Managing medical device equipment through online magnetic calibration of catheters

Abstract

The invention is entitled "Managing medical device equipment through online magnetic calibration of catheters." The invention provides a method for calibrating a medical device. The method is implemented by a calibration engine executed by one or more processors. The method includes capturing, by one or more components of a catheter, one or more voltage measurements, estimating calibration data based on the one or more voltage measurements, and outputting the calibration data to the catheter.

Description

Technical Field

[0001] This invention relates to medical devices and equipment. More specifically, this invention relates to managing medical devices and equipment through online magnetic calibration of catheters. Background Technology

[0002] Currently, as part of the manufacturing process, catheters are calibrated to ensure accurate visualization and navigation within the patient's body. During calibration, the catheter is placed in the center of a calibration chamber, such that three orthogonal fields are applied. The catheter's sensors acquire voltage measurements, and the orientation and sensitivity of each sensor are determined based on the applied three orthogonal fields. The orientation and sensitivity are stored in the catheter's memory (e.g., a read / write memory component such as an EEPROM). Currently, there is no technology for on-site or field-based catheter calibration without the use of expensive and bulky calibration chambers locally. Furthermore, due to this lack of technology, catheter aging issues (e.g., calibration parameters changing over time) remain unresolved. Summary of the Invention

[0003] According to one exemplary embodiment, a method is provided. The method is implemented by a calibration engine executed by one or more processors. The method includes capturing one or more voltage measurements by one or more components of a catheter, estimating calibration data based on the one or more voltage measurements, and outputting the calibration data to the catheter.

[0004] According to one or more embodiments, the above exemplary method implementations can be implemented as devices, systems, and / or computer program products. Attached Figure Description

[0005] A more detailed understanding can be obtained through the following specific embodiments provided by way of example and in conjunction with the accompanying drawings, wherein similar reference numerals in the drawings indicate similar elements, and wherein:

[0006] Figure 1 An illustration shows an exemplary system that can implement one or more features of the subject matter of this disclosure according to one or more embodiments;

[0007] Figure 2 A block diagram of an exemplary system according to one or more embodiments is shown;

[0008] Figure 3 An exemplary method according to one or more implementation schemes is shown;

[0009] Figure 4 Exemplary methods according to one or more implementation schemes are shown; and

[0010] Figure 5 A table is shown according to one or more exemplary embodiments. Detailed Implementation

[0011] This document discloses a system and method for managing medical device equipment via online magnetic calibration of catheters. The system and method can be implemented as an online magnetic calibration system driven by a calibration engine. In this manner, the calibration engine and online magnetic calibration system specifically utilize and transform the medical device equipment to enable / enable online magnetic calibration of catheters that are currently unavailable or cannot be performed by cardiologists and medical personnel. The calibration engine can be processor-executable code or software, which necessarily originates from the processing operations performed by the medical device equipment (e.g., the online magnetic calibration system) and the processing hardware of the medical device equipment. For ease of explanation, the calibration engine is described herein in relation to mapping the heart; however, any anatomical structure, body part, organ, or portion thereof can be a target for mapping when operating the calibration engine described herein.

[0012] One or more advantages, technological effects, and / or beneficial effects of calibration engines and online magnetic calibration systems include addressing the need for in-situ or field catheter calibration by generating automated calibration during catheter navigation within the patient's body. It should be noted that the term "online" refers to the ability to calibrate during the actual procedure. It should also be noted that the term "automated calibration" refers to the ability to adjust catheter sensitivity and / or orientation during the actual procedure. Furthermore, calibration engines and online magnetic calibration systems eliminate the need for a local calibration lab and avoid catheter aging issues, as the catheter is used immediately after calibration (e.g., not months or years later). Additionally, calibration engines and online magnetic calibration systems can be adapted and implemented within existing surgical / mapping systems and work with any catheter.

[0013] Figure 1 This is a diagram of an exemplary system (e.g., a medical device apparatus) shown as System 100, wherein one or more features of the subject matter herein may be implemented according to one or more embodiments. All or part of System 100 may be used to collect information (e.g., biometric data and / or training datasets) and / or to implement a calibration engine 101 as described herein. As shown, System 100 includes a probe 105 having a catheter 110 (including at least one electrode 111), a shaft 112, a sheath 113, and a manipulator 114. As shown, System 100 also includes a physician 115 (or a medical professional or clinician), a heart 120, a patient 125, and a bed 130 (or table). Note that illustrations 140 and 150 show the heart 120 and catheter 110 in more detail. As shown, System 100 also includes a console 160 (including one or more processors 161 and memory 162) and a display 165. It should also be noted that each element and / or item of System 100 represents one or more of that element and / or item. Figure 1 The example of system 100 shown can be modified to implement the embodiments disclosed herein. The embodiments disclosed herein can be applied similarly using other system components and setups. Additionally, system 100 may include additional components such as elements for sensing electrical activity, wired or wireless connectors, processing and display devices, etc.

[0014] System 100 can be used to detect, diagnose, and / or treat cardiac conditions (e.g., using calibration engine 101). Cardiac conditions such as arrhythmias have always been common and dangerous medical conditions, especially among the elderly. Additionally, System 100 can be used as a surgical system (e.g., one sold by Biosense Webster). As part of a system, this surgical system is configured to acquire biometric data (e.g., anatomical and electrical measurements of a patient's organ, such as heart 120) and to perform cardiac ablation procedures. More specifically, treatment of cardiac conditions such as arrhythmias often requires detailed mapping of cardiac tissue, chambers, veins, arteries, and / or electrical pathways. For example, a prerequisite for successful catheter ablation (as described herein) is that the cause of the arrhythmia is accurately located within a chamber of heart 120. Such localization can be accomplished via an electrophysiological study, during which a mapping catheter (e.g., catheter 110) introduced into the chamber of heart 120 is used to spatially resolve potentials. This electrophysiological study (so-called electroanatomical mapping) thus provides 3D mapping data that can be displayed on a monitor. In many cases, mapping and therapeutic functions (e.g., ablation) are provided by a single catheter or a group of catheters, such that the mapping catheter also operates as a therapeutic (e.g., ablation) catheter. In this case, the calibration engine 101 can be directly stored and executed by the conduit 110 as an online magnetic calibration algorithm.

[0015] In patients with normal sinus rhythm (NSR) (e.g., patient 125), the heart, including the atria, ventricles, and excitatory conduction tissues (e.g., heart 120), is electrically stimulated to beat in a synchronized, patterned manner. It should be noted that this electrical stimulation can be detected as intracardiac electrocardiogram (ICECG) data, etc.

[0016] In patients with arrhythmias (e.g., atrial fibrillation or aFib) (e.g., patient 125), abnormal areas of cardiac tissue do not follow the synchronous beating cycle associated with normal conduction tissue, in contrast to patients with NSR. Instead, the abnormal areas of cardiac tissue conduct abnormally to adjacent tissues, thus disrupting the cardiac cycle into an asynchronous rhythm. It should be noted that this asynchronous rhythm can also be detected in ICECG data. Such aberrant conduction is previously known to occur in various regions of the heart 120, such as the sinoatrial (SA) node region, the conduction pathway along the atrioventricular (AV) node, or in the myocardial tissue forming the walls of the ventricles and atria. Other conditions exist (such as fibrillation) where the pattern of abnormal conduction tissue leads to a reentrant path, causing the chambers to beat in a regular pattern, which can be multiples of the sinus rhythm.

[0017] To support the detection, diagnosis, and / or treatment of cardiac conditions by system 100, probe 105 can be guided by physician 115 to the heart 120 of patient 125 lying on bed 130. For example, physician 115 can insert shaft 112 through sheath 113 while manipulating the distal end of shaft 112 using manipulator 114 near the proximal end of catheter 110 and / or deflecting from sheath 113. As shown in illustration 140, basket catheter 110 can be fitted at the distal end of shaft 112. Basket catheter 110 can be inserted through sheath 113 in a collapsed state and then deployed within heart 120.

[0018] Typically, a catheter 110 containing an electrical sensor (e.g., at least one electrode 111) at or near its distal tip is advanced to a point in the heart 120, the sensor contacts the tissue, and data is acquired at that point, thereby measuring the electrical activity at that point in the heart 120. A disadvantage of using a catheter containing only a single distal tip electrode to map the heart chambers is the long time required to acquire data point-by-point at the necessary number of points for a detailed map of the overall chambers. Therefore, multi-electrode catheters (e.g., catheter 110) have been developed to simultaneously measure electrical activity at multiple points in the heart chambers.

[0019] A catheter 110, which may include at least one electrode 111 and a catheter needle coupled to its body, may be configured to acquire biometric data, such as electrical signals from an in vivo organ (e.g., heart 120), and / or ablate a tissue region thereof (e.g., a ventricle of heart 120). It should be noted that electrode 111 refers to any similar element or component, such as a tracking coil, piezoelectric transducer, electrode, axial sensor, or combination of elements configured to ablate a tissue region or acquire biometric data. According to one or more embodiments, catheter 110 may include one or more position sensors for determining trajectory information. Trajectory information can be used to infer motion characteristics, such as tissue contractility.

[0020] Biometric data (e.g., patient biometrics, patient data, or patient biometric data) may include one or more of the following: Local Activation Time (LAT), electrical activity, topology, bipolar mapping, reference activity, ventricular activity, dominant frequency, impedance, etc. LAT can be a time point corresponding to a threshold activity of local activation, calculated based on a normalized initial starting point. Electrical activity can be any applicable electrical signal that can be measured based on one or more thresholds and can be sensed and / or amplified based on signal-to-noise ratio and / or other filters. Topology can correspond to the physical structure of a body part or a portion of a body part, and can correspond to variations in the physical structure relative to different parts of the body part or different body parts. Dominant frequency can be a frequency or frequency range that is prevalent in a part of a body part and can differ in different parts of the same body part. For example, the dominant frequency of the PV of the heart can be different from the dominant frequency of the right atrium of the same heart. Impedance can be a resistance measurement at a given region of a body part.

[0021] Examples of biometric data include, but are not limited to, patient identification data, ICECG data, bipolar intracardiac reference signals, anatomical and electrical measurements, trajectory information, body surface (BS) ECG data, historical data, brain biometrics, blood pressure data, ultrasound signals, radio signals, audio signals, two-dimensional or three-dimensional image data, blood glucose data, and temperature data. Biometric data can generally be used to monitor, diagnose, and treat any number of various diseases, such as cardiovascular diseases (e.g., arrhythmias, cardiomyopathy, and coronary artery disease) and autoimmune diseases (e.g., type I and type II diabetes). It should be noted that BSECG data may include data and signals collected from electrodes on the patient's surface, ICECG data may include data and signals collected from electrodes inside the patient's body, and ablation data may include data and signals collected from ablated tissue. Additionally, BSECG data, ICECG data, and ablation data, along with catheter electrode location data, can be derived from one or more protocol records.

[0022] For example, catheter 110 may be used with electrodes 111 to achieve intravascular ultrasound and / or MRI catheter insertion for imaging of the heart 120 (e.g., acquiring and processing biometric data). Illustration 150 shows catheter 110 in a magnified view within a cardiac chamber of heart 120. Although catheter 110 is shown as a pointed catheter, it should be understood that any shape including one or more electrodes 111 may be used to implement the exemplary embodiments disclosed herein.

[0023] Examples of catheter 110 include, but are not limited to, linear catheters with multiple electrodes, balloon catheters including electrodes distributed on multiple ridges shaping the balloon, lasso or loop catheters with multiple electrodes, or any other suitable shape. The linear catheter may be fully or partially elastic, allowing it to twist, bend, and / or otherwise change its shape based on received signals and / or based on external forces (e.g., cardiac tissue) applied to the linear catheter. The balloon catheter may be designed such that its electrodes remain in close contact with the endocardial surface when deployed into a patient. For example, the balloon catheter may be inserted into a lumen such as a pulmonary vein (PV). The balloon catheter may be inserted into the PV in a constricted state such that the balloon catheter does not occupy its maximum volume when inserted into the PV. The balloon catheter may inflate within the PV such that those electrodes on the balloon catheter contact the entire circular segment of the PV. Such contact with the entire circular segment of the PV or any other lumen enables effective imaging and / or ablation.

[0024] According to other examples, body patches and / or BS electrodes or one or more other transmitters may also be positioned on or near the body of patient 125. A catheter 110 having one or more electrodes 111 may be positioned within the body (e.g., within the heart 120), and the position of the catheter 110 may be determined by system 100 based on signals transmitted and received between one or more electrodes 111 of the catheter 110 and the body patch and / or BS electrodes (e.g., transmitters). For example, one or more transmitters (e.g., nine transmitters) may be positioned outside the patient 125, such as under bed 130, and provide a magnetic field that induces one or more voltage measurements for detection in one or more parts through the catheter 110. Additionally, the electrodes 111 may sense biometric data from within the patient 125, such as within the heart 120 (e.g., the electrodes 111 sense the electrical potential of tissue in real time). The biometric data may be correlated with the determined position of the catheter 110, enabling the display of a rendering of the patient's body part (e.g., the heart 120) and the display of biometric data overlaid on the shape of the body part.

[0025] Probe 105 and other items of system 100 can be connected to console 160. Console 160 may include any computing device employing an online magnetic calibration algorithm (which may be included in and / or represented as calibration engine 101). According to an exemplary embodiment, console 160 includes one or more processors 161 (any computing hardware) and memory 162 (any non-transitory tangible medium), wherein the one or more processors 161 execute computer instructions relative to calibration engine 101, and memory 162 stores these instructions for execution by the one or more processors 161. For example, console 160 may be configured to receive and process biometric data and determine whether a given tissue region is conductive. In some embodiments, console 160 may be further programmed by calibration engine 101 (in software) to perform the functions of capturing one or more voltage measurements by one or more components of the catheter, estimating calibration data based on the one or more voltage measurements, and outputting the calibration data to the catheter. According to one or more embodiments, calibration engine 101 may be located external to console 160 and may be located, for example, in catheter 110, in an external device, in a mobile device, in a cloud-based device, or may be a stand-alone processor. In this respect, the calibration engine 101 can be transmitted / downloaded electronically via a network.

[0026] In one example, console 160 may be any computing device (such as a general-purpose computer) as described herein, including software (e.g., calibration engine 101) and / or hardware (e.g., processor 161 and memory 162), having suitable front-end and interface circuitry for transmitting and receiving signals to and from probe 105, and for other components of the control system 100. For example, the front-end and interface circuitry may include an input / output (I / O) communication interface that enables console 160 to receive signals from and / or transmit signals to at least one electrode 111. Console 160 may include a real-time noise reduction circuitry system typically configured as a field-programmable gate array (FPGA), followed by an analog-to-digital (A / D) ECG or electrocardiograph or electromyography (EMG) signal conversion integrated circuit. Console 160 may pass signals from A / D or EMG circuitry to another processor and / or may be programmed to perform one or more functions disclosed herein.

[0027] Display 165 may be any electronic device for the visual presentation of biometric data, and is connected to console 160. According to an exemplary embodiment, during a procedure, console 160 may facilitate the presentation of a body part rendering to physician 115 on display 165, and the storage of data representing the body part rendering in memory 162. For example, a mapping depicting motion characteristics may be rendered / constructed based on trajectory information sampled at a sufficient number of points in the heart 120. As an example, display 165 may include a touchscreen that can be configured to accept input from medical professional 115 in addition to presenting the body part rendering.

[0028] In some implementations, physician 115 may use one or more input devices (such as a touchpad, mouse, keyboard, gesture recognition device, etc.) to manipulate the rendering of components and / or body parts of system 100. For example, the input device may be used to change the position of catheter 110, causing the rendering to be updated. It should be noted that display 165 may be located in the same location or in a remote location, such as in a separate hospital or a separate network of healthcare providers.

[0029] According to one or more embodiments, system 100 may also use ultrasound, computed tomography (CT), MRI, or other medical imaging techniques utilizing catheter 110 or other medical devices to acquire biometric data. For example, system 100 may use one or more catheters 110 or other sensors to acquire ECG data and / or anatomical and electrical measurements (e.g., biometric data) of heart 120. More specifically, console 160 may be connected via cable to BS electrodes comprising an adhesive skin patch attached to patient 125. BS electrodes may acquire / generate biometric data in the form of BSECG data. For example, processor 161 may determine the positional coordinates of catheter 110 within the body part (e.g., heart 120) of patient 125. These positional coordinates may be based on impedance or electromagnetic field measured between the BS electrodes and electrodes 111 or other electromagnetic components of catheter 110. Additionally or alternatively, a positioning pad that generates a magnetic field for navigation may be located on the surface of bed 130 and may be detachable from bed 130. Biometric data may be transmitted to console 160 and stored in memory 162. Alternatively or otherwise, biometric data can be transmitted to a server, which may be local or remote, using a network as described elsewhere herein.

[0030] According to one or more exemplary embodiments, catheter 110 may be configured to ablate a tissue region of a cardiac chamber of heart 120. Illustration 150 shows catheter 110 in an enlarged view within a cardiac chamber of heart 120. For example, ablation electrodes such as at least one electrode 111 may be configured to deliver energy to a tissue region of an organ (e.g., heart 120) in vivo. The energy may be thermal and may cause damage to the tissue region by starting from the surface of the tissue region and extending into the thickness of the tissue region. Biometric data relative to the ablation protocol (e.g., ablated tissue, ablation location, etc.) may be considered ablation data.

[0031] According to one example, a multi-electrode catheter (e.g., catheter 110) can be advanced into the chamber of heart 120 relative to the acquisition of biometric data. Anterior-posterior (AP) and lateral fluorescein maps can be obtained to establish the position and orientation of each electrode. ECG can be recorded relative to a time reference (such as the P wave in a sinus rhythm from a BSECG and / or the start of a signal from electrode 111 of catheter 110 placed in the coronary sinus) from each of the electrodes 111 in contact with the cardiac surface. As further disclosed herein, the system can distinguish which electrodes record electrical activity from those that do not record electrical activity due to their lack of close proximity to the endocardial wall. After recording the initial ECG, the catheter can be repositioned, and fluorescein maps and ECG can be recorded again. An electrical mapping (e.g., via cardiac mapping) can then be constructed iteratively according to the above process.

[0032] Cardiac mapping can be achieved using one or more techniques. Generally, mapping of cardiac regions, such as the cardiac area of ​​heart 120, tissues, veins, arteries, and / or electrical pathways, can lead to the identification of problem areas such as scar tissue, sources of arrhythmia (e.g., telopolarization), healthy areas, etc. Cardiac regions can be mapped so that a visual rendering of the mapped cardiac region can be provided using a display, as further disclosed herein. Additionally, cardiac mapping (which is an example of cardiac imaging) can include mapping based on one or more modalities, such as, but not limited to, LAT, local activation velocity, electrical activity, topology, bipolar mapping, dominant frequency, or impedance. A catheter inserted into the patient's body (e.g., catheter 110) can be used to capture data corresponding to multiple modalities (e.g., biometric data), and this data can be provided simultaneously or at different times for rendering based on the physician 115's corresponding settings and / or preferences.

[0033] As an example of the first technique, cardiac mapping can be achieved by sensing the electrical properties of cardiac tissue (e.g., LAT) at a precise location within the heart 120. The corresponding data (e.g., biometric data) can be acquired via one or more catheters (e.g., catheter 110) advanced into the heart 1120 and having electrical and position sensors (e.g., electrode 111) at its distal tip. As a specific example, position and electrical activity can initially be measured at approximately 10 to approximately 20 points on the inner surface of the heart 120. These data points are typically sufficient to generate a preliminary reconstruction or mapping map of satisfactory quality of the cardiac surface. The preliminary map can be combined with data taken from additional points to produce a more comprehensive mapping map of cardiac electrical activity. In clinical settings, it is not uncommon to accumulate data at 100 or more sites (e.g., several thousand) to generate a detailed and comprehensive mapping map of cardiac chamber electrical activity. The resulting detailed map can then serve as a basis for determining therapeutic actions, such as tissue ablation as described herein, to alter the propagation of cardiac electrical activity and restore normal heart rhythm.

[0034] Additionally, cardiac mapping can be generated based on the detection of intracardiac electrical potential fields (e.g., examples of ICECG data and / or bipolar intracardiac reference signals). Non-contact techniques for simultaneously acquiring large amounts of cardiac electrical information can be implemented. For example, a catheter type with a distal end portion can be provided with a series of sensor electrodes distributed on its surface and connected to an insulating electrical conductor for connection to a signal sensing and processing device. The size and shape of the end portion can allow the electrodes to be substantially spaced from the walls of the heart chambers. The intracardiac electrical potential field can be detected during a single heartbeat. According to one example, the sensor electrodes can be distributed on a series of circumferences located in planes spaced apart from each other. These planes can be perpendicular to the long axis of the end portion of the catheter. At least two additional electrodes can be provided adjacent to each other at the ends of the long axis of the end portion. As a more specific example, the catheter can include four circumferences, with eight electrodes spaced equally angularly on each circumference. Thus, in this specific embodiment, the catheter can include at least 34 electrodes (32 circumferential electrodes and 2 end electrodes). As another more specific example, the catheter may include other multi-spindle catheters, such as those with five flexible branches, eight radial splines, or parallel spline spatula type (e.g., any of which may have a total of 42 electrodes).

[0035] As an example of electrophysiological mapping or cardiac mapping, an electrophysiological cardiac mapping system and technique based on a non-contact, non-expanding multi-electrode catheter (e.g., catheter 110) can be implemented. ECG can be obtained using one or more catheters 110 having multiple electrodes (e.g., such as between 42 and 122 electrodes). According to this specific implementation, an understanding of the relative geometry of the probe and the endocardium can be obtained through independent imaging modalities such as transesophageal echocardiography. After independent imaging, non-contact electrodes can be used to measure the cardiac surface potential and construct a mapping map from it (e.g., in some cases, using a bipolar intracardiac reference signal). The technique may include the following steps (after the independent imaging step): (a) measuring the potential using multiple electrodes disposed on a probe positioned in the heart 120; (b) determining the geometric relationship between the probe surface and the endocardial surface and / or other references; (c) generating a coefficient matrix representing the geometric relationship between the probe surface and the endocardial surface; and (d) determining the endocardial potential based on the electrode potentials and the coefficient matrix.

[0036] According to another example of electrical mapping or cardiac mapping, techniques and devices for mapping the potential distribution of cardiac chambers can be implemented. An intracardiac multi-electrode mapping catheter assembly can be inserted into the heart 120. The mapping catheter (e.g., catheter 110) assembly may include a multi-electrode array or mating reference catheter having one or more integral reference electrodes (e.g., one or more electrodes 111). Examples of mapping catheters include, but are not limited to, uniaxial sensor (SAS) catheters, biaxial sensor (DAS) catheters, and triaxial sensor (TAS) catheters.

[0037] According to one or more exemplary embodiments, the electrodes can be deployed in the form of a substantially spherical array, spatially referenced to points on the endocardial surface via a reference electrode or a reference catheter in contact with the endocardial surface. A preferred electrode array catheter may carry multiple individual electrode sites (e.g., at least 24). Furthermore, this exemplary technique is achieved by understanding the location of each electrode site in the array and understanding the cardiac geometry. These locations are preferably determined using techniques of impedance plethysmography.

[0038] Given electrical mapping or cardiac mapping, and according to another example, catheter 110 may be a cardiac mapping catheter assembly that may include an electrode array defining a plurality of electrode sites. The cardiac mapping catheter assembly may also include a lumen to receive a reference catheter having a distal tip electrode assembly that can be used to probe the heart wall. The cardiac mapping catheter assembly may include a braid of insulating wire (e.g., having 24 to 64 wires in the braid), and each wire may be used to form an electrode site. The cardiac mapping catheter assembly can be readily positioned in the heart 120 for acquiring electrical activity information from a first set of non-contact electrode sites and / or a second set of contact electrode sites.

[0039] Furthermore, according to another example, the catheter 110, which enables mapping electrophysiological activity within the heart, may include a distal tip adapted to deliver stimulation pulses for pacing the heart or an ablation electrode for ablating tissue in contact with the tip. The catheter 110 may also include at least one pair of orthogonal electrodes to generate a differential signal indicative of local cardiac electrical activity adjacent to the orthogonal electrodes.

[0040] As described herein, system 100 can be used to detect, diagnose, and / or treat heart conditions. In exemplary operation, a process for measuring electrophysiological data within the heart chambers can be implemented by system 100. The process may include, in part, positioning a set of active and passive electrodes within the heart 120, supplying current to the active electrodes to generate an electric field within the heart chambers, and measuring the electric field at the sites of the passive electrodes. The passive electrodes are contained in an array positioned on an inflatable balloon of a balloon catheter. In a preferred embodiment, the array reportedly has 60 to 64 electrodes.

[0041] As another exemplary operation, cardiac mapping can be performed by system 100 using one or more ultrasound transducers. The ultrasound transducers can be inserted into a patient's heart 120 and can collect multiple ultrasound slices (e.g., two-dimensional or three-dimensional slices) at various locations and orientations within the heart 120. The location and orientation of a given ultrasound transducer can be known, and the collected ultrasound slices can be stored so that they can be displayed at a later time. One or more ultrasound slices can be displayed corresponding to the location of probe 105 (e.g., a treatment catheter shown as catheter 110) at a later time, and probe 105 can overlay one or more ultrasound slices.

[0042] Given System 100, it should be noted that arrhythmias, including atrial arrhythmias, can be multi-wave reentrant, characterized by multiple asynchronous loops of electrical impulses dispersed around the atrial chambers and typically self-propagating (e.g., another example from ICECG data). Alternatively, or in addition to multi-wave reentrant arrhythmias, arrhythmias can also have a focal source, such as when isolated areas of tissue within the atria beat spontaneously in a rapid, repetitive manner (e.g., another example from ICECG data). Ventricular tachycardia (V-tach or VT) is a tachycardia or rapid rhythm originating in one ventricle. This is a potentially life-threatening arrhythmia because it can lead to ventricular fibrillation and sudden cardiac death.

[0043] For example, aFib occurs when the normal electrical impulses generated by the sinoatrial node (e.g., another example from ICECG data) are overwhelmed by disordered electrical impulses originating from the atrial veins and PV, causing irregular impulses to travel to the ventricles. Irregular heartbeats are generated and can last from minutes to weeks, or even years. aFib is typically a chronic condition with a small increased risk of death, usually due to stroke. The first line of treatment for aFib is medication to slow the heart rate or restore a normal rhythm. Additionally, people with aFib are often given anticoagulants to prevent them from having a stroke. The use of such anticoagulants carries the inherent risk of internal bleeding. For some patients, medication is insufficient, and their aFib is considered drug-resistant, meaning it cannot be treated with standard medical interventions. Synchronized cardioversion can also be used to convert aFib to a normal rhythm. Alternatively, patients with aFib can be treated with catheter ablation.

[0044] Catheter-based ablation therapy may include mapping the electrical properties of cardiac tissue (particularly the endocardium and cardiac volume) and selectively ablating cardiac tissue by applying energy. Electrical mapping or cardiac mapping (e.g., implemented by any electrophysiological cardiac mapping system and techniques described herein) includes creating a mapping map of the potential propagating along cardiac tissue (e.g., a voltage mapping map) or a mapping map of the time of arrival (LAT) to various tissue locations (e.g., a LAT mapping map). Electrical mapping or cardiac mapping (e.g., cardiac mapping) can be used to detect localized cardiac tissue dysfunction. Ablation, such as cardiac mapping-based ablation, can stop or alter unwanted electrical signals propagating from one part of the heart 120 to another.

[0045] The ablation process disrupts unwanted electrical pathways by creating a non-conductive ablation focus. Various forms of energy delivery for creating ablation focuses have been disclosed, including the use of microwave, laser, and more commonly radiofrequency energy to create conduction blocks along the cardiac tissue wall. Another example of energy delivery technology includes irreversible electroporation (IRE), which provides a high electric field that damages cell membranes. In a two-step procedure (e.g., mapping followed by ablation), electrical activity at various points within the heart 120 is typically sensed and measured by advancing a catheter 110 containing one or more electrical sensors (or electrodes 111) into the heart 120 and acquiring / obtaining data (e.g., generally such as biometric data, or specifically such as ECG data) at multiple points. This ECG data is then used to select the endocardial target region to be ablated.

[0046] As clinicians treat increasingly challenging conditions such as atrial fibrillation and ventricular tachycardia, cardiac ablation and other cardiac electrophysiological procedures become increasingly complex. Treatment of complex arrhythmias may rely solely on the use of three-dimensional (3D) mapping systems to reconstruct the anatomy of the cardiac chambers of interest. In this regard, the calibration engine 101 employed in the system 100 of this paper generally manipulates and evaluates biometric data or specifically ECG data and implements online calibration algorithms to generate improved tissue data that enables more accurate diagnoses, images, scans, and / or mappings for the treatment of abnormal heartbeats or arrhythmias. For example, cardiologists rely on software such as those produced by Biosense Webster, Inc. (Diamond Bar, Calif.). The 33D mapping system includes a complex fragmented atrial electrocardiography (CFAE) module to generate and analyze ECG data. The calibration engine 101 of system 100 enhances the software to generate and analyze improved biometric data, which further provides multiple pieces of information about the electrophysiological characteristics of the heart 120 (including scar tissue), representing the cardiac matrix (anatomy and function) of aFib.

[0047] Therefore, system 100 can realize 3D mapping systems such as A 33D mapping system is used to locate the potential arrhythmogenic matrix of cardiomyopathy in the detection of abnormal ECGs. The matrix associated with these cardiomyopathy is related to the presence of fragmented and prolonged ECGs in the endocardial and / or epicardial layers of the ventricular chambers (right and left). For example, low-voltage or intermediate-voltage regions can exhibit fragmented and prolonged ECG activity. Furthermore, during sinus rhythm, low-voltage or intermediate-voltage regions may correspond to key isthmuses identified during sustained and tissue ventricular arrhythmias (e.g., applicable to intolerance ventricular tachycardia, and in the atria). Generally, abnormal tissue is characterized by low-voltage ECGs. However, initial clinical experience in endocardial-epicardial mapping indicates that low-voltage regions are not always present as the sole arrhythmogenic mechanism in such patients. In fact, low-voltage or intermediate-voltage regions can exhibit fragmented and prolonged ECG activity during sinus rhythm, which corresponds to key isthmuses identified during sustained and tissue ventricular arrhythmias, e.g., only applicable to intolerance ventricular tachycardia. Furthermore, in many cases, fragmented and prolonged ECG activity is observed in areas displaying normal or near-normal voltage amplitudes (>1-1.5 mV). While the latter areas can be assessed based on voltage amplitude, they cannot be considered normal based on intracardiac signals and thus represent the true arrhythmogenic matrix. 3D mapping can localize the arrhythmogenic matrix on the endocardial and / or epicardial layers of the right / left ventricle, which can vary in distribution depending on the extent of the primary disease.

[0048] As another exemplary operation, cardiac mapping can be performed by system 100 using one or more multi-electrode catheters (e.g., catheter 110). The multi-electrode catheter is used to stimulate and map electrical activity in the heart 120 and to ablate sites of abnormal electrical activity. In use, the multi-electrode catheter is inserted into a major vein or artery, such as the femoral vein, and subsequently guided into the chamber of the heart 120 of interest. A typical ablation procedure involves inserting catheter 110, having at least one electrode 111 at its distal end, into the heart chamber. A reference electrode is provided either by adhesive to the patient's skin or by a second catheter positioned in or near the heart, or selected from one of catheter 110 or another electrode 111. Radiofrequency (RF) current is applied to the tip electrode 111 of the ablation catheter 110, and the current flows to the reference electrode through a medium surrounding it (e.g., blood and tissue). The current distribution depends on the amount of contact between the electrode surface and the tissue compared to blood, which has a higher conductivity than tissue. Heating of the tissue occurs due to its resistance. The tissue is sufficiently heated to destroy the cells in the heart tissue, resulting in the formation of a non-conductive ablation foci within the heart tissue. During this process, heating of the tip electrode 111 also occurs due to conduction from the heated tissue to the electrode itself. If the electrode temperature becomes sufficiently high, possibly above 60°C, a thin, transparent coating of dehydrated hemoglobin can form on the surface of electrode 111. If the temperature continues to rise, this dehydrated layer can become increasingly thick, causing blood clotting on the electrode surface. Because the dehydrated biomaterial has a higher resistance than endocardial tissue, the impedance to the flow of electrical energy into the tissue also increases. If the impedance increases sufficiently, an impedance rise occurs, and the catheter 110 must be removed from the body and the tip electrode 111 cleaned.

[0049] Now go to Figure 2 A diagram is shown of a system 200 according to one or more exemplary embodiments, wherein one or more features of the subject matter of this disclosure may be implemented. Relative to patient 202 (e.g., Figure 1 (Example of patient 125), system 200 includes device 204, local computing device 206, remote computing system 208, first network 210, and second network 211. Additionally, device 204 may include biometric sensor 221 (e.g., ...). Figure 1 Examples include conduit 110, processor 222, user input (UI) sensor 223, memory 224, and transceiver 225. Note that for ease of explanation and brevity, Figure 1 The calibration engine 101 in Figure 2 It is reused.

[0050] According to one implementation scheme, device 204 can be Figure 1An example of system 100, wherein device 204 may include both internal and external components. According to another embodiment, device 204 may be an external device including an attachable patch (e.g., attached to the patient's skin). According to another embodiment, device 204 may be internal to the patient 202 (e.g., subcutaneously implanted), wherein device 204 may be inserted into the patient 202 via any suitable means, including oral injection, surgical insertion via vein or artery, endoscopic procedure, or laparoscopic procedure. According to one embodiment, although in Figure 2 A single device 204 is shown, but the exemplary system may include multiple devices.

[0051] Therefore, device 204, local computing device 206, and / or remote computing system 208 can be programmed to execute computer instructions relative to calibration engine 101. For example, memory 223 stores these instructions for execution by processor 222, enabling device 204 to receive and process biometric data via biometric sensor 201. Thus, processor 222 and memory 223 represent the processor and memory of local computing device 206 and / or remote computing system 208.

[0052] Device 204, local computing device 206, and / or remote computing system 208 can be any combination of software and / or hardware that individually or jointly stores, executes, and implements the calibration engine 101 and its functions. Additionally, device 204, local computing device 206, and / or remote computing system 208 can be an electronic computer framework, including and / or employing any number and combination of computing devices and networks utilizing various communication technologies, as described herein. Device 204, local computing device 206, and / or remote computing system 208 can be easily scaled, expanded, and modularized, with the ability to change for different services or reconfigure some features independently of others.

[0053] Networks 210 and 211 can be wired networks, wireless networks, or include one or more wired and wireless networks. According to one implementation, network 210 is an example of a short-range network (e.g., a local area network (LAN) or a personal area network (PAN)). Information can be transmitted between device 204 and local computing device 206 via network 210 using any of a variety of short-range wireless communication protocols such as Bluetooth, Wi-Fi, Zigbee, Z-Wave, Near Field Communication (NFC), ultra-band, Zigbee, or infrared (IR)). Additionally, network 211 is an example of one or more of the following: an intranet, a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), a direct connection or a series of connections, a cellular telephone network, or any other network or medium capable of facilitating communication between local computing device 206 and remote computing system 208. Information can be transmitted via network 211 using any of a variety of long-range wireless communication protocols such as TCP / IP, HTTP, 3G, 4G / LTE, or 5G / new radio. It should be noted that for either network 210 or 211, wired connections can be implemented using Ethernet, Universal Serial Bus (USB), RJ-11, or any other wired and wireless connections can be implemented using Wi-Fi, WiMAX, Bluetooth, infrared, cellular networks, satellite, or any other wireless connection method.

[0054] In operation, device 204 can continuously or periodically acquire, monitor, store, and process biometric data associated with patient 202, and transmit this biometric data via network 210. Additionally, device 204, local computing device 206, and / or remote computing system 208 communicate via networks 210 and 211 (e.g., local computing device 206 may be configured as a gateway between device 204 and remote computing system 208). For example, device 204 may be… Figure 1 The system 100 is an example configured to communicate with a local computing device 206 via network 210. The local computing device 206 may be, for example, a fixed / standalone device, a base station, a desktop / laptop computer, a smartphone, a smartwatch, a tablet, or other device configured to communicate with other devices via networks 211 and 210. It may also be a physical server implemented on or connected to network 211, or a public cloud computing provider (e.g., Amazon Web Services) of network 211. The remote computing system 208 of the virtual server in the system can be configured to communicate with the local computing device 206 via network 211. Therefore, biometric data associated with the patient 202 can be transmitted throughout the system 200.

[0055] The elements of device 204 will now be described. Biometric sensor 221 may include, for example, one or more transducers configured to convert one or more environmental conditions into electrical signals, enabling the observation / acquisition / collection of different types of biometric data. For example, biometric sensor 221 may include one or more of the following: electrodes (e.g., Figure 1 Electrodes 111), temperature sensors (e.g., thermocouples), blood pressure sensors, blood glucose sensors, blood oxygen sensors, pH sensors, accelerometers, and microphones.

[0056] When executing calibration engine 101, processor 222 can be configured to receive, process, and manage biometric data acquired by biometric sensor 221, and transmit the biometric data to memory 224 via transceiver 225 for storage and / or across network 210. Biometric data from one or more other devices 204 can also be received by processor 222 via transceiver 225. As described in more detail below, processor 222 can be configured to selectively respond to different tap patterns (e.g., single or double taps) received from UI sensor 223, enabling different tasks of the patch (e.g., data acquisition, storage, or transmission) to be activated based on the detected pattern. In some embodiments, processor 222 can generate audible feedback relative to the detected gesture.

[0057] UI sensor 223 includes, for example, a piezoelectric or capacitive sensor configured to receive user input such as a tap or touch. For example, in response to a patient 202 tapping or touching the surface of device 204, UI sensor 223 can be controlled to achieve capacitive connection. Gesture recognition can be achieved via any of a variety of capacitance types, such as resistive capacitance, surface capacitance, projected capacitance, surface acoustic waves, piezoelectricity, and infrared touch. The capacitive sensor can be positioned over a small area or along the length of a surface, such that a tap or touch on the surface activates the monitoring device.

[0058] Memory 224 is any non-transitory tangible medium, such as magnetic memory, optical memory, or electronic memory (e.g., any suitable volatile and / or non-volatile memory, such as random access memory or hard disk drive). Memory 224 stores computer instructions for execution by processor 222.

[0059] Transceiver 225 may include a separate transmitter and a separate receiver. Alternatively, transceiver 225 may include a transmitter and receiver integrated into a single device.

[0060] In operation, device 204 uses calibration engine 101 to observe / obtain biometric data of patient 202 via biometric sensor 221, stores the biometric data in memory, and shares the biometric data across system 200 via transceiver 225.

[0061] Now go to Figure 3 This illustrates an embodiment based on one or more exemplary implementations (e.g., by...). Figure 1 and / or Figure 2 Method 300 is performed by calibration engine 101. Method 300 addresses the need for in-situ or field catheter calibration by generating automated calibration during current clinical procedures and during the navigation of catheter 110 within patient 125 (e.g., across the entire mapping volume).

[0062] The method begins at box 320, where calibration engine 101 retrieves first calibration data stored in the memory of catheter 110 during use (e.g., in the current clinical procedure). The first calibration data may be stored during catheter preparation or during the last calibration activity, in either case prior to the current clinical procedure.

[0063] Typically, calibration data includes one or more parameters, such as sensitivity and angle (e.g., orientation). Sensitivity may be the coil sensitivity of each component of catheter 110 (e.g., the sensitivity of each sensing coil, which is related to the volts / gauss produced by that sensing coil). Angle may be the angle between pairs of components of catheter 110.

[0064] At box 340, calibration engine 101 captures one or more voltage measurements from catheter 110. Each of these voltage measurements may be captured by one or more components of catheter 110. More specifically, the one or more voltage measurements may be voltage readings acquired at one or more points by each component or a specific group of components of catheter 110 (e.g., electrodes 111, sensors, etc.) as catheter 110 navigates within patient 125 (e.g., across the entire mapping volume). According to embodiments, the one or more voltage measurements may originate from one or more transmitters. In this respect, the one or more voltage measurements are known to system 100.

[0065] At box 360, calibration engine 101 estimates second calibration data based on the one or more voltage measurements. According to one or more embodiments, calibration engine 101 uses each voltage reading acquired by each component to determine the real-time sensitivity and real-time angle of the second calibration data.

[0066] At box 380, calibration engine 101 outputs second calibration data to conduit 110, such that the second calibration data is applied to conduit 110 (e.g., rewriting the first calibration data in the memory of conduit 110). In this way, the first calibration data at box 320 can be modified by the second calibration data estimated in box 360 (e.g., real-time sensitivity and real-time angle).

[0067] At arrow 390, method 300 loops. In this respect, calibration engine 101 can repeat method 300 to further improve or adjust any stored calibrations. That is, if any online calibration data (estimated at box 360) differs from the stored calibration data (called at box 320), calibration engine 101 can use the online calibration data to obtain better performance for conduit 110 (e.g., the conduit may function differently over time due to aging).

[0068] Now go to Figure 4 This illustrates an embodiment based on one or more exemplary implementations (e.g., by...). Figure 1 and / or Figure 2 The calibration engine 101 performs method 400. This method begins at block 410, where the calibration engine 101 captures one or more voltage measurements at the current location during clinical procedures. According to one or more embodiments, the calibration engine 101 collects measurements (e.g., voltage readings) from one or more points in space (each current location of the catheter 110 during advancement) at the sensing coil of the catheter 110, which can then be used by the calibration engine 101 to estimate parameters.

[0069] In an exemplary embodiment, system 100 may be an electrophysiological system (e.g., The system may be part of the electrophysiological system. Additionally, catheter 110 may include a SAS sensor. The SAS sensor includes an axial sensor (sensing coil) with a calibration parameter (e.g., coil sensitivity). Each sensing coil can collect voltage measurements from each of nine (in this specific embodiment) transmitters at a single point. That is, the total number (T) of measurements is equal to the number (M) of transmitters calibrated for each axial sensor (S) at each point (X) (e.g., (M*S)*X = T). At maximum collection, the SAS sensor collects nine measurements at a single point (e.g., (9*1)*1 = 9).

[0070] In addition, conduit 110 may include a DAS sensor. The DAS sensor includes two axial sensors. The DAS sensor has three calibration parameters (e.g., the sensitivity of the two coils and the angle between them). In a system with nine transmitters, the DAS sensor collects eighteen voltage measurements at a single point (e.g., (9*2)*1 = 18).

[0071] Furthermore, the conduit 110 may include a TAS sensor. The TAS sensor includes three axial sensors. The TAS sensor has six calibration parameters (e.g., three coil sensitivities and three angles between coil pairs). Thus, a total of twenty-seven voltage measurements are captured at a single point (when nine transmitters are present) (e.g., (9*3)*1 = 27).

[0072] At decision box 420, calibration engine 101 determines whether additional voltage measurements are needed for calibration. If additional voltage measurements are needed for calibration, method 400 proceeds to box 430 (as indicated by the "Yes" arrow). Method 400 then proceeds through box 410 to decision box 420. If additional voltage measurements are not needed for calibration, method 400 proceeds to box 460 (as indicated by the "No" arrow).

[0073] To determine whether additional voltage measurements are needed, the conduit engine 101 can utilize a minimum threshold number associated with the type of conduit used and compare this minimum threshold number with the number of one or more voltage measurements captured. In this way, the calibration engine 110 and system 100 can maintain a rule that the number of voltage measurements is not less than the number of unknown parameters. Furthermore, the number of coils and / or transmitters drives the minimum threshold number.

[0074] According to one or more embodiments, calibration engine 101 can calibrate the SAS, DAS, and / or TAS sensors of conduit 110. For calibrating a SAS sensor (i.e., one axial sensor), the minimum threshold number is six voltage measurements from six transmitters to ensure that calibration engine 101 has sufficient measurements to estimate calibration data from a single point. For calibrating a DAS sensor (i.e., two axial sensors), the minimum threshold number is ten voltage measurements from five transmitters (e.g., 10 = 5 * 2) to ensure that calibration engine 101 has sufficient measurements to estimate calibration data from a single point. For calibrating a TAS sensor (i.e., three axial sensors), the minimum threshold number is twelve voltage measurements from four transmitters (e.g., 12 = 4 * 3) to ensure that calibration engine 101 has sufficient measurements to estimate calibration data from a single point. If calibration engine 110 and system 100 collect data from more than a single point, the minimum threshold number can be four transmitters for the DAS sensor and three transmitters for the TAS sensor. Therefore, one or more technical effects, advantages and / or beneficial effects of calibration engine 110 and system 100 are that they can be adapted to existing surgical / mapping systems to work with any catheter.

[0075] At box 430, catheter 110 is advanced along the path to change the current position to the next position. Note that if calibration engine 101 is calibrating along this path, catheter 110 may move between (e.g., predetermined) positions. Depending on the implementation, this path may be approximately the size of the expected working volume (e.g., a scan from one side of the heart chamber to the other).

[0076] According to one or more implementation schemes, additional points can be collected within a short period of time when catheter 110 is guided or advanced. For example... Figure 5 As shown in Table 500, if conduit 110 is navigated and 10 points are collected, 270 voltage measurements are obtained. Similarly, if conduit 110 is navigated and 100 points are collected, 2700 voltage measurements are obtained.

[0077] At box 460, calibration engine 101 estimates calibration data (e.g., at least twelve parameters) based on one or more voltage measurements. Examples of parameters include, but are not limited to, position, orientation angle, sensitivity of each sensor, and mutual angles between each sensor.

[0078] According to one or more embodiments, at least twelve parameters may include six position / orientation parameters and six calibration parameters for the TAS sensor. It should be noted that a TAS sensor typically includes three coil sensitivities and three angles between three pairs of coils (e.g., six calibration parameters), as discussed herein.

[0079] like Figure 5 As shown in Table 500, if 270 voltage measurements are acquired, sixty position / orientation parameters and six calibration parameters can be estimated (e.g., 66 parameters). Similarly, if 2700 voltage measurements are acquired, 600 position / orientation parameters and six calibration parameters can be estimated (e.g., 606 parameters). It should be noted that each of the position / orientation parameters depends on the TAS position, and therefore the number of position / orientation parameters increases to correspond to the number of positions (from boxes 410 and 420). It should also be noted that each of the calibration parameters does not depend on the TAS position, and therefore the number of calibration parameters remains six. One or more advantages, technical effects, and / or beneficial effects of the calibration engine 101 and the online magnetic calibration system include the ability to estimate calibration data from several points across the entire calibration volume, as this estimation is more robust relative to local field distortion.

[0080] For example, for a TAS sensor, it's important to note that a total of 27 measurements are acquired at a single point. It's also important to note that catheter calibration improves when more points are collected to increase the number of measurements (e.g., the more measurements acquired during the procedure, the more robust the estimations used for calibration data will be). As shown in Table 500, for 10 points, 270 measurements can be used to estimate 66 parameters, 6 of which are calibration parameters. For 100 points, 2700 measurements can be used to estimate 606 parameters (again, 6 of which are calibration parameters). The estimated calibration parameters can then be combined with previously known geometric relationships between the sensor and the catheter, ultimately providing the catheter's position and orientation during the navigation procedure. Therefore, the resulting position can be accurate, even if not better than the calibration provided by the current calibration chamber.

[0081] At box 480, calibration engine 101 applies calibration data to catheter 110. Additionally, according to one or more embodiments, the estimated calibration parameters can then be combined with a known prior relationship between the sensor and catheter 110. For example, the TAS sensor is aligned with axis 112.

[0082] According to one or more embodiments, a calibration engine 101 within the magnetic positioning system utilizes a mathematical model (e.g., a set of formulas) that includes multiple inputs. These multiple inputs may include, but are not limited to, a magnetic field model (e.g., magnetic field values ​​at each point in the calibration volume), calibration data as described herein, and sensor positions and orientations in the calibration volume. The model output is a prediction of the voltage value generated by each sensing coil. When the calibration engine 101 operates in normal mode, the magnetic field is known because it is stored in the field generator's memory, the calibration data is known because it is stored in the conduit memory, and the sensor positions and orientations are estimated by finding position and orientation values ​​such that the model-predicted voltage best matches the actual measured voltage. When the calibration engine 101 operates in calibration mode, the magnetic field is known because it is stored in the field generator's memory, and the calibration data, as well as the sensor positions and orientations, are estimated by finding calibration data values ​​and position and orientation values ​​such that the model-predicted voltage best matches the actual measured voltage. Furthermore, in calibration mode, the position estimation does not need to be as robust as in normal mode (because the calibration engine 101 has more parameters to estimate). However, by using multiple points, calibration engine 101 can robustly estimate calibration data (e.g., because it is independent of the selected points). It should be noted that calibration engine 101 can begin in calibration mode until calibration data is estimated and can switch to normal mode (e.g., using any estimated calibration data instead of the stored data).

[0083] Additionally, calibration engine 101 can utilize calibration data to determine the lifespan of catheter 110 and to determine electrode / coil degradation based on previous data. For example, calibration engine 101 can set and check a threshold for the difference between stored calibration parameters and online estimated calibration parameters to prevent catheter 110 from being used (e.g., by deactivating catheter 110) if it is excessively degraded (e.g., exceeding the threshold). When catheter 110 is still usable (e.g., although exceeding the threshold), calibration engine 101 and system 100 can notify physician 115 (or medical professional or clinician) based on the threshold, and physician 115 can decide to use catheter 110 anyway (e.g., based on the knowledge that use does not pose an excessive risk).

[0084] The flowcharts and block diagrams in the accompanying drawings illustrate the architecture, functionality, and operation of possible specific implementations of systems, methods, and computer program products according to various embodiments of the invention. In this regard, each block in a flowchart or block diagram may represent a module, segment, or portion of instructions comprising one or more executable instructions for implementing a specified logical function. In some alternative implementations, the functions indicated in the blocks may not occur in the order shown in the drawings. For example, depending on the function involved, two consecutively shown blocks may actually be executed substantially simultaneously, or the blocks may sometimes be executed in reverse order. It should also be noted that each block in the block diagrams and / or flowcharts, and combinations of blocks in the block diagrams and / or flowcharts, may be implemented by a system based on dedicated hardware that performs the specified function or action, or by a combination of dedicated hardware and computer instructions.

[0085] While features and elements have been specifically described above, those skilled in the art will recognize that each feature or element can be used alone or in any combination with other features and elements. Furthermore, the methods described herein can be implemented in a computer program, software, or firmware incorporated in a computer-readable medium for execution by a computer or processor. As used herein, a computer-readable medium should not be construed as a transient signal itself, such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through waveguides or other transmission media (e.g., light pulses passing through fiber optic cables), or electrical signals transmitted through wires.

[0086] Examples of computer-readable media include electronic signals (transmitted via wired or wireless connections) and computer-readable storage media. Examples of computer-readable storage media include, but are not limited to, registers, cache memory, semiconductor memory devices, magnetic media such as internal hard disks and removable disks, magneto-optical media, optical media such as optical discs (CDs) and digital versatile discs (DVDs), random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), static random access memory (SRAM), and memory sticks. A processor associated with software can be used to implement a radio frequency transceiver used in a terminal, base station, or any host computer.

[0087] It should be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, unless the context clearly indicates otherwise, the singular forms “an,” “a,” and “the / described” include plural references. It should also be understood that the terms “comprising” and / or “including”, when used in this specification, specify the presence of the stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0088] The descriptions of various embodiments herein are presented for illustrative purposes and are not intended to be exhaustive or limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is chosen to best explain the principles of the embodiments, their practical application or improvement relative to commercially available technologies, or to enable others skilled in the art to understand the disclosed embodiments.

Claims

1. A method for calibrating a medical device, the method comprising: A calibration engine executed by one or more processors calls the first calibration data stored in memory; The calibration engine captures one or more voltage measurements of one or more components of the catheter, wherein the one or more components include at least one axial sensor in the calibration volume; The calibration engine uses a mathematical model to predict the voltage value generated by the at least one axial sensor, wherein the input to the mathematical model includes a magnetic field model, which includes the magnetic field value at each point in the calibration volume; The calibration engine estimates the second calibration data based on the one or more voltage measurement results by finding calibration data values, as well as location and orientation values, that make the model-predicted voltage best match the actual measured voltage. as well as The calibration engine outputs the second calibration data to the conduit.

2. The method according to claim 1, wherein, The one or more voltage measurements include voltage readings obtained by each of the one or more components or a specific group of components.

3. The method according to claim 1, wherein, The first calibration data and / or the second calibration data include one or more parameters, including sensitivity and angle.

4. The method according to claim 3, wherein, The sensitivity includes the coil sensitivity of each of the one or more components of the catheter.

5. The method according to claim 3, wherein, The angle includes the angle between at least one pair of components of the conduit.

6. The method according to claim 1, wherein, The voltage measurements of the at least one axial sensor originate from at least three transmitters.

7. The method according to claim 1, wherein, The conduit includes at least one of a uniaxial sensor, a biaxial sensor, and a triaxial sensor.

8. The method according to claim 1, wherein, The first calibration data and / or the second calibration data include position / orientation and calibration parameters.

9. A system for calibrating a medical device, the system comprising: A memory that stores processor-executable code for calibrating the engine and first calibration data; One or more components of the catheter, wherein the one or more components include at least one axial sensor in the calibration volume; One or more processors, communicatively coupled to the memory, are configured to execute processor-executable code to cause the system to perform the following operations: The calibration engine retrieves the first calibration data; The calibration engine uses a mathematical model to predict the voltage value generated by the at least one axial sensor, wherein the input to the mathematical model includes a magnetic field model, which includes the magnetic field value at each point in the calibration volume; The calibration engine captures one or more voltage measurements from the at least one axial sensor; The calibration engine estimates second calibration data by finding calibration data values, as well as location and orientation values, so that the model-predicted voltage best matches the actual measured voltage, based on the one or more voltage measurement results. as well as The calibration engine outputs the second calibration data to the conduit.

10. The system according to claim 9, wherein, The one or more voltage measurements include voltage readings obtained by each of the one or more components or a specific group of components.

11. The system according to claim 10, wherein, As the catheter is navigated within the patient's body, voltage readings are acquired at one or more points.

12. The system according to claim 9, wherein, The first calibration data and / or the second calibration data include one or more parameters, including sensitivity and angle.

13. The system according to claim 12, wherein, The sensitivity includes the coil sensitivity of each of the one or more components of the catheter.

14. The system according to claim 12, wherein, The angle includes the angle between at least one pair of components of the conduit.

15. The system according to claim 9, wherein, The voltage measurements of the at least one axial sensor originate from at least three transmitters.

16. The system according to claim 9, wherein, The conduit includes at least one of a uniaxial sensor, a biaxial sensor, and a triaxial sensor.

17. The system according to claim 9, wherein, The first calibration data and / or the second calibration data include position / orientation and calibration parameters.

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