System and method for performing localization within a body

Abstract

This document provides systems and methods for performing localization in a patient.SOLUTION: A method for localization within a body includes providing at least one processor coupled to at least one data storage device, establishing and calibrating, by the at least one processor, a localization coordinate system within the body by executing a first localization mode, recalibrating, by the at least one processor, the localization coordinate system by executing a second localization mode, and localizing, by the at least one processor, a device within the localization coordinate system using the first localization mode and the second localization mode. The first localization mode may be an impedance-based localization mode and the second localization mode may be a magnetic-based localization mode, or vice versa.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is filed under the heading "Systems and Methods for Performing "Localization Within a Body" was held in June 2019. Priority is claimed to U.S. Provisional Patent Application No. 62 / 857,055, filed on April 4, 2014. No. 6,239,999, which is incorporated herein by reference in its entirety.

[0002] This application does not claim priority, but is incorporated herein by reference in its entirety. for Calculating Patient Information" , related to U.S. Provisional Application No. 62 / 757,961, filed November 9, 2018. No. 6,239,999, which is incorporated herein by reference.

[0003] This application does not claim priority, but is incorporated herein by reference in its entirety. The U.S. patent application, filed on May 8, 2018, entitled "Processing System" This application may be related to Provisional Application No. 62 / 668,659, which is incorporated herein by reference. To be incorporated.

[0004] This application does not claim priority, but is incorporated herein by reference in its entirety. ng Cardiac Conduction Patterns” in 2018. No. 62 / 619,897, filed January 21, 2003, and "System f or Identifying Cardiac Conduction Patter U.S. Provisional Application No. 62 / 668,647, filed May 8, 2018, entitled "NS" and the like, each of which is incorporated herein by reference.

[0005] This application does not claim priority, but is incorporated herein by reference in its entirety. The patent application was filed on October 11, 2017, under the title "Force Control" Patent Cooperation Treaty Application No. PCT / US2017 / 056064, which may be related to Patent Application No. PCT / US2017 / 056064 is an "Ablation System" The application was filed on October 11, 2016, under the title "m with Force Control" No. 62 / 406,748 filed on Dec. 1, 2002, and U.S. Provisional Application ... with Force Control" was filed on May 20, 2017. This application claims priority to U.S. Provisional Application No. 62 / 504,139, each of which is hereby incorporated by reference. are incorporated herein by reference.

[0006] This application does not claim priority, but is incorporated herein by reference in its entirety. Dynamic Display System and Method Possible related to U.S. Application No. 16 / 097,955, filed October 31, 2018 U.S. Application No. 16 / 097,955 is a "Cardiac Information on Dynamic Display System and Method" The application was filed on May 3, 2017, and is incorporated herein by reference in its entirety as International Publication No. 2017 / 192769. Patent Cooperation Treaty Application No. PCT / US2017 / 030915, published as a U.S. patent application. 371, and the application is filed in the national phase under Article 371. The "Cardiac Information Dynamic Display" A U.S. provisional patent application filed on May 3, 2016, entitled "System and Method" This application claims priority to application Ser. No. 62 / 331,351, each of which is incorporated herein by reference. To be incorporated.

[0007] This application does not claim priority, but is incorporated herein by reference in its entirety. d Methods of Medical Uses of Same,Includ ing Diagnostic and Treatment Uses for th U.S. Application No. 16 / 012, filed June 19, 2018, entitled "The Heart" 16 / 012,051, which is incorporated herein by reference. er,System and Methods of Medical Uses of Same,Including Diagnosis and Treatment The patent application was filed on February 20, 2015, entitled "Uses for the Heart." This is a continuation of U.S. Patent No. 10,004,459. The issue is "Catheter, System and Methods of Medica l Uses of Same,Including Diagnostic and Treatment Uses for the Heart” in August 2013 The application was filed on the 30th and published as International Publication No. 2014 / 036439. 371 of Patent Cooperation Treaty Application No. PCT / US2013 / 057579 The WO 2014 / 036439 pamphlet is based on the "Sys tem and Method for Diagnosing and Treati A U.S. patent filed on August 31, 2012, entitled "Inducing Heart Tissue" This application claims priority to Provisional Application No. 61 / 695,535, each of which is incorporated herein by reference. will be incorporated into

[0008] The present application does not claim priority, but r Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways” in 2015 May be related to U.S. Patent Application No. 14 / 762,944, filed July 23 , U.S. Patent Application No. 14 / 762,944 is entitled "Expandable Catheter Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways” The application was filed on the 7th of this month and published as International Publication No. 2014 / 124231. 371 of Patent Cooperation Treaty Application No. PCT / US2014 / 015261 The WO 2014 / 124231 pamphlet is based on the "Exp andable Catheter Assembly with Flexible Printed Circuit Board(PCB)Electrical Pat U.S. Provisional Patent Application No. 61 / 762, filed February 8, 2013, entitled "Hways" No. 363, each of which is incorporated herein by reference.

[0009] This application does not claim priority to, but is incorporated by reference in its entirety in "Method and Device for Determining and Presenting Surface C harge and Dipole Densities on Cardiac Wa U.S. Patent Application No. 16 / 014,377, filed June 21, 2018, entitled "Iron-Coated Electrode Compositions for Implantation of Fluorescent Microscopes," 0, and U.S. Patent Application No. 16 / 014,370 is entitled "Method and Device for Determining and Presenti ng Surface Charge and Dipole Densities o A U.S. patent filed on February 17, 2017, entitled "N Cardiac Walls" This is a continuation of U.S. Patent Application No. 15 / 435,763 The issue is titled "Method and Device for Determining and Presenting Surface Charge and Dipole De nsities on Cardiac Walls” on September 25, 2015. This is a continuation of U.S. Patent No. 9,610,024, which was filed in the United States. Issue 024 is "Method and Device for Determining and Presenting Surface Charge and Dipole "Densities on Cardiac Walls" November 2014 This is a continuation of U.S. Patent No. 9,167,982, filed on the 19th. No. 167,982 is "Method and Device for Determining ing and Presenting Surface Charge and Di "Polar Densities on Cardiac Walls" in 2014 U.S. Patent No. 8,918,158 (hereinafter the '158 patent) issued on December 23, Continuing application No. 158 is a "Method and Device for Dete rmining and Presenting Surface Charge an d Dipole Densities on Cardiac Walls" U.S. Patent No. 8,700,119 (hereinafter U.S. Patent No. '119) issued on April 15, 2014 Patent No. 119 is a continuation of the patent application "Method and Device for D etermining and Presenting Surface Charge and Dipole Densities on Cardiac Walls” No. 8,417,313 (hereinafter '313') issued on April 9, 2013, entitled No. 313 is a continuation of the "Method and Device for Determining and Presenting Surface Char ge and Dipole Densities on Cardiac Walls " filed on August 3, 2007, and is referred to as International Publication No. 2008 / 014629. PCT Application No. CH2007 / 000380, published as a patent application under 37 U.S.C. 1, and WO 2008 / 014629 is a national phase application Claiming priority from Swiss Patent Application No. 1251 / 06 filed on August 3, 2006 No. 6,299,133, each of which is incorporated herein by reference.

[0010] This application does not claim priority, but is incorporated herein by reference in its entirety. for the Geometric Determination of Elect rical Dipole Densities on the Cardiac Wa U.S. Patent Application No. 15 / 882,097, filed January 29, 2018, entitled "Iron-Coated Microwave Oven," No. 15 / 882,097, which is incorporated herein by reference, may be related to U.S. Patent Application No. 15 / 882,097, entitled "Device and Method for the Geometric Determinati on of Electrical Dipole Densities on the A patent application filed on December 25, 2016 entitled "Cardiac Wall" This is a continuation of U.S. Patent No. 9,913,589, which is a "Devi ce and Method for the Geometric Determin ation of Electrical Dipole Densities on The Cardiac Wall” filed on October 19, 2015 in the United States This is a continuation of U.S. Patent No. 9,504,395, which is a "D device and Method for the Geometric Deter mination of Electrical Dipole Densities on the Cardiac Wall" filed on July 19, 2013. This is a continuation of U.S. Patent No. 9,192,318, which is "Device and Method for the Geometric Det termination of Electrical Dipole Densitie 's on the Cardiac Wall' was published on August 20, 2013. and published as U.S. Patent No. 2010 / 0298690 (hereinafter the '690 publication). The 690 publication is a continuation of Patent No. 8,512,255 and is entitled "A Device and dMethod for the Geometric Determination of Electrical Dipole Densities on the C The application was filed on January 16, 2009, entitled "Gardiac Wall" and published in International Publication No. 200 Patent Cooperation Treaty Application No. PCT / IB20, published as Pamphlet No. 9 / 090547 09 / 000071, a national stage application under 371 of the U.S. Patent Act, and International Publication No. No. 2009 / 090547 is a Swiss patent application filed on January 17, 2008. This application claims priority to U.S. Patent Application No. 00068 / 08, each of which is incorporated herein by reference. be incorporated into the book.

[0011] This application does not claim priority, but is incorporated herein by reference in its entirety. for the Geometric Determination of Elect rical Dipole Densities on the Cardiac Wa No. 15 / 926,187, filed March 20, 2018, entitled "II. Potentially related, U.S. application Ser. No. 15 / 926,187 is entitled "Device and Method for the Geometric Determination f Electrical Dipole Densities on the Car U.S. Patent No. 9,968, filed August 8, 2017, entitled "Diac Wall" 268, and U.S. Patent No. 9,968,268 is a "Device and Method for the Geometric Determination of Electrical Dipole Densities on the Ca U.S. Patent No. 9,757, filed September 6, 2013, entitled "Rdiac Wall" ,044, and U.S. Patent No. 9,757,044 is a "Device and dMethod for the Geometric Determination of Electrical Dipole Densities on the C "ardiac Wall" in the pamphlet of International Publication No. 2012 / 122517 Patent Cooperation Treaty application PCT / US2012 / 02, published as (hereinafter '517) No. 8593 is a national stage application under 35 U.S.C. § 371, and No. 517 is a provisional application under U.S. Provisional Patent Application No. 6 No. 1 / 451,357, each of which is incorporated herein by reference. be incorporated into the book.

[0012] This application does not claim priority, but is incorporated herein by reference in its entirety. Electrode Pairs for a Catheter" in 2017 May be related to U.S. Design Patent Application No. 29 / 593,043, filed February 6th. and U.S. Design Patent Application No. 29 / 593,043 is a "Transducer-Elect Rode Pair for a Catheter" on December 2, 2013. This is a divisional application of U.S. Design Patent No. D782,686, which was filed in the same manner as U.S. Design Patent No. D78 No. 2,686 is "Catheter System and Methods of M edical Uses of Same,Including Diagnostic and Treatment Uses for the Heart” Patent Cooperation Treaty Application No. PCT / US2013 / 057579, filed August 30, 2013 No. 371, and Patent Cooperation Treaty Application No. PCT / U No. S2013 / 057579 is "System and Method for Dia "Gnosing and Treating Heart Tissue" Priority claimed from U.S. Provisional Patent Application No. 61 / 695,535, filed August 31, 2012 No. 6,239,593, which is incorporated herein by reference.

[0013] The present application does not claim priority, but r Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways” in 2015 May be related to U.S. Patent Application No. 14 / 762,944, filed July 23 , U.S. Patent Application No. 14 / 762,944 is entitled "Expandable Catheter Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways” Patent Cooperation Treaty Application No. PCT / US2014 / 015261, filed on April 7, National stage application under Section 371 of the US Patent Act, Patent Cooperation Treaty Application No. PCT / US2014 / 015261 is "Expandable Catheter Assembly w ith Flexible Printed Circuit Board(PCB)E The U.S. patent application, entitled "Patent Licensing and Medical Pathways," was filed on February 8, 2013. This application claims priority to Provisional Patent Application No. 61 / 762,363, which is incorporated herein by reference. be absorbed.

[0014] This application does not claim priority to, but is incorporated by reference in its entirety in its entirety. The patent application was filed on August 24, 2018, entitled "Intent Access Device." May be related to U.S. Patent Application No. 16 / 111,538, U.S. Patent Application No. 16 / No. 111,538 is "Gas-Elimination Patient Access U.S. Patent No. 10,071, filed on July 14, 2016, entitled "Device" 10,071,227 is a continuation of U.S. Patent No. 10,071,227, which is a "Gas-Elimination" "National Patient Access Device" in January 2015 Patent Cooperation Treaty Application No. PCT / US2015 / 11312, filed on the 14th, National stage application under Section 371, Patent Cooperation Treaty application PCT / US2015 / 11 Issue 312 is "Gas-Elimination Patient Access Development U.S. Provisional Patent Application No. 61 / 928,747, filed January 17, 2014, entitled "ICE" No. 04, which is incorporated herein by reference.

[0015] This application does not claim priority, but is incorporated herein by reference in its entirety. ser Interface System and Method” in 2016 This application may be related to U.S. Patent Application No. 15 / 128,563, filed September 23, 2015. and U.S. Patent Application No. 15 / 128,563 is entitled "Cardiac Analysis U ser Interface System and Method” in 2015 Patent Cooperation Treaty Application No. PCT / US2015 / 22187, filed March 24, 2015, U.S. National stage application under Section 371 of the Patent Act, Patent Cooperation Treaty application PCT / US2015 / 22187 issue is "Cardiac Analysis User Interface The patent application was filed on March 28, 2014, entitled "System and Method for Developing a Novel Electromagnetic Compatibility System ... This application claims priority to U.S. Provisional Patent Application No. 61 / 970,027, which is incorporated herein by reference. To be incorporated.

[0016] This application does not claim priority to, but is incorporated herein by reference in its entirety by reference to, "Devices and Methods s for Determination of Electrical Dipole Densities on a Cardiac Surface” in 2016 This application may be related to U.S. Patent Application No. 14 / 916,056, filed March 2, 2014. , U.S. Patent Application No. 14 / 916,056 is entitled "Devices and Methods for Determination of Electrical Dipole Densities on a Cardiac Surface” in 2014 Patent Cooperation Treaty application PCT / US2014 / 54942, filed September 10, This is a national stage application under Section 371 of the Patent Cooperation Treaty (PCT) application PCT / US2014 / No. 54942 is entitled "Devices and Methods for Determining ation of Electrical Dipole Densities on A U.S. patent application filed on September 13, 2013, entitled "A Cardiac Surface" This application claims priority from Provisional Patent Application No. 61 / 877,617, which is incorporated herein by reference. be absorbed.

[0017] This application does not claim priority, but is incorporated herein by reference in its entirety. m and Method Useful in the Acquisition a nd Analysis of Cardiac Information” Related U.S. Patent Application No. 15 / 569,457, filed October 26, 2017 US Patent Application No. 15 / 569,457 is entitled "Localization Standards for ystem and Method Useful in the Acquisiti on and Analysis of Cardiac Information” Patent Cooperation Treaty application PCT / US2016 / 03, filed May 13, 2016, entitled 2420, a national stage application under 371 of the U.S. Patent Act, and a Patent Cooperation Treaty application PC T / US2016 / 032420 is "Localization System and d Method Useful in the Acquisition and A 2015, titled "Analysis of Cardiac Information" This application claims priority to U.S. Provisional Patent Application No. 62 / 161,213, filed May 13, 2013. which is incorporated herein by reference.

[0018] This application does not claim priority thereto, but is incorporated herein by reference in its entirety. tion Test Tank and Testing System and Me U.S. Patent Application No. 15 / 569, filed October 25, 2017, entitled "Method" 231, and U.S. Patent Application No. 15 / 569,231 was filed in 2016. Patent Cooperation Treaty application PCT / US2016 / 031823, filed May 11, U.S. National stage application under Section 371 of the Patent Act, Patent Cooperation Treaty application PCT / US2016 / 031823 is "Cardiac Virtualization Test Ta nk and Testing System and Method” This application claims priority from U.S. Provisional Patent Application No. 62 / 160,501, filed May 12, 2005. , which is incorporated herein by reference.

[0019] This application does not claim priority thereto, but is incorporated herein by reference in its entirety. tion Test Tank and Testing System and Me U.S. Patent Application No. 15 / 569, filed October 25, 2017, entitled "Method" 185, which was filed in 2016. Patent Cooperation Treaty application PCT / US2016 / 032017, filed May 12, U.S. National stage application under Section 371 of the Patent Act, Patent Cooperation Treaty application PCT / US2016 / 032017 issue is "Ultrasound Sequencing System a U.S. Provisional Patent Application No. 62, filed May 12, 2015, entitled "Anti-Irradiation Method for Imaging a Fluorescent Device," / 160,529, which is incorporated herein by reference.

[0020] This application does not claim priority, but is incorporated herein by reference in its entirety. "Stem with Efficiency Algorithm" in 2018 May be related to U.S. Patent Application No. 16 / 097,959, filed October 31, U.S. Patent Application No. 16 / 097,959 is entitled "Cardiac Mapping System "Stem with Efficiency Algorithm" in 2017 Patent Cooperation Treaty application PCT / US2017 / 030922, filed on May 3, This is a national stage application under Section 371 of the Patent Cooperation Treaty (PCT) application PCT / US2017 / Issue 030922 is "Cardiac Mapping System with Eff The patent application was filed on October 26, 2016, entitled "Patent Ciency Algorithm" This application claims priority to U.S. Provisional Patent Application No. 62 / 413,104, which is incorporated herein by reference. To be incorporated.

[0021] This application does not claim priority, but is incorporated herein by reference in its entirety. Amazing Cardiac Conduction Patterns" May be related to U.S. Provisional Patent Application No. 62 / 619,897, filed January 21, 2008 , which is incorporated herein by reference.

[0022] This application does not claim priority, but is incorporated herein by reference in its entirety. ying Cardiac Conduction Patterns” This application may be related to U.S. Provisional Patent Application No. 62 / 668,647, filed May 8, 2018. and is incorporated herein by reference.

[0023] This application does not claim priority, but is incorporated herein by reference in its entirety. The patent application was filed on May 8, 2018, entitled "Integrated Circuit Processing System" This application may be related to U.S. Provisional Application No. 62 / 668,659, which is incorporated herein by reference. will be incorporated into

[0024] The present invention relates generally to medical diagnostic and treatment systems, and more particularly to systems for collecting physiological data from a patient, e.g. For example, it relates to a system for recording cardiac data. [Background technology]

[0025] Systems used by clinicians to perform medical procedures, such as diagnostic and / or therapeutic procedures , typically involving one or more patient parameters, e.g., electrical and / or mechanical properties of tissue, and medical Other patient information that may be useful in performing the procedure may be assessed. The procedure can be performed on untreated tissue (e.g., pre-treatment), partially treated tissue (e.g., This often includes evaluation of the tissue being treated (e.g., during treatment) and / or the treated tissue (e.g., post-treatment). Performing evaluations at the point of care is often difficult due to limited space and other reasons. The accuracy and specificity of available assessments are limited, leading to a lack of safety and / or efficacy of treatment. This could lead to:

[0026] In such a system, localization is performed to locate the catheter and its components in the patient. The localization may be performed within a specific anatomical structure, for example, within a cardiac chamber. Some localization modes may be spatially distributed or spatially localized. The present invention uses a rapidly varying field that is present in the patient's anatomy or that is sensitive to the patient's anatomy. In some cases, the field interacts with one or more specific local properties of the anatomy. They may interact to produce measurable effects or changes that encode spatial information. Impedance-based location is one mode that is often used, and that mode In this study, a current or voltage field is applied to the body, and the resulting field is distributed throughout the body, causing changes in the entire body. As a result, the corresponding voltage or current varies with position. By measuring the voltage or current at any point, the measured position in the body can be The impedance measurements can be decoded by one of any number of means. These changes are susceptible to changes in conditions during treatment, such as those associated with the living body. These changes affect the impedance measurements. A less common form of location is magnetic-based location. This approach is specific and relies on magnetic elements, such as coils, to generate and sense magnetic fields. To use the locating function, the device to be located typically requires a magnetic element. Only a limited number of catheters have such elements. The use of any of the prescribed methods may result in less than desirable outcomes for the performance of the procedure. It may also be useful in

[0027] Providing improved localization to enable improved performance of diagnostic and therapeutic procedures within the body A system that can do this is needed. Summary of the Invention [Means for solving the problem]

[0028] According to one aspect of the inventive concept, there is provided a method for processing physiological information, a processor coupled to a data storage device, and a Providing a plurality of functional elements positioned within, on, and / or proximal to the body; A location coordinate system is established for signals from a first set of functional elements using a first location mode. Establishing and calibrating the localization coordinate system by processing the first set a second set of signals from a second set of functional elements using a second location mode; The first location mode includes recalibrating the second location mode by processing the second location mode. This is different from the location mode.

[0029] In some embodiments, the first and second location modes are impedance-based From location mode, magnetic-based location mode, and ultrasonic-based location mode is selected from the group consisting of:

[0030] In some embodiments, the first location mode is impedance-based location It is a mode.

[0031] In some embodiments, the first location mode is a magnetic-based location mode. do.

[0032] In some embodiments, the first location mode is an ultrasound-based location mode. be.

[0033] In some embodiments, the second location mode is impedance-based location. It is a mode.

[0034] In some embodiments, the second location mode is a magnetic-based location mode. do.

[0035] In some embodiments, the second location mode is an ultrasound-based location mode. be.

[0036] In some embodiments, the localization coordinate system is a three-dimensional (3D) coordinate system.

[0037] In some embodiments, the origin of the localization coordinate system is located inside the body.

[0038] In some embodiments, the origin of the localization coordinate system is located within an organ of the body. .

[0039] In some embodiments, the organ is the heart.

[0040] In some embodiments, the method further comprises administering at least one object to an organ and / or body. inserting, wherein at least one object includes a functional element from the plurality of functional elements.

[0041] In some embodiments, the method includes positioning at least one object in a localization coordinate system, a signal from at least one functional element of the object, and / or a first set of signals, and / or determining the location based on the second set of signals.

[0042] In some embodiments, the at least one object comprises at least one catheter functional element. Each includes one catheter.

[0043] In some embodiments, the catheter functional element is configured to generate a first and / or second set of signals. The signal source includes one or more signal sources that generate at least a portion of the

[0044] In some embodiments, the catheter function elements include one or more ultrasound elements.

[0045] In some embodiments, the catheter functional elements include one or more ultrasound sensors, transmitters, and / or a transducer.

[0046] In some embodiments, the catheter functional element includes one or more magnetic elements.

[0047] In some embodiments, the one or more magnetic elements include one or more magnetic coils.

[0048] In some embodiments, the catheter functional element comprises one or more voltage or potential signal generating and and / or sensing elements.

[0049] In some embodiments, the at least one catheter comprises a diagnostic catheter.

[0050] In some embodiments, the diagnostic catheter is used for magnetic-based localization. The magnetic element includes one or more magnetic elements.

[0051] In some embodiments, the diagnostic catheter is used for impedance-based localization. It includes one or more electrodes used.

[0052] In some embodiments, the diagnostic catheter is used for ultrasound-based localization. It includes one or more ultrasonic elements.

[0053] In some embodiments, the method includes localizing the diagnostic catheter within the localization coordinate system. It further includes determining

[0054] In some embodiments, the diagnostic catheter is a cardiac mapping catheter, The electrical functional element senses and / or records electrical potentials associated with cardiac activity and / or localization. The device includes a plurality of electrodes configured to

[0055] In some embodiments, the diagnostic catheter is a basket catheter, The functional element includes a basket array of electrodes.

[0056] In some embodiments, the diagnostic catheter is a lasso catheter, and the catheter mechanism The active element includes an array of electrodes.

[0057] In some embodiments, the diagnostic catheter includes an actuator that is slidable within the lumen of the sheath. a shaft having a distal end including an eta, for deploying an array of functional elements within the body; Here, the shaft, sheath, and / or actuator include one or more functional elements.

[0058] In some embodiments, the shaft and the actuator each have one or more functions. The method includes connecting the auxiliary electrode on the shaft and the actuator. The method includes determining, with a processor, a relative distance measurement between the sensor and an auxiliary electrode on the sensor.

[0059] In some embodiments, the method comprises determining the shape of the array of functional elements based on distance measurements. The method further includes determining with a processor:

[0060] In some embodiments, the array of functional elements is a basket array, and the processor The shape of the basket array is determined.

[0061] In some embodiments, the diagnostic catheter includes at least one additional functional element. , which are located on the shaft and contain electrodes, coils, transducers, and / or and a physical sensor, wherein the at least one further functional element is selected from the group consisting of: Used for cardiac activity mapping and / or localization.

[0062] In some embodiments, the array of functional elements is a basket array and the auxiliary electrodes are: The method includes at least one magnetic sensor on the actuator and / or shaft. The position and / or orientation of the skeletal array can be adjusted by adjusting the actuator and / or shaft and determining with a processor using both the magnetic sensor and the magnetic location. .

[0063] In some embodiments, the basket array of functional elements has a known configuration and the method comprises: a processor, using the known configuration of the basket array, to identify functional elements of the basket array; and locating one or more of the plurality of sensors based on the determined position of the at least one magnetic sensor. include.

[0064] In some embodiments, the method for locating one or more of the basket array-based functional elements is This means that the estimation of the position and orientation of all elements in the basket array can be performed using magnetic localization. Including what you can do.

[0065] In some embodiments, the method further comprises determining the location and / or orientation of one or more additional devices. When using magnetic location, you can magnetically determine the location of one or more elements of one or more additional devices. By evaluating, calculating, and / or determining for an electrically localized basket array The method further includes determining, with a processor,

[0066] In some embodiments, the method further comprises: The relative positions of the objects are determined using one or more localization methods, such as ultrasonic localization and / or impedance localization. The method further includes determining, with a processor, using the space-based location.

[0067] In some embodiments, the method includes using the location signal to perform in-device location. and the location signal is transmitted to a device and / or functional element located therein. transmitted to and / or received from the device and / or are sent to and / or received from the functional elements.

[0068] In some embodiments, at least one catheter is a catheter of a second set. A second diagnostic catheter including the functional element is included.

[0069] In some embodiments, the second set of catheter functional elements includes cardiac activity mapping. and / or includes one or more electrodes used for localization.

[0070] In some embodiments, the second diagnostic catheter is positioned within the coronary sinus of the heart. A coronary sinus mapping catheter constructed and positioned as follows:

[0071] In some embodiments, the coronary sinus mapping catheter includes at least one catheter The catheter shaft may include a magnetic element, an electrode, or a magnetic element. , coils, ultrasound elements, transducers, and / or physiological sensors is selected from.

[0072] In some embodiments, the coronary sinus mapping catheter comprises a magnetic-based localization catheter. It includes one or more magnetic elements used in

[0073] In some embodiments, the coronary sinus mapping catheter is an impedance-based It includes one or more electrodes used to locate the

[0074] In some embodiments, the coronary sinus mapping catheter is configured to perform ultrasound-based location characterization. It contains one or more electrodes used to measure

[0075] In some embodiments, the method further comprises placing a coronary sinus mapping catheter in a localized location. Further includes locating within a landmark.

[0076] In some embodiments, the coronary sinus mapping catheter is a lasso catheter. .

[0077] In some embodiments, the at least one catheter comprises a therapeutic catheter.

[0078] In some embodiments, the therapeutic catheter includes at least one therapeutic function element.

[0079] In some embodiments, the at least one therapeutic function element comprises at least one ablation element. Includes electrodes.

[0080] In some embodiments, the treatment catheter is used for magnetic-based localization. The magnetic element includes one or more magnetic elements.

[0081] In some embodiments, the treatment catheter is used for impedance-based localization. It includes one or more electrodes used.

[0082] In some embodiments, the treatment catheter is used for ultrasound-based localization. It includes one or more ultrasonic elements.

[0083] In some embodiments, the method includes positioning at least one therapeutic element within a localization coordinate system. The method further includes locating the

[0084] In some embodiments, the plurality of functional elements are positioned outside and / or on the body. and / or A second set of functional elements is included.

[0085] In some embodiments, the external functional element may be an impedance functional element, a magnetic functional element, and functional elements.

[0086] In some embodiments, the functional element type is an electrode, a voltage or potential sensor, an ultrasound transmitter, a group consisting of a machine, an ultrasonic sensor, an ultrasonic transducer, a magnetic element, and a magnetic coil; is selected from the group.

[0087] In some embodiments, the method includes positioning at least one object in a localization coordinate system by: Positioning using signals generated and / or sensed by at least some external functional elements The method further includes identifying the location of the object.

[0088] In some embodiments, the at least one object comprises at least one catheter .

[0089] In some embodiments, the at least one catheter includes at least one diagnostic catheter. Includes the taeter.

[0090] In some embodiments, the at least one catheter includes at least one therapeutic catheter. Includes the taeter.

[0091] In some embodiments, the method includes providing at least one wearable garment. the wearable garment comprises a first set and / or a second set of functional elements; and a wearable garment including at least some of the external functional elements, the external functional elements including one or more of the following: maintains contact, pressure, and / or position of the external functional element against the body.

[0092] In some embodiments, the at least one wearable garment comprises a vest, a suit, a shirt, a It may take the form of a jacket, bodysuit, or part thereof.

[0093] In some embodiments, at least a portion of the external functional element is It is removable from the Rubble clothing.

[0094] In some embodiments, at least a portion of the external functional element is The device is embedded or placed within the wearable garment.

[0095] In some embodiments, the wearable garment comprises at least two different external functional elements. as one or more of the functional elements of the first set and / or the second set, which an impedance functional element, a magnetic functional element, and an ultrasonic functional element; can be.

[0096] In some embodiments, the at least two external functional elements include a magnetic functional element and an impedance functional element. - Includes dance function elements.

[0097] In some embodiments, the at least two external functional elements include a magnetic functional element and an ultrasonic functional element. Contains functional elements.

[0098] In some embodiments, the at least two external functional elements are impedance functional elements and ultrasound functional elements.

[0099] In some embodiments, a magnetic functional element, an impedance functional element, and an ultrasonic functional element are The group of elements includes electrodes, voltage or potential sensors, ultrasonic transmitters, ultrasonic sensors, ultrasonic The transducer includes at least two of a wave transducer, a magnetic element, and / or a magnetic coil.

[0100] In some embodiments, the method comprises: provide a patch that includes at least some of the external functional elements, including one or more of This includes:

[0101] In some embodiments, the method includes attaching the patch to the body trunk.

[0102] In some embodiments, one or more of the patches comprises at least two different external functional elements. as a first set and / or a second set of one or more functional elements, which are magnetic a functional element selected from the group consisting of an air function element, an impedance function element, and an ultrasound function element; can be.

[0103] In some embodiments, the at least two external functional elements include a magnetic functional element and an impedance functional element. - Includes dance function elements.

[0104] In some embodiments, the at least two external functional elements include a magnetic functional element and an ultrasonic functional element. Contains functional elements.

[0105] In some embodiments, the at least two external functional elements are impedance functional elements and ultrasound functional elements.

[0106] In some embodiments, a magnetic functional element, an impedance functional element, and an ultrasonic functional element are The group of elements includes electrodes, voltage or potential sensors, ultrasonic transmitters, ultrasonic sensors, ultrasonic The transducer includes at least two of a wave transducer, a magnetic element, and / or a magnetic coil.

[0107] In some embodiments, the method comprises recording physiological data at one or more recording locations of the functional element. Record and convert physiological data into patient information at one or more target locations that are different from the recording locations. This further includes converting the

[0108] In some embodiments, the method further comprises: collecting physiological data from a first set and / or a second set of physiological data; The method further includes recording at one or more recording locations of the functional element of the set.

[0109] In some embodiments, at least a portion of the physiological data is from a first set and / or is embodied in a second set of signals.

[0110] In some embodiments, the method further comprises applying a transfer matrix to the physiological data at one or more recording locations. and applying the method to determine patient information at one or more target locations different from the recording location. Included.

[0111] In some embodiments, the method further comprises: The method further includes generating the signal from the signal.

[0112] In some embodiments, generating a transfer matrix is ​​a function of the relationship between the recording position and the target position. This involves characterizing the tissue properties between the

[0113] In some embodiments, the transfer matrix is ​​a scale matrix.

[0114] In some embodiments, the scale matrix is ​​a combined scale matrix.

[0115] In some embodiments, generating a combined scale matrix comprises combining multiple scales. Generate a scale matrix and combine multiple scale matrices into a combined scale matrix. This includes combining

[0116] In some embodiments, different ones of the multiple scale matrices are are generated at different locations within

[0117] In some embodiments, the method further comprises the step of: The localization data from at least two scale matrices must be sufficiently comparable to be able to combine them. This includes determining whether the

[0118] In some embodiments, if at least two scale matrices are not sufficiently comparable , then adjust at least one of the two scale matrices and compare them. Make it possible.

[0119] In some embodiments, adjusting at least one of the at least two scale matrices The adjustment is done by adjusting at least one of the scale matrices that affects the scale estimate of the combined scale matrix. This involves updating one localization parameter, e.g., catheter geometry.

[0120] In some embodiments, if at least two scale matrices are sufficiently comparable Then, at least two scale matrices are stitched together to produce a combined scale matrix. Generate the rule matrix.

[0121] In some embodiments, the scale matrix is ​​a measure of the rate of change of the field values.

[0122] In some embodiments, the field value is a voltage or impedance field.

[0123] In some embodiments, calibrating the localization coordinate system includes estimating a scale matrix. This includes:

[0124] In some embodiments, the method comprises measuring a voltage difference between functional elements having a known spacing. The method further includes estimating the scale matrix by:

[0125] In some embodiments, the functional elements are on the catheter and their dimensions are predetermined. can be.

[0126] In some embodiments, the method comprises measuring the conversion and and / or estimating field properties with a processor to describe the field.

[0127] In some embodiments, the physiological fluctuations of the patient include cardiac and / or respiratory cycles.

[0128] In some embodiments, a particular cyclical point in the patient's physiological fluctuations is determined to be the point at which the field complexity is greatest. This simplifies modeling and allows for the identification of favorable physiological responses at these specific time points. Due to the condition, the applied field has reduced spatial nonlinearity, which makes it easier to describe the field. This results in less input.

[0129] In some embodiments, these time points are determined based on the T and / or P waves of the patient's ECG signal. be temporarily located in close proximity.

[0130] In some embodiments, measuring signals at specific times over a broader period of time is , which leads to the invariance of the source, which has a period that matches the observation period and is independent of other sources. Their contribution to the signal change can be observed within these measurements.

[0131] In some embodiments, the transformations (e.g., models) that describe other sources are based on observations. It can be estimated based on the

[0132] In some embodiments, the signal artifacts may include discrete impulses, The signal is optionally triggered by a short, high amplitude exogenous signal such as a pulsing pulse.

[0133] In some embodiments, the discrete impulses have steep leading and / or trailing edges. This generates a waveform that contains components with "sharp" structures.

[0134] In some embodiments, if an artifact is present in the localization signal, the processor observe a short "jump" at the determined location of one or more recording electrodes. Optionally, the localization signal may be measured by measuring the impedance recorded by one or more localized electrodes. It is a space-based location signal.

[0135] In some embodiments, the method is based on observing signal fluctuations during non-artifact periods. and performing a threshold algorithm, wherein the threshold algorithm is based on one or more records. Optionally, the archiferous electrode is configured to limit jumps observed at the location of the recording electrodes. A filtering period comparable to and / or longer than the length of the exogenous signal that triggers the effect. Median filtering of signals with gaps is also used to limit the observed position shift. It is used for this purpose.

[0136] In some embodiments, the method further comprises adding one or more additional filters to a component having sharp features. and applying the signal including the component in a processor to the signal, the component being negligible enough to be observed. Optionally, filtering artifacts at the locations of the recording electrodes. A jump can be ignored after applying two or more filters.

[0137] In some embodiments, the method further comprises filtering sharp structures in the recorded signal by filtering the first filter with the second filter. Applying it before the filter limits the exposure of such sharp structures to the localized position of the catheter. Optionally, the method further includes processes that help prevent the occurrence of jumps in the data from appearing as observable jumps in the data. In the alternative, the first filter is a median filter.

[0138] In some embodiments, the method includes detecting a pacing pulse with a processor and responding thereto. In response, ignoring or filtering signals recorded during the presence of pacing pulses; Adversely affect the localization of one or more other electrodes that are localized while pacing is present. It further includes preventing the skin from becoming irritated.

[0139] In some embodiments, the method includes locating one or more functional elements relative to the body. and wherein locating further includes determining the location of the functional element by comparing the functional element with its orientation relative to the body. The difference in field value between the position and the position where the field value is known is measured, and the measured difference is scaled. This involves estimating the output by multiplying it with a rule matrix, where the resulting output is The position of the sensor relative to the position of the sensor.

[0140] In some embodiments, the localization signal is recorded via one or more electrodes within the heart. When the common mode signal is transmitted through an unintended circuit path, the common mode signal has a predominantly common mode component. and / or filtering from the interconnect system to substantially reduce leakage of the location signal. This includes reducing

[0141] In some embodiments, the method comprises the steps of: The method further includes using a common mode choke in the processor, wherein the common mode signal is transmitted through one or more Prevent leakage into unintended circuit paths and / or interconnection systems. A common mode filter or common mode choke is a device that can eliminate one or more unintended circuit paths and and / or act as a high impedance path for the interconnect system.

[0142] In some embodiments, the method comprises the steps of: Further includes unimpeded passage of pacing pulses to enable the intended pacing function. Optionally, the pacing pulses may be used to block one or more unintended circuit pathways and / or interactions. Electrodes connected to the connection system via a common mode filter or common mode choke It is recorded by

[0143] In accordance with another aspect of the inventive concept, there is provided a physiological processing information system, comprising: a processor coupled to a data storage device, and coupled to the processor to , on, and / or proximally disposed first and second sets of functional elements The processor provides a plurality of functional elements including a first set of functions. and processing a first set of signals from the functional elements to determine a location location using a first location mode. establishing and calibrating a standard and processing a second set of signals from a second set of functional elements; configured to recalibrate the localization coordinate system using the second localization mode, The location mode is different from the second location mode.

[0144] In some embodiments, the first and second location modes are impedance-based From location mode, magnetic-based location mode, and ultrasonic-based location mode is selected from the group consisting of:

[0145] In some embodiments, the first location mode is impedance-based location It is a mode.

[0146] In some embodiments, the first location mode is a magnetic-based location mode. .

[0147] In some embodiments, the first location mode is an ultrasound-based location mode. be.

[0148] In some embodiments, the second location mode is impedance-based location. It is a mode.

[0149] In some embodiments, the second location mode is a magnetic-based location mode. .

[0150] In some embodiments, the second location mode is an ultrasound-based location mode. be.

[0151] In some embodiments, the localization coordinate system is a three-dimensional (3D) coordinate system.

[0152] In some embodiments, the origin of the localization coordinate system is located inside the body.

[0153] In some embodiments, the origin of the localization coordinate system is located within the internal organ.

[0154] In some embodiments, the organ is the heart.

[0155] In some embodiments, the system comprises at least one device insertable into the organ and / or body. and at least one object further comprising a functional element from the plurality of functional elements. nothing.

[0156] In some embodiments, the processor is configured to: , signals from at least one functional element of the object, and / or the first set and / or the second set The system is configured to determine location based on a set of signals.

[0157] In some embodiments, the at least one object comprises at least one catheter functional element. The device includes at least one catheter.

[0158] In some embodiments, the catheter functional element is configured to generate a first and / or second set of signals. The signal source includes one or more signal sources configured to generate at least some of the

[0159] In some embodiments, the catheter function elements include one or more ultrasound elements.

[0160] In some embodiments, the catheter functional elements include one or more ultrasound sensors, transmitters, and / or a transducer.

[0161] In some embodiments, the catheter functional element includes one or more magnetic elements.

[0162] In some embodiments, the one or more magnetic elements include one or more magnetic coils.

[0163] In some embodiments, the catheter functional element comprises one or more voltage or potential signal generating and and / or sensing elements.

[0164] In some embodiments, the at least one catheter comprises a diagnostic catheter.

[0165] In some embodiments, the diagnostic catheter is used for magnetic-based localization. The magnetic element includes one or more magnetic elements.

[0166] In some embodiments, the diagnostic catheter is used for impedance-based localization. It includes one or more electrodes used.

[0167] In some embodiments, the diagnostic catheter is used for ultrasound-based localization. It includes one or more ultrasonic elements.

[0168] In some embodiments, the processor positions the diagnostic catheter within the localization coordinate system. It is configured to identify.

[0169] In some embodiments, the diagnostic catheter is a cardiac mapping catheter, The electrical functional element senses and / or records electrical potentials associated with cardiac activity and / or localization. The device includes a plurality of electrodes configured to:

[0170] In some embodiments, the diagnostic catheter is a basket catheter, The functional element includes a basket array of electrodes.

[0171] In some embodiments, the diagnostic catheter is a lasso catheter, and the catheter mechanism The active element includes an array of electrodes.

[0172] In some embodiments, the diagnostic catheter includes an actuator that is slidable within the lumen of the sheath. a shaft having a distal end including an eta, and deploying an array of functional elements within the body; The shaft, sheath, and / or actuator may include one or more functional elements.

[0173] In some embodiments, the shaft and the actuator each have the form of an auxiliary electrode. and a processor for controlling an auxiliary electrode on the shaft and an actuator. The auxiliary electrode is configured to determine a relative distance measurement between the auxiliary electrode and the sensor.

[0174] In some embodiments, the processor determines the shape of the array of functional elements based on the distance measurements. The method is configured to determine the

[0175] In some embodiments, the array of functional elements is a basket array, and the processor The shape of the basket array is determined.

[0176] In some embodiments, the diagnostic catheter comprises at least one catheter member disposed on the shaft. and one or more other functional elements, which may be electrodes, coils, transducers, and / or physiological sensors, wherein at least one further functional element is selected from the group consisting of cardiac activity sensors; Used for dynamic mapping and / or localization.

[0177] In some embodiments, the array of functional elements is a basket array and the auxiliary electrodes are: at least one magnetic sensor on the actuator and / or shaft; and a processor adjusts the position and / or orientation of the basket array by adjusting the actuator and / or the shaft The method is configured to determine using at least one magnetic sensor and magnetic localization.

[0178] In some embodiments, the basket array of functional elements has a known configuration and is The sensor uses the known configuration of the basket array to measure the determined value of at least one magnetic sensor. and configured to locate one or more of the functional elements of the basket array based on the determined position. can be.

[0179] In some embodiments, the processor determines the positions and The orientation is estimated using magnetic localization and the basket array-based one or more functional elements is configured to locate the

[0180] In some embodiments, the processor determines the location and / or Orientation is determined using magnetic localization to one relative to a magnetically localized basket array. By evaluating, calculating, and / or determining the position of one or more elements of the above additional devices. The method is configured to determine the following:

[0181] In some embodiments, the processor may further include one or more additional The relative location of the devices can be determined using one or more localization methods, such as ultrasound localization and / or infrared localization. The method is configured to determine the location using impedance-based location.

[0182] In some embodiments, the processor performs in-device localization based on an internally located device. location signals transmitted to and / or received from devices and / or functional elements, and / or transmitted to and / or received from externally located devices and / or functional elements. It is configured to perform using the location signal.

[0183] In some embodiments, at least one catheter is a catheter of a second set. A second diagnostic catheter including a functional element is included.

[0184] In some embodiments, the second set of catheter functional elements includes cardiac activity mapping. and / or includes one or more electrodes used for localization.

[0185] In some embodiments, the second diagnostic catheter is positioned within the coronary sinus of the heart. A coronary sinus mapping catheter constructed and positioned as follows:

[0186] In some embodiments, the coronary sinus mapping catheter includes at least one catheter The catheter shaft includes a number of functional elements, such as electrodes, magnetic elements, and From the group consisting of coils, ultrasound elements, transducers, and / or physiological sensors are selected.

[0187] In some embodiments, the coronary sinus mapping catheter comprises a magnetic-based localization catheter. It includes one or more magnetic elements used in

[0188] In some embodiments, the coronary sinus mapping catheter is an impedance-based It includes one or more electrodes used to locate the

[0189] In some embodiments, the coronary sinus mapping catheter is configured to perform ultrasound-based location characterization. It contains one or more ultrasonic elements used to determine

[0190] In some embodiments, the processor is configured to locate the coronary sinus mapping catheter. It is further configured to locate within the coordinate system.

[0191] In some embodiments, the coronary sinus mapping catheter is a lasso catheter. .

[0192] In some embodiments, the at least one catheter comprises a therapeutic catheter.

[0193] In some embodiments, the therapeutic catheter includes at least one therapeutic function element. nothing.

[0194] In some embodiments, the at least one therapeutic function comprises at least one ablation Includes electrodes for use.

[0195] In some embodiments, the treatment catheter is used for magnetic-based localization. The magnetic element includes one or more magnetic elements.

[0196] In some embodiments, the treatment catheter is used for impedance-based localization. It includes one or more electrodes used.

[0197] In some embodiments, the treatment catheter is used for ultrasound-based localization. It includes one or more ultrasonic elements.

[0198] In some embodiments, the processor locates the at least one treatment element in a localization coordinate system The device is configured to locate within the

[0199] In some embodiments, the plurality of functional elements are positioned outside and / or on the body. and an external functional element, wherein the external functional element is one of the first set and / or the second set. Contains one or more of the functional elements.

[0200] In some embodiments, the external functional element may be an impedance functional element, a magnetic functional element, and functional elements.

[0201] In some embodiments, the functional element type is an electrode, a voltage or potential sensor, an ultrasound transmitter, a group consisting of a machine, an ultrasonic sensor, an ultrasonic transducer, a magnetic element, and a magnetic coil; is selected from the group.

[0202] In some embodiments, the system locates at least one object in the localization coordinate system by: Positioning using signals generated and / or sensed by at least some external functional elements The device is further configured to identify the location.

[0203] In some embodiments, the at least one object comprises at least one catheter .

[0204] In some embodiments, the at least one catheter includes at least one diagnostic catheter. Includes the taeter.

[0205] In some embodiments, the at least one catheter includes at least one therapeutic catheter. Includes the taeter.

[0206] In some embodiments, the system further comprises at least one wearable garment. The wearable garment may include one or more of the first and / or second set of functional elements. The wearable garment comprises at least some external functional elements, including a top, and is attached to the body. Maintaining contact, pressure, and / or position of external functional elements.

[0207] In some embodiments, the at least one wearable garment comprises a vest, a suit, a shirt, a It may take the form of a jacket, bodysuit, or part thereof.

[0208] In some embodiments, at least a portion of the external functional element is It is removable from the Rubble clothing.

[0209] In some embodiments, at least a portion of the external functional element is The device is embedded or placed within the wearable garment.

[0210] In some embodiments, the wearable garment comprises at least two different external functional elements. as one or more of the functional elements of the first set and / or the second set, They are from the group consisting of impedance functional elements, magnetic functional elements, and ultrasonic functional elements. be selected.

[0211] In some embodiments, the at least two external functional elements include a magnetic functional element and an impedance functional element. - Includes dance function elements.

[0212] In some embodiments, the at least two external functional elements include a magnetic functional element and an ultrasonic functional element. Contains functional elements.

[0213] In some embodiments, the at least two external functional elements are impedance functional elements and ultrasound functional elements.

[0214] In some embodiments, a magnetic functional element, an impedance functional element, and an ultrasonic functional element are The group of elements includes electrodes, voltage or potential sensors, ultrasonic transmitters, ultrasonic sensors, ultrasonic The transducer includes at least two of a wave transducer, a magnetic element, and / or a magnetic coil.

[0215] In some embodiments, the system comprises a first set and / or a second set of functional components. and a patch including at least some of the external functional elements, the patch including at least one of the external functional elements. include.

[0216] In some embodiments, the patch is adhereable to the trunk of the body.

[0217] In some embodiments, one or more patches comprise at least two different external functional elements. as one or more of the first set and / or second set of functional elements, which are magnetic a functional element, an impedance functional element, and an ultrasonic functional element; do.

[0218] In some embodiments, the at least two external functional elements include a magnetic functional element and an impedance functional element. - Includes dance function elements.

[0219] In some embodiments, the at least two external functional elements include a magnetic functional element and an ultrasonic functional element. Contains functional elements.

[0220] In some embodiments, the at least two external functional elements are impedance functional elements and ultrasound functional elements.

[0221] In some embodiments, a magnetic functional element, an impedance functional element, and an ultrasonic functional element are The group of elements includes electrodes, voltage or potential sensors, ultrasonic transmitters, ultrasonic sensors, ultrasonic The transducer includes at least two of a wave transducer, a magnetic element, and / or a magnetic coil.

[0222] In some embodiments, the system stores the physiological data at one or more recording locations of the functional component. The physiological data is recorded at one or more target locations different from the recording location. It is configured to convert at the

[0223] In some embodiments, the processor is configured to process the first set of physiological data and / or the second set of physiological data. The set of functional elements is configured to record at one or more recording locations.

[0224] In some embodiments, at least a portion of the physiological data is from a first set and / or is embodied in a second set of signals.

[0225] In some embodiments, the processor derives the transfer matrix from the physiological data at one or more recording locations. data to determine patient information at one or more target locations that are different from the recording location. It is configured as follows.

[0226] In some embodiments, the processor may further include a processor for converting the transfer matrix into a first set and / or a second set. The signal is generated from the signal of the bit.

[0227] In some embodiments, the processor measures tissue properties between the recording location and the target location. The method is configured to generate a transfer matrix by characterizing

[0228] In some embodiments, the transfer matrix is ​​a scale matrix.

[0229] In some embodiments, the scale matrix is ​​a combined scale matrix.

[0230] In some embodiments, the processor processes the combined scale matrix as a plurality of scales. Generate a scale matrix and combine multiple scale matrices into a combined scale matrix. The signal is generated by combining the signal and the received signal.

[0231] In some embodiments, the system adjusts different ones of the scale matrices to the position. The image is configured to be generated at different positions within a location-specific coordinate system.

[0232] In some embodiments, the processor is configured to: is large enough to be able to combine localization data from at least two scale matrices. It is configured to determine whether they are comparable.

[0233] In some embodiments, if at least two scale matrices are not sufficiently comparable The processor adjusts at least one of the at least two scale matrices to It is constructed to make them comparable.

[0234] In some embodiments, the processor is configured to: At least one of the scale matrices that influences the scale estimation of the combined scale matrix. The catheter geometry is adjusted by updating one localization parameter. It is composed of:

[0235] In some embodiments, if at least two scale matrices are sufficiently comparable , the processor stitches together at least two scale matrices to produce a combined The method is configured to generate a scale matrix based on the calculated values.

[0236] In some embodiments, the scale matrix is ​​a measure of the rate of change of the field values.

[0237] In some embodiments, the field value is a voltage or impedance field.

[0238] In some embodiments, the processor calculates the position feature by estimating a scale matrix. It is configured to calibrate a fixed coordinate system.

[0239] In some embodiments, the processor measures the voltage difference between functional elements having known spacing. The method is further configured to estimate the scale matrix by determining

[0240] In some embodiments, the functional elements are on the catheter and their dimensions are predetermined. can be.

[0241] In some embodiments, the processor performs the following at specific periodic points in the patient's physiological variation: The transform and / or field properties are estimated and configured to describe the field.

[0242] In some embodiments, the physiological fluctuations of the patient include cardiac and / or respiratory cycles.

[0243] In some embodiments, a particular cyclical point in the patient's physiological fluctuations is determined to be the point at which the field complexity is greatest. This simplifies modeling and allows for the identification of favorable physiological responses at these specific time points. Due to the condition, the applied field has reduced spatial nonlinearity, which makes it easier to describe the field. This results in less input.

[0244] In some embodiments, these time points are determined based on the T and / or P waves of the patient's ECG signal. be temporarily located in close proximity.

[0245] In some embodiments, measuring signals at specific times over a broader period of time is , which leads to the invariance of the source, which has a period that matches the observation period and is independent of other sources. Their contribution to the signal change can be observed within these measurements.

[0246] In some embodiments, the transformations and / or models describing the other sources are based on observations. It can be estimated based on the above.

[0247] In some embodiments, the signal artifacts may include discrete impulses, The signal is optionally triggered by a short, high amplitude exogenous signal such as a pulsing pulse.

[0248] In some embodiments, the discrete impulses have steep leading and / or trailing edges. This generates a waveform that contains components with "sharp" structures.

[0249] In some embodiments, if an artifact is present in the localization signal, the processor to observe short "jumps" at the determined positions of one or more recording electrodes. Optionally, the localization signal is recorded by one or more localized electrodes. The impedance-based localization signal is generated.

[0250] In some embodiments, the processor is configured to: and configured to perform a thresholding algorithm based on one or more Optionally, the arch is configured to limit the jumps observed at the location of the recording electrodes. Filtering that is comparable to and / or longer than the length of the exogenous signal that causes the artifact Median filtering of signals with periods also limits the observed position shifts. Used for:

[0251] In some embodiments, the processor may apply one or more additional filters to the image having sharp structures. It is applied to signals containing components that are difficult to detect and filter out artifacts sufficiently so that they are negligible to observe. Optionally, the jump in the position of the recording electrode may be It can be ignored after applying two or more filters.

[0252] In some embodiments, the processor filters sharp structures in the recorded signal by applying a first filter to a second filter. Applying a 2 filter before the catheter will limit the localization of such sharp structures. Optionally, the first The filter is a median filter.

[0253] In some embodiments, the processor detects a pacing pulse and in response ignoring and / or filtering signals recorded during the presence of pacing pulses , adversely affecting the localization of one or more other electrodes that are localized while pacing is present. It is configured so as not to have an adverse effect.

[0254] In some embodiments, the system includes a step of locating one or more functional elements relative to the body. and determining the location of the functional element by comparing the functional element and its position relative to the body and the field values ​​with known values. and multiplying the measured difference by a scale matrix. The resulting output is the sensor's position relative to the known position. It is the position.

[0255] In some embodiments, the localization signal is recorded via one or more electrodes within the heart. When the common mode signal is transmitted, it has a predominantly common mode component, and the processor must be careful not to transmit the common mode signal to unintended circuits. filtering from the network path and / or interconnection system to substantially eliminate leakage of location signals The present invention is configured to effectively reduce the noise.

[0256] In some embodiments, the processor may include a common mode filter or a common mode choker. Using a network, a common-mode signal may be transmitted through one or more unintended circuit paths and / or interconnections. Optionally, a common mode filter is configured to prevent leakage into the system. or common mode chokes to prevent one or more unintended circuit paths and / or interconnection systems It acts as a high impedance path to the system.

[0257] In some embodiments, the common mode filter or common mode choke is The pacing pulse passing through the common-mode filter or common-mode choke is not impeded and Optionally, the pacing pulses are configured to enable the pacing functions shown in the figure. common mode filters into one or more unintended circuit paths and / or interconnection systems Or recorded by electrodes connected via a common mode choke.

[0258] In accordance with an aspect of the inventive concept, a method for forming a localization coordinate system is shown and described. It is served as a platter.

[0259] According to an aspect of the inventive concept, a method for locating an object in a localization coordinate system is provided. are provided as described.

[0260] According to an aspect of the inventive concept, a system for establishing and calibrating a localization coordinate system comprises: Provided as shown and described.

[0261] According to an aspect of the inventive concept, a system for locating an object in a localization coordinate system is provided. , provided as shown and described.

[0262] In accordance with an aspect of the inventive concept, a localization patch is provided as shown and described. .

[0263] In accordance with aspects of the inventive concept, a location-specific wearable garment may be provided, as shown and described. Provided.

[0264] The technology described herein, along with its attributes and attendant advantages, is illustrated by exemplary embodiments. Best appreciated in light of the following detailed description taken in conjunction with the accompanying drawings, which are set forth as: and will be understood. [Brief explanation of the drawings]

[0265] [Figure 1] 1 shows a schematic diagram of one embodiment of a system for performing intrabody device localization consistent with the concepts of the present invention. [Figure 1A] 2 shows a schematic diagram of an embodiment of a portion of the system of FIG. 1 useful for localization consistent with the concepts of the present invention. [Figure 2] 2 shows a diagram of one embodiment of a portion of one or more catheters forming part of the system of FIG. 1 consistent with the concepts of the present invention. [Figure 3] 1 illustrates a flowchart of one embodiment of a method for initializing, calibrating, and / or correcting a location system consistent with the concepts of the present invention. [Figure 4] 1 shows a flowchart of one embodiment of a method for initializing an internal body coordinate system consistent with the concepts of the present invention. [Figure 5] 1 shows a flowchart of one embodiment of a method for localization calibration consistent with the concepts of the present invention. [Figure 6] 1 shows a flowchart of one embodiment of a method for generating a combined scale matrix consistent with the concepts of the present invention. [Figure 7] 1 shows a flowchart of one embodiment of a method for transposing a device's location into a set of location coordinates consistent with the concepts of the present invention. [Figure 8]2 shows a schematic diagram of one embodiment of portions of the system of FIG. 1 applied to the body, consistent with the concepts of the present invention. [Figure 9] 1 illustrates one embodiment of a circuit diagram for a high input impedance mapping system consistent with the concepts of the present invention. [Figure 10] 1 shows an embodiment of a schematic diagram of a portion of a console and mapping catheter consistent with the concepts of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0266] Reference will now be made in detail to embodiments of the present technology, examples of which are illustrated in the accompanying drawings, in which like reference numerals refer to: However, the description does not necessarily limit the scope of the present disclosure to a specific embodiment. It is not intended to be limiting to the embodiments described herein, and various modifications, equivalents, and equivalents are possible. It should be construed to include equivalents and / or alternatives.

[0267] The terms "comprising" (and "comprise" and "comprises") " and any form of "having"); "having" (and "have" and any form of "has" such as "has"), "including" (and and any form of "including," such as "includes" and "include"); or "Containing" (and "contains" and "contain") As used herein, any form of "comprising" (e.g., "comprising") refers to the completeness of the described feature. It does not explicitly state the existence of wholes, steps, operations, elements, and / or components. , one or more other features, entities, steps, operations, elements, components, and / or It will be understood that this does not preclude the presence or addition of other groups.

[0268] The terms first, second, third, etc. are used herein to refer to various limitations, elements, components, regions, etc. Although regions, layers and / or sections are described, these limitations, elements, components, regions, layers, It is further understood that the and / or sections are not to be limited by those terms. These terms should not be construed as meaning a single definition, element, component, region, layer, or section. is used only to distinguish from a limit, element, component, region, layer, or section of Therefore, the first limitation, element, component, region, layer, or section described below may be termed a second limitation, element, component, region, layer, or section. , without departing from the scope of the present invention.

[0269] An element may be "on," "attached to," "connected to," or "on" another element. When something is referred to as being "attached" it refers to whether it is directly on or above another element. , may be connected or coupled to, or one or more intervening elements may be present. In other words, an element is "directly on" or "directly attached" to or "directly connected" to another element. When reference is made to "being" or "directly attached," there are no intervening elements present. Other words used to describe relationships between elements should be interpreted in the same way. (e.g., "between" and "directly between", "adjacent" and "directly adjacent").

[0270] The first element is "in," "on," and / or "within" the second element When referring to a first element, the first element is located inside the interior space of the second element, a portion of the second element, It may be located internally (e.g., inside the wall of the second element) and may be located externally and / or internally of the second element. It is further understood that the present invention may be arranged in one or more of the above-described portions. It would be.

[0271] As used herein, the term "proximate" refers to a first component or When used to describe a second component of a location or proximity to a location, the second component one or more locations near a first component or location and within, on, and / or inside a second component or location The term should be interpreted to include location, e.g., anatomical site (e.g., target tissue site). Components placed close to the anatomical site are components placed close to the anatomical site, and It includes components positioned within, on, and / or inside the anatomical site.

[0272] "Beneath," "below," "lower," "above," "more" Spatial terms such as "upper" refer to the location of an element and / or feature, e.g., as shown in a drawing. Describe the relationship to another element(s) and / or feature(s) as understood Spatial terms may be used to indicate orientation in addition to the directions shown in the drawings. It is intended to cover different orientations of the device during use and / or operation. It will be further understood that, for example, if the device in the drawings is turned over, different elements or features may be present. An element described as "below" and / or "beneath" another element or feature is therefore not necessarily "above" another element or feature. The device may be oriented otherwise (e.g., 90°). or rotated to another orientation), and spatially related descriptions used herein may be , to be interpreted accordingly.

[0273] As used herein, "reduce," "reducing," " Terms such as "reduction" are intended to include a reduction in quantity, including a reduction to zero. Reducing the likelihood of occurrence includes preventing occurrence. The terms "preventing," "prevention," and "prevention" are used interchangeably. These terms include "decrease," "decrease" and the act of "decrease," respectively.

[0274] As used herein, the term "and / or" refers to two elements with or without the other. It should be construed as a specific disclosure of each particular feature or component. For example, "A and / or B" means (i) A, (ii) B, and (iii) each specific The disclosures are to be construed as though each were individually set forth herein.

[0275] As used herein, the term "one or more" means 1, 2, 3, 4, 5, 6, 7, 8, It can mean 9, 10, or more, up to any number.

[0276] The terms "and combinations thereof" and "and combinations thereof" respectively may be used herein after a list of items that are to be included, either singly or collectively. For example, A component, process, or combination thereof selected from the group consisting of A, B, C, and combinations thereof. and / or another item may be one, two, three or more items A, one, two, three or more items B, A set of one or more components including item B, and / or one, two, three or more items C. This shall be done.

[0277] In this specification, unless otherwise specified, "and" can mean "or" and "also" can mean "or." "Has" can mean "and." For example, if a feature is described as having A, B, or C, The features may include A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A, B, and C, the feature can be one of A, B, or C. It may have only one or two.

[0278] The term "configured (or set)" as used in this disclosure means, for example, "suitable for" "has been," "capable," "designed," "adapted," "made," and "possible" "configured" can be used interchangeably with "configured" depending on the context. )" does not just mean "specially designed" in terms of hardware. Alternatively, in some cases, the phrase "configured device" may refer to a device configured with another device. It may also mean "capable of" operating with a device or component.

[0279] As used herein, the term "threshold" refers to a desired or undesired state. In some embodiments, the maximum level, minimum level, and / or range of values ​​correlated to The system parameter is above a minimum threshold, below a maximum threshold, within a threshold range of values, and / or is maintained outside a threshold range of values ​​to cause a desired effect (e.g., effective treatment), and / or or to prevent or otherwise address undesirable events (e.g., adverse device and / or clinical events). In some embodiments, the system parameter is reduced (hereinafter "prevented") by the following method. above a first temperature threshold (e.g., above a first temperature threshold to induce a desired therapeutic effect in tissue) above) and below a second threshold (e.g., a second temperature to prevent unwanted tissue damage In some embodiments, the threshold is determined based on patient variability, system The time is determined to include a safety margin, e.g., to account for variability, tolerances, etc. When used in this document, "above threshold" means above a maximum threshold, below a minimum threshold, or below a threshold. and / or for parameters that are outside the threshold range.

[0280] The term "diameter" as used herein to describe non-circular shapes is used to describe It should be considered as the diameter of an imaginary circle that approximates the shape of the component, e.g., the cross section of the component. When describing a cross section such as a shall be interpreted as representing the diameter of an imaginary circle having the same cross-sectional area.

[0281] As used herein, the terms "major axis" and "minor axis" of a component refer to the axis of the component, respectively. The length and diameter of an imaginary cylinder with the smallest volume that can completely surround an element.

[0282] As used herein, the term "functional element" refers to a component that is constructed and configured to perform a function. The term "functional element" should be interpreted as including one or more elements arranged in a In some embodiments, the functional element may include a transducer. configured to deliver and / or otherwise treat tissue (e.g., treatment Alternatively or additionally, functional elements (e.g., A functional element (including a functional component) is a function of one or more parameters, e.g., a patient's physiological parameters, a patient's anatomy, biological parameters (e.g., tissue morphology parameters), patient environmental parameters, and / or system parameters. In some embodiments, the sensor or Another functional element may be configured to perform a diagnostic function (e.g., a In some embodiments, the functional element is configured to perform a therapeutic function. configured to perform (e.g., deliver therapeutic energy and / or therapeutic agent) In some embodiments, a functional element is a component constructed and arranged to perform a function. It contains one or more elements, the function of which is to deliver energy, extract energy (e.g. , to cool a component), to deliver a drug or other agent, to a system component or a patient manipulate tissue, change parameters such as patient physiological parameters or system parameters, Recording or otherwise sensing, and a group consisting of one or more of these in combination A "functional assembly" is an assembly that performs a function, such as a diagnostic and / or therapeutic function. The functional assembly may include an assembly constructed and arranged to A functional assembly may include one or more functional elements.

[0283] As used herein, the term "transducer" refers to a device that receives energy or any input. is understood to include any component or combination of components that receives input and produces output. For example, the transducer may include electrodes that transmit electrical energy. The device may include electrodes that receive and distribute electrical energy to tissue (e.g., depending on the size of the electrode). In some configurations, the transducer converts an electrical signal into an arbitrary output, e.g. For example, light (e.g., transducers including light-emitting diodes or light bulbs), sound (e.g., ultrasonic a transducer including a piezoelectric crystal configured to deliver acoustic energy), pressure, Thermal energy, cryogenic energy, chemical energy, mechanical energy (e.g., motor or are transducers including solenoids), magnetic energy, and / or different electrical signals ( For example, Bluetooth or another wireless communication element. A transducer can convert a physical quantity (e.g., a variation in a physical quantity) into an electrical signal. The transducer may include any component that delivers energy and / or a drug to tissue. For example, the transducer can deliver electrical energy (e.g., including one or more electrodes) to the tissue. Transducers (e.g., lasers, light-emitting diodes, and / or or a transducer containing optical components such as a lens or prism), which applies mechanical energy to tissue - (e.g., a transducer including a tissue manipulation element), applying acoustic energy to tissue (e.g., transducers containing piezoelectric crystals), chemical energy, electromagnetic energy, magnetic energy and combinations of one or more thereof.

[0284] As used herein, the term "mapping procedure" refers to the imaging of organ tissue (e.g., the brain) a patient performing a test on the patient to generate electrical activity information related to the patient's tissue, such as cardiac tissue; This includes clinical procedures performed.

[0285] As used herein, the term "localization procedure" refers to a procedure for establishing a coordinate system and transmitting electronic signals, etc. One or more signals from the system can be used to detect one or more objects or portions of objects (referred to herein as In some embodiments, the location process includes a process for determining the location of an object. The signal is one or more signals generated from one or more sources (e.g., electrodes) and spatially and / or one or more signals that vary as a function of time and from which the generated signals are recorded. Incorporates sensors (e.g., electrodes) to measure the signal. The recording location of the sensors is localized. It may be on the object or may be at a location separate from the object being localized. Generated signals using analysis of measured signals and / or calculations on measured signals The position of the sensor and / or object relative to one or more sources of the signal can be determined. The localization method can incorporate two or more generated signals, a sensor and a signal source. The number and / or accuracy of positional relationships between the sensor and the object are increased. They can be multiple co-located components. In some embodiments, the signal change as a function of time and / or space can be calculated by: In another embodiment, the localization process involves the interaction of the object, the sensor, and the environment. The inherent or pre-existing features of the sensor and / or the measurement environment can be measured, for example, by using a By measuring the signal from the accelerometer and incorporating information from the accelerometer signal into the analysis, and measure.

[0286] As used herein, the term "ablation procedure" refers to the removal of unwanted electrical activity, e.g. For example, cardiac arrhythmias (e.g., atrial fibrillation) or undesirable conditions in the brain (e.g., seizures or ablative therapeutic procedures performed on patient tissues identified as contributing to activity related to tremor This includes:

[0287] For clarity, certain features of the invention that are described in the context of separate embodiments may also be referred to individually. It is understood that they may be provided in combination in one embodiment. Therefore, various features of the invention that are described in the context of a single embodiment may also be used separately or in any combination. It may be provided in any suitable subcombination. For example, any of the components set out in any of the claims may be provided in any suitable subcombination. All features (whether independent or dependent) can be combined in any given way. It will be appreciated that this may be tailored.

[0288] At least some of the drawings and descriptions of the present invention focus on elements relevant to a clear understanding of the present invention. Although the present invention has been simplified to fit the above-mentioned embodiments, for the sake of clarity, it will be understood by those skilled in the art that the present invention is also part of the present invention. It should be understood that the present invention excludes other elements that may be understood to include However, such elements are well known in the art and they do not necessarily provide a better understanding of the present invention. As it is not intended to facilitate understanding, a description of such elements is not provided herein. .

[0289] The functional features, operations, and / or steps described herein or otherwise incorporated herein To the extent that such functional features, operations, and the like are understood to be included in various embodiments of the inventive concept, The operations and / or steps may be represented as functional blocks, units, modules, operations and / or methods. Such functional blocks, units, modules, etc. may be embodied in a method. To the extent that the operations and / or methods include computer program code, The computer program code may be stored in a computer readable medium, such as a non-transitory memory and and can be stored on a medium or the like and executable by at least one computer processor. be.

[0290] Provided herein are systems and methods for calculating patient information. The physiological data is recorded at one or more recording locations and transformed using a transformation, e.g., a transfer matrix, The patient information is determined at one or more target locations, which may be remote from the recording location. It may be recorded by electrodes placed on and / or within the patient's skin, and may include electrical and / or Other patient information may include target locations, including the patient's organs (e.g., heart or brain). The system of the present concept can be used to determine the transformation. These may include components such as electrodes, magnets, coils, or other sensors and transducers. The tissue properties between the recording and target locations are characterized using patient information. The method may be performed on a patient, and / or one or more mammalian subjects.

[0291] Referring now to FIG. 1, a diagram illustrating the location of at least one device within the body consistent with the concepts of the present invention is shown. FIG. 1 is a schematic diagram of an embodiment of a system 10 configured to perform location localization. 10 cooperatively record and analyze physiological information and diagnose physiological conditions and / or diseases. and / or various components configured to treat physiological conditions and / or diseases; The system 10 may include a console 5000, which A system that includes one or more processors, data storage devices, and functional modules, and that cooperatively operates multiple Receives data and information from different external functional elements, processes the received data and information, and outputs output, e.g., information shown on one or more displays, to the processed data and information The generated data is based at least in part on the

[0292] The external functional element is configured for insertion into a body, such as a human body or a patient P. It may include one or more catheters 1000. In various embodiments, one or more catheters At least one of the probes may be insertable into a chamber of the heart H, and the system 10 may include: Record and analyze physiological information to diagnose physiological conditions and / or diseases and / or cardiac Such drugs may be adapted to treat physiological conditions and / or diseases associated with H. The catheter and / or its functional elements may be adapted to multiple location techniques or modes, e.g., impedance The location is determined using a combination of magnetic, ultrasonic, and electrical localization. The external functional elements may also include electrodes, magnetic elements, and / or combinations thereof. The patch may include one or more patches 500 (e.g., patches 510, 520, 550). , can be external to the patient, for example, patch 500 is configured to be attached to the torso of patient P. The patch 500 and catheter 1000, or components thereof, may be configured to store data and and information to the console, functioning of the different location modes used, e.g., impedance The device may be configured to perform magnetic, and / or ultrasonic localization techniques.

[0293] In FIG. 1, multiple catheters 1000 are provided for one or more diagnostic, localization, and / or therapeutic purposes. FIG. 1A shows a portion of the system of FIG. 1 useful for localization. FIG. 2 shows a schematic diagram of a portion of one or more catheters forming part of the system of FIG. A diagram of one embodiment is shown. The system may include a console 5000, which may include at least The various processing and data storage elements or functional modules of a special purpose computer Includes various different types of diagnostic, therapeutic, and localization functional elements, e.g., internal and external The functional components are coupled to the console 5000 for use on or with the patient P. In various embodiments, a display (such as output component 60 described below) coupled to the console and driven at least in part by the console, ,display, images, graphs, etc., from one or more external sources, e.g., multiple catheters. 1000 and / or a plurality of patches 500, based on processing of the information and data received from the The control unit 100 may be configured to provide a

[0294] In the embodiment shown, the plurality of catheters 1000 includes at least one diagnostic catheter. The catheters include, for example, diagnostic catheter 1100 and / or diagnostic catheter 1200. 2 shows an exemplary embodiment of a portion of a diagnostic catheter 1100. The catheter 1100 includes a basket array 1150 that includes a plurality of splines 1157. One or more of the plurality of splines 1157 includes one or more functional elements. The active element senses and / or records electrical potentials related to cardiac activity and / or for localization. In various embodiments, the array 1150 is configured to include between 3 and 8 splices. In the particular example of FIG. 2, array 1150 includes six splines, each The plane includes a number of sensing, recording, and / or locating devices as functional elements.

[0295] As shown in FIGS. 1, 1A, and 2, one or more of the splines 1157 may be connected to the electrodes 1151, 1152, 1153, 1154, 1155, 1156, 1157a, 1156b, 1156c, 1156d, 1156e, 1156f, 1156i, 1156i, 151 functional elements useful for cardiac activity mapping and / or localization. The electrodes 1151 are configured to sense and record useful data. for determination and / or in some embodiments, used to deliver ablation energy. The electrodes 1151 may be coupled to a console 5000, which may may be configured to drive the electrodes 1151 and receive and record data from the electrodes 1151 One or more of the splines 1157 further includes an ultrasonic transducer (UST) 1153. The ultrasonic transducer may include at least one ultrasonic emitter and an ultrasonic sensor. The lancet 1153 may be inserted into the basket array 1150 or into another catheter or catheters within the heart H. may be configured for localization of elements and generate images of the heart H or other anatomical structures. The device may also be configured to sense useful data to update and / or update the device.

[0296] The catheter 1100 slides within a lumen 1325 within the shaft 1320 of the sheath 1300. The sheath 1300 includes a catheter shaft 1120 configured to A transseptal sheath used for insertion and translation into the P, and for carrying the basket array 1150 to the heart. The sheath 1300 can include at least one functional element 1390. For example, electrodes, coils, ultrasound transducers, etc., may be located at the distal end of the shaft 1320. In some embodiments, the functional element 139 0 includes one or more transducers as described above. A handle 1110, which is used to steer the catheter, connects the catheter shaft 1120 and the syringe. The basket array 1150 is located at the proximal end of the catheter shaft. 1120. In various embodiments, the array 1150 extends from the distal end of the catheter. an expandable / collapsible basket array coupled to the distal end of the shaft 1120; The actuator 1121 may be or may include a It is slidable and has a distal end that is coupled or engaged to the distal end of the array 1150. In various embodiments, the actuator 1121 may, for example, straighten the spline 1157. 1150. The splines 1150 are then extended distally to collapse the array 1150. 57 outwardly, retracting proximally to expand array 1150.

[0297] In various embodiments, the catheter shaft 1120, the array 1150, and / or the actuator The controller 1121 can include one or more functional elements, which can be located at one or more positions. Localization methods, such as magnetic localization, impedance-based localization, and / or ultrasound to generate, sense, and / or record data useful in performing location determination of the base. Referring to FIG. 2, the actuator 1121 comprises one or more magnetic elements 115 2, which can be "driven" via console 5000 to generate a magnetic field, or or "sense" the magnetic field, i.e., the console 5000 is coupled to the magnetic element 1152. and may be configured to drive magnetic elements 1152 to establish magnetic fields useful for localization. Thus, the location may be determined, for example, by the array 1150 and / or its functional elements, actuators 11 21, and / or another functional element within the patient P or heart H, such as an ablation catheter. In this embodiment, at least one magnetic element 11 52 is an actuator when fully or substantially fully extended. 1121, for example, located at or near the center.

[0298] A set of auxiliary functional elements 1158, e.g., electrodes, are attached to the distal end of the shaft 1120. Optionally, a sensor 1121 may be included to measure the position of the actuator 1121. In two embodiments, the auxiliary electrode 1158a is located on, in, or at the distal end of the shaft 1120. Another auxiliary electrode 1158b-c is located at the distal end and is used to control the actuator 1121 The auxiliary electrode 11 on the shaft 1120 is placed on, in, or on the actuator 1121. The relative distance measurements between 118a and one or more auxiliary electrodes 118b-c can be measured, for example, by This can be used by actuator 5000 to determine the relative distance. 121 and shaft 1120 may include electrodes 1158a-c, Used as a "measuring stick" to help determine the shape of the basket array 1150 The catheter 1100 may also include at least one other functional element 1190. 1120, which may include electrodes, coils, and / or physiology disposed on the catheter shaft 1120. In some embodiments, the functional element 1190 is a functional sensor, as described above. Although not shown in FIG. 2, actuator 1 121 may, in various embodiments, include one or more USTs 1153. In an embodiment, the position and orientation of the basket array 1150 is determined by the magnetic sensors described herein. The basket array 1150 is determined using the basket array 1152 and magnetic location system. Using known configurations, one or more USTs 1153 and / or electrodes 1151 may be magnetic sensors. The location may be determined based on the determined position of the sensor 1152 (e.g., the basket array). The overall position and orientation of all elements of the I-1150 are estimated using a magnetic location system. In some embodiments, one or more additional devices (e.g., catheter 1 The position and / or orientation of the electrode array 1250 of 200 can be determined using a magnetic localization system. , the magnetic field of one or more elements of the additional device (e.g., electrodes 1251 of electrode array 1250) By evaluating the position relative to the electrically localized basket array 1150, For example, the relative position of the additional device with respect to the basket array 1150 is determined by one or more localization methods, such as ultrasound localization and / or Or may be determined using impedance-based localization. This in-device localization involves identifying the location of an internally placed device (e.g., a device within a patient). signals transmitted and received from the patient), and / or externally (e.g., externally to the patient, e.g., signals (a signal sent through one or more patches similar to those listed) This is achieved using location specific signals.

[0299] 1 and 1A, in various embodiments, the second diagnostic catheter 1200 includes: Catheter 1200 may be included as needed. For example, in some embodiments, The catheter 1200 may be a coronary sinus mapping catheter, which maps the coronary sinus of the heart H. The catheter 1200 is constructed and arranged for positioning within the venous sinus. The functional element may be an electrode 1251, e.g., used for cardiac activity mapping and / or localization. The electrode array 1250 may also include an electrode array 1250 having a shape of an electrode. , may include one or more magnetic elements 1252, which may be used for magnetic localization. The catheter 1200 also includes at least one other functional element 1290, e.g., a catheter may include electrodes, coils, and / or physiological sensors placed on the ter shaft 1220. In some embodiments, the functional element 1290 may include one or more Includes a transducer.

[0300] 1 and 1A, in various embodiments, the treatment catheter 1500 may also include, for example, For example, system 10 may be configured for insertion into the heart H (or other anatomical structure) of patient P. The treatment catheter 1500 may be, for example, an ablation catheter. For example, radiofrequency (RF) ablation catheters, alternative light energy catheters catheters, microwave therapy catheters, cryoablation catheters, or ultrasound or is another acoustic energy catheter. The energy delivered by the therapeutic catheter The energy may be constant or direct, switched, alternating, or powered. may be delivered as pulsed energy and / or modulated or phased energy The therapeutic effect of the energy delivered by the catheter is achieved through direct and / or indirect contact. The catheter can be delivered by (e.g., without physical contact, by field effect, etc.). The tool 1500 may include a shaft 1520 with a handle 1510 at its proximal end. The distal end of the shaft 1520 includes a treatment array including at least one functional element 1551. 1550. By way of example, the functional elements of the therapy array 1550 may be of one or more types energy delivery element(s) 1551, e.g., one or more RF delivery electrodes, optical energy delivery electrodes, one or more optical components, thermal energy, and / or ultrasonic energy for delivering ghee In some embodiments, the device may include one or more acoustic transducers for delivering a signal. In this embodiment, electrodes 1551a-d may be used for ablation therapy, but in another embodiment, one electrode (e.g., electrode 1551a) may be used for ablation, and the remaining electrodes 1551b-c One or more may still be present for location purposes, e.g., if array 1550 is cooled. In various embodiments, functional element 1551a may include a cryoablation tip. , can be a treatment element (e.g., RF, CRYO, etc.), and the functional elements 1551b, c, d are , may be electrodes for locating the therapeutic element 1551a. The catheter 1550 includes four electrodes 1551a-d for RF ablation. 1500 may also include at least one other functional element 1590, such as a camera. Electrodes, coils, and / or physiological sensors located on the catheter shaft 1520. In some embodiments, the functional element 1590 may include one or more Includes a transducer.

[0301] 1 and 1A, in various embodiments, another optional functional catheter 16 00 may also be included in the system 10, for example, to monitor the heart H (or other anatomical structure) of the patient P. The optional catheter 1600 is a diagnostic catheter, The catheter may be a catheter for catheterization, a catheter for treatment, or a combination thereof. The catheter 1600 may include, but is not limited to, a handle 1610 at its proximal end. The distal end of the shaft 1620 may include at least one For example, an electrode (or another functional element) may be arranged in a functional array 1650. ) 1651 functional elements of the treatment array 1650, e.g., mapping, diagnosis, treatment, and / or or localization electrodes or elements are disclosed herein. The catheter 1600 may be a lasso catheter, e.g., a biased catheter in a loop configuration as shown. Includes a tapping catheter.

[0302] 1 and 1A, the patch 500 is placed on the body, e.g., the torso, of a patient P. The patch 500 may be configured to connect the console 5000 to one or more cables or Using a cable assembly 501 or other wired or wireless data transfer element or technology The patch 500 may be a skin-contacting patch and may be attached to the patient P's torso. Each patch includes one or more types of functional elements. The patch 500 includes at least one impedance patch 510 (e.g., a voltage or The patch may include a patch for measuring and / or applying a current, which may be used to measure impedance at the patch. at least one impedance function element configured to measure Each has one impedance electrode 515. Impedance measurements are taken by the console 5 000 to perform impedance mode localization. The patch 500 may include an impedance function element and apply an impedance field. , may include at least one magnetic patch 520, which is configured to measure a magnetic field. and at least one magnetic functional element, for example at least one coil 525, The magnetic field measurements are used by the console 5000 to perform magnetic mode localization. The patch 500 may include a magnetic functional element and apply a magnetic field. It may include at least one ultrasonic-based functional element, such as an ultrasonic sensor and / or transmitter. The ultrasound signals received and / or transmitted by the patch are transmitted by the console 5000. can be used to perform localization in ultrasound mode, for example, by using a catheter or Detect the presence or location of a body structure or device applied to or inserted into the body, such as a sheath Put out.

[0303] In some embodiments, the patch is attached to a wearable garment or portion thereof, e.g., a vest. The garment may be configured to be incorporated into a jacket, suit, shirt, or bodysuit. The garment may be made of a material that maintains contact, pressure, and / or position of the functional element against the garment. Integrating materials with elastic or compressive properties to reduce contact, pressure, and / or stiffness of the functional element against the body. The garment may include multiple layers and may include one or more functional elements or A portion of the material may be maintained within such layers. The garment may include optical, electrical, and / or The garment may be made of or contain a magnetically permeable material. The garment may be made of or include one or more patches. The outer surface may include a

[0304] In some embodiments, one or more of the patches 500 may be of two or more different types. 1 and 1A may be a combination (or "combo") patch that includes the functional elements of Illustrated are embodiments of different types of combo patches. For example, combo patch 550 may include at least At least one magnetic element and at least one impedance element, and optionally another For example, functional elements may include functional components 599 of various types, typically It can be a 12-lead EKG / ECG (electrocardiogram) element placed. The patch 550 has electrodes 515 and magnetic coils 525 in the same positions as the patches 510 and 520, respectively. 5. The patch 510 may include all the functions of the patch 510 and 520, as well as the EKG / ECG function. Alternatively or additionally, the system 10 may be configured to perform one or more EKG / ECG leads (or patches) 560 may be included.

[0305] In various embodiments, any one or more of the patches 510, 520, and 550 may include: It may include at least one other functional element 599. Beyond the EKG / ECG functional element, Element 599 may be, for example, a general sensor, transducer, and / or other functional element. , such as an accelerometer, sweat detector, physiological sensor, and / or imaging marker (e.g., radiometric radiopaque markers, MR markers, acoustic reflective markers) As another example, in some embodiments, functional element 599 may be a microwave functional element, an ultra It may be or include a sonic functional element, or a combination thereof.

[0306] In some embodiments, the patch 500 may include a porous material to form the porous conductive patch 500. 00, which allows the patient's skin to breathe, thereby reducing sweating In some embodiments, the porous patch 500 , can be completely immersed in a conductive "coating" material, resulting in (the patch) The entire structure is conducting, e.g. the "coating" is a 3D structure rather than a 2D layer on the surface of the patch. In some embodiments, the conductive coating may provide the same electrical conductivity as the The patch may be wet or dry and may be impregnated with a hydrogel to provide electrical conductivity with the skin of the patient P. Avoid the need to secure

[0307] The various catheters 1000 and patches 500 are connected to the console 5000 in several ways. The coupling may be via either wired or wireless devices and / or technologies. In this mode, the console 5000 receives, processes, and transmits data and information from multiple external sources. and one or more processors and data storage devices useful for storing and / or transmitting the Improved localization of one or more devices relative to the body may be achieved. In this embodiment, the console 5000 may communicate with one or more external devices, such as a cardiac or other anatomical drive, interrogate, and / or control diagnostic, mapping, and / or treatment devices for cardiac structures; The device may be configured to:

[0308] In the embodiment of FIG. 1, the console 5000 includes an imaging module 5010, a mapping module 5020, a module 5020, a treatment module 5030, and a user interface module 5050. The imaging module 5010 generates at least one image of the heart or cardiac H. and a method for providing, generating, acquiring, updating, storing, and maintaining at least one heart chamber of the heart. The imaging module 5010 receives imaging information from at least one imaging device 50. The imaging device may receive anatomical information (e.g., cardiac anatomical information) from from one or more images or imaging sources or systems, e.g., computed tomography (CT) ) such as collected from scans, fluoroscopy, x-ray, MRI, and / or ultrasound imagers It can be configured as follows.

[0309] In various embodiments, the console 5000 includes an imaging module 5010, which receives and stores image information from at least one imaging device 50. The device 50 may be a magnetic resonance imaging (MRI) device, a fluoroscopy device, and / or a cardiac model. The image may be or may include at least one of the sources of the image. The image processing module 5010 performs the following operations based on the data and information received from the imaging device 50: For example, it may be configured to provide, generate, and / or update an anatomical model of the heart H.

[0310] The console 5000 transmits cardiac activity mapping information to electrodes (e.g., catheters or pads). The device may further include a mapping module 5020 configured to receive the signal from the sensor (electrode), Generate cardiac electrical activity maps, where cardiac activity is measured using a variety of parameters such as voltage, surface charge, and dipole density. It is more than one thing.

[0311] The console 5000 may further include a treatment module 5030, which may be used to administer a treatment catheter. and causing the tel 1500 to deliver or deliver therapeutic energy to one or more locations of the heart H. This is configured to drive the mapping or the image generated by the system 10. Closed-loop energy delivery may also be based on other information. For example, the therapeutic catheter 1 500 is any of the components mentioned herein, known in the art, or hereafter developed. It may be or include an ablation catheter of the type The catheter may be inserted into any other type of therapeutic device known in the art, such as a drug or device. It may be a delivery system or a catheter.

[0312] The console 5000 may further include a user interface module 5050, It includes one or more user input and output components 60, such as a two-dimensional display, a three-dimensional Displays, keyboards, mice, touchscreens, printers, 3D printers, communications The system is configured to exchange data information with the system.

[0313] The imaging module 5010 may additionally or alternatively include one or more ultrasound functional elements, e.g. configured to receive data and information from, for example, a UST element 1153 on the catheter 1100. It can be done.

[0314] In various embodiments, the console 5000 is capable of establishing and maintaining multiple location modes. The location subsystem 5100 is configured to: 0 receives location information from the patch 500 and catheter 1000 and processes that information. Multiple location modes may be combined to generate device location information. These modes include at least one of an impedance location mode and a magnetic location mode. In some embodiments, the multiple location modes may include at least one of: Alternatively or additionally, at least one ultrasound localization mode may be included. In an embodiment, the first positioning mode is an impedance positioning mode, which is for a patient established using one or more impedance electrodes 515 configured to sense impedance values related to P. A change in impedance is determined from the impedance values obtained.

[0315] In various embodiments, the positioning subsystem 5100 includes an impedance positioning module 5110. The impedance positioning module 5110 includes processing functionality for implementing the impedance positioning mode. The impedance positioning module 5110 may include an impedance signal generator 5111, which is configured to generate a drive signal for driving an impedance-based positioning element, such as electrode 1151.

[0316] In various embodiments, the positioning subsystem 5100 includes a magnetic positioning module 5120. The magnetic positioning module 5120 includes processing functionality for implementing the magnetic positioning mode. The magnetic positioning module 5120 may include a magnetic field signal generator 5121, which is configured to generate a drive signal for driving an internal and / or external magnetic coil, such as magnetic element 1152. The console 5000 may also include or be coupled to an external fixed magnet 5125. The fixed magnet 5125 may be a fixed magnetic field generator and may take the form of a magnetic sensor that provides a fixed coordinate reference, for example, to an operating room, an operating table, a patient, etc. The magnetic positioning module 5120 receives information and data from a fixed magnet 5125, such as a fixed coordinate reference, or associated with the fixed magnet 5125, and magnetic Gas localization may be performed.

[0317] In various embodiments, the location subsystem 5100 optionally includes an auxiliary location module. The auxiliary location module 5130 may include an auxiliary location mode. and an auxiliary location signal generator 5131 configured to drive any signals required for Auxiliary location modes include, for example, an additional magnetic location mode, an additional impedance The location mode may be a sensor location mode, an ultrasonic location mode, or a microwave location mode. .

[0318] The location subsystem 5100 includes a location processor or processing module 5150. 5110, which may include transmitting device location information to an impedance location processor 5110 and Both the magnetic location processor 5120 and, if present, the optional auxiliary location processor For example, the location processor 5150 generates the location information based on the output of the location processor 5130. Impedance localization and magnetic localization can be used to determine if the catheter 1000 or a portion thereof The minute may be localized within the patient P and / or the heart H of the patient P.

[0319] In various embodiments, the console 5000 may be distributed on, within, and / or across the body. One or more elements to generate a distribution (e.g., a field) and measure one or more properties of the distribution For example, distributions include voltage, current, magnetic, electromagnetic (e.g., RF, microphone) The distribution may be over a volume of the body and / or may be a pressure distribution. Or when applied to an entire volume, it encodes spatial information, i.e., the distribution As it varies as a function of and / or orthogonality) have a relationship (e.g., corresponding or mapped values) to the spatial coordinates of the volume. The distribution follows the corresponding physics applicable to the generated energy modality. To estimate the distribution, we use a set of one or more equations (e.g., Max) that follow the physics of the problem. The solution of the unknowns in the equations (field equations such as the Wells equation) can be established. The collection of fields followed by calculation or modeling of the field solutions allows the pursuit of one or more field properties or characteristics. This may be accomplished with or without additional constraints, assumptions, or prior knowledge. In this paper, the calculation or modeling of a field solution to obtain device location information is a method for solving a field problem. In some embodiments, the calculation or modeling of the field solution may be carried out in part. For example, partial solutions may be limited to geometric or spatial domains (e.g., heart chambers). As another example, a partial solution can be a partial solution of all possible field properties. may be limited to solving a set of field equations corresponding to a subset (e.g., field gradients For properties such as (The size is not explicitly estimated.)

[0320] In some embodiments, the field distribution is determined by one or more electric or electromagnetic sources, e.g., voltage or current. The impedance locating module 5110 generates This application can result in the generation of one or more corresponding field distributions, e.g., generated through space. This leads to the voltages, currents, and / or magnetic fields that are generated by the field distribution, or the corresponding distribution in space where the field is applied. Measurements of properties that affect the field (such as the distribution of local impedance across a volume, such as a patient's torso) This may be implemented using a set of one or more sensor elements distributed at one or more locations within the Combining information from sensor elements to produce a quantitative description of the field and its properties (e.g., a model) For example, at least three sensors providing simultaneous recordings can be used to estimate the three-way It is possible to model a multidimensional field, for example a three-dimensional field.

[0321] In some embodiments, the number of simultaneous measurements required can be reduced by taking advantage of known limits on the field degrees of freedom. By controlling the number of sensors over time, e.g., by controlled mechanical variation of the sensors, A series of constrained or controlled measurements are taken through a set of positions (e.g., a known sequence of operations). For example, a single electrode can be used at a known distance. crossing or controlled directions (e.g., in the case of a 3D Cartesian coordinate system, the three cardinal directions) Moving the electrodes in a short time (e.g., seconds) can adequately sample the 3D space and estimate the field. As another example, a distance with a known distance (e.g., Euclidean distance, manufactured distance) Using a set of two or more electrodes, two electrodes can be used in three or more directions (e.g., 3D dimension). For the default coordinate system, the deflection, rotation, and sweep directions are oriented in the three main directions. The vehicle may be steered forward, backward, forward, or some combination thereof. The configuration requires that the electrodes be oriented in three unique directions (e.g., directions that are 3° or more apart) or that the electrodes be spaced apart. The set of sampled orientations is unique enough to form two unique planes in 3D space. In some embodiments, a set of algorithms We quantify the degree of directional sampling using Feedback may be provided to the user regarding the quality. Feedback may be used to An indicator can be provided to the user that sampling is sufficient. insufficient or users are not completing sampling optimally or efficiently to a sufficient degree. In some embodiments, the sources and sensors described above are interchangeable. (The sensor can remain in a static position while the source is distributed in space.) or moved throughout space).

[0322] In the next section we will explain the simple linear field approach. Field Source(s) The field (e.g., patch) can be optimally configured to reduce the field degrees of freedom. The patch configuration (e.g., position and / or orientation) that generates the constant current is aligned along the direction of the current ( A linearly varying voltage field can be generated (using parallel equipotential surfaces), resulting in The three-dimensional spatial description of the field is completely acquired by two or more spatially distributed sensors. Furthermore, the generated field satisfies Maxwell's equations that govern the electromagnetic field. Applying the method to a second unique current direction only requires the use of one or more additional sensors. Again, to accommodate the third unique current direction, only four or more sensors total are required. In essence, we obtain three simultaneous but independent field models, each of which is a Maxwellian satisfying independent sets of equations. This configuration is a full third-order This is one method of identifying the original location.

[0323] In the next section, we will consider general fields that satisfy the governing field equations. An approach to achieve this is described below. The field established by and is described by the simplified Maxwell equations: obtain. ∇·(σ∇v)=0, via the volume and corresponding boundary conditions J·n={(0, if the current source is not present on the outer surface where the current density is applied, at the patch) A complete solution to this problem, which provides the distribution of the voltage field v within the body, is the patch and its placement on the body surface. This can be obtained by knowing the boundary condition (J) which depends on the patient, and the body conductivity distribution σ. Prior knowledge of the boundary conditions and conductivity distribution of the fluid can be difficult to obtain. A simplified model can be used to generate an approximate solution to this problem. This solution is based on the patient-specific torso 3D models of the image, e.g., models obtained from segmented CT and / or MRI images. This can be further enhanced by Dell.

[0324] In some embodiments, the field distribution within the heart is measured to navigate the electrodes within the heart. The blood pool must be estimated, thus alleviating the need to know the surface boundary conditions J. Since the conductivity of the tube is constant over space, the governing equation is the Laplace equation ∇ 2 Simplify to v=0 This effectively reduces the need to know the conductivity distribution σ. can be effectively reduced and solved using a reduced set of sensor measurements. The structure of the field (region of limited conductivity change) is such that the field deviation is negligible and the Laplace Therefore, the solution to the Laplace equation can be found in these regions For example, these regions may be located in thin conductive tissue structures (such as the atrial wall). In some embodiments, the solution of the Laplace equation may comprise the use of Green's functions. can be analytically approximated by

number

number

[0325] The limitation of the Green's function design is that one set of measurements (voltage or current) from one set of distributed points Transformation to provide a voltage in a desired area as a function of the field current (other field properties, such as current, may also be used). The points at which measurements are taken may be within or outside the desired region. The governing field equations that apply are the same for the various sources, so the simulation solution, analytical solution, or experiment using a set of controlled sources (resulting from the same physics) A series of measurements taken from an experiment can be used to estimate the transformation. Suitable measurements consist of both points where the voltage is known and points where it is desired to detect the voltage.

[0326] The estimated transformation is then used to convert the voltages in the desired region to the positions used in the estimation process. This conversion follows the same physics as This allows you to act on all sources that you attribute (which describes the controlled source). The method involves applying voltage measurements to various configurations of (known) points across the region of interest (used in the prediction process). voltages generated by controlled sources (including all voltages used in If a new configuration of points with measured voltages is available, The transformations to obtain the voltages at all other locations can be deduced from the stored values.

[0327] The solution to a linear field set is simplified to the required solution for computing the field model. This is an advantage because it reduces the number of measurements that are made. The method is to measure the nonlinearities in the field and correct for them. The nonlinearity seen from multiple sources applied to the patient can be estimated by the following method: are numerically combined (e.g., by addition, weighted addition, and / or nonlinear combination) via a laser beam, can generate a field with minimal or at least reduced nonlinearity. , which reduces the burden of accurately estimating the structure of the nonlinearity of the field. This can be limited to the range required to guide the field combination to reduce linearity. The process may then be repeated. The reduced estimation burden is proportional to the number of sensor measurements, This can mean a reduction in noise requirements for measurements generated by various sources. In addition to combining the fields numerically, physical patches (of various sizes and and / or shape patches, etc., can be guided based on this method.

[0328] Varies as a function of time due to natural variations in the various parameters governing the field setup Changes in various parameters may be due to physiological changes, e.g., trunk impedance. , changes in the shape of the body, or the interface between the patch and the body or the movement of the body. At different times, the field distribution changes and the If the field is too large, it can affect the localization process. Second, the description of the field can be updated to fit different temporal states. The update can be an adjustment or correction applied to the estimate, or a different The applicable field modulation or temporal state may be a function of the field or the medium in which the field persists. These measurements are correlated with the state of the field. The process of creating consistency, stability, and precision among a field of conditions is called a "reference." In various embodiments, the application of the field criteria is referred to as "application of the field criteria" through various temporal states. This can be done using adjustments to the sensor measurement signals to make them consistent with each other. The measurements from these sensors can be from a series of measurements or from different sensor locations. The values ​​may be used to extract a modulation signal corresponding to the temporal nature of the change in the field. If applied, different fields can be used to increase the redundancy of the localization process, and then can be used to correct for various artifacts, such as impedance sources and magnetic fields. Applying both field sources, a localization system with each energy modality can be created. The signals measured by the electrodes / magnetic sensors belong to two different energy modalities. The number can be written as follows: S(t) = position(t) + physiology(t) + artifact(t) where "S" is the measured sensor signal, and is determined by the sensor position and the It varies as a function of other physiological and external (e.g., artifact) factors. Physical changes are experienced simultaneously by both magnetic and electric fields (e.g., breathing). allows us to describe the physiological (t) part of the signal between the two modalities as follows:

number

number

[0329] Various transformations have specific signatures within the energy modality (temporal / spatial / frequency ) and can separate various factors. For example, From the collected signals, frequency separation is performed to identify the individual inducers of the signals from the energy modalities. Field modeling can also be used to create a transformation function. Execute a specific step, e.g., controlled movement of a sensor or source, controlled field disturbance Then, the transformation can be estimated.

[0330] As an example, the transformation shown above is a linear combination transformation, but other forms of transformations can also be used. These transformations are governed by the physics of the problem.

[0331] In various embodiments, the spatial description of the field may be used to estimate the position of the sensor. A field description is an estimate of the spatial distribution of a particular property of the field, e.g., impedance localization. The sensor measurements can be converted into field characteristics by processing, which can be estimated. and used to decode the sensor's position.

[0332] The transformations and / or field properties used by the system 10 to describe the field may be determined by the patient specific periodic points in physiological fluctuations (e.g., cardiac and / or respiratory cycles), e.g., field It can be estimated at a point of minimum complexity (e.g., to simplify modeling). At these specific times, due to favorable physiological conditions, the applied field exhibits spatial nonlinearity. This simplifies the field description and requires less input. In some embodiments, these points are close in time to the T wave and / or P wave of the ECG signal. In addition, signals can be measured at specific points in time over a wider period of time. can lead to invariance of the source, which has a period that matches the observation period, Contributions to signal variation from other sources may be observed within these measurements. A transformation (e.g., a model) describing the source can be inferred based on the observations.

[0333] In some embodiments, the artifacts in the recorded signal include discrete impulses. (e.g., caused by a short, high-amplitude exogenous signal, e.g., a pacing pulse) This discrete impulse is a waveform that contains components with "sharp" structures (e.g., a steep leading edge). Such artifacts can produce waveforms with a high and / or low edge. Signals (e.g., impedance-based localization signals recorded by electrodes to be localized) signal), a short "jump" in the determined position of the recording electrode In some embodiments, the system 10 may be The threshold algorithm is based on observing signal fluctuations during a test period. The recording electrode position can be configured to limit the jumps observed. The length of the filter is comparable to and / or longer than the length of the extraneous signal causing the artifact. Median filtering of the signal with a period also limits the observed position shift. In some embodiments, one or more additional filters may be used to By applying this to a signal containing structured components, the system 10 observes Filter artifacts sufficiently to make them negligible (e.g., at the position of the recording electrode). (Jumps in the signal are ignored after applying two or more filters). , applying a first filter (e.g., a median filter) before a second filter The process of limiting the amount of such sharp structures is difficult to observe at the localized position of the catheter. This can help prevent pages from appearing as jumps. The sing pulse is applied to the electrode (which is also localized using impedance localization). When delivered via a pacing pulse, the artifacts caused by the pacing pulse are relatively small. In some embodiments, this artifact may be localized. This saturation and / or effect on the recorded signal amplitude may be sufficient to saturate the recording circuitry. Any changes in the channel frequency may be used by the system 10 to facilitate the presence of pacing on the channel. The system 10 can then detect those signals recorded while pacing is present. The signal may be ignored or otherwise filtered to prevent pacing while pacing is present. This avoids adversely affecting the localization of one or more other electrodes that are localized on the same electrode.

[0334] In various embodiments, the console 5000 includes a transformation (such as a scale matrix) 5155. It converts the raw localization information into a position relative to the anatomical model 5255 and The optical model 5255 may also form part of the console 5000 or may be The scale matrix 5155 determines the rate of change of the field values ​​(e.g., is a measurement of the impedance field (rate of change of voltage) and the field characteristics that can be used in the localization process. This is an example of identifying the characteristics. The process of localization using the scale matrix determines the position of the sensor. This allows for simple linear operators to estimate the position. The process of estimating the sensor position is based on the sensor position. and a location (e.g., a location whose location relative to the anatomical structure and field values ​​is known). The difference between the values ​​(e.g., voltage) of the The output of the resulting process is the position of the sensor relative to the known position. The scale matrix 5155 may be a function of at least one of the following: formed from localization data that can be adjusted or corrected based on a reference point or frame of reference .

[0335] In various embodiments, the console 5000 may include an anatomical subsystem 5200. 11, which receives anatomical information from the diagnostic catheter 1100 and measures the heart H or a portion thereof. In some embodiments, the generated anatomical model comprises: This may include information received from the external imaging device 50 via the imaging module 5010. The anatomical subsystem 5200 provides real-time, near-real-time visualization of the anatomical model. In various embodiments, the anatomical subsystem may be configured to update the The system 5200 may include an ultrasonic module 5210 and an ultrasonic signal generator 5211. The ultrasound module 5210 is connected to the ultrasound transducer of the first diagnostic catheter 1100. The ultrasound transducer may be configured to drive / record any other ultrasound transducer in the system 10. The ultrasonic module 5210 may drive a laser element, for example, a functional element 1153. The ultrasound signal generator 5211 is used to generate an ultrasound drive signal, which is transmitted through the catheter 1100. In general, the ultrasonic transducers of the system 10 may be excited.

[0336] The anatomical subsystem 5200 optionally includes an anatomical import module 522. 0, which receives anatomical information from an external imager 50 and converts that information into an ultrasound module. 5210 to provide, for example, improved accuracy and / or resolution. Create an "enhanced" anatomical model 5255 that can

[0337] FIG. 3 illustrates a method for initializing, calibrating, and / or correcting a location system consistent with the concepts of the present invention. 7 shows a flowchart of an embodiment of a method 7100 for The data storage, processing, and generation portion is implemented by the console 5000 of FIG. 1 or its components. It can be performed as follows.

[0338] In step 7110, an external component is positioned and one or more catheters 1000 are inserted into the patient. In various embodiments, a first location mode is initialized and coordinates The coordinate system is established, then a second location mode is initialized, and the coordinate system is connected to the first and second location modes. The device is recalibrated using the fixed mode. A coordinate system is established to locate the device within the patient P. provides a frame of reference for

[0339] For example, in one embodiment, the first location mode is an impedance location mode. The second location mode may be a magnetic location mode. Initializing the location mode involves attaching the external patch 500 to the patient P's torso. The patch 500 may include at least an impedance electrode 515. The magnetic location mode, which is the location mode, can be set. Initialize magnetic location mode The step of administering the external patch 500 to the patient P may include applying the external patch 500 to the patient P's torso, the patch comprising: At least the magnetic element 525. That is, in various embodiments, the impedance pad A fixed magnet 510, a magnetic patch 520, and / or a combo patch 550 may be used. 5125 may also be positioned under a table supporting the patient P, etc. may also include inserting one or more of the catheters 1000 into the patient P, wherein Such catheters have two localization modes, e.g., impedance and magnetic saccade. For example, the diagnostic catheter 110 includes elements useful for establishing at least one of the following: 0 / 1200 or both are inserted into the body of patient P and A specific mode can be initialized and calibrated.

[0340] In step 7120, with the physical patch 500 and catheter 1000 in place, The first location determination mode is initialized by location components, such as electrodes 515 for impedance location mode or magnetic location This includes activating the magnetic elements 525 for the fixed mode to establish a coordinate system within the patient P. That is, patch 500 is used to generate signals that establish a three-dimensional coordinate system (X, Y, Z). The coordinate system is used to determine the position of the catheter and its elements within the patient P. That is, the location is established. One embodiment of a method 7200 that may be used is provided.

[0341] In step 7130, the coordinate system is determined based on the first localization mode and the inserted catheter. For example, the catheter 1100 having the basket array 1150 is used for calibration. 4 provides one embodiment of a method 7200 that may be used to implement step 7130. According to this method, the established coordinate system is first calibrated so that localization can be performed. Calibration involves determining the initial scale of the X, Y, and Z axes of the coordinate system and the origin of the coordinate system at the sensor position. This can be used to determine with an initial assessment the area where the therapy will be applied (e.g., within a cardiac chamber).

[0342] In step 7140, a second location mode, e.g., a magnetic location mode, is initialized. Initiating the second localization mode in this step may result in a magnetic field The physical placement of magnetic elements, e.g., magnetic elements 525 of patch 500, is achieved in step 7110. However, the second location mode requires If the placement of magnetic elements has not been realized, they can be realized in this step. The element is activated or energized to initialize the magnetic location mode. 0 may be adapted to initialize the magnetic location mode.

[0343] With both location modes initialized, the coordinate system is determined in step 7150 as follows: The first and second location modes are used to recalibrate the coordinate system, i.e., the first location mode is used to recalibrate the coordinate system. The device may be calibrated using a location mode and then using a second location mode. The differences can be mathematically resolved to produce a single calibration of the coordinate system. 5 to establish a reference point or fixed magnetic field for a room (or other volume) This establishes a coordinate system that is independent of the position of the patient P. can be used to verify the adjustment of the coordinate system settings with a patch on the patient's torso. This allows for maintaining localization calibration throughout the procedure. This may be because the shape of the patient's torso changes during the procedure, for example, due to breathing.

[0344] In step 7160, the coordinate system is already determined using the first and second location modes. Therefore, the process proceeds to step 7160, A device (e.g., catheter 1000) in a coordinate system can be located using a single localization mode. and / or both location modes to locate the device. Step 7160 includes sub-steps 7161 and 7162. Sub-step 7161 , using a single localization mode, i.e., impedance localization or magnetic localization Sub-step 7162 includes locating the catheter 1000. at least one of the two localization modes, e.g., impedance localization and magnetic This includes locating using location determination, which is sometimes called dual-mode location determination. In either case, locating the catheter is important both within the patient P and in the reference frame. This involves determining the position of the catheter or its functional elements within a coordinate system. To localize the catheter, functional elements of the catheter are used to record signals, e.g. As in substep 7161, use electrodes on the catheter or sheath to measure impedance. The location information is being emitted to the patient P by one or more patches 500 for location information. The signal can be recorded using at least one magnetic element on the catheter or sheath, e.g. For example, the magnetic field being generated by one or more patches 500 may be recorded (or sensed) to obtain a magnetic position. Alternatively or additionally, the catheter may be located using a location identifier. To locate the catheter, a functional element of the catheter or sheath is energized to act as a signal source. For example, electrodes on a catheter can be connected to the impedance The catheter can be considered as a voltage source that can be located using the One magnetic element is energized to generate a magnetic field and is located using magnetic localization. For catheters where both impedance and magnetic functional elements are enabled, Both localization modes can be used to locate the same catheter in the same coordinate system, such as with Tip 7162. can be located with respect to

[0345] For localization using two modes (or dual-mode localization), magnetic field-based The localization mode is not affected by variations in body impedance. According to this aspect, there is provided a means for augmenting at least an impedance-based location system; In various embodiments, the magnetic location mode is , using electronic subsystems or components different from those used in impedance location. If necessary, magnetic fields can be generated and measured.

[0346] In various embodiments, the current that generates the impedance field is in-line with the patch 500. The electrical current is passed through a coil 525 created (e.g., in-line with the patch electrode 515) can be used to generate a magnetic field, and then use the same method to measure the impedance field of an electronic device. The method can also be used to measure magnetic fields.

[0347] A magnetic sensor (e.g., one or more coils 1152 of the basket 1150) is used for position determination. The drive coil / sensor may be added to improve sensitivity. The impedance electrode 515 may include an added magnetic material (ferrite). The various coils 525 created can be used to connect devices within the body (e.g., basket array 115 0) can be constructed on the body for optimal sensitivity for localization.

[0348] Still using the same receiving method used by the impedance electrode 515, the magnetic field The drive coil 525 that generates the current is driven with a higher current to provide an improvement to the magnetic localization. This method allows for a higher current to be applied to the coil 525 and for the inductor 526 to achieve improved sensitivity. This produces a lower current applied to the impedance localization patch electrode 515, which Split the power output from the Console 5000 driver electronics or add a second driver The power splitting scheme can be achieved by having the coil, patch, and / or Or it can be based on the design of the impedance of the interface connecting these elements. These methods involve adjusting the field frequency and / or the coil impedance to the nominal body impedance. A combination of impedance measurements (enhanced with a coupling circuit to optimize the power division process) The output power may be directed to various elements based on the power consumption (which may be determined by the power consumption).

[0349] In step 7170, the console 5000 performs a step 7170 on the result of sub-step 7162, e.g. For example, the position of a catheter localized using both impedance and magnetic localization. Check for consistency between location results. Discrepancies are resolved by checking the location determined from each location mode. Step 7: The location of the device or functional element within the target system can be determined. If there is a discrepancy as determined in 170, the method moves to step 7175 to perform a recalibration procedure. is executed, which means returning to step 7130 or step 7150 to recalibrate the coordinate system. However, if there is no discrepancy, or if the discrepancy is within acceptable limits or is established, If the blood pressure is below a predetermined threshold, the system 10 may be used to perform a treatment, e.g., a diagnosis and / or a therapy. The procedure may be performed using impedance and magnetic position sensors for devices used in diagnostic and / or therapeutic procedures. Location using both location modes can be performed in this way. This may continue during such procedures.

[0350] FIG. 4 illustrates a method 7200 for initializing a coordinate system within the body of a patient P consistent with the concepts of the present invention. 7 shows a flowchart of one embodiment of various data storage, processing, and generation of method 7200. The portion may be executed by the console 5000 of FIG. 1 or a component thereof. Method 7200 may be used to implement method step 7120 of method 7100 of FIG. The method may be performed in either an impedance location mode (step 7120) or a magnetic location mode. (Step 7140).

[0351] In step 7210, an external component such as a patch 500 is placed on the patient P, and one The catheter 1000 is inserted into the patient P. In various embodiments, the localization part The device 500 is intended to be placed on the body of a patient P, and the resulting field vectors The sets of torques are nearly orthogonal and form a right-handed (RH) coordinate system. Once applied, the RH system can be established from the measured voltage. Depending on the temporal pattern of the applied source, it may be a DC, AC, and / or pulsed field (DC Voltage measurements can determine the sign of the measurement. For example, an AC field In this case, the AC voltage measurement generated is based on the phase of the applied waveform at which the measurement is made. The change in sign of the voltage is reflected by the axis with respect to the physiological coordinate system. The process of computationally determining the orientation of the localization system relative to the patient is called automatic orientation. This is called auto-orientation. The first part of auto-orientation is to establish the sign of the voltage. This automatic orientation is performed according to the following steps: The direction of the change in voltage between a pair of electrodes placed at a known orientation relative to the localization axis is used to obtain The ECG leads are attached to various fixed positions on the body relative to the heart. This placement gives the collection of electrodes a known orientation relative to the heart chamber. The direction of the coordinate axis can be used to establish the direction of the coordinate axis. In the current implementation, the localization X axis The ECG leads V5 and V6 are located on the left side of the heart chamber. The voltages from these leads are compared to the voltages of the electrodes from the cardiac volume to establish the direction of the X axis. do.

[0352] The reference electrode / patch location for the localization system is on the lower back, creating a Y-axis. This placement fixes the origin of the Y axis on the waist. The voltage at the position may be zero, and the voltage from a catheter placed near the heart From a comparison with the voltage, the direction of this axis can be established.

[0353] Various internal electrode positions relative to each other may also be used, for example, in the lower IVC The position of the monopolar electrode is aligned inferiorly to the heart.

[0354] The voltage difference between the patches is a function of the direction of the demodulated current and the impedance. By observing the pressure difference, the direction of the axis can be established.

[0355] A spatial coordinate system that satisfies the right-hand rule may be used. This rule establishes the orientation of the coordinate system. The current flowing between the patches indicates the direction of the patch orientation, and the The orientation of the switch establishes the direction of the localization axis. In this implementation, the right-handed condition is the direction of the Z axis. is used along with the estimated direction of current from the three axes within the heart chamber to fix

[0356] An additional approach to determining magnitude reversal is the use of the basket method used to determine direction. The voltage vectors on the pre-grouped electrodes 1151 on the set 1150 may be based on the voltage vectors on the pre-grouped electrodes 1151 on the set 1150. As shown above, the basket electrode 1151 is splined from the bottom of the spline 1157. This can be seen as the Z-axis direction to the top of each spline 1157. The first and last pair of electrodes 1151 on the 57, and each spline 11 for backup 57. On the XY plane perpendicular to the Z axis, Four symmetrically opposed electrodes 1151 on the selected spline 1157 are grouped together. , which represent the X and Y directions, each of which has a pair of electrodes 1151. It is generally preferred to use the pair of electrodes 1151 that are furthest apart from each other to achieve this.

[0357] For example, the search for two pairs of electrodes 1151 in the X-axis and Y-axis directions is performed by the bottom (spline 1157 If these four electrodes 1151 are good nodes, At any given time, they are selected for direction determination. If the nodes are good, they are used in the calculation. If the poles 1151 are close to each other, noise can obscure the calculation. to search for two pairs of electrodes 1151 above and below the center (of each spline 1157), Alternatively, find electrodes 1151 that are all good nodes and use those electrode pairs. In this way, the X and Y directions can be determined by the Two pairs of good quality electrodes 1151 are used to calculate the direction and reduce the possibility of noise This results in a more robust approach.

[0358] In step 7220, a catheter, e.g., catheter 1100, initiates a localization field. That is, in some embodiments, a single catheter, e.g. For example, a diagnostic catheter can be used to initialize the calibration field and define the coordinate system used for localization. Once this catheter is located within the heart H, the origin of the coordinate system can be established. The system is then used to determine whether additional catheters are near the heart. From this preliminary catheter, an initial calibration of the field can also be established. , which may include an estimate of the scale matrix 5155. As a result, the initial scale of the catheter The rule and nominal expected shape are further used to detect whether additional catheters are in the region of interest. possible.

[0359] In step 7240, the console calculates the coordinates within the region of interest, e.g., the initialized coordinate system Determines whether an additional catheter is detected within the If so, the method proceeds to step 7245 where calibration continues using the detected catheter. Calibration is performed on catheters that are not functioning properly or at all. If no additional catheters are detected, the method may be performed to eliminate the electrodes. The method also proceeds directly to step 7250. If executed, the method also proceeds from the completion of step 7245. Then proceed to step 7250, which returns additional catheter information, if any. This includes fine-tuning the coordinate system based on the

[0360] FIG. 5 is a flow diagram of one embodiment of a method 7300 for localization calibration consistent with the concepts of the present invention. The various data storage, processing, and generation portions of the method 7300 are shown in the flowchart of FIG. The console 5000 may be implemented by, for example, For example, predefined catheters for different basket arrays or other catheter types. The device may have local or remote access to the catheter 110. The basket array 1150 may be a single basket array 1150, which includes a plurality of electrodes 1151. The Le 5000 may be configured with known device configurations for catheters, such as basket arrays. You may choose 50.

[0361] By locating at least two of the electrodes 1151, the catheter can be positioned in a specific basket. In step 7310, the system 10 may verify that the device has a network configuration. Locate at least two electrodes.

[0362] The localization process to generate field characteristics such as scale factors depends on the dimensions of the basket. and shape (e.g., basket array 1150 of catheter 1100), Due to manufacturing variations and sheath deflection (e.g., sheath 1300), the actual shape may differ from the default. If the device shape is not known, the location results may be modified. In addition, the reliability of the positions of the various sensors (relative to each other or to the anatomy) System outputs that rely on knowledge of the location and device geometry models also suffer from errors. This may be the case.

[0363] In various embodiments, the console 5000 may be configured to accommodate a set of predetermined or known catheters. The method may include using known basket shapes (e.g., the shape of the basket array 1150). The scale factor can be estimated by finding which one of the states optimizes the system performance. Therefore, the shape and scale of the basket 1150 for location determination are The optimization of the factors is determined.

[0364] The scale matrix 5155 may be used to convert from localization voltage to spatial position. The scale matrix can be estimated by measuring the voltage difference between electrodes with known spacing. This is achieved by measuring the voltage of the catheter, the dimensions of which can be predetermined. For example, a mapping catheter 1100 having a known shape may be used for this purpose. However, the estimation of the scale matrix 5155 is and the actual catheter being used.

[0365] A set of scale factors can be first estimated, for example, for a set of given catheter shapes: A series of scale factors can be generated using the correction scale factors. Minimizing errors in various system outputs depends on having reliable localization of the This error can be used to determine the optimal scale factor to use. Examples of system outputs that can be used are: (1) catheter with known spacing; Alternatively, the shape and / or size of the electrodes, e.g., the folded basket array 1150, may be different from that of the previously (2) an ultrasound point cloud; and (3) a focal source (ultrasound or electric) that may have a known inter-electrode spacing. ) consistency in imaging.

[0366] Additionally, ultrasonic-based basket shape detection is used to determine the shape of the basket 1150. An ultrasound point cloud is a representation of ultrasound values ​​in three-dimensional space, where the values ​​are at specific points in the 3D space. The presence or absence of a point object can be indicated. Measurements are necessary to understand the spatial variation of the various measured signals. can be an electrical signal such as a biopotential or a localization signal. The shape of the meter is used to establish scaling (scale matrix 5155), which The transformation from the voltage field to a spatial distribution is performed. The error in predicting the shape of the catheter is The effect of the Kale factor can lead to errors in catheter localization.

[0367] An ultrasonic transducer (e.g., ultrasonic transducer 1 on basket 1150) 152) can be used to measure the shape of the catheter. This can be done by measuring the ultrasonic pulses from the transducer. If the transducers 1152 are facing away from each other (even if they are not completely opposite), The ultrasonic signal leaking from the cuplain can be measured by the transducer 1152. Low frequency ultrasonic signals may also be used for this purpose, with backplanes attenuating the ultrasonic signals. This is because the efficiency of the plane decreases with frequency. The resolution of the estimation of the position of the transducer 1152 is determined by the method Since it contains a single source, the frequency is lower but still maintained, and the The temporal / spatial transfer functions through the plane are known and / or measured. The resolution to detect the source position is improved even at lower frequencies by phase-lock detection and / or It can be increased using methods such as template matching with predicted transfer functions.

[0368] The shape of the catheter can also be determined by applying a source to the various electrodes. These sources are the electrical / potential sources applied to a particular electrode (e.g., at least one electrode). These sources generate a well-defined field structure. The shape of the catheter can be determined using the known position of the electrodes. Measurements can enhance the estimation process by providing additional independent inputs. Measurements from the electrodes can be used as a reference to guide the estimation of the catheter shape. do.

[0369] Additionally, information about the state of the electrodes can be determined by taking additional measurements. The polar states can be, for example, contact with an object or structure (such as tissue), lack of contact with an object, or contact with an object. intermittent contact, orientation of the electrode relative to the object, and / or general or detailed information about nearby structures In some embodiments, this determination is made by applying a source to one or more electrodes. , changes in the properties of nearby electrodes or between nearby electrodes (impedance changes, field potentials, or currents) This can be achieved by measuring the amplitude or density of the electric field. The electrode is in contact with the tissue at a certain moment, and the adjacent electrode is in contact with the tissue. At the same time as sinking the voltage at each electrode, the impedance between the electrodes is determined. When either electrode comes into contact with a structure such as an object or tissue, the impedance The detection of a change in impedance between the electrodes can indicate contact with tissue. Furthermore, when a source is applied between two electrodes, the field distribution generated by the source is , which depends on the impedance distribution of the medium. As above, we measure the field at several positions This information can then be expanded to estimate the impedance of the medium. Alternatively, the impedance distribution of the medium can also be inferred directly from measurements. Once the impedance distribution is estimated, tissue structures that exhibit impedance changes can be identified. The structure can be reconstructed as well, and useful information such as the proximity of the electrodes to the tissue structure can be determined. .

[0370] Furthermore, by applying a source-sink method between several sets of electrodes (e.g. For example, continuously or repeatedly, simultaneously or sequentially), the system The state of tissue contact may be determined dynamically. Use a set to ensure not only direct contact of one or more electrodes with tissue, but also the proximity of the electrodes to the tissue. In some embodiments, the state of tissue contact or tissue proximity may be used to calculate It can provide feedback to the user or be combined with other functions of the system. together to fine-tune or adjust the information calculated by the system or presented to the user. In some embodiments, tissue contact can be used to obtain simultaneous status information, e.g. By using only anatomical data from electrodes that have contact with tissue, or Establishing a representation of anatomical objects by rejecting anatomical data that lacks such state information In some embodiments, the creation of the anatomical structure can be adjusted or fine-tuned. This can be established using organizational proximity detection from the network.

[0371] In some embodiments, the source-sink approach may be based on sensitivity or specificity to one or more conditions. If the frequency varies as a function of wave number, it can be performed at multiple frequencies. For example, two different sets of If two fabric types respond similarly to one frequency but differently to a second frequency, Contact or proximity with different tissue types can be distinguished by evaluating responses at both frequencies. The two frequencies can be transmitted simultaneously or sequentially. In addition, all tissue types has capacitive and resistive components to the impedance, so the capacitive part is different. This can be used to determine the contrast characteristics between the different states. extracted by using impedance as proximity to tissue, e.g. The information can be further improved.

[0372] The method moves to step 7320, where the device configuration from step 7310 A determination is made whether or not the electrode location should be confirmed. A positive indication is , the process proceeds to step 7325. In step 7325, an inter-electrode configuration test is performed. 1150. Alternatively, an ultrasound or other configuration test may be performed as described above in step 7325. In one embodiment of step 7325, the nearest catheter in the basket 1150 One electrode 1158a on the ether shaft and one electrode 1158b on the basket actuator 1121 Two electrodes 1158b, c (i.e., shafts that expand or collapse the basket) are placed ) is obtained by estimating the basket's elongation and shape (as shown in Figure 2). The two actuators 1121 can serve as rulers in the localization field. The electrodes 1158b, c are in this embodiment such that the actuator 1121 is linear and comparatively Because of their static stiffness, they are always separated by a fixed distance. V(1, 2) is connected to one of the actuator electrodes 1158b, c and the shaft electrode 1158a. The voltage offset V(1, 3) between the actuator electrodes 1158b, c Scaling the known separation by the ratio of voltage V(1,3) to voltage V(1,2) provides an estimate of the position of the actuator 1121 relative to the catheter shaft 1120. The basket shape vs. actuator extension table is interpolated to find the basket shape at any extension state. The shape of the electrode 1150 (the position of the electrode 1151, the position of the ultrasonic transducer 1153, and Equivalently, two fixed points on the catheter shaft can provide A fixed electrode and a single electrode on the actuator 1121 can serve the same purpose.

[0373] In various embodiments of step 7325, the method includes: Use sensor measurements from a group of sensors to assess the quality of a measurement or subgroup of measurements. Based on the quality of the measurements, the data from the sensors may be used in further location processing. The measurement quality of the sensor depends on the applied localization field being the maximum possible for a particular sensor configuration. These can be identified to include spatial features that lead to a limited group of useful measurements. A voltage field designed to be linear over a specific region in a specific space is distributed Only the sensor group that measures the voltage can produce a linear voltage variation. A catheter with a 3D sensor distribution can be completely represented by a linear spatial function. Electrodes that deviate from the normal structure can be excluded from further analysis. The spatial functions are given by the set of spherical harmonics. This ensures that the physics of the problem is also satisfied in this process. To allow for certain practical nonlinear variations in this field setting, a quadratic function is introduced into the field The quadratic energy can be added to the description based on an understanding of the expected nonlinearity of the field. This understanding of the field nonlinearity can be obtained from historical data or from experiments and simulations. In addition, physical particles can be measured in a linear field, parallel to each other, or at specific known angles to each other. The randomly set electrode groups have a known ratiometric measurement relationship. , the quality of the electrode measurements can be tested. Furthermore, a calibration process (e.g., from adjacent or current areas) can be performed. A set of sensors (e.g., one or more sensors with known positional relationships) can be used to measure the The consistency of the fit of the measurements from the sensor (upper sensor) may be checked.

[0374] Following step 7325, the method proceeds to step 7326 where the device configuration is verified. If not, an alert is generated in step 7327. However, if the configuration is confirmed in step 7326, the method continues to step 7330. The method may also proceed from step 7320 to step 7330.

[0375] In step 7330, the device configuration is compared to the location results, and in step 7340 In step 7, a determination is made as to whether a mismatch exists. At step 345, the device is calibrated based on a known device configuration. Regardless of 7345, the method continues to step 7140 of method 7100 of FIG.

[0376] FIG. 6 illustrates a method for generating a combined scale matrix 5155 consistent with the concepts of the present invention. 7 shows a flowchart of one embodiment of method 7400. The processing and generation portions may be executed by the console 5000 of FIG. 1 or components thereof. In various embodiments, the console 5000 may be configured to control the generation of a device or functional components of a device. a scale matrix 51 for converting the localization information of the anatomical model 52 to a relative position of the anatomical model 55; 55. In various embodiments, the scale matrix 5155 may include at least one reference It may be formed from localization data that may be adjusted or corrected based on points or reference frames.

[0377] In step 7410, a device such as a basket array 1150 of a catheter 1100 is The sensor is positioned within a patient P, for example, within a chamber of a heart H, which may be referred to as a localized region or region of interest. As mentioned above, the configuration of the device is known. The device is used to obtain location information. Information is recorded for specific device locations within the region of interest. For example, a basket array 1150 electrodes 1151 are used to determine localization information for each electrode 1151 The voltage may be recorded.

[0378] In step 7420, a first scale matrix 5155 is calculated based on the known device configuration and stage. Based on the recorded location information from the chip 7410, the specific device location within the region of interest is determined. In step 7430, the device is repositioned within the region of interest. In step 7440, the additional location information is recorded. The second scale matrix is ​​generated by subtracting the existing (or first) scale matrix from the is compared with the rule matrix.

[0379] In step 7450, a second existing scale matrix is ​​compared in step 7440. In step 7450, the console 5000 If the scales from the two scale matrices are similar enough that the localization data can be combined, If the scales are not sufficiently comparable, the method returns to step 7460. and one or both of the scales are adjusted to make them comparable. In this embodiment, the second scale is adjusted to be comparable to the first scale. The adjustment of localization parameters that affect the scale estimation, such as the catheter shape, This may include updating the data, which may be performed according to various methods described herein. If the scales are deemed comparable, the method moves to step 7470, where a second The scale matrix and the existing (e.g., first) scale matrix are stitched together. The process returns to step 7430 and At step 7470, the sampled volume, e.g., all or substantially all of the components of the heart chamber, is sampled. This can be repeated by generating a combined scale matrix.

[0380] The method 7400 of FIG. 6 may include one or more different types of catheters (e.g., basket catheters). Catheter 1110 with Ray 1150 and / or Lasso-shaped catheter 1200 The method 7325 may be implemented using a catheter shape (basket or lasso shape). It can output the quality of the ablation catheter (e.g., shape) and estimate the appropriate electrodes for field calibration. These catheter measurements are then used to calculate the catheter size, as described herein. The scale can be estimated from the estimated model of the catheter shape and field. An internal source (e.g., an electrode source) provided on the catheter detects the shape of the catheter. and / or using an ultrasound transducer to measure the shape of the catheter or other The position of the electrodes can be detected.

[0381] The geometry of the catheter is determined by the number of electrodes on the various subsets that form the physical structure of the catheter. This can be further verified by checking the consistency of the voltage distribution, e.g., a lasso array. And / or the basket array is parallel and / or plane, and / or perpendicular and / or plane. A line can consist of two or more electrodes, which can be arranged in a set of planes. The lengths of these lines are ratiometrically related, and the ratiometric relationship of the measured voltages To study this ratiometric behavior, the current flows perpendicular to the The voltage drop due to the current on the line depends on the length of the line. This allows you to determine whether the various lines are showing the correct voltage reading ratio to each other. This can be used to check the quality of the catheter or determine the shape of the catheter. The design of the applied current involves a mathematical combination of applied localization currents. The projection of the voltage due to the electrodes onto the circle in the plane gives the sinusoidal pattern of the measured voltage. Therefore, placing it in a field with a nearly constant current (the field from the patch above) A catheter consisting of equal length segments oriented in different directions is Measure the voltage that can be fitted to a sine wave over the entire set of segments. Based on the quality of the electrode, the quality of the electrode can be confirmed. Also, the quality or shape of the basket can be determined in a similar manner. Furthermore, using a field consisting of a linear region, the first order spherical harmonics describe the field A fit to a linear function is used to estimate the local field, and deviations from the fit are The electrode quality can be checked by determining the electrode. A maximum quadratic function may also be used.

[0382] Alternatively, once the basket shape is determined, the electrode set can be determined using the steps above. In certain embodiments, the scale matrix of the region of interest may be estimated from the catheter (e.g., Segmentation with electrodes from (lasso, ablation, and / or basket catheters) Using the set of points, the scale matrix of the currents along the line can first be determined, and then The scale on the plane can be determined. To determine the scale on the plane, the scan of the two currents is These currents are generally non-orthogonal to each other. The scale is The voltage is estimated by fitting a sine function to the voltage of each current using a set of Alternatively, to stabilize the scale estimation (e.g., especially the segment limit), (when a specific distribution is available and fitting to a sinusoidal function is difficult), various segments The elements can be constructed to utilize the ratiometric structure of the sinusoidal functions and combine currents. These are combined to create pairs of orthogonal currents, from which the individual scales can be stably determined. The orthogonalization process and stable estimation of scale allow us to find the appropriate segments along a particular direction. For example, a segment along the direction of current may be selected by selecting the scale of the current. Create a quadrature current by using segments that are at an angle equal and opposite to the direction of the current. This process can then be repeated for one additional plane to obtain a Then we combine these two scales on the plane to get the complete triplet. Dimensional scales may be created.

[0383] Measurement of scale changes in space can be further realized using linear field domains, which is , a simple localization current design can describe subregions within the heart chamber. As such, sub-dimensional catheters (e.g., lasso, ablation, and / or basket catheters) An example of a simple localization current is the It is generated in the heart by a patch 500 attached to the surface. and can be estimated by piecewise linear assumptions within the heart. The change in area occurs when a catheter of known dimensions changes length along a line or arcuate trajectory. This can be seen when the fit deviates from a sinusoidal function along the The region that can be perfectly described by the linear fit can be considered a linear region, and the deviation from a linear fit is can be used to determine the complexity of the field estimates needed to describe the localization field in the region.

[0384] If a change in scale is observed, the scale may be enlarged. As the catheter moves, the continuity of the scale is predicted. Any one-dimensional (1D) catheter can be used to increase the scale. The process estimates new scales for adjacent regions and creates integrated fields with known regions. Parameters governing the continuity of scale information and the expected smoothness of the field can be estimated from historical data, which gives a set of parameters to estimate the field state. This can guide the quality of the etching process.

[0385] One such parameter is the expected scale change between two adjacent locations. This is used to check whether the newly estimated field is a reasonable estimate. If the field is valid, it is stitched into the set of estimated fields. Use adjacent fields to assess catheter shape and quality for suitability for use in localization This produces a smooth and consistent field. In addition, the field is By controlling the parameters, it is possible to stitch specific points in the respiratory cycle. Various fields or field corrections can also be adjusted for this type of gating process. Thus, it can be generated.

[0386] Some examples of parameters that can be estimated from historical data include: This includes the distribution of the field within the blood vessels and / or the characteristic structure of the field in specific areas such as veins. In practice, historical data is used to estimate a template that describes the field structure and then to compare it with the actual categorization. Measurements from the iontophoresis device can then be used to represent the field in the region of interest of a given patient. The parameters of the template may be estimated.

[0387] In some embodiments, the field characteristics are determined by the number of all possible electrode pairs in the basket array 1150. can be obtained by using all of the equations (48 2 ×3) high In such cases, the formulation of the scaling matrix is In the method of formulating the scale matrix, the average scale matrix 5 is used for the center of gravity position. 155 is as follows:

number

[0388] To obtain better field characteristics, the system 10 solves a 47 x 3 simultaneous equation system. The above scale matrix 5155 can be calculated at the position of each electrode 1151 by This results in 48 scale matrices 5155, which are used for 48 different positions in 3D space. characterizes the center of gravity position of the basket array 1150 at a given time. is not only the center of gravity, but also the location of the basket region (i.e., the location of the electrode 1151) may not represent the entire field picture and therefore may not be electrode-specific for a given time frame. has a scale matrix 5155 of

[0389] The above approach to formulating the scale matrix 5155 assumes that the field is a linear field. However, deviations from the linear assumption can cause localization errors (indeed, (The location field may be a nonlinear field.)

[0390] The system 10 may be configured to implement a method for capturing the curvature of a field, The rule matrix 5155 may have terms that can characterize the curvature of the field. The scaling matrix allows the field to deviate from linearity, but at the same time allows us to characterize its nonlinearity. and can be given by the following formula:

number

[0391] In various embodiments, the system calculates how the field is scaled in addition to the electrode-specific scale matrix calculations. It can be configured to paint a better picture of how the Since there are enough measurements, the curvature and scale factor can be determined.

[0392] In various embodiments, a two-stage approach for electric field (E-field) estimation using sub-dimensional electrode arrays The method may be implemented by using a basket electrode array of the catheter 1100. To obtain an estimate of the electric field vector in the region not sampled by 1150, This may involve using several sets of electrodes with known inter-electrode distances. Generally, the area of ​​interest (e.g., a vein or atrial appendage) is sampled using a basket. Sampling at 1150 may not be possible even in that contracted state. In this case, the lasso catheter 1 can be constrained in one or two spatial dimensions. 600 and / or ablation catheters 1500. It is feasible to obtain potential measurements by using a lasso around the circumference of a nominally circular catheter. A set of electrodes 1651 arranged on the sides, while the ablation catheter 1500 typically indicates three (useful) electrodes 1551 in a linear array. In both cases, The physical separation between adjacent electrodes is known.

[0393] Both catheters can be flexible, but limit attention to adjacent electrode pairs and allow for easy placement between electrodes. The separation of can remain approximately constant even with associated catheter shape distortions. To compensate for the reduced dimensions of the associated electrode array, the catheter is constructed with three spatial in space (e.g., by the operator) in such a way that all dimensions are sampled. It needs to be directed or moved (robotically or by a system). This occurs because there is no prior directional information to relate the electrode positions to physical coordinates. In other words, the physical separation between electrodes and electrode pairs may be well constrained, but may be arbitrary. The axial projection of the segment (i.e., the length of the segment) in global coordinates x, y, projection onto the z-axis) is unknown.

[0394] A two-stage predictor / corrector method is developed to overcome the above difficulties. The E-field vectors are orthogonal Any catheter that can be assumed to form a base and then has a known length l between adjacent electrodes The ether segment provides constraints related to length, field strength, and potential difference as follows:

number

number

[0395] Note that the spatial coordinates are now aligned to the three field gradients: pairs (i.e., all pairs whose physical separation is known independently of catheter deformation). By expressing the above relationship over the sampling time interval, the three field vectors We obtain a system of overdetermined equations for the vector components in a basis aligned with the local field gradient. Due to the lack of registration information, these vectors are The global coordinate system is assumed to be parallel to the "patch" reference frame. The sampled field is implicitly assumed to be uniform and constant over the time required to acquire the sample. Next, we rotate the field components obtained above into the localization reference frame to obtain , generate the following array of "predicted" scale factors, which transform the potential differences into physical vectors: can be exchanged.

number

[0396] The correction step is to convert the set of field vectors / scale factors into the set of scale factors above. We generalize this by assuming that the orientation of each segment generated by the test is correct. The axial projection of the segment between the two electrodes is given by,

number

number

[0397] Electrode localization using a "modifier" set of scale factors is performed on the sampling catheter. Depending on the characteristics of the catheter, one of two methods may be used: For electrodes, the center of gravity of the electrode array is located using a two-point approximation of the mean measured potential and the integral. obtain.

number

[0398] The method is a conjugate gradient descent down a robustly defined 10D (10-dimensional) error surface. The core sampled by the basket catheter 1100 may include an estimate of the side field. The estimation of the field vector in the region around or outside the volume is done by sampling the surrounding region. The orientation of the catheter (e.g., lasso catheter 1200, 1600) is determined by a known coordinate base. One way to proceed is to use a core whose surrounding fields are known. We assume that the field perturbations can be expressed as a nine-dimensional (9D) "scale factor" space. The key is to define an error function in terms of which we can query by means of conjugate gradient methods. is conjugated along the resulting 10D error surface until the error is assumed to be sufficiently small. Shift the initial guess in the gradient direction. One possible error function is the error function for the sampling catheter (e.g. For example, the known (physical) length of the electrode-carrying segment of the lasso catheter 1600 and the The sum of the Euclidean distances between adjacent electrodes localized using the current estimate of the vector The most convenient initial guess is to use the subfield of the core field "close" to the region of interest. is the average scale matrix 5155 obtained from the set. In what follows, we refer to this as the “reference” field. Call.

[0399] The proposed error function is defined as follows:

number

[0400] 9 scale factors λ k,l The gradient of the error function with respect to is

number

[0401] 9D scale factor λ k,l The gradient of the error function with respect to is

number

number

number

[0402] The nine gradient terms are local directions in scale factor space along which the error increases most rapidly. Reversing the direction of each term in the gradient array results in a conjugate gradient, which results in a smaller error. This is the direction of steepest descent towards the difference.

[0403] From the initial guess (i.e., the 9D scale factor terms that define the reference field), 9 gradient terms are iterated. The reference field is then successively corrected until the error is assumed to be sufficiently small. The 9D scale factor is the coordinate basis of the reference field, relative to the known physical dimensions of the catheter. It allows for localization of the sampling catheter with minimal length error.

[0404] An alternative expression for the error function is given as follows:

number

[0405] A slightly more complex approach is to apply the error functions of the two methods sequentially and then match them in subsequent iterations. The methodology is to switch from one segment to another. The sum of the difference in the lengths of the segments and At the same time, we try to minimize both the difference in the total length of the catheter and the total length of the segments. The goal is to (attempt to) control both the length of each segment.

[0406] In various embodiments, the system 10 provides a high performance implementation of a position planarity assessment algorithm. The purpose of the algorithm is to measure the number of auxiliary catheters (1200, 1500, 1600, etc.) ) are sufficiently distributed in space during the calibration process, As a result, the data can be used for optimal scale matrix 5155 fitting.

[0407] The algorithm uses data representing 1000 locations within the atrium, e.g. The frame is examined. Three selected electrodes (e.g., 12 Each frame of voltage data is taken from electrode 1 to The position vectors are transferred from electrode 1 to electrode 3 and from electrode 2 to electrode 3, respectively.

number

number

[0408] To evaluate multiple positions, all relevant position vectors are analyzed.

number

number

[0409] However, this is not the most efficient approach, as there may be hundreds or thousands of combinations of locations. Since the range is large, we construct various combinations of positions into matrices of various sizes, and then transpose and multiply the matrices. The process of performing the calculations can be computationally intensive, which also means a lot of memory overhead. do.

[0410] In a particular algorithm, there are two vectors per catheter position: N positions One combination of has a location matrix of size 2N × 3, and a covariance matrix of size 3 × 3It can be a symmetric matrix.

[0411] To eliminate redundancy in the covariance calculation, the covariance within each catheter position is calculated first. do.

number

[0412] The calculation of the covariance of various combinations of positions can be a sum rather than a multiplication, saving extra notes. No cash is consumed.

number

[0413] For symmetric matrices, the singular values ​​are the same as the eigenvalues, so the eigenvalue decomposition is more expensive. It can be used instead of SVD.

[0414] Also, for a matrix X[M,N], the singular values ​​are X * are the square roots of the eigenvalues ​​of the N×N matrix X The same strategy applies here. We can calculate the inverse of a 2x2 matrix using the formula .

number

[0415] In our case we have a further special case, b=0, and therefore

number

[0416] FIG. 7 illustrates a method for transposing a device's location into a set of location coordinates consistent with the concepts of the present invention. 7 shows a flowchart of one embodiment of method 7500. Various data stores of method 7500: The processing and generating parts are executed by the console 5000 of FIG. 1 or its components. obtain.

[0417] In step 7510, a first device, e.g., one of the catheters 1000, is The catheter is localized within a localization coordinate system. The location may be localized using a magnetic and / or a magnetic location mode. In other words, the auxiliary localization signal is generated from an electrode of a first device, such as the auxiliary functional element 1190. The sensor may be, for example, an electrode, a magnetic coil, an ultrasound transducer, or a physiological sensor. do.

[0418] In step 7530, the second device calculates the coordinates in the auxiliary coordinate system relative to the first device. In step 7550, the position of the second device is localized in the primary coordinate system. The first and second devices are then transposed to the primary location coordinate system. It is localized within the reference frame.

[0419] The console 5000, and its components, are positioned during a procedure, e.g., a diagnostic or therapeutic procedure. However, insufficient location of the target volume (such as the left atrium) may be required. Accurate sampling may result in a compactly distributed field estimate. The basket array 1150 is then placed on the anatomical scan (e.g., the anatomical model 5255). If the field created at each discrete centroid position is not moved smoothly and continuously during the construction, The estimates are clustered so that significant gaps exist and field estimates are explicitly used. An electrode (e.g., electrode 1 of catheter 1550) moving across this gap cannot 551) may experience localization discontinuities as the field estimates transitions between clusters. There is a gender.

[0420] In various embodiments, the console 5000 constructs a convex hull around the entire centroid cloud. Within the convex hull, the console constructs a conformal Cartesian grid, where conformal and means that the grid fills the volume of the convex hull without extending outwards to the boundary of the convex hull. In this grid, at a specified interval on each coordinate axis, the console calculates each grid point as a centroid cloud. The IQ potential and field scale factors are calculated by assigning them to the elements of the Delaunay triangulation of the The console 5000 interpolates from the corner points to the grid points, for example, using barycentric interpolation. The localization is then performed by interpolating the known grid positions and the interpolated IQ potentials and scale factors. This is done by averaging the distances from a set of nearest grid points using The averaging is done by interpolating from the four centroids that make up the corners of the boundary Delaunay volume element. This is advantageous due to the inherent uncertainty.

[0421] Another problem is the continuous infusion of conductive fluids (e.g., saline) during electrophysiology (EP) procedures. Changes in blood conductivity due to ingestion can adversely affect impedance-based localization. However, in accordance with the concepts of the present invention, known inter-electrode spacings and configurations can be utilized. The catheter (e.g., catheter 1100 with electrode 1151) is impedance The impedance of the device can be measured to determine the conductivity at a desired frequency. This can be done at intervals during the procedure and calculated during construction of the anatomy. The corrected scale factor is, for example, This allows for improved localization of the catheter (e.g., therapeutic catheter array 1550).

[0422] The console 5000, and its components, may be used to perform anatomy during a procedure, e.g., a diagnostic or therapeutic procedure. The catheter having the array 1150 may be further configured to build or update a biological structure. Algorithm to generate anatomical structures (anatomical model 5255) using Rule 1100 The step may involve assisted localization (e.g., one or more catheters 10 used in the system 10). 000 location), so that the mismatch is Potential for occurrence between navigation and the surface of an anatomical structure (anatomical model 5255) This potential mismatch occurs when catheter 1500 is an ablation catheter. In some cases this is particularly undesirable.

[0423] In accordance with an aspect of the inventive concept, the console 5000 addresses the potential mismatch problem. Scanning an anatomical structure (creating an anatomical model 5255) During the process of forming a basket array 1150, all functioning electrodes 1151 (e.g., For example, the so-called "raw" localization data of the 48 electrodes 1151 in Figure 2 is recorded during the recording process. During scanning, the spline electrodes 1151 are continuously available throughout the scan. , widely manipulated around the entire cardiac chamber, with a high probability of reaching the endocardial surface over a wide area. Plot the trajectory of the electrode 1151 throughout the time it scans the anatomy. Imagine this by algorithmically defining the outer boundary of the spline electrode 1151. It is easy to depict the surface on which the trajectory can be measured, and its trajectory is limited by the endocardial surface. There may be a mismatch between the orbital plane and the generated anatomical surface, which , at least in part, between the auxiliary catheter navigation and the generated anatomical surface. Therefore, the anatomical model 5255 can be used to visualize the heart chambers over the cardiac cycle. Because of the size average, the location of the "locate" may be recorded as "outside" the heart chamber. In some cases, for example, when the electrode is placed on the endocardial surface during diastole. The line electrode 1151 localization domain is, at least in part, a secondary localization domain. All points of any electrode 1151 during the creation of an anatomical structure need to be correlated, e.g. The volume enclosing Λ ≡ ...

[0424] This property allows the localization domain to be volumetrically scaled to best fit the anatomical domain. The effectiveness of assisted navigation of the anatomy 5255 can be improved. There are several algorithmic enhancements that can be applied to achieve effective improvements. Such algorithms include, but are not limited to: 1) The x, y, and z values ​​for the anatomical centroid from each located point to the anatomical surface Radial projection of. 2) Best fit from the localization domain to the anatomical domain based on three factors Affine transformation of the volume of the object. 3) Best fit from localization domain to anatomical domain based on nine factors Affine transformation of the volume of the object. 4) Transformation from the localization domain to the anatomical domain after applying intermediate processing steps For example, an "anti-jitter" filter can be applied to the position acquired during scanning. Applying it to specific data, the dimensional dynamics of the spline electrode 1151 can be expressed as an auxiliary electrode (e.g. 1551) can be more closely matched. 5) Update the online scanning tool to provide feedback to operators. , the spline electrode 1151 adequately samples the endocardial surface for scale matching purposes. This can ensure that the

[0425] The console 5000 may, for example, be a basket array 1150 ultrasonic transducer. However, a fixed origin may be used to construct the anatomical model 5255. The anatomical structure (anatomical model 5255) created by radial averaging from It suffers from shadowing of structures nearly parallel to the radial vector and inadequate averaging, but , using the anatomical structure 5255 created by radial averaging as a starting point, All ultrasonic hits within a rectangular pillar associated with a surface element are identified and averaged. The resulting point is placed at the average distance from the element center along the element normal. The vertex is generated by averaging over neighboring elements and the original element / vertex map Hold.

[0426] Also, during the procedure, the accuracy of the localization depends on the size and orientation of the diagnostic catheter 1100 during the procedure. Improved accuracy is achieved by better estimating the size and shape of the basket (e.g., the shape of the basket 1150). One way to do this is to generate a localization signal between the catheter electrodes 1151. The field is then generated and used to measure the distance between the electrodes 1151, the local field constant, and the distance from the heart wall. Another method is to create an external magnetic field, can be sensed by a coil 1152 in physical contact with the catheter 1100.

[0427] The local field generates a differential electric field at a location-specific frequency between two separate catheter electrodes 1151. or by forming a remote electrode (such as a skin patch 500) and a local receiver, e.g., a catheter. By generating a single-ended magnetic field between the coil 1152 located on the It can be set as follows.

[0428] Further with respect to the location of auxiliary electrodes (e.g., 1551, 1651), such location is a region where the localization source field is well characterized (i.e., basket 1150) from the "core" region occupied by the center of gravity by the basket array 1150. This can be achieved by extrapolation into surrounding areas that have not been sampled. Field curvature outside the "core" region introduces localization errors related to the physical location of the auxiliary electrodes There are cases where this happens.

[0429] Each localized source field, considered as a static scalar field, is harmonic and charge-free, so The field fluctuations satisfy the Laplace equation. The extrapolation of the fields outside the "core" region is therefore given by This can be achieved using surface harmonic approximation, and the auxiliary catheters (1500, 1600, etc.) , the extrapolated field may be used to localize the peripheral electrode field. Proceed as follows:

[0430] The basket center of gravity is located in each frame, preferably at the position of each basket 1150. Using an integrated assisted localization technique that utilizes the measured characteristics of the three source fields Each centroid position is associated with the mean potential of each source field.

[0431] Construct the interior surface of the anatomical structure 5255 that largely coincides with the centroid cloud. For this purpose, a spherical shell meshed with an unstructured triangular grid is sufficient, but higher-order surfaces, e.g. For example, a symmetric ellipse or a generalized ellipse can also be used. At each node of the mesh, three The source potentials are interpolated using the inverse of the "core"-based auxiliary localization procedure.

number

[0432] When the source field values ​​are captured in the spherical shell, the spherical harmonic coefficients a l,m The set of and matches the following:

number

[0433] The solution of the LLS problem for three sets of coefficients is given by the order of the basis functions considered (l above). The total number of basis functions is the square of the degree plus 1. For example, three orders provide 16 total basis functions, each of the three potential distributions in this example. A rough rule of thumb is that the angular resolution is approximately given by pi / l, so Three distinct regions can be recognized along any hemispheric meridian. Specifying a value greater than 0 often leads to an ill-posed inverse problem, and the "S The condition number of the eigenvalues ​​increases, and eigenvalues ​​related to noise or non-physical variations become dominant. In some cases, it is possible to vary the requested order and obtain a decomposition with a feasible condition number. There are cases where this happens.

[0434] The spherical harmonic transform is a nonlinear transformation from position (in terms of coordinates γθ and φ) to potential Therefore, localization is the determination of a position based on three measurements relative to the source field. Instead, the position estimate is given by the The position update is obtained using the "t aux loc" procedure (via the spherical harmonic transform) Repeat until the potential associated with the updated position matches the measured potential. A pure Newton iteration is sufficient, and the gradient at each sample point is calculated in terms of spherical harmonic basis functions. It is approximated by a series of difference terms constructed from the calculated potentials.

[0435] Alternatively, once the spherical harmonic coefficients are calculated, the source field is expanded and the are listed on both the internal and external grids and their positions are calculated from the potential using a look-up table. Arbitrary precision can be achieved by using the following, along with trilinear interpolation of gridded data, if desired: It can be obtained by constructing a sufficiently fine grid and sampling it.

[0436] Localization by spherical harmonic extrapolation does not accurately reproduce the position and potential of the center of gravity, which is Since the number is calculated from the averaged centroid potential (the "position" input to the spherical mesh is Note that the spherical harmonic field is the target represents the "averaged" potential within the volume of the sample.

[0437] Furthermore, problems arise when assisted localization by integration of superimposed discrete harmonic fields. That is, the signal obtained from a centrally located electrode array (e.g., basket 1150) Electrode localization in the peripheral region of the atrium using the field estimates is affected by the field curvature. For example, a localization field in the center of the left atrium may be confused with the PV ostium or other structures. The field estimate may not accurately describe the potential gradient near the structure. Unless the entire volume is available, the potential The poles may be located inaccurately. Therefore, it is necessary to take the field estimate over the entire volume. It is desirable to obtain the harmonic source field, assuming there is no charge in the region of interest. The assumption can be used to advantage.

[0438] However, the system 10 addresses this by implementing various location methods. The overall harmony that fills the potentials measured by the mapping catheter 1100 can be The field is constructed by assuming the existence of a set of points, externally projected onto the anatomical structure 5255. At each point, a charge is located and its charge is distributed, typically nearly uniformly, over the surface of the tangent sphere. The voltage at any point in space induced by a load is the Coulomb potential given by do. φ=K / γ where K is a constant proportional to the charge, and γ is the Euclidean distance between the charge and the point of interest. be.

[0439] The superposition of fields generated by the combination of charges distributed on the surface is given by become.

number

[0440] of the center of gravity (i.e., the position of the basket array 1150 for which the localization potential is known). The potential induced in the ensemble, as a function of the now unknown charge, can be written in matrix form as I can write.

number

[0441] Therefore, in most cases, it is necessary to adopt a regularization such as K=[A t A+λ 2 I] -1 A t φ where A is the nxm matrix above, and λ is the regularization parameter, which is the higher-order contribution is chosen to attenuate the distribution dominated by low-order contributions that approximate the dipole field. Once the charge distribution is determined, the localized potential can be calculated at any point in space.

[0442] In some embodiments, the system 10 provides accurate calculation of the scale matrix for localization. The basket 1150 and another E All localizations of P catheters (e.g., 1200, 1500, 1600) are at the scale It depends on a matrix 5155, which maps voltages to positions. Current methods for this are under the assumption of having a perfectly linear voltage field, and therefore ,Departures from linearity introduce errors in localization, which can occur, for example, near pulmonary veins. Another method is to calculate the scale matrix 5155, with the goal of reaching a localization accuracy of 1 mm. It is essential to consider the feasibility of the method. The linearity of the voltage is a function of the This is a reasonable assumption in the region, but not across the atrium where the catheter is manipulated near the pulmonary veins. isn't it.

[0443] The potential of the baskets 1150 provides excellent sampling information from the area in which they are located. This is used to characterize the voltage field in the region of the basket array 1150. In various embodiments, the system 5000 may use known high-order nonlinear analytical functions. This function can be used to fit the potential of an electrode (e.g., electrode 1151). Characterize the voltage fluctuations within the area enclosed by the sketch 1150. As an example, A second-order polynomial may be selected to fit the basket 1150 voltage as follows: .

number

[0444] Compared to alternative methods for calculating the scale matrix 5155, the above method characterize the field in better agreement with respect to the source (e.g., the actual electrophysiological activity of cardiac tissue) can.

[0445] In various embodiments, when a voltage distribution across space is generated, the measured potential is By integrating from a known position (for example, from the centroid position where the potential is known), we obtain The location can be determined by the

number

number

[0446] The integrated position is averaged over a set of reference centroids to determine whether the centroid position or potential noise is present on the auxiliary electrode. It may be advantageous to prevent this from being carried over to the location.

[0447] Once the field description is established, sensors are localized based on the spatial encoding of the field. A voltage to spatial coordinate map can be used for this purpose. An interpolation function can be created. The generation of the scale matrix can be done by using the voltage and Scale matrix-based methods are methods that can generate piecewise linear transformations between the scalar and scalar spaces. is advantageous because of its simplicity (numerical stability, computational resource needs) and is piecewise linear or nearly linear It works in fields, but the mapping from voltage to spatial coordinates works in more general fields.

[0448] In various embodiments, when a voltage distribution across space is generated, the voltage is proportional to the position (in spherical coordinates) a nonlinear relationship from the coordinates γ (in terms of θ and φ, or in terms of Cartesian coordinates x, y, z) to the electric potential Therefore, localization is based on three measurements of the source field. Determining the position requires a voltage-to-position inverse transformation that cannot be expressed analytically. In this state, the location estimate is obtained using the current aux loc procedure, The position is then transformed (via a spherical harmonic transform) such that the potential associated with the updated position is It is repeatedly updated until it matches the measured potential. A simple Newton iteration is sufficient. The gradient at each sample point is constructed from the potential calculated with spherical harmonic basis functions. It is approximated by a series of difference terms.

[0449] Alternatively, once a method for estimating the voltage field is established, the source field can be extended to the core The regions are listed on a grid both inside and outside the region, and their positions are calculated using a lookup table. Arbitrary accuracy can be achieved by trilinear interpolation of gridded data, if desired. Both can be obtained by constructing and sampling a sufficiently fine grid.

[0450] Localization of electrode potentials is based on a continuous but possibly curved electric field vector within the target cardiac chamber. are the eigenfunctions of the vector. Then, localizing potentials far from the relevant effective area results in the "true" (but unknown) potential. There will be an offset from the target potential. The use of this scale factor can be useful when different scale factors are used for different electrodes. There may be a non-physical offset between the electrodes.

[0451] In various embodiments, the system 10 implements methods configured to address this problem. According to the method, a group of positions in the basket array 1150 identified by the position Each centroid in the target heart chamber is located if its position is known relative to some arbitrary origin. defines a single realization of a continuous "averaged" localization field of If the potential can be described numerically, any electrode can be simply written as a coordinate in the field corresponding to the measured potential. Obviously, the position can be easily determined by calculating

[0452] The associated arrays correspond to known positions and potentials of a set of localized basket arrays 1150. To find the successive field, we specify the functional form of the target manifold. Here, we use the generalized Assume a quadratic form given by α ij V i V j +β i V i +γ i Here, the index refers to the three location-specific source fields. It will be appreciated that other functional forms may be used as well.

[0453] The position of each located centroid is then approximated as follows:

number

[0454] The above expression for each located centroid results in a set of equations, which are determined by the coefficient α , β, and γ, assuming that there are more than 10 centroids located, we perform a linear minimum binomial. It can be solved in the multiplicative (LLS) sense.

[0455] Once the coefficients associated with each of the three coordinate dimensions are available, localization can be performed simply by Then, simply plug the potentials obtained from the electrodes into the quadratic equation above and calculate the appropriate sum. do.

[0456] In another embodiment of field-based localization, ignoring the second-order components, three points are located on each IQ axis. The linear terms (and constants) remain. The combined nine linear terms are then stored in the basket array 1151. This corresponds to a scale matrix averaged over the region sampled by These terms allow averaging out the anomalous behavior sampled in the first frame. may be more beneficial than the "single central scale factor" approach.

[0457] In generating a reliable localization of a group of electrodes, the location of a second group of electrodes is , the structural model of the combined first and second groups of electrodes is can be established by fitting to the localized positions of , SVD-based best fit are some examples of methods that can be used here. This allows for locating sensors for which no localization field measurements are available.

[0458] In accordance with an aspect of the inventive concept, the system 10 is The device may be configured to implement a method for predicting the voltages of the first and second electrodes of the device. The electrodes 1551a (tip) and 1551b (second electrode) of the catheter 1500 are Impedance is measured by treatment delivery as well as by electrophysiology (EP) connected to the catheter. ) devices (electronic modulation) can be significantly affected by voltage breakdown. , resulting in a shift in the positions of electrodes 1551a and 1551b.

[0459] The voltage measurement at electrodes 1551c and 1551d (third and fourth electrodes) can be performed using, for example, RF Significantly less susceptible when energy is delivered through the tip electrode 1551a These two electrodes 1551c, d are used to connect the second electrode 1551b and the tip electrode 1551c. 551a and therefore their positions, improving their localization. The ablation catheter 1500 operates in a radiation source-free environment, The voltage distribution of the electrode must have harmonic characteristics, and the linear field satisfies the harmonic condition and abrasion The voltage across the catheter can be expressed as:

number

number

[0460] These estimates are then used to locate the catheter instead of the measured voltage. obtain.

[0461] Thus, the method involves first and second pulses of the ablation catheter 1500 during RF delivery. It provides for predicting the voltage of the second electrode (1551a, b). The equation incorporated into the original estimate of Tell's location was: V2 = V3 + (scale factor derived from V3 and V4) × (distance between V3 and V2) It can be written as follows: V2=V3+((V3-V4) / D34)×D23=V3(1+D23 / D34)-V4 (D23 / D34)

[0462] The same concept can be applied to use the distance from the third electrode 1551c to the distal tip 1551a. The distal tip position was obtained. V1=V3+((V3-V4) / D34)×(D23+D12)

[0463] Starting with the equation for estimating V1 and substituting it into the equation for estimating V2, it gives This reduces exactly to the above estimate of V1 based on

[0464] In various embodiments, the system 10 includes a method for achieving iterative closest point of approach (ICP). can be implemented to align geometrically similar point sets with different axial extents. Through different methodologies, e.g., the contact of the surface of interest with the By tracing the local path of the meter (1100, 1200, 1500, 1600, etc.) or by local positioning as done by the system (e.g., basket 1150). The anatomical structures generated by ultrasound projected from a set of devices are displayed with different numbers of meshes. Schnodes may have different origins, different orientations, and different sizes, possibly on each axis. The patent may include different scales along the lines of "anatomical model(s) 5255" The standard technique for ICP can be confused by the size difference and the concentric Instead of registration, anatomical alignment is performed at the expense of poor correlation in all other regions. This results in parts of the structure matching closely.

[0465] The system 10 combines multiple runs of ICP with scaling operations. This issue can be addressed by using the 5255 model, which allows for the creation of meshes between different anatomical meshes. The registration can be iteratively improved to a "best" state, where the R MS offset is effectively minimized. For the purposes of this description, the ultrasound anatomy is referred to as " Anatomy of the "Fixed" (5255 F ), while the anatomy of the contact is called "mobile" Anatomical Structure(5255 M ) The procedure is implemented as follows: 1) Perform a standard ICP procedure. Use the ICP output to rotate and manipulate the moving anatomy. and move in parallel. 2) Axial ratios between aligned anatomical structures (e.g., along each of the three coordinate axes) Determine the ratio of fixed to mobile anatomical structures and compare the mobile anatomical structures. Scale the structure. 3) Perform steps 1 and 2 a total of three times.

[0466] The output of the iterative ICP procedure is three sets of rotation, translation, and scaling matrices (localization (a different scaling matrix from the 5155 used), which is can be applied to any point on a moving (contact) anatomical structure for the purpose of transforming it into space. .

[0467] For best results, trimming extended structures, e.g., veins and appendages, to remove movable anatomical structures. The results obtained when matching the anatomy of the structure and contact and removing outliers to reduce bias. do.

[0468] The translation, rotation, and scaling obtained from each of the three ICP alignment steps Using the gauging matrix, the position of the moving contact anatomy is converted into that of the fixed ultrasound anatomy. Transform it into the space of

number

[0469] The scaling step is implemented as follows:

number

[0470] FIG. 8 is a schematic of a hybrid in vivo / in vitro test method setup consistent with the concepts of the present invention. 5 shows one or more impedance patches 510 placed on the subject S, e.g. , patch 510a shown on the front of subject S, and patch 51 shown on the back of subject S. The test setup is, for example, as shown, E placed around the torso of subject S. It includes an array of KG / ECG type leads 560.

[0471] Using the test setup of Figure 8, the voltage (or impedance) field is For example, the impedance field driven between the patches 510 may be evaluated based on several factors. The patch size, patch impedance, and The parameters, such as the size of the patch 510, can be varied to include the anatomical structures within the subject S. Therefore, the dispersion of the electrodes varies with different anatomies, e.g., different subjects, and patch characteristics. The correlation between the location and the simulation was carried out using the evaluated localization signal (voltage field). As shown, for example, the surface area of ​​patch 510b can be A portion of the patch 510b is folded or peeled off so that only a portion of the patch is in contact with the skin of the subject S. This reduction in surface area can be achieved by can be measured by the surrounding EKG / ECG leads 560.

[0472] In some embodiments, the EKG / ECG leads 560 are In order to achieve this, the patches can be spaced evenly along the axis of the voltage field at known distances. Allows detailed evaluation of voltage field changes related to 10 parameter changes (size, shape, etc.) To do so.

[0473] Figure 9 shows a circuit diagram of a high input impedance mapping system. The stability of the location correlates with the input impedance of the mapping system. The native input impedance of the mapping system is Interconnect devices, such as a stimulation device, a recording system, and / or another 3D mapping system. The diagram shown is a strategic input impedance. The device is configured to provide protection to the electrode while simultaneously allowing stimulation to be delivered to the electrode.

[0474] The circuitry is located in an auxiliary interface box, e.g., between patient P and console 500 in FIG. 0 (pin box shown in Figure 9). The stimulus can be detected between nodes A1 and A2 by the probe shown in FIG. The lobe delivers the applied electrical pulse to node A1 when the pacing channel is enabled. A signal is applied to A2, which allows for the correct switch configuration and pulses to Alternatively, application of the probe signal may be eliminated and pacing pulses may be detected. The first pacing pulse detected at A2 will trigger the correct This allows for a new switch configuration and allows subsequent pacing pulses to be delivered.

[0475] For pacing pulse detection, the switch configuration with B1 closed and B2 open ensures that the signal , allowing the buffer circuit that protects the input impedance to be bypassed. If no switching pulse is detected (normal operation), switch B1 opens and B2 closes, which buffers the location signal from leakage through external paths and creates voltage fluctuations do.

[0476] Alternatively, the signal may be directed through various paths based on the amplitude and frequency of the signal. The coupling circuit utilizes various signal functions so that different paths are selected by the signal to achieve the optimum signal. For example, the pacing signal may be transmitted through an isolated circuit, e.g. For example, various semiconductor device characteristics such as diodes are used around the buffer circuit. Various PN junction semiconductor devices can be used to bypass various signals. The burden of using the necessary detection and / or switching methods to properly route In some embodiments, the signal may include differential and common mode components ( For example, a signal carried on two or more channels of an electrical system may have a common and a differential component. This common mode and differential nature of the signals can be used to separate one or more signals (e.g. , one or more components of one or more signals) may be transmitted via unintended circuit pathways, e.g., stimulators, recording via a path connected to the system and / or peripheral devices such as a 3D mapping system As described herein, the position can be prevented (e.g., filtered). When location-specific signals are recorded via one or more electrodes in the heart, they primarily contain common-mode components. Filtering common-mode signals from these unintended circuit paths This significantly reduces leakage of the localization signal. A filter (also referred to herein as a common mode choke) is used to reduce the common mode signal. signal leaks into interconnected electronic systems (e.g., one or more unintended circuit paths) The common mode choke can be interconnected with the channel carrying the location signal. By mounting it between the interconnected electronic systems, the common mode choke Common-mode currents from these interconnect systems appear as high impedance paths to the In addition, differential signals, such as pacing pulses (e.g., Recorded by electrodes connected to a system interconnected through a common mode choke The common-mode choke passes unimpeded through the pacing pulses intended for the device. Enables enhanced pacing functionality.

[0477] FIG. 10 shows a console and mapping catheter, including electrodes and ultrasound transducers. The accuracy of the localization varies with the size and orientation of the array 1150 during the procedure. This can be improved by better estimating the shape. One way to do this is to Generate localization signals between electrodes on or within the body, e.g., electrodes 1151 of array 1150 In some embodiments, the localization signal is transmitted via one or more electrodes. The catheters may be delivered either inside or on the body, although the following example shows that they may be delivered on the same catheter inside the body. , which may be used to create a field in the vicinity of the catheter. One or more electrodes 1151 are used to measure impedances generated at one or more locations in space. The impedance fields can be measured simultaneously or sequentially to determine the properties of the impedance fields, e.g., geometric It can be used to calculate properties such as scaling, skew, and / or nonlinearity. In some embodiments, the calculated properties may vary over time (e.g., physiological processes). Gradual drift over time that may occur from the system or sudden shifts that may occur from the interconnection of additional equipment. (e.g., to).

[0478] In some embodiments, measurements of the generated impedance field may be used to localize the generated impedance field. This is done from a set of electrodes that includes electrodes that were not used to transmit a signal. Such "passive" electrodes can be used to spatially sample the field near the catheter. A mathematical model is "fitted" to a series of measurements made by "passive" electrodes to An estimate or approximation of the impedance field characteristics near the terminal can be made. In form, the "fitting" method may be an optimization method (such as least squares) or principal component analysis. In some embodiments, the fitting method may take into account historical information (e.g., the same subject). and / or from another subject) can be used as a starting point, e.g., by weighting, The computational adaptation can be a set of criteria that describes the accuracy of the fit. , whereby the current measurement and the previous measurement can be sequentially improved or optimized based on the In particular, these sources attached to individual electrodes "learn" the correspondence between the fields in space. Create a point source like distribution. If the source is far from the tissue, The distortion of this point source is negligible. Proximal to the tissue, a small area of ​​tissue creates a dispersion of the field. This will result in changes in impedance at the tissue interface and (It depends on the current density due to the source.) The current density is highest closest to the source, so The tissue region closest to the source generates the most significant part of the strain. This region is small in size and The resulting field is a point solution, since it can only exist if the source is close to the tissue. Using this knowledge of the spatial distribution function of the field, we can By fitting the model to a group of sensor measurements, the field distribution can be estimated. The estimated fields can then be used in various localization processes. For example, these can be The shape of the catheter, its position relative to other catheters can be estimated, This includes locating the source electrode.

[0479] For further accuracy of this localization method, the strain due to the tissue is updated by an iterative process. and an iterative process accounts for the presence of nearby impedance changes (tissue structures). This is used during the estimation of the possible field model. Multiple sources applied to the tissue are used for this purpose to measure the tissue that interacts with the applied field. The presence and structure of

[0480] Furthermore, applications that can detect the presence of tissue near the catheter include: The method may involve obtaining a measurement of the mismatch indicated in the placement of the electrodes in the anatomy. When contacting an anatomical structure, the electrode is separated from the anatomical surface. Measurement of catheter mismatch is based on the localization or anatomical structure near the mismatch. In some embodiments, the user may input software inputs It can also be shown that there is a local mismatch between localization and anatomical structures through This user feedback can also be used to set adjustments to account for mismatches. It can be used.

[0481] In another application, the structure of adjacent tissues may be determined using the above method. Thus, an indication of catheter-tissue contact (bonding) can be created using this information.

[0482] In some embodiments, the localization signal is used to determine the distance between the electrodes, e.g., It is delivered to the body via one or more electrodes and is transmitted via the impedance of the body, e.g., blood. The potential (voltage) between the electrodes when a current is conducted and returned ("sunk") through one or more electrodes. ) is measured directly.

[0483] In some embodiments, a source applied at the electrode is used to detect unintentional electrical current from the electrode. The effect of leakage current can be measured. The leakage current is measured at the input of various electronic devices attached to the electrodes. This can occur due to low impedance. Leakage currents are generated by the applied localization field. Point sources generate field distributions that can distort the actual measurement of leakage current. Therefore, the measurement of leakage current (or its effect on the measurement at the electrodes) can be performed by applying Combined with the estimated distortion field pattern due to the measured source, Alternatively, an applied source may be used to correct for errors in the leakage current from the electrodes. By matching the amount of leakage current, the leakage current can be canceled. This allows the measurement value to be corrected. This can reduce the calculation load (which affects accuracy) when creating the model.

[0484] The following describes how the aforementioned location signals are used in conjunction with existing electrical signals of the system 10 as described herein. A description of a system and / or method for generating and transmitting within the context of a child device. In addition to generating, transmitting, and measuring location signals, the system 10 may also include a 10 MHz Generates and receives ultrasound information and measures and records biopotential recordings (electrical recordings of cardiac activity) do.

[0485] The system 10 may include a single-ended switched ultrasonic transmitter, which may be 10 M or Hz pulses to excite a transducer on the catheter. As an example, closing switches A1 and B1 (as shown in Figure 10) The pulse passes through the labeled transducers and returns to the common conductor as shown in the diagram above. A simple modification to a single-ended system allows the same transmitter to transmit each of the transistors on a common conduction path. Different localization signals (between frequencies of 10 and 100 kHz) between adjacent electrodes of the transducer In the diagram above, this is the case with switches A1 and Close any of the other {A2, A3, A4} switches to activate each voltage that matches the closed switch. This is achieved by sourcing and sinking fields from the poles. Specifically, the wideband transmitter: Standard operating mode for ranging unipolar high-energy radiofrequency pulses to the ultrasound crystal (cardiac surface) ) via a local RF ground or via a differential low-current low-frequency voltage between the two catheter electrodes. current (alternative mode for measuring the distance between electrodes) do.

[0486] The console 5000 may include signal combining circuitry, for example, R Alternatively or additionally, the console 50 may include a signal coupling circuit including a C filter and a transformer. 00 may include alternative signal coupling circuits that connect to the multiplexed conduction paths described herein. Then, appropriate signal coupling paths are combined to provide a specific type of signal ( For example, frequency-based combined pacing signals may be optimally delivered. , switching configurations, without the need for additional switching hardware. The signal can then be processed.

[0487] In some embodiments, the ultrasound module 5210 is a The magnetic field generating coil may be configured to detect magnetic signals (e.g., radio frequency magnetic signals) from the magnetic field generating coil. For example, the system may determine the location of the catheter (e.g., its location within a patient's heart chamber). The system 10 may include a wideband generator, and may generate single-ended and / or differential wideband and / or narrowband signals. Generate a band signal, for example, with a frequency of 1.5 kHz to 10 MHz, or 10 kHz to 10 MHz. These drive signals can be of any complexity and can be configured as ultrasonic transmission pulses, magnetic field generators (e.g., high-frequency magnetic field generators), and / or differential electric field generators. These drive signals can be supplied using the same transmission circuit of the ultrasonic module 5210, for example, through signal path switching on the output circuit of the ultrasonic module 5210. These drive signals are applied to a coil and / or antenna (referred to as "coil" in this specification) disposed outside the system 10 to create an external magnetic field that can be sensed by the coil of the localized catheter. Alternatively or additionally, these drive signals can be configured to generate a single-ended magnetic field between a remote electrode (e.g., the skin patch of the system 10) and a local receiver (e.g., a coil) disposed on the localized catheter. Alternatively or additionally, these signals can generate a single-ended magnetic field (e.g., a high-frequency magnetic field) between the remote electrode of the system 10 and a local receiver disposed on the localized catheter, and these drive signals can further include a single-ended burst (e.g., a high-energy burst) supplied to the ultrasonic transducer 1153 (e.g., for ultrasonic ranging).

[0488] The frequencies used to localize the device within the heart H need to be selected to overcome various challenges. Low frequencies (e.g., 1 kHz < x < 20 kHz) enable high input impedance that helps reduce the interaction between localized devices. Frequencies in the range of 1 Hz to 1 kHz are part of biopotential measurements, and the externally However, these signals are not sufficient for reliable measurement of biopotentials. A scheme that also offers the advantage of impedance and does not interfere with biopotential measurements (e.g., 5 ms It can also be used to locate devices with short pulses (less than 1 kHz). Frequencies between 0 kHz and 10 kHz add additional challenges due to variability in tissue impedance. At higher frequencies, the impedance field tends to become more linear, In some embodiments, higher frequencies result in lower input power. The output impedance is sensed by the system amplifier, which is However, low and high frequencies can be By applying the same or simultaneously, the system 10 (or console 5000 ) allows for higher input impedance, a linear field, and proper sampling without compromising performance. For example, if a piece of electronic equipment is attached to the patient, If the input impedance is different at low and high frequencies, a correction term is applied. , which may explain the change in the localization signal based on the difference measured at the two frequencies. Impedance has both resistive and capacitive terms and consequently the field distribution, which depends on tissue impedance, depends on two terms: The effect of the capacitance term varies with frequency, which results in a phase shift at different frequencies. Combining the fields reduces the effect of tissue impedance on the field distribution. A less complex field distribution can be obtained by This is used to improve electrode localization. In the interleaved signal scheme, The ratio between the high and low frequencies may vary depending on implementation requirements.

[0489] It should be understood that the above embodiments are provided as illustrative examples only, and further embodiments are within the scope of the present invention. Any feature described herein with respect to any one embodiment is not intended to be limiting. It may be used alone or in combination with other features described, and may be used in any other implementation. In combination with one or more features of any embodiment, or in any combination of any other embodiment. Furthermore, within the scope of the present invention as defined in the appended claims, Equivalents and modifications not described above may also be used without departing from the spirit and scope of the invention.

[0490] What is described above is believed to be the best mode and / or alternative preferred embodiments. Although the invention has been described, various modifications may be made therein and the invention or inventions may be implemented in various forms. The present invention may be implemented in various aspects and embodiments, which may be applied to many applications, some of which are It is understood that only the claims set forth herein are to be interpreted literally. and equivalents thereof, including all modifications and variations that come within the scope of the claims. It is intended to claim everything.

[0491] Certain features of the invention that are, for clarity, described in the context of separate embodiments may also be , may be provided in combination in a single embodiment. Conversely, for the sake of brevity, Furthermore, various features of the invention that are described in the context of a single embodiment may also be used separately or in any suitable combination. These compounds may be provided in any suitable subcombination.

[0492] For example, all features (independent or dependent) recited in any of the claims may be included. It is understood that the elements (whether or not they are present) may be combined in any given way.

Claims

1. 1. A method for processing physiological information, comprising: A processor coupled to a data storage device and a and providing a plurality of functional elements disposed within, on, and / or proximal to the body. and, A localization coordinate system is calculated from the first set of functional elements using a first localization mode. establishing and calibrating by processing a first set of signals of The localization coordinate system is then adjusted to a second set of functional elements using a second localization mode. and recalibrating by processing a second set of signals from wherein the first location mode is different from the second location mode. method.

2. The first and second location modes are an impedance-based location mode, a magnetic Select from the group consisting of: ultrasonic-based location mode, and ultrasonic-based location mode 10. The method of claim 1 or any other claim,

3. 10. The method of claim 1, wherein the first location mode is an impedance-based location mode.

2. The method of claim 2, or any other claim.

4. 3. The method of claim 2, wherein the first location mode is a magnetic-based location mode.

10. A method according to any of the preceding claims.

5. 3. The method of claim 2, wherein the first location mode is an ultrasound-based location mode; A method according to any other claim.

6. wherein the second location mode is an impedance-based location mode.

2. The method of claim 2, or any other claim.

7. 2. The method of claim 1, wherein the second location mode is a magnetic-based location mode.

10. A method according to any of the preceding claims.

8. 3. The method of claim 2, wherein the second location mode is an ultrasound-based location mode; A method according to any other claim.

9. 10. The method of claim 1, wherein the localization coordinate system is a three-dimensional (3D) coordinate system. The method described in paragraph .

10. 10. The method of claim 9, wherein the origin of the localization coordinate system is located within the body. The method according to claim 1.

11. 11. The method of claim 10, wherein the origin of the localization coordinate system is located within the body organ. is a method according to any other claim.

12. 12. The method of claim 11 or any other claim, wherein the organ is a heart.

13. inserting at least one object into the organ and / or the body, 10. The method of claim 1, wherein at least one object includes a functional element from the plurality of functional elements. The method according to another claim.

14. The at least one object is located in the localization coordinate system, and the function of the at least one object is determined. signals from the active elements, and / or the first set of signals, and / or the second set of signals 14. A method according to claim 13 or any other claim, comprising signal-based location determination. 。

15. The at least one object includes at least one catheter containing a catheter functional element.

15. The method of claim 14, or any other claim, comprising:

16. The catheter functional element may receive at least a portion of the first and / or second set of signals.

16. The method of claim 15 or any other claim, comprising one or more signal sources generating:

17. 15, wherein the catheter functional elements include one or more ultrasound elements, or any other The method according to claim .

18. The catheter functional elements may include one or more ultrasound sensors, transmitters, and / or transducers.

18. The method of claim 17 or any other claim, comprising a laser.

19. 15, or any other claim, wherein the catheter functional elements include one or more magnetic elements. The method according to claim 1.

20. 20. The method of claim 19, wherein the one or more magnetic elements include one or more magnetic coils. The method according to claim .

21. The catheter functional elements include one or more voltage or potential signal generating and / or sensing elements.

16. The method of claim 15 or any other claim.

22. 15, wherein the at least one catheter comprises a diagnostic catheter. The method according to another claim.

23. The diagnostic catheter includes one or more magnetic elements used for magnetic-based localization.

23. The method of claim 22 or any other claim.

24. The diagnostic catheter includes one or more electrodes used for impedance-based localization.

23. The method of claim 22 or any other claim, including a pole.

25. The diagnostic catheter includes one or more ultrasound elements used for ultrasound-based localization.

23. The method of claim 22 or any other claim, comprising:

26. further comprising locating the diagnostic catheter within the localization coordinate system.

23. The method of claim 22 or any other claim.

27. The diagnostic catheter is a cardiac mapping catheter, and the catheter functional element is configured to sense and / or record electrical potentials associated with cardiac activity and / or localization, 23. The method of claim 22 or any other claim, comprising a plurality of electrodes.

28. The diagnostic catheter is a basket catheter, and the catheter functional element is an electrode 23. The method of claim 22, or any other claim, comprising an array of baskets of

29. The diagnostic catheter is a lasso catheter, and the catheter functional element is an electrode 23. The method of claim 22 or any other claim, including a ray.

30. The diagnostic catheter has a distal end including an actuator slidable within a lumen of a sheath. and deploying an array of functional elements within the body, the array including a shaft having 22, or any of the above, wherein the sheath and / or the actuator comprise one or more functional elements.

10. A method according to any of the preceding claims.

31. Each of the shaft and the actuator has one or more functional elements attached to the auxiliary electrodes. The method may further comprise: The relative distance between the auxiliary electrode on the shaft and the auxiliary electrode on the actuator determining with said processor a distance measurement.

31. The method of claim 30 or any other claim.

32. determining with the processor a shape of the array of functional elements based on the distance measurements; and 32. The method of claim 31 or any other claim.

33. The array of functional elements is a basket array, and the processor 33. The method of claim 32 or any other claim, wherein the shape of the ray is determined.

34. The diagnostic catheter may include at least one other functional element on the shaft. The location is determined and consists of electrodes, coils, transducers, and / or physiological sensors. and at least one other functional element selected from the group 3. The method of claim 2, wherein one further functional element is used for cardiac activity mapping and / or localization. 0, or the method of any other claim.

35. The array of functional elements is a basket array, and the auxiliary electrodes are and at least one magnetic sensor on the rotor and / or the shaft, and the method further comprises: The position and / or orientation of the basket array is controlled by the actuator and / or the system. The processor determines the position using at least one magnetic sensor on the shaft and magnetic positioning. further comprising:

32. The method of claim 31 or any other claim.

36. The basket array of functional elements has a known configuration, and the method comprises: At the processor, using the known configuration of the basket array, and determining a position of the functional element of the basket array based on the determined position of another magnetic sensor. locating one or more 36. The method of claim 35 or any other claim.

37. Locating one or more of the functional elements of the basket array base includes: The estimation of the position and orientation of all elements in the sket array can be done using magnetic localization.

37. The method of claim 36 or any other claim, comprising:

38. determining the position and / or orientation of one or more additional devices from said first device using magnetic localization; and positioning one or more elements of one or more additional devices in the magnetically localized basket. determining by said processor by evaluating, calculating, and / or determining against an array; [0033] 36. The method of claim 35 or any other claim.

39. The relative position of the one or more additional devices with respect to the basket array is determined by one or more localization methods, such as ultrasonic localization and / or impedance-based localization. determining, with a processor, 39. The method of claim 38 or any other claim.

40. In-device localization is a localization signal that is generated by a device and / or The information transmitted to and / or received from the functional element and / or the externally located device and and / or functional elements using location signals transmitted to and / or received from the functional elements. [0033] 40. The method of claim 39 or any other claim.

41. The at least one catheter includes a second set of catheter functional elements.

16. The method of claim 15, or any other claim, including a second diagnostic catheter.

42. The second set of catheter functional elements may be used to perform the cardiac activity mapping and / or location characterization.

42. The method of claim 41 or any other claim, comprising one or more electrodes used for measurement. 。

43. The second diagnostic catheter is constructed and arranged for placement within the coronary sinus of the heart. 41 or any other claim, wherein the catheter is a coronary sinus mapping catheter. How to do it.

44. The coronary sinus mapping catheter has at least one catheter function element. The catheter shaft is then positioned to accommodate electrodes, magnetic elements, coils, ultrasound elements, and transducers. and / or a physiological sensor.

44. The method of claim 43, or any other claim, comprising one or more catheter functional elements.

45. The coronary sinus mapping catheter may include one or more catheters for use in magnetic-based localization.

44. The method of claim 43 or any other claim, comprising a magnetic element of

46. The coronary sinus mapping catheter is used for impedance-based localization.

44. The method of claim 43 or any other claim, comprising one or more electrodes.

47. The coronary sinus mapping catheter may include one or more catheters used for ultrasound-based localization.

44. The method of claim 43, or any other claim, comprising an electrode on

48. and further positioning the coronary sinus mapping catheter within the positioning coordinate system. Included in 44. A method according to claim 43 or any other claim.

49. 43. The method of claim 43, wherein the coronary sinus mapping catheter is a lasso catheter.

10. A method according to any of the preceding claims.

50. 15, wherein the at least one catheter comprises a therapeutic catheter. The method according to another claim.

51. 50, or any of the preceding claims, wherein the therapeutic catheter includes at least one therapeutic function element. The method according to another claim.

52. 6. The method of claim 5, wherein the at least one therapeutic function element includes at least one ablation electrode.

10. A method according to claim 1 or any other claim.

53. The therapeutic catheter includes one or more magnetic elements used for magnetic-based localization.

51. The method of claim 50 or any other claim.

54. The treatment catheter includes one or more electrodes used for impedance-based localization.

51. The method of claim 50, or any other claim, including a pole.

55. The treatment catheter includes one or more ultrasound elements used for ultrasound-based localization.

51. The method of claim 50, or any other claim, comprising:

56. and further comprising locating the at least one treatment element within the localization coordinate system. 50, or the method of any other claim.

57. The plurality of functional elements may include external functional elements disposed outside and / or on the body. element, wherein the external functional element comprises one or more of the first set and / or the The method of claim 1 or any other claim, including a second set of functional elements.

58. The external functional element comprises an impedance functional element, a magnetic functional element, and a functional element.

58. The method of claim 57, or any other claim, wherein the functional element is selected from a group of functional element types. method.

59. The functional element types include electrodes, voltage or potential sensors, ultrasonic transmitters, ultrasonic sensors, a magnetic element selected from the group consisting of an acoustic transducer, a magnetic element, and a magnetic coil; 58. The method of claim 58 or any other claim.

60. At least one object in the localization coordinate system is located by at least some of the external functions. further comprising locating using signals generated and / or sensed by the elements.

58. The method of claim 57 or any other claim.

61. 60. The method of claim 60, wherein the at least one object comprises at least one catheter.

10. A method according to any of the preceding claims.

62. the at least one catheter comprises at least one diagnostic catheter.

62. The method of claim 61 or any other claim.

63. the at least one catheter comprises at least one therapeutic catheter.

62. The method of claim 61 or any other claim.

64. At least one wearable garment, the first set and / or the second set At least some of the external functional elements, including the one or more of the set of functional elements and a device for maintaining contact, pressure, and / or position of the external functional element relative to the body. providing at least one wearable garment, 58. The method of claim 57 or any other claim.

65. The at least one wearable garment may be a vest, a suit, a shirt, a bodysuit, 65. A method according to claim 64, or any other claim, taking the form of a method or part thereof.

66. At least a portion of the external functional element is removed from the at least one wearable garment.

65. The method of claim 64 or any other claim, wherein the device is removable.

67. At least a portion of the external functional element is embedded within the at least one wearable garment.

65. The method of claim 64 or any other claim, wherein the surface is embedded or positioned.

68. The wearable garment comprises at least two different external functional elements, the first and / or one or more of the functional elements of said second set include an impedance matching circuit. at least one selected from the group consisting of a functional element, a magnetic functional element, and an ultrasonic functional element; 65. The method of claim 64 or any other claim, wherein the method further comprises two different external functional elements.

69. The at least two external functional elements include a magnetic functional element and an impedance functional element.

69. The method of claim 68 or any other claim.

70. the at least two external functional elements include a magnetic functional element and an ultrasonic functional element.

69. The method of claim 68 or any other claim.

71. The at least two external functional elements include an impedance functional element and an ultrasonic functional element.

69. The method of claim 68 or any other claim, comprising:

72. The magnetic functional element, the impedance functional element, and the ultrasonic functional element The group includes electrodes, voltage or potential sensors, ultrasonic transmitters, ultrasonic sensors, ultrasonic transducers, 7. The method of claim 6, further comprising at least two of a transducer, a magnetic element, and / or a magnetic coil. 8, or the method of any other claim.

73. the external functional elements of the first set and / or the second set of functional elements; a package including at least some of the external functional elements, 58. The method of claim 57 or any other claim, comprising providing a

74. attaching the patch to the body trunk.

74. The method of claim 73 or any other claim.

75. One or more of the patches may comprise at least two different external functional elements, the first one or more of the functional elements of the first set and / or the second set may include a magnetic functional element, an electric and an ultrasound functional element.

74. The method of claim 73 or any other claim, wherein the method further comprises two different external functional elements.

76. The at least two external functional elements include a magnetic functional element and an impedance functional element.

76. The method of claim 75 or any other claim.

77. the at least two external functional elements include a magnetic functional element and an ultrasonic functional element.

76. A method according to claim 75 or any other claim.

78. The at least two external functional elements include an impedance functional element and an ultrasonic functional element.

76. The method of claim 75 or any other claim, comprising:

79. The magnetic functional element, the impedance functional element, and the ultrasonic functional element The group includes electrodes, voltage or potential sensors, ultrasonic transmitters, ultrasonic sensors, ultrasonic transducers, 8. The method of claim 7, further comprising at least two of a transducer, a magnetic element, and / or a magnetic coil. 5, or the method of any other claim.

80. recording physiological data at one or more recording locations of the functional element, and and converting the physiological data into patient information at one or more target locations. , the method of claim 1 or any other claim.

81. Physiologically, one or more recording locations of the first set and / or the second set of functional elements are and recording the biological data.

81. The method of claim 80 or any other claim.

82. At least a portion of the physiological data may be collected from the first set and / or the second set.

81. The method of claim 80 or any other claim, wherein the method is embodied in a signal.

83. A transfer matrix is ​​applied to the physiological data at one or more recording locations to obtain a transfer matrix different from the recording locations. determining patient information at one or more target locations, 81. The method of claim 80 or any other claim.

84. generating the transfer matrix from the first set and / or the second set of signals; Further comprising:

84. The method of claim 83 or any other claim.

85. Generating the transfer matrix characterizes tissue properties between the recording locations and target locations.

84. The method of claim 83 or any other claim, comprising marking.

86. 84. A method according to claim 83 or any other claim, wherein the transfer matrix is ​​a scale matrix. 。

87. 87. The method of claim 86, wherein the scale matrix is ​​a combined scale matrix. The method according to claim 1.

88. Generating the combined scale matrix may include generating a plurality of scale matrices. and combining the plurality of scale matrices into a combined scale matrix. 87, or the method of any other claim.

89. Different ones of the plurality of scale matrices are 89. The method of claim 88 or any other claim, wherein

90. At least two of the plurality of scale matrices are Determine whether the location data from the columns are sufficiently comparable to be combined.

90. The method of claim 89 or any other claim, comprising determining

91. If the at least two scale matrices are not sufficiently comparable, then the at least Adjusting at least one of the two scale matrices to make them comparable.

91. The method of claim 90 or any other claim.

92. Adjusting at least one of the at least two scale matrices comprises adjusting the set of At least one localization parameter that affects the scale estimation of the combined scale matrix. 91, or any other claim, including updating a meter, e.g., catheter shape. The method according to claim 1.

93. If the at least two scale matrices are sufficiently comparable, then Stitch two scale matrices together to generate the combined scale matrix.

91. The method of claim 90 or any other claim, comprising:

94. 86, or any other claim, wherein the scale matrix is ​​a measure of the rate of change of field values. The method described in paragraph .

95. 94, or any other claim, wherein the field value is a voltage or impedance field. The method described.

96. calibrating the localization coordinate system includes estimating the scale matrix.

87. A method according to claim 86 or any other claim.

97. The scale matrix is ​​calculated by measuring the voltage difference between functional elements with known spacing. further comprising estimating 97. The method of claim 96 or any other claim.

98. 98. The method of claim 97, wherein the functional elements are on a catheter and their dimensions are predetermined. is a method according to any other claim.

99. At specific periodic times in the patient's physiological fluctuations, the transformation and / or field characteristics are applied to the process. and describing the field by estimating the field with a 95. The method of claim 94 or any other claim.

100. 99. The method of claim 99, wherein the physiological variations of the patient include cardiac and / or respiratory cycles. The method according to another claim.

101. The particular periodic time point of the patient's physiological fluctuations is the time point at which the field complexity is minimal. , which simplifies the modeling, At these specific times, for favorable physiological conditions, the applied field is spatially Reduced nonlinearity, which makes the field easier to describe and requires fewer inputs; 100. The method of claim 99 or any other claim.

102. These time points are located temporally adjacent to the T-wave and / or P-wave of the patient's ECG signal.

100. The method of claim 99 or any other claim, wherein:

103. Measuring the signal at specific times over a wider period of time allows for the constancy of the source. leading to The invariance has a period that matches the observation period and is sensitive to signal changes from other sources. The contribution of can be observed within these measurements:

100. The method of claim 99 or any other claim.

104. Transformations and / or models describing said other sources are inferred based on said observations. The method of claim 103 or any other claim.

105. the signal artifacts include discrete impulses; optionally triggered by a brief, high-amplitude exogenous signal such as a pacing pulse; 100. The method of claim 99 or any other claim.

106. The discrete impulses have "sharp" structures with steep leading and / or trailing edges.

106. The method of claim 105 or any other claim, wherein the method generates a waveform including a component having:

107. If the artifact is present in the localization signal, the processor observing a short "jump" at the determined position of the recording electrode; Optionally, said localization signal is recorded by said one or more electrodes being localized. an impedance-based localization signal, 105. The method of claim 105 or any other claim.

108. Implementing a threshold algorithm based on observation of signal fluctuations during artifact-free periods Further including, wherein the threshold algorithm determines the observed values ​​at the locations of the one or more recording electrodes. configured to limit jumps, Optionally, a time period comparable to said length of the extraneous signal causing said artifact and / or The median filtering of the signal with a longer filtering period is also , which is used to constrain the observed position shift, 107. The method of claim 107 or any other claim.

109. One or more additional filters are applied to this signal containing components with sharp structures by the processor. Applying the filter filter to the artifacts sufficiently so that they are negligible to observe. including, and including, Optionally, the jump in the position of the recording electrodes is performed by applying two or more filters. can be ignored after 108. The method of claim 108 or any other claim.

110. The sharp structure of the recorded signal is controlled by applying a first filter before a second filter. In this case, a sharp structure appears as an observable jump at the localized position of the catheter. and further comprising the process of preventing or mitigating Optionally, the first filter is a median filter.

110. The method of claim 109 or any other claim.

111. Detecting a pacing pulse with the processor and, in response, and ignoring or filtering signals recorded while the pacing is present. so as not to adversely affect the localization of one or more other electrodes localized between them. [0033] 110. The method of claim 109 or any other claim.

112. and further comprising: locating one or more of the functional elements relative to the body, wherein the Localization involves determining the location of a functional element by the functional element and its location relative to the body and field values ​​are known; Measure the difference in field value between the positions and estimating the difference by multiplying the measured difference by the scaling matrix. 、 where the resulting output is the position of the sensor relative to the known position 、 84. The method of claim 83 or any other claim.

113. The localization signal, when recorded via one or more electrodes within the heart, is primarily a common and the method further comprises: Filtering the common mode signals from unintended circuit paths and / or interconnection systems ringing the location signal to substantially reduce leakage of the location signal.

10. The method of claim 1 or any other claim.

114. The processor uses a common mode filter or a common mode choke to If a common mode signal is present in the one or more unintended circuit paths and / or interconnection systems and further comprising preventing leakage of the Optionally, said common mode filter or common mode choke comprises: Acting as a high impedance path for unintended circuit paths and / or interconnect systems Capable, 113. The method of claim 113 or any other claim.

115. The pacing signal passes unimpeded through the common mode filter or common mode choke. and further including a pulse to enable the intended pacing function; Optionally, the pacing pulses are directed to the one or more unintended circuit pathways and / or The common mode filter or common mode choke is connected to the interconnection system. recorded by the electrodes attached to the 113. The method of claim 114, or any other claim.

116. a processor coupled to a data storage device; a plurality of functional units coupled to the processor and located within, on, and / or proximal to the body; a plurality of functional elements including a first set of functional elements and a second set of functional elements; providing a wherein the processor: A first set of signals from the first set of functional elements is processed to perform a first location mode. establishing and calibrating a localization coordinate system using a A second set of signals from the second set of functional elements is processed to perform a second location mode. configured to recalibrate the localization coordinate system using a the first location mode is different from the second location mode; Physiological processing information system.

117. The first and second location modes are an impedance-based location mode, a magnetic Select from the group consisting of: ultrasonic-based location mode, and ultrasonic-based location mode 116. The system of claim 116 or any other claim.

118. 10. The method of claim 1, wherein the first location mode is an impedance-based location mode. 117, or a system according to any other claim.

119. 117. The method of claim 117, wherein the first location mode is a magnetic-based location mode. is a system according to any other claim.

120. 117. The method of claim 117, wherein the first location mode is an ultrasound-based location mode. Or a system according to any other claim.

121. wherein the second location mode is an impedance-based location mode. 117, or a system according to any other claim.

122. 117. The method of claim 117, wherein the second location mode is a magnetic-based location mode. is a system according to any other claim.

123. 117. The method of claim 117, wherein the second location mode is an ultrasound-based location mode. Or a system according to any other claim.

124. 116, or any other embodiment, wherein the localization coordinate system is a three-dimensional (3D) coordinate system.

10. The system of claim 9.

125. 124, or any of the methods of claim 124, wherein the origin of the localization coordinate system is located within the body. A system according to another claim.

126. 13. The method of claim 12, wherein the origin of the localization coordinate system is located within an organ of the body. 5, or any other claim.

127. 127. The system of claim 126 or any other claim, wherein the organ is a heart.

128. At least one object insertable into the organ and / or the body, at least one object including a functional element from the number of functional elements; 117. A system according to claim 116 or any other claim.

129. The processor: At least one object in the localization coordinate system is located according to a functional element of the at least one object. and / or based on the first set and / or the second set of signals. configured to identify the location by 129. A system according to claim 128 or any other claim.

130. The at least one object is at least one catheter including a catheter functional element.

130. The system of claim 129 or any other claim, comprising:

131. The catheter functional element may receive at least a portion of the first and / or second set of signals. 130, or any other claim, including one or more signal sources configured to generate 2. The system of claim 1 .

132. 130, wherein the catheter functional elements include one or more ultrasound elements, or any other The system of claim 1.

133. The catheter functional elements may include one or more ultrasound sensors, transmitters, and / or transducers.

133. The system of claim 132 or any other claim, including a sensor.

134. 130, wherein the catheter functional elements include one or more magnetic elements, or any other 10. The system of claim 9.

135. 135. The method of claim 134, wherein the one or more magnetic elements include one or more magnetic coils. The system of claim 1.

136. The catheter functional elements include one or more voltage or potential signal generating and / or sensing elements.

130. A system according to claim 130 or any other claim.

137. 130, or any of the preceding claims, wherein the at least one catheter comprises a diagnostic catheter. A system according to another claim.

138. The diagnostic catheter includes one or more magnetic elements used for magnetic-based localization.

137. A system according to claim 137 or any other claim.

139. The diagnostic catheter includes one or more electrodes used for impedance-based localization.

138. The system of claim 137 or any other claim, including a pole.

140. The diagnostic catheter includes one or more ultrasound elements used for ultrasound-based localization.

138. The system of claim 137 or any other claim, comprising:

141. The processor is adapted to locate the diagnostic catheter within the localization coordinate system.

138. A system according to claim 137 or any other claim, configured to:

142. The diagnostic catheter is a cardiac mapping catheter, and the catheter functional element is configured to sense and / or record electrical potentials associated with cardiac activity and / or localization, 138. The system of claim 137 or any other claim, comprising a plurality of electrodes.

143. The diagnostic catheter is a basket catheter, and the catheter functional element is an electrode 138. The system of claim 137, or any other claim, comprising an array of baskets.

144. The diagnostic catheter is a lasso catheter, and the catheter functional element is an electrode 138. The system of claim 137 or any other claim, including a ray.

145. The diagnostic catheter has a distal end including an actuator slidable within a lumen of a sheath. and deploying an array of functional elements within the body, the array including a shaft having 137, wherein the sheath and / or the actuator comprise one or more functional elements; or A system according to any other claim.

146. Each of the shaft and the actuator has one or more functional elements attached to the auxiliary electrodes. and the processor is configured to: 145, or configured to determine a relative distance measurement between the auxiliary electrode of is a system according to any other claim.

147. The processor determines a shape of the array of functional elements based on the distance measurements.

147. A system according to claim 146 or any other claim, configured to:

148. The array of functional elements is a basket array, and the processor 148. A system according to claim 147 or any other claim, which determines the shape of a ray.

149. The diagnostic catheter may include at least one other functional element on the shaft. The location is determined and consists of electrodes, coils, transducers, and / or physiological sensors. and at least one other functional element selected from the group One further functional element is used for cardiac activity mapping and / or localization. 145, or a system according to any other claim.

150. The array of functional elements is a basket array, and the auxiliary electrodes are at least one magnetic sensor on the rotor and / or shaft; The processor controls the position and / or orientation of the basket array by the actuator. using at least one magnetic sensor and magnetic location on the rotor and / or shaft configured to determine, 147. A system according to claim 146 or any other claim.

151. the basket array of functional elements has a known configuration; The processor uses the known configuration of the basket array to and determining a position of the functional element of the basket array based on the determined position of another magnetic sensor. configured to locate one or more 151. A system according to claim 150 or any other claim.

152. The processor calculates the position and orientation of all elements of the basket array based on magnetic position and estimating the location of one or more of the functional elements of the basket array base using the identification.

152. A system according to claim 151 or any other claim, configured to:

153. The processor determines the position and / or orientation of one or more additional devices using magnetic localization. and determining the position of one or more elements of the one or more additional devices using the magnetic localization. determining by evaluating, calculating, and / or determining against the configured basket array; configured to:

151. A system according to claim 150 or any other claim.

154. The processor may further include a processor for determining the phase of the basket array of the one or more additional devices. The paired locations can be determined using one or more localization methods, such as ultrasound localization and / or impedance based localization. configured to determine using the location of the source, 154. A system according to claim 153 or any other claim.

155. The processor may be configured to detect location-specific signals from devices and / or functions located within the processor. transmitted to and / or received from the element and / or externally located devices and / or or within the device using location signals transmitted and / or received from functional elements. configured to perform location determination; 154. A system according to claim 154 or any other claim.

156. The at least one catheter includes a second set of catheter functional elements.

131. The system of claim 130 or any other claim, including a second diagnostic catheter. 。

157. The second set of catheter functional elements may be used to map the cardiac activity and / or position. 156 or any other claim, including one or more electrodes used for identification. system.

158. The second diagnostic catheter is constructed and arranged for placement within the coronary sinus of the heart. 156 or any other claim, wherein the catheter is a coronary sinus mapping catheter. The system.

159. The coronary sinus mapping catheter has at least one catheter function element. The catheter shaft is then positioned to accommodate electrodes, magnetic elements, coils, ultrasound elements, and transducers. and / or a physiological sensor. The system of claim 158, or any other claim, further comprising one or more catheter functional elements. Tem.

160. The coronary sinus mapping catheter may include one or more catheters for use in magnetic-based localization.

159. The system of claim 158 or any other claim, including a magnetic element.

161. The coronary sinus mapping catheter is used for impedance-based localization.

159. The system of claim 158 or any other claim, comprising one or more electrodes.

162. The coronary sinus mapping catheter may include one or more catheters used for ultrasound-based localization.

159. The system of claim 158 or any other claim, including an electrode on the

163. The processor positions the coronary sinus mapping catheter within the localization coordinate system.

159. The system of claim 158 or any other claim, further comprising: identifying the location of the target object.

164. 158. The coronary sinus mapping catheter is a lasso catheter; or A system according to any other claim.

165. 130, or any of the preceding claims, wherein the at least one catheter comprises a therapeutic catheter. A system according to another claim.

166. The therapeutic catheter includes at least one therapeutic function element. A system according to any other claim.

167. 10. The method of claim 1, wherein the at least one therapeutic function element includes at least one ablation electrode. 66, or a system according to any other claim.

168. The therapeutic catheter includes one or more magnetic elements used for magnetic-based localization.

165. A system according to claim 165 or any other claim.

169. The treatment catheter includes one or more electrodes used for impedance-based localization.

166. The system of claim 165 or any other claim, including a pole.

170. The treatment catheter includes one or more ultrasound elements used for ultrasound-based localization.

166. The system of claim 165 or any other claim, comprising:

171. The processor localizes the at least one treatment element within the localization coordinate system.

166. A system according to claim 165 or any other claim, configured to:

172. The plurality of functional elements may include external functional elements disposed outside and / or on the body. element, wherein the external functional element comprises one or more of the first set and / or the 117. The system of claim 116 or any other claim, including a second set of functional elements. 。

173. The external functional element comprises an impedance functional element, a magnetic functional element, and a functional element. 172 or any other claim selected from a group of functional element types. system.

174. The functional element types include electrodes, voltage or potential sensors, ultrasonic transmitters, ultrasonic sensors, a magnetic element selected from the group consisting of an acoustic transducer, a magnetic element, and a magnetic coil; The system of claim 173 or any other claim.

175. At least one object in the localization coordinate system is located by at least some of the external functions. and further configured to locate using signals generated and / or sensed by the element. Ru, 173. A system according to claim 172 or any other claim.

176. 175, wherein the at least one object comprises at least one catheter; or A system according to any other claim.

177. the at least one catheter comprises at least one diagnostic catheter.

177. A system according to claim 176 or any other claim.

178. the at least one catheter comprises at least one therapeutic catheter.

177. A system according to claim 176 or any other claim.

179. At least one wearable garment, the first set and / or the second set at least some of the external functional elements including said one or more of the set of functional elements; maintaining contact, pressure, and / or position of the external functional element relative to the body; further comprising at least one wearable garment; 173. A system according to claim 172 or any other claim.

180. The at least one wearable garment may be a vest, a suit, a shirt, a bodysuit, 179. A system according to claim 179 or any other claim, taking the form of or a portion thereof. 。

181. At least a portion of the external functional element is removed from the at least one wearable garment.

180. A system as claimed in claim 179 or any other claim which is removable.

182. At least a portion of the external functional element is embedded within the at least one wearable garment.

179. The system of claim 179 or any other claim, wherein the system is embedded or disposed on the surface of the substrate. 。

183. The wearable garment comprises at least two different external functional elements, the first and / or one or more of the functional elements of said second set include an impedance matching circuit. at least one selected from the group consisting of a functional element, a magnetic functional element, and an ultrasonic functional element; 179. The system of claim 179, or any other claim, comprising at least two different external functional elements. Tem.

184. The at least two external functional elements include a magnetic functional element and an impedance functional element.

184. A system as claimed in claim 183 or any other claim.

185. the at least two external functional elements include a magnetic functional element and an ultrasonic functional element.

183. A system according to claim 183 or any other claim.

186. The at least two external functional elements include an impedance functional element and an ultrasonic functional element.

184. The system of claim 183 or any other claim, comprising:

187. The magnetic functional element, the impedance functional element, and the ultrasonic functional element The group includes electrodes, voltage or potential sensors, ultrasonic transmitters, ultrasonic sensors, ultrasonic transducers, 10. The method of claim 1, further comprising: 83, or a system according to any other claim.

188. the external functional elements of the first set and / or the second set of functional elements; a package including at least some of the external functional elements, Further provided with 173. A system according to claim 172 or any other claim.

189. 188, or any other claim, wherein the patch is attachable to the body trunk. The system described in

190. One or more of the patches may comprise at least two different external functional elements, the first one or more of the functional elements of the first set and / or the second set may include a magnetic functional element, an electric and an ultrasound functional element.

188. The system of claim 188, or any other claim, comprising at least two different external functional elements. Tem.

191. The at least two external functional elements include a magnetic functional element and an impedance functional element.

190. A system as claimed in claim 190 or any other claim.

192. the at least two external functional elements include a magnetic functional element and an ultrasonic functional element.

190. A system according to claim 190 or any other claim.

193. The at least two external functional elements include an impedance functional element and an ultrasonic functional element.

191. The system of claim 190 or any other claim, comprising:

194. The magnetic functional element, the impedance functional element, and the ultrasonic functional element The group includes electrodes, voltage or potential sensors, ultrasonic transmitters, ultrasonic sensors, ultrasonic transducers, 10. The method of claim 1, further comprising: 90, or a system according to any other claim.

195. recording physiological data at one or more recording locations of the functional element, and and configured to convert the physiological data into patient information at one or more target locations.

116. A system according to claim 116 or any other claim.

196. The processor may include one or more of the first set and / or the second set of functional elements. 195, or any of the above. A system according to another claim.

197. At least a portion of the physiological data may be collected from the first set and / or the second set.

197. The system of claim 196 or any other claim, embodied in a signal.

198. The processor: A transfer matrix is ​​applied to the physiological data at one or more recording locations to obtain a transfer matrix different from the recording locations. and determining patient information at one or more target locations, 195. A system according to claim 195 or any other claim.

199. The processor: generating said transfer matrix from said first set and / or said second set of signals; It consists of 198. A system according to claim 198 or any other claim.

200. The processor: The transfer matrix is ​​calculated by characterizing tissue properties between the recording and target locations. configured to generate 199. A system according to claim 198 or any other claim.

201. 198. The system of claim 198, or any other claim, wherein the transfer matrix is ​​a scale matrix. Stem.

202. 201, wherein the scale matrix is ​​a combined scale matrix; A system according to another claim.

203. The processor processes the combined scale matrix to generate a plurality of scale matrices. and combining the plurality of scale matrices into a combined scale matrix. The system of claim 202 or any other claim, wherein the system is configured to generate Tem.

204. Different ones of the plurality of scale matrices are calculated at different positions in the localization coordinate system.

204. A system according to claim 203 or any other claim, configured to generate:

205. The processor is configured to: sufficiently comparable so that the localization data from the two scale matrices can be combined. 204 or any other claim, configured to determine whether The system.

206. If the at least two scale matrices are not sufficiently comparable, the processor: At least one of the at least two scale matrices is adjusted to make them comparable.

206. The system of claim 205 or any other claim, configured to:

207. The processor may further process at least one of the at least two scale matrices as a At least one location determining step that affects the scale estimation of the combined scale matrix. configured to adjust by updating a parameter, e.g., catheter shape , claim 206, or any other claim.

208. If the at least two scale matrices are sufficiently comparable, the processor: stitching the at least two scale matrices together to produce the combined scale matrix; 205. The system of claim 205 or any other claim, configured to generate a matrix of Stem.

209. 201, or any other claim, wherein the scale matrix is ​​a measure of the rate of change of field values.

2. The system of claim 1 .

210. 209, or any other claim, wherein the field value is a voltage or impedance field. The system described in

211. The processor calculates the localization coordinate system by estimating the scale matrix.

202. The system of claim 201 or any other claim configured to calibrate.

212. The processor: The scale matrix is ​​calculated by measuring the voltage difference between functional elements with known spacing. further configured to estimate, 212. A system according to claim 211 or any other claim.

213. 213. The method of claim 212, wherein the functional elements are on a catheter and their dimensions are predetermined. Or a system according to any other claim.

214. The processor may generate a transformation and / or a field at specific periodic times of the patient's physiological fluctuations. configured to estimate properties of the field to describe the field; 209. A system according to claim 209 or any other claim.

215. 214, or any of the claims 214 to 217, wherein the physiological variations of the patient include cardiac and / or respiratory cycles. A system according to another claim.

216. The particular periodic time point of the patient's physiological fluctuations is the time point at which the field complexity is minimal. , which simplifies the modeling, At these specific times, for favorable physiological conditions, the applied field is spatially Reduced nonlinearity, which makes the field easier to describe and requires fewer inputs; 215. A system according to claim 214 or any other claim.

217. These time points are located temporally adjacent to the T-wave and / or P-wave of the patient's ECG signal.

215. The system of claim 214 or any other claim, wherein:

218. Measuring the signal at specific times over a wider period of time allows for the constancy of the source. leading to The invariance has a period that matches the observation period and is sensitive to signal changes from other sources. The contribution of can be observed within these measurements:

215. A system according to claim 214 or any other claim.

219. Transformations and / or models describing said other sources are inferred based on said observations. The system of claim 218 or any other claim.

220. the signal artifacts include discrete impulses; optionally triggered by a brief, high-amplitude exogenous signal such as a pacing pulse; 215. A system according to claim 214 or any other claim.

221. The discrete impulses have "sharp" structures with steep leading and / or trailing edges.

220. A system according to claim 220 or any other claim, which generates a waveform including a component having Hmm.

222. If the artifact is present in the localization signal, the processor at the determined position of the recording electrode, a short "jump" is observed. 、 Optionally, said localization signal is recorded by said one or more electrodes being localized. an impedance-based localization signal, 221. A system according to claim 220 or any other claim.

223. The processor selects a threshold algorithm based on observation of signal fluctuations during artifact-free periods. configured to run the program, wherein the threshold algorithm is configured to: configured to limit jumps, Optionally, a time period comparable to said length of the extraneous signal causing said artifact and / or The median filtering of the signal with a longer filtering period is also , which is used to constrain the observed position shift, 223. A system according to claim 222 or any other claim.

224. The processor may apply one or more additional filters to signals containing components with sharp structures. and filtering sufficiently so that the artifacts are negligible to observe. and Optionally, the jump in the position of the recording electrodes is performed by applying two or more filters. can be ignored after 224. A system according to claim 223 or any other claim.

225. The processor filters sharp structures in the recorded signal by filtering a first filter before a second filter. By applying the catheter to the catheter, sharp structures are restricted from being observable at the localized location. Prevent or reduce the appearance of rash, Optionally, the first filter is a median filter.

225. A system according to claim 224 or any other claim.

226. The processor detects a pacing pulse and, in response, and ignoring and / or filtering signals recorded while the pacing is present. does not adversely affect the localization of one or more other electrodes that are localized while present. configured to 225. A system according to claim 224 or any other claim.

227. locating one or more of the functional elements relative to the body and determining the positions of the functional elements; the functional element and its location relative to the body and field values ​​are known; measuring the difference in field values ​​between the positions; and multiplying the measured difference by the scale matrix. The system is configured as follows: where the resulting output is the position of the sensor relative to the known position 、 199. A system according to claim 198 or any other claim.

228. The localization signal, when recorded via one or more electrodes within the heart, is primarily a common It has a monomode component, The processor may further include a processor for detecting the common mode signal from unintended circuit paths and / or interconnect systems. configured to filter the localization signal from the system to substantially reduce leakage of the localization signal. will be 117. A system according to claim 116 or any other claim.

229. The processor uses a common mode filter or a common mode choke to If a common mode signal is present in the one or more unintended circuit paths and / or interconnection systems configured to prevent leakage into Optionally, said common mode filter or common mode choke comprises: Acting as a high impedance path for unintended circuit paths and / or interconnect systems Capable, 229. A system according to claim 228 or any other claim.

230. The common mode filter or the common mode choke is is configured to allow unimpeded passage of pacing pulses through the common mode choke, Enables intended pacing function, Optionally, the pacing pulses are directed to the one or more unintended circuit pathways and / or The common mode filter or common mode choke is connected to the interconnection system. recorded by the electrodes attached to the 228, 229, or any other claim.

231. A method for forming a localization coordinate system has been shown and described.

232. A method for locating an object in a localization coordinate system has been shown and described.

233. As shown and described, a system for establishing and calibrating a localization coordinate system.

234. As shown and described, a system for locating an object in a localization coordinate system.

235. Localization patches shown and explained.

236. Location-specific wearable garment shown and described.

Images