device model of the catheter (e.g., 1.0 in the range of 0.0 to 1.0), and, given the relative accuracy of magnetic tracking, the device model of the sheath is laterally aligned with the tracked position of the device model of the catheter. When the catheter is configured for impedance tracking and the sheath is configured for impedance tracking, based on information from the catheter parameter data regarding the likelihood of accurate tracking, the device model of the catheter can be assigned a confidence value less than 1.0, and the device model of the sheath can be assigned a confidence value less than 1.0. In this configuration, the positions of both the catheter and the sheath are adjusted based on their relative weights. Alternatively, the user may choose to manually control these adjustments, for example, adjusting the sheath without adjusting the catheter.

[0082] Figure 4 An example catheter assembly 400 with multiple separate distal regions having catheter elements is shown. The catheter assembly includes a catheter 402 and a sheath 404, which may be... Figure 1 Examples of catheter 105 and sheath 110. The distal region of catheter 402 includes a shaft 406 disposed on a longitudinal axis A1 and having a proximal region 408 and a distal region 410. The distal region 410 in the example catheter 402 includes a plurality of electrodes 412 for ablation of tissue. The plurality of electrodes 412 in this example include a tip electrode 414 and annular electrodes 416, 418 carried on the distal portion 420 of shaft 406. The catheter shaft 406 may be flexible along its entire length of the distal region, but in the example shown, the distal portion 420 carrying the electrodes 412 is rigid and inflexible. The catheter shaft 406 may include a navigation device (not shown) located in or near the distal portion 420 within shaft 406 for magnetic tracking.

[0083] The distal portion of the sheath 404 may define a lumen along the longitudinal axis A2, such that the catheter 402 may be carried within the lumen. The distal portion of the sheath 404 includes a proximal region 428 and a distal region 430. The distal region 430 includes a plurality of annular electrodes 432, 434 for impedance tracking and sheath detection of the catheter electrodes 412. In one example, the electrophysiological system 50 applies sheath detection to determine whether the distal portion 420 of the catheter is positioned within the sheath 404 and / or the number of catheter electrodes 412 exposed beneath the sheath 404. Examples of sheath detection are described in U.S. Patent Application Serial No. 16 / 686,591 entitled “SHEATH DETECTION USING LOCAL IMPEDANCE INFORMATION”, filed November 18, 2019 by Salehi et al. and assigned to the assignee, the contents of which are incorporated herein by reference only to the extent consistent with the contents of this specification. In this example, the distal region of the sheath 404 is flexible along its entire length, including the distal region 430 of the sheath, except for the relatively small distal portion.

[0084] The EAM system 70 generates device models of the distal regions of catheter elements 402, 404 for processing. In one example, the device model includes data from the distal tip of the catheter element to the proximal boundary of the articulated segment or distal region of the catheter element. For example, the device model for each catheter element 402, 404 includes one point and three device segments. The point is the tip of the catheter element. The furthest point of the catheter element is the tip, such as the catheter tip 440 and the sheath tip 450. The device segments of the device model of the catheter element include a head segment, a neck segment, and a body segment. Head segments 442, 452 include the distal rigid tip segment of the catheter element. Neck segments 444, 454 include flexible articulated segments adjacent to head segments 442, 452, respectively. Body segments 446, 456 include the nearest flexible segment on the catheter element, which may be flexible but not passively articulated.

[0085] Based on the electrode locations and the values ​​of the electrode tangents, the EAM system can constrain each device segment of the device model to a geometry. The geometry used to represent a device segment can include points, lines, circles, any other defined geometry, or splines. For catheter 402, an example device model is fitted as follows: head segment 442 is fitted as a line to electrode 412, tip 440 is fitted as a point at the end of head segment 442, and if the neck of catheter 402 extends from sheath 404, neck segment 444 is fitted as a spline. For sheath 404, an example device model is fitted as follows: neck segment 454 is fitted as a spline (in other examples, this segment could be fitted as a circle or line), head segment 452 is fitted as a line using the tangent of the distal electrode 432, and tip 450 is fitted as a point at the end of head segment 452. For flexible devices such as sheaths, the splines fitted to the electrodes can take the shortest path connecting the electrodes, subject to smoothness constraints (such as the continuity of the first and second spatial derivatives). However, for example, the path may not satisfy the known distance between the electrodes. To satisfy this constraint, a simple geometric object, such as a circle, can be used to constrain the spline to part or all of the flexible device segment. In one example, a geometric object such as a circle can be used to add additional points, constraining the spline to fit using only points. In another example, a geometric object such as a circle can be used to calculate the tangent, constraining the spline to fit using both points and tangents. In yet another example, a geometric object such as a circle can be used to calculate the distance between the tangent and the electrode, constraining the spline to fit using points, tangents, and the distance between the electrodes.

[0086] In the following example, catheter 402 is tracked via magnetic tracking and sheath 404 is tracked via impedance tracking, and the tracking of the catheter is assigned a confidence value of 1.0 (e.g., in the range of 0.0 to 1.0). Therefore, during the application of process 300, the device model of sheath 404 is adjusted and aligned to fit the model of catheter 402. In another embodiment, the tracking of sheath is assigned a confidence value of 1.0, so the device model of catheter is adjusted to align and fit the model of sheath. In another embodiment, both devices are assigned confidence values ​​between 0.0 and 1.0 due to other measures of noise level or tracking accuracy, so the two device models are shifted toward each other, for example toward a noise-weighted average. Furthermore, catheter assembly 400 performs sheath detection. In one embodiment, process 300 receives input regarding the position of catheter components and applies constraints periodically (e.g., several times per second). For example, the process may include a sampling rate of 20 Hz. Other sampling rates are also considered.

[0087] Sheath detection data may be included along with catheter position data 210, such as the state or number of electrodes exposed on catheter 402. For example, sheath detection data may report covered, partially covered, and uncovered states. A covered state is when sheath 404 completely covers catheter 402, such as when sheath 404 covers all electrodes 412 on catheter 402. A partially covered state is when some, but not all, of the electrodes 412 on catheter 402 are exposed from under sheath 404. An uncovered state is when all electrodes 412 of catheter 402 are exposed from under sheath 404. In other embodiments, the covered state may be determined by purely geometric means that quantify the geometric relationship between two device models. In other cases, the covered state may initially be determined by user input, and state transitions may be implemented by a state machine that uses geometric information to control transitions between adjacent states.

[0088] In the covered state, if the catheter tip 440 advances beyond the (distal) nearest sheath electrode 432, constraints are imposed on the device models of catheter elements 402, 404. The point on the sheath body 456 closest to the tip of the catheter head 442 is determined. The device model of the sheath body 456 is translated to be coaxial with the nearest point of the device model of the catheter head 442. In terms of spatial coaxiality, the two device models are constrained to intersect at that point and have parallel tangents at that point. Furthermore, the sheath tip 450 is adjusted to match the number of exposed electrodes 412, which is zero in the covered state. To translate the device model of the sheath 404 onto the device model of the covered catheter 402—which involves a transformation of the device along a vector from one point to another—the device model of the sheath body 456 is moved laterally onto the device model of the catheter head 442 and longitudinally to satisfy sheath detection without exposed electrodes. The device model of sheath 404 is also rotated or otherwise modified around the tip of the device model of catheter to match the local tangent of catheter 402.

[0089] In the partially covered state, the device model of the sheath head 452 is translated to be coaxial with the device model of the catheter head 442, and the device model of the sheath tip 450 is translated to expose the number of electrodes indicated by the sheath detection data. To translate the device model of the sheath 404 to the device model of the catheter 404 in the partially covered state—which involves a transformation along a vector from one point to another—the shortest vector between the device models of the sheath tip 450 and the catheter head 442 defines the translation. The device model of the sheath 404 is moved longitudinally to accommodate the sheath detection data for the appropriate number of exposed electrodes. The device model of the sheath tip 450 is also rotated or otherwise modified about the device model of the catheter tip 440 to match the local tangent of the catheter tip 440.

[0090] In the uncovered state, if the protrusion of catheter tip 440 is less than the boundary of catheter neck 444, a constraint is imposed on the device model of catheter elements 402, 404. The device model of sheath head 452 is translated to align with the hinge of the device model of catheter neck 444. Furthermore, the device model of sheath tip 450 is longitudinally adjusted to match the number of exposed electrodes 412, which are all electrodes in the uncovered state. To translate the device model of sheath 404 to the covered state of catheter 402—which involves a transformation of the device along a vector from one point to another—the device model of sheath tip 450 is laterally moved to the device model of catheter head 442, and the device model of sheath tip 450 is longitudinally moved to satisfy sheath detection of all exposed electrodes. The device model of sheath tip 450 is also rotated or otherwise modified around the device model of catheter tip 440 to match local tangents.

[0091] Figures 5A-5D An example implementation of process 300 applied to catheter assembly 400 is shown. In the example implementation shown, the position of catheter 402 is determined via magnetic tracking, and the position of sheath 404 is determined via impedance tracking. In this case, the tracking of catheter 402 is assigned a confidence value of 1.0, so during the application of process 300, the device model of sheath 404 is adjusted and aligned to fit the determined position of the device model of catheter 402. Furthermore, electrophysiological system 50 includes sheath detection technology, and process 300 implements the use of sheath detection data as part of catheter position data 210.

[0092] Figure 5A The actual location of the catheter assembly 400 in space and deployed within a heart chamber is shown. The catheter assembly 400 includes coaxially arranged catheter elements, such as a catheter 402 and a sheath 404. The sheath 404 forms an elongated lumen, and the catheter 402 is disposed within the lumen. The catheter 402 and the sheath 404 are movable together in space and are movable relative to each other along axis A10, and as shown, the catheter 402 extends from the sheath 404 such that the catheter tip 440 extends beyond the sheath tip 450.

[0093] Figure 5B A visual representation of the catheter assembly 500, a device model constructed by independently tracking catheter elements 402 and 404 prior to application process 300, is shown. The device model of the catheter assembly 500 includes device models of catheter 502 and sheath 504, respectively, corresponding to catheter 402 and sheath 404. Figure 5BThis is an exaggerated representation of the differences in the device models of catheter elements 502 and 504, used for illustration. The device model of catheter 502 includes a device model catheter tip 540, and the device model of sheath 504 includes a device model sheath tip 550. As shown, prior to application process 300, the device model of catheter 502 is laterally displaced from the device model of sheath 504 under offset. Also as shown, the device model of catheter 502 is arranged along axis A12, and the device model of catheter 504 is arranged along axis A14, where axes A12 and A14 do not coincide but are deflected by rotational displacement prior to application process 300. Although the catheter assembly 400 is coaxial within the heart, according to independent tracking, the device models of catheter 502 and sheath 504 appear to float and appear to be located in different positions in space. Process 300 will laterally align the device model of sheath 504 with the device model of catheter 502 at the location of the device model of catheter 502. For example, the axes A12 and A14 of the device models 502 and 504 in the illustration will be parallel and then overlap. Process 300 aligns the device model of the longitudinal adjustment sheath 504 with the device model of the catheter 502 at the position of the device model of the catheter 502.

[0094] Figure 5C A visual representation of the device model catheter 502 and device model sheath 504, laterally aligned in process 300, is shown, such as at 308. In this example, the device model of sheath 504 is translated to the position of the device model of catheter 502 to correct for misalignment. Furthermore, the device model of sheath 504 is rotated to the position of catheter 502 to correct for deflection. In this example, axes A12 and A14 now coincide to intersect and include parallel tangents. Also as shown, the device model of catheter 502 protrudes from the device model of sheath 504, or remains longitudinally or axially displaced therefrom.

[0095] Figure 5D A visual representation of the device model catheter 502 and device model sheath 504, longitudinally adjusted during process 300, is shown, such as at 310. In this example, the position of the device model sheath 504 is translated along axis A14 to the position of the device model catheter 502 to correct for protrusions, which can be based on sheath detection data, such as the number of electrodes 412 exposed on catheter 402. For example, as... Figure 5A As shown, when the catheter 402 extends from the sheath 404 to expose the three electrodes 412, the device model of the sheath 504 is longitudinally adjusted along the axis to indicate the three device model electrodes 512 exposed on the device model of the catheter 502. As indicated, axes A12 and A14 coincide. Figure 5D As shown, deviations, skews, and protrusions are corrected, and a device model of the catheter assembly 500 can be provided at 312 for visualization.

[0096] Process 300 uses translations, rotations, or shape deformations calculated independently for each data sample (such as several times per second) to correct the device model for the tracked catheter element. However, when the physical movement of catheter 402 actually moves smoothly within the patient relative to sheath 404, using sheath detection on the spaced electrodes 412 can cause the visualization of the device model of catheter assembly 500 to appear to jump from one electrode to another. For example, in an example where the position correction of sheath 404 is calculated as the minimum correction to satisfy the applied constraints, the corrected sheath position (relative to the catheter position) remains at the distal edge of the first exposed electrode, even as catheter 402 is further advanced to expose the second electrode from beneath sheath 404. Once sheath detection determines that catheter 402 has been advanced from sheath 404 to expose the second electrode, the device model of sheath 504 will jump in the visualization to show both exposed electrodes 512.

[0097] This effect is Figures 6A-6F As shown in the diagram. The physical catheter assembly 400 includes a catheter 402 having at least three electrodes 412 and a sheath. Process 300 applies sheath detection to a device model of the catheter assembly 500. From Figures 6A to 6F The catheter 402 is gradually advanced from the sheath tip 450, and the resulting associated visualization is shown in each figure.

[0098] exist Figure 6A In the image, sheath 404 covers catheter 402 and electrode, and associated visualization 601 shows a device model of sheath 504 covering device model of catheter 502.

[0099] exist Figure 6B In the image, an electrode 412 on the catheter 402 is exposed from below the sheath 404, and the associated visualization 602 shows a device model of the catheter 502, with one electrode 512 located at the tip of the device model of the sheath 550.

[0100] exist Figure 6C In the middle, catheter 402 from Figure 6B The position shown extends further from the sheath tip 450, but since only one electrode 412 is exposed, the associated visualization 603 shows a device model of the catheter 502 with one electrode 512 located at the device model tip of the sheath 550.

[0101] exist Figure 6D In the visualization, the second electrode 412 on catheter 402 is exposed beneath the sheath 404, and the associated visualization 604 shows a device model of catheter 502 with the two electrodes 512 located at the device model tip of the sheath 550. In the real-time visualization, catheter 502 appears to jump from one exposed electrode 512 to two exposed electrodes 512.

[0102] exist Figure 6E In the middle, catheter 402 from Figure 6D The position shown extends further from the sheath tip 450, but since only two electrodes 412 are exposed, the associated visualization 605 shows a device model of the catheter 502 with the two electrodes 512 located at the device model tip of the sheath 550.

[0103] exist Figure 6F In the visualization, the third electrode 412 on catheter 402 is exposed beneath the sheath 404, and the associated visualization 606 shows a device model of catheter 502 with the three electrodes 512 located at the tip of the device model of sheath 550. In the real-time visualization, catheter 502 appears to jump from two exposed electrodes 512 to three exposed electrodes 512.

[0104] The user experience is improved if the visualization of the device model of the conduit assembly 500 at 312 is constrained to represent the actual physical conduit assembly 400, and the movement of the device model of the conduit element is smoothly presented and represents physical movement.

[0105] Figure 7A process 700 is shown at 310 of process 300 for longitudinally adjusting a first position of a first catheter element and a second position of a second catheter element. Process 700 can be applied to a catheter assembly including coaxially arranged catheter elements (such as a first catheter element and a second catheter element). The first catheter element (such as a sheath) forms an elongated lumen defining a longitudinal axis, and the second catheter element (such as an ablation catheter) is disposed within the lumen. The first and second catheter elements are movable relative to each other along the longitudinal axis. The first catheter element includes a first tracking sensor configured to generate a first electrical signal, and the second catheter element includes a second tracking sensor configured to generate a second electrical signal. The tracking sensor may include a tracking electrode or a combination of a magnetic tracking sensor and a tracking electrode for exposure relative to the sheath, such as via a sheath detection mechanism. A controller (such as controller 200) is configured at 702 to generate a first position of the first catheter element based on the first electrical signal and a second position of the second catheter element based on the second electrical signal. In response to detected longitudinal movement of the second catheter element relative to the first catheter element along the longitudinal axis, the controller at 704 applies historical corrections to the first and second positions based on previously determined first and second position vectors to obtain initially corrected first and second positions. In response to detected longitudinal movement of the second catheter element relative to the first catheter element along the longitudinal axis, the controller at 706 applies longitudinal adjustments to the initially corrected first and second positions based on constraints applied to the detected longitudinal movement. As part of generating visualization at 312, the controller at 708 generates an anatomical map of the organ for the electrophysiological procedure, including visualization of the catheter assembly with longitudinal adjustments.

[0106] Figure 8 The representation of the first position vector and the second position vector or correction vector 800 is shown in conjunction with the representation of the device model catheter assembly 500, which is due to... Figure 5B The catheter components 402 and 404 are constructed for independent tracking prior to application process 300. As described above, the physical catheter assembly 400 is as follows: Figure 5A As shown, and Figure 5B and Figure 8The illustration shows that, prior to application procedure 300, the device model of catheter 502 is laterally displaced from the device model of sheath 504 under deviation. In this example, the correction vector 800 is located in three-dimensional space and extends from the tip of the device model of sheath 550 in three-dimensional space to the tip of the device model of catheter 540 in three-dimensional space. In one example, the correction vector 800 may be stored in the controller's memory 204 as a previously determined set of coordinates for the correction vector 800. Other data may be stored along with the correction vector 800, such as parameters of the electrophysiological procedure. For example, the correction vector 800 may be included along with parameters such as: time or elapsed time in the electrophysiological procedure, position relative to an anatomical structure or the anatomical position of the correction vector 800, the associated time period of the respiratory cycle of the correction vector 800, temperature, and other parameters. In one example, for each instance of longitudinal movement of sheath 404 relative to catheter 402 detected during the electrophysiological procedure, the correction vector 800 may be generated by the controller 200 and stored in memory 204. For example, for each instance where the sheath 404 exposes or covers the electrode 412 on the catheter 402, a correction vector 800 can be generated and stored, based on independent parameters (such as sheath detection) related to the exposure of the electrode relative to the sheath during an electrophysiological procedure.

[0107] Figure 9 A correction map 900 is shown, representing all correction vectors 910 in three-dimensional space 902 during an electrophysiological procedure, where the sheath is corrected to align with the catheter. For example, correction vectors 910 may represent all previously determined correction vectors for the electrophysiological procedure. In this example, the three-dimensional space is indicated via Cartesian coordinates 904, 906, 908 relative to a reference of the EAM system 50. For example, correction map 900 may be overlaid on an anatomical diagram of the heart, and each correction vector 800 of the plurality of correction vectors 910 may correspond to a location of the heart where the sheath has been corrected to align with the catheter with high confidence in both the transverse and longitudinal directions. Thus, a subset of correction vectors can be determined based on the anatomical location of the catheter assembly 400. When each correction vector 800 is associated with parameters of the electrophysiological procedure, such as time or elapsed time, a subset of correction vectors can be determined based on physiological parameters. In the example shown, the first subset of the correction vector 920 is based on a first time period (such as a more recent time period in an electrophysiological procedure); the second subset of the correction vector 930 is based on a second time period (such as the furthest time period in an electrophysiological procedure); and the third subset of the correction vector 940 is based on a third time period (such as an intermediate time period in an electrophysiological procedure).

[0108] At 704, the controller applies historical corrections to the first and second positions based on previously determined first and second position vectors to obtain initially corrected first and second positions. In one example, the previously determined first and second position vectors are based on a single correction vector 800 among a plurality of correction vectors 910. For example, the single correction vector on which the previously determined first and second position vectors are based could be a correction vector stored at a first time or a correction vector stored at a most recent time. This correction vector is applied to determine the historical corrections to the first and second positions. In another example, the previously determined first and second position vectors are based on a combination of correction vectors 800 among a plurality of correction vectors 910. For example, the combination of correction vectors 800 could be based on all correction vectors 910 in the correction diagram 900. In yet another case, the previously determined first and second position vectors are based on parameters of the electrophysiological procedure, such as all or part of the correction vectors at a particular anatomical location, or all or part of the correction vectors within a particular time period, or a combination of parameters, such as all or part of the correction vectors at a particular anatomical location (such as the location closest to the current location of catheter assembly 400) and all or part of the correction vectors at a particular time period (such as the most recent time period). Examples of combining or merging correction vectors to obtain a previously determined first and second position vector may include averaging the vectors or applying a weighted average to the vectors, such as applying more weight to the correction vector of the most recent time and less weight to the correction vector of an earlier time.

[0109] In this example, the historical correction based on the previously determined first and second position vectors at 704 is an estimate of the translation correction. This estimate is based on one or more prior correction vectors 800, such as those associated with the first and second positions of the conduit element. At 704, applying the historical correction to the first and second positions generates a device model with the initial corrections for the first and second positions.

[0110] Then, the device model of the catheter element with the initially corrected first and second positions is subjected to the aforementioned lateral alignment and longitudinal adjustment with respect to process 300. For example, the device model of the catheter element with the initially corrected first and second positions is corrected using translation, rotation, shape deformation, sheath detection, or other constraints such as those applied to detected longitudinal movements to provide longitudinal adjustment in process 300. In some cases, the generation of the initially corrected first and second positions of the device model will create an accurate representation of the physical position of the catheter element, and no further constraints are imposed during sampling. The initially corrected first and second positions of the device model are generated based on the application of historical corrections to the previously determined first and second position vectors, thereby providing motion smoothing.

[0111] Figure 10 An example flowchart 1000 of process 700 is shown. At each sampling 1002, such as at each sampling period in process 700, a determination is made regarding whether a high confidence level exists for the correction, such as at 1004 whether the number of exposed electrodes 412 determined from independent parameters (such as sheath detection) has changed compared to the previous sampling. If the number of exposed electrodes 412 has not changed at 1004, then at 1006, a historical correction based on previously determined first and second position vectors is applied to the first and second positions of the first and second catheter elements. For example, at 1006, a previously determined first and second position vector based on one or more correction vectors 800 among a plurality of correction vectors 910 is applied to generate a device model with initial corrected first and second positions. Subsequently, at 1008, based on the constraints described with respect to process 300, a longitudinal adjustment is applied to the device model at the initially corrected first and second positions.

[0112] If the number of exposed electrodes 412 changes at 1004, the previously determined first and second position vectors are updated at 1010 with a new correction vector 800. Furthermore, the correction map can be updated when the number of exposed electrodes changes by one, or whenever the calculated correction has high confidence. Additionally, the correction map can be understood as providing only partial correction, depending on the context, such as the proximity of the components in the chamber to the spatial location where the correction map can be updated. Subsequently, at 1006, historical corrections based on the updated previously determined first and second position vectors are applied to the first and second positions of the first and second catheter elements. At 1008, translation corrections are applied to the device model at the initially corrected first and second positions, based on the constraints described with respect to process 300.

[0113] Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of this disclosure. For example, while the embodiments described above relate to specific features, the scope of this disclosure also includes embodiments with different combinations of features and embodiments that do not include all of the described features. Therefore, the scope of this disclosure is intended to cover all such alternatives, modifications, and variations, and all equivalents thereof, as falling within the scope of the claims.

Claims

1. A system for electrophysiological procedures, the system comprising: A catheter assembly comprising a plurality of coaxially arranged catheter elements, the plurality of catheter elements including a first catheter element and a second catheter element, the first catheter element forming an elongated lumen defining a longitudinal axis, and the second catheter element disposed within the lumen, the first catheter element and the second catheter element being movable relative to each other along the longitudinal axis, wherein the first catheter element includes a first tracking sensor configured to generate a first electrical signal, and the second catheter element includes a second tracking sensor configured to generate a second electrical signal; and The controller is configured as follows: A first position of the first catheter element is generated based on the first electrical signal, and a second position of the second catheter element is generated based on the second electrical signal; In response to the detected longitudinal movement of the second catheter element relative to the first catheter element along the longitudinal axis: Historical corrections are applied to the first and second positions based on previously determined first and second position vectors to obtain the first and second positions with initial corrections. Based on the constraint imposed on the detected longitudinal movement, longitudinal adjustment is applied to the first and second positions of the initial correction; and An anatomical diagram of the organ for which the electrophysiological program is generated, including visualization of the catheter assembly with the longitudinal adjustment.

2. The system according to claim 1, wherein, The controller is configured to update the previously determined first and second position vectors in response to detected longitudinal movement of the second catheter element along the longitudinal axis relative to the first catheter element.

3. The system according to claim 2, wherein, The updated previously determined first and second position vectors are based on multiple previously determined first and second position vectors.

4. The system according to any one of claims 2 and 3, wherein, The update of the previously determined first and second position vectors is based on the parameters of the electrophysiological program.

5. The system according to any one of claims 2-4, wherein, The update of the previously determined first and second position vectors is based on the time period of the electrophysiological procedure.

6. The system according to any one of claims 2-5, wherein, The update of the previously determined first and second position vectors is based on the anatomical location of the electrophysiological procedure.

7. The system according to any one of claims 2-6, wherein, The update of the previously determined first and second position vectors is based on multiple parameters of the electrophysiological program.

8. The system according to any one of claims 1-7, wherein, The controller is configured to laterally align the first position with the second position based on lateral and rotational shifts determined from the first position and the second position.

9. The system according to claim 8, wherein, The first catheter position includes a first position and a first tangent in space, and the second catheter position includes a second position and a second tangent in space, wherein the first position and the first tangent are laterally aligned with the second position and the second tangent based on lateral offset and rotational deflection determined from the first tangent and the second tangent.

10. The system according to any one of claims 1-9, wherein, The controller is configured to track the first catheter element via impedance tracking and the second catheter element via magnetic tracking.

11. The system according to any one of claims 8-10, wherein, The controller is configured to laterally align the second position to the first position.

12. The system according to any one of claims 1-11, wherein, The controller is configured to apply the longitudinal adjustment to the second position relative to the first position.

13. The system according to any one of claims 1-12, wherein, The detected longitudinal movement of the second catheter element along the longitudinal axis relative to the first catheter element is based on an independent parameter that detects the relationship between the sheath and the electrodes on the catheter.

14. The system according to claim 13, wherein, The independent parameters include the sheath detection mechanism.

15. The system according to any one of claims 1-13, wherein, The first catheter element includes a catheter sheath.

16. A system for electrophysiological procedures, the system comprising: A catheter assembly comprising a plurality of coaxially arranged catheter elements, the plurality of catheter elements including a first catheter element and a second catheter element, the first catheter element forming an elongated lumen defining a longitudinal axis, and the second catheter element disposed within the lumen, the first catheter element and the second catheter element being movable relative to each other along the longitudinal axis, wherein the first catheter element includes a first tracking sensor configured to generate a first electrical signal, and the second catheter element includes a second tracking sensor configured to generate a second electrical signal; and The controller is configured as follows: A first position of the first catheter element is generated based on the first electrical signal, and a second position of the second catheter element is generated based on the second electrical signal; In response to the detected longitudinal movement of the second catheter element relative to the first catheter element along the longitudinal axis: Historical corrections are applied to the first and second positions based on previously determined first and second position vectors to obtain the first and second positions with initial corrections. Based on the constraint imposed on the detected longitudinal movement, longitudinal adjustment is applied to the first and second positions of the initial correction; and An anatomical diagram of the organ for which the electrophysiological program is generated, including visualization of the catheter assembly with the longitudinal adjustment.

17. The system according to claim 16, wherein, The controller is configured to update the previously determined first and second position vectors in response to detected longitudinal movement of the second catheter element along the longitudinal axis relative to the first catheter element.

18. The system according to claim 17, wherein, The updated previously determined first and second position vectors are based on multiple previously determined first and second position vectors.

19. The system according to claim 17, wherein, The update of the previously determined first and second position vectors is based on the parameters of the electrophysiological program.

20. The system according to claim 17, wherein, The update of the previously determined first and second position vectors is based on the time period of the electrophysiological procedure.

21. The system according to claim 17, wherein, The update of the previously determined first and second position vectors is based on the anatomical location of the electrophysiological procedure.

22. The system according to claim 17, wherein, The update of the previously determined first and second position vectors is based on multiple parameters of the electrophysiological program.

23. The system according to claim 16, wherein, The controller is configured to laterally align the first position with the second position based on lateral and rotational shifts determined from the first position and the second position.

24. The system according to claim 23, wherein, The first catheter position includes a first position and a first tangent in space, and the second catheter position includes a second position and a second tangent in space, wherein the first position and the first tangent are laterally aligned with the second position and the second tangent based on lateral offset and rotational deflection determined from the first tangent and the second tangent.

25. The system according to claim 16, wherein, The controller is configured to track the first catheter element via impedance tracking and the second catheter element via magnetic tracking.

26. The system according to claim 16, wherein, The controller is configured to laterally align the second position to the first position.

27. The system according to claim 16, wherein, The controller is configured to apply the longitudinal adjustment to the second position relative to the first position.

28. The system according to claim 16, wherein, The detected longitudinal movement of the second catheter element along the longitudinal axis relative to the first catheter element is based on an independent parameter that detects the relationship between the sheath and the electrodes on the catheter.

29. The system according to claim 28, wherein, The independent parameters include the sheath detection mechanism.

30. The system according to claim 16, wherein, The first catheter element includes a catheter sheath.

31. The system according to claim 16, wherein, The second catheter element includes an ablation catheter.

32. A system for electrophysiological procedures, the system comprising: A catheter assembly comprising a plurality of coaxially arranged catheter elements, the plurality of catheter elements including a first catheter element and a second catheter element, the first catheter element forming an elongated lumen defining a longitudinal axis, and the second catheter element disposed within the lumen, the first catheter element and the second catheter element being movable relative to each other along the longitudinal axis, wherein the first catheter element includes a first tracking sensor configured to generate a first electrical signal, and the second catheter element includes a second tracking sensor configured to generate a second electrical signal; and The controller is configured as follows: A first position of the first catheter element is generated based on the first electrical signal, and a second position of the second catheter element is generated based on the second electrical signal; In response to the detected longitudinal movement of the second catheter element relative to the first catheter element along the longitudinal axis based on sheath detection: Historical corrections are applied to the first and second positions based on previously determined first and second position vectors to obtain the first and second positions with initial corrections. Based on the constraint imposed on the detected longitudinal movement, longitudinal adjustment is applied to the first and second positions of the initial correction; and An anatomical diagram of the organ for which the electrophysiological program is generated, including visualization of the catheter assembly with the longitudinal adjustment.

33. The system according to claim 32, wherein, The controller is configured to update the previously determined first position vector and second position vector in response to a detected longitudinal movement of the second catheter element along the longitudinal axis relative to the first catheter element, wherein the updated previously determined first position vector and second position vector are based on a plurality of previously determined first position vectors and second position vectors.

34. A system for electrophysiological procedures, the system comprising: A catheter assembly comprising a plurality of coaxially arranged catheter elements, the plurality of catheter elements including a first catheter element and a second catheter element, the first catheter element forming an elongated lumen defining a longitudinal axis, and the second catheter element disposed within the lumen, the first catheter element and the second catheter element being movable relative to each other along the longitudinal axis, wherein the first catheter element includes a first tracking sensor configured to generate a first electrical signal, and the second catheter element includes a second tracking sensor configured to generate a second electrical signal; and The controller is configured as follows: The first catheter element is tracked via impedance tracking, and the second catheter element is tracked via magnetic tracking; A first position of the first catheter element is generated based on the first electrical signal, and a second position of the second catheter element is generated based on the second electrical signal; In response to the detected longitudinal movement of the second catheter element relative to the first catheter element along the longitudinal axis based on sheath detection: Based on the previously determined first and second position vectors, historical corrections are applied to the first and second positions to obtain the first and second positions with initial corrections. Based on the constraint imposed on the detected longitudinal movement, longitudinal adjustment is applied to the first and second positions of the initial correction; and An anatomical diagram of the organ for which the electrophysiological program is generated, including visualization of the catheter assembly with the longitudinal adjustment.

35. The system according to claim 34, wherein, The controller is configured to apply the longitudinal adjustment to the second position relative to the first position.

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