System and method for computing patient information

Abstract

Systems and methods for calculating patient information are provided herein. The method includes determining a transfer matrix, recording electrical potentials via a first set of recording electrodes located at a first set of recording locations to create a first set of recorded signals, and calculating patient information for a set of target locations by applying the transfer matrix to the first set of recorded signals. The transfer matrix is ​​a characteristic of electrical properties of tissue between the first set of recording locations and the set of target locations.

Description

[0001] Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 757,961, filed on November 9, 2018, entitled “Systems and Methods for Computing Patient Information,” which is incorporated herein by reference.

[0003] Although this application does not claim priority to, but may be related to, U.S. Application Serial No. 16 / 335,893, filed on March 22, 2019, and entitled “Ablation System with Force Control,” which is a 35 USC 371 national phase application of Patent Cooperation Treaty Application No. PCT / US2017 / 056064, filed on October 11, 2017, and entitled “Ablation System with Force Control,” published as WO2018 / 071490, which claims priority to U.S. Provisional Application Serial No. 62 / 406,748, filed on October 11, 2016, and entitled “Ablation System with Force Control,” and U.S. Provisional Application Serial No. 62 / 406,748, filed on May 20, 2017, and entitled “Ablation System with Force Control,” filed on No. 62 / 504,139 entitled "Ablation System with Force Control", each of which is incorporated herein by reference.

[0004] Although this application does not claim priority to the following applications, it may be related to the following applications: U.S. application serial No. 16 / 097,955, entitled “Cardiac Information Dynamic Display System and Method,” filed on October 31, 2018, which is Patent Cooperation Treaty Application No. PCT / US2017 / 030915, entitled “Cardiac Information Dynamic Display System and Method,” filed on May 3, 2017, and published as 35 USC 371 national phase application of WO 2017 / 192769, which Patent Cooperation Treaty Application No. PCT / US2017 / 030915 claims priority to U.S. Provisional Application Serial No. 62 / 331,351, entitled “Cardiac Information Dynamic Display System and Method,” filed on May 3, 2016, each of which is incorporated herein by reference.

[0005] Although this application does not claim priority to the following applications, it may be related to the following applications: U.S. Application Serial No. 16 / 012,051, filed on June 19, 2018, entitled “Catheter, System and Methods of Medical Uses of Same, Including Diagnostic and Treatment Uses for the Heart”, which is a continuation of U.S. Patent No. 10,004,459, filed on February 20, 2015, entitled “Catheter, System and Methods of Medical Uses of Same, Including Diagnostic and Treatment Uses for the Heart”, which is a continuation of U.S. Patent No. 10,004,459, filed on August 30, 2013, entitled “Catheter System and Methods of Medical Uses of Same, Including Diagnostic and Treatment Uses for the Heart Heart (Catheter system and medical use of catheter system, including diagnostic and therapeutic uses of the heart)" Patent Cooperation Treaty Application No. PCT / US2013 / 057579, published as 35 USC 371 National Phase Application of WO 2014 / 036439, which Patent Cooperation Treaty Application No. PCT / US2013 / 057579 claims priority to U.S. Provisional Application Serial No. 61 / 695,535, entitled "System and Method for Diagnosing and Treating Heart Tissue", filed on August 31, 2012, each of which is incorporated herein by reference.

[0006] Although the present application does not claim priority to the following applications, it may be related to the following applications: U.S. patent application serial No. 16 / 242,810, filed on January 8, 2019, entitled “Expandable Catheter Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways”, which is a continuation of U.S. patent application serial No. 14 / 762,944, filed on July 23, 2015, entitled “Expandable Catheter Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways”, which is a continuation of U.S. patent application serial No. 14 / 762,944, filed on February 7, 2014, entitled “Expandable Catheter Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways”. Patent Cooperation Treaty Application No. PCT / US2014 / 015261, entitled “Expandable Catheter Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways,” published as 35 USC 371 National Phase Application of WO 2014 / 124231, which claims priority to U.S. Provisional Application Serial No. 61 / 762,363, filed on February 8, 2013, entitled “Expandable Catheter Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways,” each of which is incorporated herein by reference.

[0007] Although this application does not claim priority to the following applications, it may be related to the following applications: U.S. Patent Application Serial No. 16 / 533,028, filed on August 6, 2019, entitled “Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls”, which is a continuation of U.S. Patent Application Serial No. 16 / 014,370, filed on June 21, 2018, entitled “Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls”, which is a continuation of U.S. Patent Application Serial No. 16 / 014,370, filed on February 17, 2017, entitled “Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls” No. 15 / 435,763, entitled “Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls,” which is a continuation of U.S. Patent No. 9,610,024, filed on September 25, 2015, entitled “Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls,” which is a continuation of U.S. Patent No. 9,167,982, filed on November 19, 2014, entitled “Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls,” which is a continuation of U.S. Patent No.9,167,982 is a continuation of U.S. Patent No. 8,918,158, issued on December 23, 2014, entitled “Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls” (hereinafter referred to as the '158 Patent), which is a continuation of U.S. Patent No. 8,700,119, issued on April 15, 2014, entitled “Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls” (hereinafter referred to as the '119 Patent), which is a continuation of U.S. Patent No. 8,700,119, issued on April 9, 2013, entitled “Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls” (hereinafter referred to as the '119 Patent). and Dipole Densities on Cardiac Walls,” which is a continuation of U.S. Patent No. 8,417,313 (hereinafter referred to as the '313 patent), which is a continuation of PCT Application No. PCT / CH2007 / 000380, entitled “Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls,” filed on August 3, 2007, 35 USC 371 National Phase Application published as WO 2008 / 014629, which PCT Application No. PCT / CH2007 / 000380 claims priority to Swiss Patent Application No. 1251 / 06 filed on August 3, 2006, each of which is incorporated herein by reference. .

[0008] Although this application does not claim priority to the following applications, it may be related to the following applications: U.S. patent application serial No. 16 / 568,768, filed on September 12, 2019, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall”, which is a continuation of U.S. patent application serial No. 15 / 882,097, filed on January 29, 2018, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall”, which is a continuation of U.S. patent application serial No. 15 / 882,097, filed on December 25, 2016, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall”. The present invention is a continuation of U.S. Patent Application No. 9,913,589, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall”, which is a continuation of U.S. Patent Application No. 9,504,395, filed on October 19, 2015, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall”, which is a continuation of U.S. Patent Application No. 9,192,318, filed on July 19, 2013, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall”, which is a continuation of U.S. Patent Application No. 9,192,318, filed on July 19, 2013, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall”, which is a continuation of U.S. Patent Application No.9,192,318 is a continuation of U.S. Patent No. 8,512,255, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall,” issued on August 20, 2013, published as US2010 / 0298690 (hereinafter referred to as the '690 application), which is a 35 U.S.C. patent application No. PCT / IB2009 / 000071, entitled “A Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall,” filed on January 16, 2009, published as WO2009 / 090547. 371 National Phase Application, Patent Cooperation Treaty Application No. PCT / IB2009 / 000071 claims priority to Swiss Patent Application 00068 / 08 filed on January 17, 2008, each of which is incorporated herein by reference.

[0009] Although this application does not claim priority to the following applications, it may be related to the following applications: U.S. patent application serial No. 16 / 389,006, filed on April 19, 2019, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall”, which is a continuation of U.S. application serial No. 15 / 926,187, filed on March 20, 2018, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall”, which is a continuation of U.S. application serial No. 15 / 926,187, filed on August 8, 2017, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall”. No. 9,968,268, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall,” which is a continuation of U.S. Patent No. 9,757,044, filed on September 6, 2013, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall,” which is a 35 U.S.C. patent application No. PCT / US2012 / 028593, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall,” published as WO 2012 / 122517 (hereinafter the '517 application) 371 National Phase Application, Patent Cooperation Treaty Application No. PCT / US2012 / 028593 claims U.S. Patent Provisional Application Serial No.61 / 451,357, each of which is incorporated herein by reference.

[0010] Although this application does not claim priority to, it may be related to the following applications: U.S. design patent application serial No. 29 / 681,827, entitled “Set of Transducer-Electrode Pairs for a Catheter,” filed on February 28, 2019, which is a divisional of U.S. design patent application serial No. 29 / 593,043, entitled “Set of Transducer-Electrode Pairs for a Catheter,” filed on February 6, 2017, which is a divisional of U.S. design patent application serial No. 29 / 593,043, entitled “Transducer-Electrode Pair for a Catheter,” filed on December 2, 2013. No. D782,686, entitled “Catheter System and Methods of Medical Uses of Same, Including Diagnostic and Treatment Uses for the Heart,” which is a 35 USC 371 national phase application of Patent Cooperation Treaty Application No. PCT / US2013 / 057579, filed on August 30, 2013, entitled “Catheter System and Methods of Medical Uses of Same, Including Diagnostic and Treatment Uses for the Heart,” which claims priority to U.S. Provisional Application Serial No. 61 / 695,535, entitled “System and Method for Diagnosing and Treating Heart Tissue,” filed on August 31, 2012, each of which is incorporated herein by reference.

[0011] Although this application does not claim priority to the following applications, it may be related to the following applications: U.S. patent application serial No. 16 / 111,538, entitled “Gas-Elimination Patient Access Device”, filed on August 24, 2018, which is a continuation of U.S. Patent No. 10,071,227, entitled “Gas-Elimination Patient Access Device”, filed on July 14, 2016, which is a 35 U.S.C. patent application No. PCT / US2015 / 11312, entitled “Gas-Elimination Patient Access Device”, filed on January 14, 2015. 371 National Phase Application, Patent Cooperation Treaty Application No. PCT / US2015 / 11312 claims priority to U.S. Patent Provisional Application Serial No. 61 / 928,704, entitled “Gas-Elimination Patient Access Device,” filed on January 17, 2014, which is incorporated herein by reference.

[0012] Although this application does not claim priority to the following applications, it may be related to the following applications: U.S. patent application serial No. 15 / 128,563, entitled “Cardiac Analysis User Interface System and Method,” filed on September 23, 2016, which is a 35USC 371 national phase application of Patent Cooperation Treaty Application No. PCT / US2015 / 22187, entitled “Cardiac Analysis User Interface System and Method,” filed on March 24, 2015, which claims priority to U.S. Patent Provisional Application Serial No. 61 / 970,027, entitled “Cardiac Analysis User Interface System and Method,” filed on March 28, 2014, which is incorporated herein by reference.

[0013] Although this application does not claim priority to, it may be related to the following applications: U.S. Patent Application Serial No. 14 / 916,056, filed on March 2, 2016, entitled “Devices and Methods for Determination of Electrical Dipole Densities on a Cardiac Surface,” which is a 35 USC 371 national phase application of Patent Cooperation Treaty Application No. PCT / US2014 / 54942, entitled “Devices and Methods for Determination of Electrical Dipole Densities ona Cardiac Surface,” filed on September 10, 2014, which Patent Cooperation Treaty Application No. PCT / US2014 / 54942 claims priority to U.S. Patent Application Serial No. 14 / 916,056, filed on March 2, 2016, entitled “Devices and Methods for Determination of Electrical Dipole Densities on a Cardiac Surface,” which is a 35 USC 371 national phase application of Patent Cooperation Treaty Application No. PCT / US2014 / 54942, entitled “Devices and Methods for Determination of Electrical Dipole Densities ona Cardiac Surface,” filed on September 13, 2013 Dipole Densities on a Cardiac Surface" which is incorporated herein by reference.

[0014] Although this application does not claim priority to the following applications, it may be related to the following applications: U.S. patent application serial No. 15 / 569,457, filed on October 26, 2017, entitled “Localization System and Method Useful in the Acquisition and Analysis of Cardiac Information”, which is a 35 USC 371 national phase application of Patent Cooperation Treaty Application No. PCT / US2016 / 032420, entitled “Localization System and Method Useful in the Acquisition and Analysis of Cardiac Information”, filed on May 13, 2016, which Patent Cooperation Treaty Application No. PCT / US2016 / 032420 claims priority to U.S. patent application serial No. 15 / 569,457, entitled “Localization System and Method Useful in the Acquisition and Analysis of Cardiac Information”, filed on May 13, 2015, entitled “Localization System and Method Useful in the Acquisition and Analysis of Cardiac Information” Priority to U.S. Patent Provisional Application Serial No. 62 / 161,213, entitled "Positioning System and Method for Acquiring and Analyzing Cardiac Information," which is incorporated herein by reference.

[0015] Although this application does not claim priority to the following applications, it may be related to the following applications: U.S. patent application serial No. 15 / 569,231, entitled “Cardiac Virtualization Test Tank and Testing System and Method,” filed on October 25, 2017, which is a 35 USC 371 national phase application of Patent Cooperation Treaty Application No. PCT / US2016 / 031823, filed on May 11, 2016, which claims priority to U.S. Patent Provisional Application Serial No. 62 / 160,501, entitled “Cardiac Virtualization Test Tank and Testing System and Method,” filed on May 12, 2015, which is incorporated herein by reference.

[0016] Although this application does not claim priority to the following applications, it may be related to the following applications: U.S. patent application serial No. 15 / 569,185, entitled “Cardiac Virtualization Test Tank and Testing System and Method,” filed on October 25, 2017, which is a 35 USC 371 national phase application of Patent Cooperation Treaty Application No. PCT / US2016 / 032017 filed on May 12, 2016, which claims priority to U.S. Patent Provisional Application Serial No. 62 / 160,529, entitled “Ultrasound Sequencing System and Method,” filed on May 12, 2015, which is incorporated herein by reference.

[0017] Although this application does not claim priority to, it may be related to the following applications: U.S. Patent Application Serial No. 16 / 097,959, filed on October 31, 2018, entitled “Cardiac Mapping System with Efficiency Algorithm,” which is a 35 USC 371 national phase application of Patent Cooperation Treaty Application No. PCT / US2017 / 030922, entitled “Cardiac Mapping System with Efficiency Algorithm,” filed on May 3, 2017, which claims priority from Patent Cooperation Treaty Application No. PCT / US2017 / 030922, entitled “Cardiac Mapping System with Efficiency Algorithm,” filed on October 26, 2016. No. 62 / 413,104, entitled "Cardiac Mapping System with Efficient Algorithm," which is incorporated herein by reference.

[0018] Although this application does not claim priority to the following applications, it may be related to the following applications: Patent Cooperation Treaty Application No. PCT / US2019 / 014498, entitled “System for Identifying Cardiac Conduction Patterns,” filed on January 22, 2019, which claims priority to U.S. Patent Provisional Application Serial No. 62 / 619,897, entitled “System for Recognizing Cardiac Conduction Patterns,” filed on January 21, 2018, and U.S. Patent Provisional Application Serial No. 62 / 668,647, entitled “System for Identifying Cardiac Conduction Patterns,” filed on May 8, 2018, each of which is incorporated herein by reference.

[0019] Although this application does not claim priority to the following applications, it may be related to the following applications: Patent Cooperation Treaty Application No. PCT / US2019 / 031131, entitled “Cardiac Information Processing System,” filed on May 7, 2019, which Patent Cooperation Treaty Application No. PCT / US2019 / 031131 claims priority to U.S. Provisional Application Serial No. 62 / 668,659, entitled “Cardiac Information Processing System,” filed on May 8, 2018, and U.S. Provisional Application Serial No. 62 / 811,735, entitled “Cardiac Information Processing System,” filed on February 28, 2019, each of which is incorporated herein by reference.

[0020] Although this application does not claim priority to the following applications, it may be related to the following applications: U.S. Patent Provisional Application Serial No. 62 / 835,538, entitled "System for Creating a Composite Map", filed on April 18, 2019, which is incorporated herein by reference.

[0021] Although this application does not claim priority to the following applications, it may be related to the following applications: U.S. Patent Provisional Application Serial No. 62 / 925,030, entitled "System for Creating a Composite Map", filed on October 23, 2019, which is incorporated herein by reference. Technical Field

[0022] The present invention relates generally to medical diagnostic and treatment systems, and more particularly to systems for recording physiological data from a first location to provide patient information at a different location. Background Art

[0023] Systems used by clinicians to perform medical procedures such as diagnostic and / or therapeutic procedures typically require evaluation of one or more patient parameters (such as electrical and / or mechanical properties of tissue), as well as other patient information useful in performing the medical procedure. Among them, the operation of treating (e.g., ablating) tissue typically includes evaluation of untreated tissue (e.g., before treatment), partially treated tissue (e.g., during treatment), and / or treated tissue (e.g., after treatment). Due to limited space and other reasons, it is often difficult to perform the evaluation at the treatment site. The accuracy and specificity of the available evaluations may be limited and result in a lack of safety and / or lack of effectiveness of the treatment.

[0024] There is a need for systems that provide tissue and other patient information in a secure, efficient, reliable, and simplified manner. Summary of the invention

[0025] According to one aspect of the present invention, a method for calculating patient information includes: determining a transfer matrix; recording electric potentials via a first set of recording electrodes located at a first set of recording positions to create a first set of recorded signals; and calculating patient information of a set of target positions by applying the transfer matrix to the first set of recorded signals.

[0026] In some embodiments, the first set of recording electrodes includes one or more electrodes.

[0027] In some embodiments, the first set of recording electrodes includes two or more electrodes.

[0028] In some embodiments, the first set of recording electrodes includes one or more electrodes selected from the group consisting of: surface electrodes, internal body electrodes, transcutaneous electrodes, subcutaneous electrodes, and combinations thereof.

[0029] In some embodiments, the first set of recording electrodes includes: at least one electrode positioned on the patient's skin, at least one electrode positioned on the endocardial surface of the cardiac chamber, and / or at least one electrode within the cardiac chamber offset from the endocardial wall of the cardiac chamber.

[0030] In some embodiments, the first set of electrodes includes: a set of electrodes configured to be positioned on the patient's skin and comprising a material selected from the group consisting of platinum iridium, gold, polymers (e.g., polymer coatings), carbon, copper, silver-silver chloride, conductive gels, and combinations thereof.

[0031] In some embodiments, the first set of electrodes comprises: a set of electrodes configured to be positioned within the body of a patient and comprising a material selected from the group consisting of: platinum iridium, gold, a polymer (eg, a polymer coating), carbon, and combinations thereof.

[0032] In some embodiments, the first set of recording electrodes includes one, two or more electrodes selected from the following: one or more electrodes configured to transmit and / or receive positioning signals, multiple electrodes configured to generate ECG signals (such as an ECG array of at least 9 or at least 12 electrodes), multiple electrodes configured to generate high-density ECGi signals, one or more electrodes configured to deliver cardiac pacing energy, one or more electrodes configured to deliver defibrillation energy, one or more electrodes configured to deliver therapeutic energy, and combinations thereof. One, two or more electrodes can be positioned on and / or within the patient's clothing. The patient's clothing can include clothing selected from the following: a vest, a shirt, a belt, a waistband, and combinations thereof.

[0033] In some embodiments, the first set of recording electrodes is positioned on and / or within the patient's clothing. The patient's clothing may include clothing selected from the following: a vest, a shirt, a belt, a waistband, and combinations thereof. The first set of recording electrodes can be positioned relative to the patient in a vertical arrangement, a horizontal arrangement, a diagonal arrangement, and / or a spiral arrangement. The first set of electrodes can be positioned on and / or within the patient's clothing in a defined pattern, and the pattern can define a coordinate system. The first set of electrodes can be configured to provide: arrhythmia monitoring, positioning of a device positioned within the patient's body, and / or a map of electrical information (such as voltage information, dipole density information, and / or surface charge information) of the patient's heart.

[0034] In some embodiments, the first set of recording locations includes one or more locations on the patient's skin. The first set of recording locations may include locations selected from the following: chest, back, torso, shoulder, abdomen, skull, face, arm, leg, groin, and combinations thereof. The set of target locations may also include one or more locations within the patient's body. The one or more locations within the patient's body may include a location close to the patient's heart. The one or more locations within the patient's body may include one or more locations selected from the following: epicardial surface, within cardiac tissue, endocardial surface, within a cardiac cavity, pericardial cavity, pericardium, and combinations thereof.

[0035] In some embodiments, the first group of recording locations includes one or more locations within the patient's body. The first group of recording locations may include one or more in-body locations selected from the following: within a cardiac cavity, on the endocardial surface, on the epicardial surface, and combinations thereof. The first group of recording locations may include one or more in-body locations selected from the following: esophagus, epicardium, pericardium, interstitial fluid and / or other tissue structures surrounding the heart, interstitial fluid and / or other tissue structures under the skin, subcutaneous tissue, spinal tissue, brain tissue, and combinations thereof. The first group of recording locations may include one or more locations within the patient's heart and / or otherwise close to the patient's heart. The first group of recording locations may include one or more locations selected from the following: epicardial surface, within cardiac tissue, endocardial surface, within a cardiac cavity, pericardial cavity, pericardium, and combinations thereof.

[0036] In some embodiments, the first set of recording locations includes locations on the patient's skin and locations within the patient's body.The system can be configured to multiplex signal sources and receivers between electrodes on the patient's skin and recording electrodes within the patient's body.

[0037] In some embodiments, the calculated patient information includes information selected from the group consisting of electrical information, voltage information, surface charge information, tissue charge information, dipole density information, tissue density information, electrogram flow information, impedance information, phase information, and combinations thereof.

[0038] In some embodiments, the calculated patient information includes tissue density information. The tissue density information may include information related to changes in tissue density over time. Changes in tissue density over time may include changes caused by ablation of tissue.

[0039] In some embodiments, the transfer matrix includes characteristics of electrical properties of tissue between a first set of recording locations and a set of target locations.

[0040] In some embodiments, determining the transfer matrix includes: transmitting a set of drive signals via a set of drive electrodes located at a set of drive positions; and recording the transmitted drive signals via a second set of recording electrodes located at a second set of recording positions to create a second set of recorded signals. The transfer matrix can be determined by comparing the second set of recorded signals with the transmitted set of drive signals. The set of drive electrodes can include one or more electrodes. The set of drive electrodes can include two or more electrodes. The two or more electrodes can be positioned at least 2 mm apart from each other. The set of drive electrodes can be positioned on and / or within the patient's clothing. The patient's clothing can include clothing selected from the following: vests, shirts, belts, waistbands, and combinations thereof. The set of drive positions can include locations within the patient's body. The set of drive positions can include locations selected from the following: within a chamber of the heart, an endocardial surface, an epicardial surface, a pericardial cavity, an esophagus, and combinations thereof. The set of drive positions can include locations inside the heart. The second set of recording positions can include locations on the patient's skin. The set of drive positions can include locations on the patient's skin. The set of drive positions can include skin locations selected from the following: chest, back, torso, shoulders, abdomen, thorax, and combinations thereof. The second set of recording locations may include locations within the patient's body. The second set of recording locations may include locations selected from the following: within a cardiac cavity, on an endocardial surface, on an epicardial surface, the pericardium, the esophagus, the interstitial fluid and / or other tissue structures surrounding the heart, the interstitial fluid and / or other tissue structures under the skin, subcutaneous tissue, spinal tissue, brain tissue, and combinations thereof. The drive signal may include: a first drive signal at a first frequency from a first drive electrode, and a second drive signal at a second frequency from a second drive electrode. The first frequency and the second frequency may be different. The first drive signal and the second drive signal may be delivered simultaneously. The drive signal may include: a first drive signal at a first frequency from a first drive electrode, and a second drive signal at a second frequency from a second drive electrode. The first drive signal and the second drive signal may be delivered sequentially. The first frequency and the second frequency may be the same frequency. The transfer matrix may be determined using the amplitude and / or phase of the second set of recorded signals. The transfer matrix may include a numerical scaling factor based on a comparison of the amplitude and / or phase of the second set of recorded signals with the amplitude and / or phase of the set of drive signals. The transfer matrix may be determined using the amplitude and phase of the second set of recorded signals. The emission of the set of drive signals and the recording of the emitted drive signals may occur within at least one physiological cycle of the patient. The physiological cycle may include a cycle selected from the group consisting of a cardiac cycle, a respiratory cycle, a pressure cycle, and combinations thereof. The transfer matrix may compensate for the patient's respiration. The transfer matrix may compensate for the patient's cardiac motion. The transfer matrix may include a time-dependent transfer matrix including one or more components / factors that vary in concert with the physiological cycle.Calculating the calculated patient information may include aligning the time-dependent transfer matrix with the physiological cycle. The transfer matrix may adapt proportionally over time. Determining the transfer matrix may also include incorporating information from the calculated and / or selected standardized transfer matrix.

[0041] In some embodiments, determining the transfer matrix comprises calculating and / or selecting a standardized transfer matrix. The standardized transfer matrix may be selected based on patient parameters. The patient parameters may include parameters selected from the group consisting of: sex, weight, height, body or body part dimensions, body mass index (BMI), chest circumference, location of the esophagus, size of the atrium, filling of the atrium volume, atrial pressure, fat to water ratio, air to water to fat ratio, bone location, medications taken, medication levels, electrolyte levels, pH, pO2, pCO2, weight of water, and combinations thereof.

[0042] In some embodiments, the transfer matrix is ​​modified over time. The transfer matrix may be modified based on at least one changing patient parameter. The at least one changing patient parameter may include at least two changing patient parameters, and the transfer matrix may be modified based on the at least two changing patient parameters. The changing patient parameters may include at least one periodically changing patient parameter, and the transfer matrix may be modified based on at least one periodically changing patient parameter. The transfer matrix may be modified to compensate for the patient's breathing. The transfer matrix may be modified to compensate for the patient's cardiac motion. The method may also include monitoring at least one changing patient parameter. The monitoring may include continuous monitoring of at least one changing patient parameter. The transfer matrix may be continuously modified. The monitoring may include intermittent monitoring of at least one changing patient parameter. The transfer matrix may be intermittently modified.

[0043] In some embodiments, applying the transfer matrix to the first set of recorded signals includes applying a linear geometric function of the transfer matrix to the first set of recorded signals.

[0044] In some embodiments, the method further comprises collecting patient physiological data. The patient physiological data may comprise data selected from the group consisting of: circadian data, cardiac data, respiratory data, patient medication data, skin impedance data, perspiration data, thoracic and / or abdominal space data, water weight data, hematocrit level data, wall thickness data, heart wall thickness data, and combinations thereof. The patient physiological data may be collected by at least one sensor. The patient physiological data may be collected by at least two sensors. The at least one sensor may comprise one, two, three or more sensors selected from the group consisting of: magnetic sensors, water sensors, perspiration sensors, skin impedance sensors, glucose sensors, pH sensors, PO2 sensors, pCO2 sensors, SpO2 sensors, heart rate sensors, pressure sensors, blood pressure sensors, spinal sensors, brain electrodes, brain sensors, flow sensors, blood flow sensors, motion sensors, and combinations thereof. At least one sensor may be positioned on and / or within a patient's garment. The patient's garment may comprise a garment selected from the group consisting of: a vest, a shirt, a belt, a waistband, and combinations thereof. The method may further comprise identifying changes in physiological data over time, and the transfer matrix may be modified based on the identified changes.

[0045] In some embodiments, the method further comprises: recording the voltage of the patient at the α position; and determining the electrical information at the β position. The β position may be a different position from the α position. The determined electrical information may be based on the output of the inverse solution, and a transfer matrix may be applied to improve the quality of the determined electrical information. The transfer matrix may take into account spatial anisotropy and / or temporal anisotropy.

[0046] In some embodiments, the method further comprises performing a device positioning operation to determine device location information. A transfer matrix may be applied to improve the quality of the determined device location information. The method may further comprise performing a real-time update of the positioning data.

[0047] The technology described herein and its attributes and attendant advantages will be best appreciated and understood from the following detailed description when read in conjunction with the accompanying drawings in which representative embodiments are depicted by way of example. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Figure 1 A schematic diagram of a system for calculating information related to one or more parameters of a patient consistent with the present inventive concepts is shown.

[0049] Figure 1A A schematic diagram of a system for calculating information related to one or more parameters of a patient's heart consistent with the present inventive concepts is shown.

[0050] Figure 2A flow chart of a method for calculating patient information using a transfer matrix based on recorded signals consistent with the present invention is shown.

[0051] Figure 3 A flow chart of a method for determining a transfer matrix based on recorded signals and using the transfer matrix to calculate patient information consistent with the concept of the present invention is shown. DETAILED DESCRIPTION

[0052] Reference will now be made in detail to embodiments of the present technology, examples of which are shown in the accompanying drawings. Similar reference numerals may be used to refer to similar parts. However, this specification is not intended to limit the disclosure to specific embodiments, and it should be construed to include various modifications, equivalents and / or alternatives to the embodiments described herein.

[0053] It will be understood that when used herein, the words “comprise” (and any form of comprising, such as “comprises” and “comprises”), “have” (and any form of having, such as “have” and “has”), “include” (and any form of including, such as “includes” and “include”) or “contain” (and any form of containing, such as “contains” and “contain”) specify the presence of stated features, integers, steps, operations, elements and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or groups thereof.

[0054] It should also be understood that although the terms first, second, third, etc. may be used herein to describe various limitations, elements, components, regions, layers, and / or portions, these limitations, elements, components, regions, layers, and / or portions should not be limited by these terms. These terms are only used to distinguish one limitation, element, component, region, layer, or portion from another limitation, element, component, region, layer, or portion. Therefore, without departing from the teachings of the present application, the first limitation, element, component, region, layer, or portion discussed below may be referred to as a second limitation, element, component, region, layer, or portion.

[0055] It should also be understood that when an element is referred to as being "on," "attached to," "connected to," or "coupled to" another element, it can be directly on or over the other element, or directly connected to or coupled to the other element, or one or more intervening elements may be present. Conversely, when an element is referred to as being "directly on," "directly attached," "directly connected," or "directly coupled to" another element, there are no intervening elements. Other words used to describe the relationship between elements should be interpreted in a similar manner (e.g., "between" versus "directly between," "adjacent" versus "directly adjacent," etc.).

[0056] It should also be understood that when a first element is referred to as being "in," "on," and / or "inside" a second element, the first element may be positioned: within an interior space of the second element, within a portion of the second element (e.g., within a wall of the second element); positioned on an outer surface and / or inner surface of the second element; and one or more combinations of these.

[0057] As used herein, when used to describe a first component or first location being proximate to a second component or second location, the term "proximate" will be considered to include one or more locations near the second component or second location, as well as locations in, on, and / or within the second component or second location. For example, a component positioned proximate to an anatomical site (e.g., a target tissue site) should include components positioned proximate to the anatomical site, as well as components positioned in, on, and / or within the anatomical site.

[0058] As shown, for example, in the figures, spatially relative terms such as "below", "lower", "below", "above", "upper", etc., may be used to describe elements and / or feature relationships with other (one or more) elements and / or (one or more) features. It should also be understood that spatially relative terms are intended to include different orientations of the device in use and / or operation in addition to the orientation shown in the figures. For example, if the device in the figure is turned over, elements described as being "below" and / or "below" other elements or features will be oriented as being "above" the other elements or features. The device can be oriented in other ways (e.g., rotated 90 degrees or in other orientations), and the spatially relative descriptions used herein are interpreted accordingly.

[0059] As used herein, the terms "reduce", "reduce", "reduced" and the like include a reduction in quantity, including a reduction to zero. Reducing the likelihood of an occurrence will include preventing it from occurring. Accordingly, the terms "prevent", "block" and "prevent" shall include the actions of "reduce", "reduce" and "reduced", respectively.

[0060] The term "and / or" as used herein should be considered as a specific disclosure of each of the two specified features or components with or without the other. For example, "A and / or B" should be considered as a specific disclosure of each of (i) A, (ii) B, and (iii) A and B, just as if each were individually stated herein.

[0061] As used herein, the term "one or more" may mean one, two, three, four, five, six, seven, eight, nine, ten or more, up to any number.

[0062] The terms "and combinations thereof" and "and combinations of these" may each be used herein after a list of items that are included individually or collectively. For example, a component, process, and / or other item selected from: A, B, C, and combinations thereof, would include a group of one or more components that includes: one, two, three, or more of item A; one, two, three, or more of item B; and / or one, two, three, or more of item C.

[0063] In this specification, unless explicitly stated otherwise, "and" may mean "or", and "or" may mean "and". For example, if a feature is described as having A, B, or C, the feature may have A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A, B, and C, the feature may have only one or two of A, B, or C.

[0064] The expression "configured (or set)" used in the present disclosure may be used interchangeably with, for example, expressions "suitable for", "capable of", "designed to", "adapted to", "made to", and "capable of", depending on the situation. The expression "configured (or set)" does not only mean "specially designed" in hardware. Alternatively, in some cases, the expression "a device is configured to" may mean that the device "can" operate together with another device or component.

[0065] As used herein, the term "threshold" refers to a maximum level, a minimum level, and / or a range of values ​​associated with a desired or undesirable state. In some embodiments, a system parameter is maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and / or outside a threshold range of values ​​to cause a desired effect (e.g., effective treatment) and / or to prevent or otherwise reduce (hereinafter referred to as "prevent") undesirable events (e.g., equipment and / or clinical adverse events). In some embodiments, a system parameter is maintained above a first threshold (e.g., above a first temperature threshold to cause a desired therapeutic effect on a tissue) and below a second threshold (e.g., below a second temperature threshold to prevent undesirable tissue damage). In some embodiments, a threshold is determined to include a safety margin to account for patient variability, system variability, tolerance, and the like. As used herein, "exceeding a threshold" involves a parameter exceeding a maximum threshold, being below a minimum threshold, being within a threshold range, and / or being outside a threshold range.

[0066] The term "diameter" as used herein to describe non-circular geometric shapes is considered to be the diameter of an imaginary circle that approximates the geometric shape being described. For example, when describing a cross-section (such as the cross-section of a component), the term "diameter" should be considered to mean the diameter of an imaginary circle having the same cross-sectional area as the cross-section of the component being described.

[0067] As used herein, the terms "major axis" and "minor axis" of a component are the length and diameter, respectively, of a hypothetical cylinder of the smallest volume that can completely enclose the component.

[0068] As used herein, the term "functional element" is considered to include one or more elements that are constructed and arranged to perform a function. Functional elements may include sensors and / or transducers. In some embodiments, functional elements (e.g., functional elements configured as therapeutic elements) are configured to deliver energy and / or otherwise treat tissue. Alternatively or additionally, functional elements (e.g., functional elements including sensors) may be configured to record one or more parameters, such as patient physiological parameters, patient anatomical parameters (e.g., tissue geometry parameters), patient environmental parameters and / or system parameters. In some embodiments, sensors or other functional elements are configured to perform diagnostic functions (e.g., collect data for performing diagnosis). In some embodiments, functional elements are configured to perform therapeutic functions (e.g., to deliver therapeutic energy and / or therapeutic agents). In some embodiments, functional elements include one or more elements, and the one or more elements are constructed and arranged to perform a function selected from the following: delivering energy, extracting energy (e.g., to cool components), delivering drugs or other agents, manipulating system components or patient tissues, recording or otherwise sensing parameters such as patient physiological parameters or system parameters, and one or more combinations of these. A "functional component" may include a component constructed and arranged to perform a function such as a diagnostic and / or therapeutic function. A functional component may include an expandable component. A functional component may include one or more functional elements.

[0069] The term "transducer" as used herein includes any component or combination of components that receives energy or any input and produces an output. For example, a transducer may include an electrode that receives electrical energy and distributes the electrical energy to tissue (e.g., based on the size of the electrode). In some configurations, the transducer converts an electrical signal into any output, such as light (e.g., the transducer includes a light emitting diode or a light bulb), sound (e.g., the transducer includes a piezoelectric crystal configured to deliver ultrasonic energy), pressure, thermal energy, cryogenic energy, chemical energy, mechanical energy (e.g., the transducer includes a motor or solenoid), magnetic energy, and / or different electrical signals (e.g., Bluetooth or other wireless communication elements). Alternatively or additionally, a transducer can convert a physical quantity (e.g., a change in a physical quantity) into an electrical signal. The transducer may include any component that delivers energy and / or an agent to tissue, such as a transducer configured to deliver one or more of the following: electrical energy to the tissue (e.g., the transducer includes one or more electrodes), optical energy to the tissue (e.g., the transducer includes a laser, a light emitting diode, and / or optical components such as a lens or prism), mechanical energy to the tissue (e.g., the transducer includes a tissue manipulation element), acoustic energy to the tissue (e.g., the transducer includes a piezoelectric crystal), chemical energy, electromagnetic energy, magnetic energy, and combinations of one or more of these.

[0070] As used herein, the term "mapping procedure" shall include a clinical procedure performed on a patient that yields electrical activity information associated with tissue of the patient, such as organ tissue (eg, brain or heart tissue).

[0071] As used herein, the term "positioning operation" shall include the process of establishing a coordinate system and using one or more signals such as electrical signals to determine the position of one or more objects or parts of objects (herein "objects") within the system. In some embodiments, the positioning process combines one or more signals generated from one or more sources (e.g., electrodes) and combines sensors (e.g., electrodes) that measure the generated signals from a recording position, and the signals vary as a function of space and / or time. The recording position of the sensor may be on the object being positioned, or the recording position of the sensor may be separated from the object being positioned. Analysis of the measured signals and / or calculations performed on the measured signals may be used to determine the positional relationship between the sensor and / or object and one or more sources of the generated signals. The positioning method may combine two or more generated signals to increase the number or accuracy of the positional relationship between the sensor and the signal source. The sensor and the object may be a single component and / or the sensor and the object may be a plurality of components located together. In some embodiments, the signal variation as a function of time and / or space includes the interaction of the signal with the measurement environment. In other embodiments, the positioning process measures inherent or existing characteristics of the object, sensor, or measurement environment, such as by measuring signals from an accelerometer positioned on the object or sensor and incorporating information from the accelerometer signals into the analysis.

[0072] As used herein, the term "ablation procedure" shall include an ablation therapeutic procedure performed on patient tissue that has been identified as contributing to unwanted electrical activity, such as activity associated with an arrhythmia of the heart (e.g., atrial fibrillation) or an unwanted state of the brain (e.g., seizure or tremor).

[0073] It will be appreciated that certain features of the invention described in the context of separate embodiments for the sake of clarity may also be provided in combination in a single embodiment. Conversely, various features of the invention described in the context of a single embodiment for the sake of brevity may also be provided individually or in any suitable sub-combination. For example, it will be appreciated that all features set forth in any (whether independent or dependent) claim may be combined in any given manner.

[0074] It should be understood that at least some of the drawings and descriptions of the present invention have been simplified to focus on elements relevant to a clear understanding of the present invention, and other elements that would be understood by a person of ordinary skill in the art and that may also comprise a part of the present invention have been omitted for clarity. However, because these elements are well known in the art and because they do not necessarily contribute to a better understanding of the present invention, a description of these elements is not provided herein.

[0075] Provided herein are systems and methods for calculating patient information. Patient physiological data is recorded at one or more recording locations, and a transfer matrix is ​​used to determine patient information at one or more target locations that may be remote from the recording locations. Electrical information may be recorded by electrodes placed on the patient's skin and / or within the patient's body, and electrical and / or other patient information may be calculated at a target location, such as the target location including an organ of the patient (e.g., heart or brain). The system contemplated by the present invention may include components for determining a transfer matrix, such as electrodes or other sensors that characterize tissue properties between a recording location and a target location, features performed on a patient and / or one or more similar mammalian objects for which patient information is to be calculated.

[0076] Reference now Figure 1 , a schematic diagram of a system for calculating information related to one or more parameters of a patient consistent with the present inventive concept is shown. The system 10 includes a recording component 300, a recording electrode 311; the recording component 300 is configured to receive information from a set of one or more sensors; each of the recording electrodes 311 is placed at one or more associated recording locations 312 of the patient, such as the patient P1 shown in the figure. The system 10 may also include a console 200, the console 200 includes a processing unit 250, the processing unit 250 receives the signal generated by the recording electrode 311 via the recording component 300, and stores the associated recorded signal 313 (e.g., in an electronic memory 252). The processing unit 250 includes an algorithm 255 and a transfer matrix 290. The processing unit 250 can be configured so that the algorithm 255 applies the transfer matrix 290 to convert the recorded signal 313 into the calculated patient information 95, wherein the information 95 represents the patient's physiological parameter information at one or more patient locations 90 (e.g., one or more skin locations and / or one or more internal locations of the patient).

[0077] The transfer matrix 290 is (all applicable) tissue, volume V X The mathematical features of are suitable for determining patient information 95 at one or more patient locations 90 based on recordings made at one or more recording locations 312. The recording locations 312 and the individual patient locations 90 define an intermediate volume (e.g., a tissue volume and / or an air-filled space), a volume V I1, where volume V I1 The spatial definition of the set of points (e.g., convex hull) collectively represented by the recording locations 312 and the patient locations 90. Note that in some embodiments, one or more patient locations 90 are located within a tissue region or volume (herein, a "region" or "volume") defined only by the recording locations 312. The patient information 95 calculated at a single patient location 90 is highly dependent on the volume V I1 The calculated patient information 95 also depends (although less so) on the volume V that is primarily responsible. I1 In addition, but with volume V I1 Approximate volume V P1 The total active volume, volume V T1 , by the main acting volume V I1 With volume V P1 Volume V X One or more volumes V may be included T1 (For example, the volume V for each patient position 90 T1 ), so that each volume V T1 All are volume V X A subset of .

[0078] Volume V X The transfer matrix 290 may include various forms of tissue (e.g., skin, subcutaneous tissue, blood vessel wall tissue, blood, heart and / or other organ tissue, bone and / or bone marrow), interstitial spaces, and / or open spaces (e.g., spaces within a patient's lungs). The transfer matrix 290 may be configured to account for changes in tissue and / or changes in volume V. X Other changes from one location to another within the volume V X Time-varying volumes may be included, such as volumes that vary during the cardiac cycle (e.g., due to expansion and contraction of the heart and subsequent movement of surrounding tissue) and / or volumes that vary during the respiratory cycle (e.g., due to expansion and contraction of the lungs and subsequent movement of surrounding tissue). Transfer matrix 290 may be configured to take into account volume V X The time-varying volume of X The transfer matrix 290 may include tissue having one or more tissue parameters, such as tissue parameter information 80 that varies over time, such as impedance (e.g., impedance changes due to breathing), pH, temperature, pO2, and / or pCO2 that varies over time. XIn some embodiments, the transfer matrix 290 compensates for electrode variations, such as evaporation of the surface electrode (e.g., from polarization of the current) and / or oxidation of the electrode (e.g., from blood reactants). In some embodiments, the processing unit 250 stores (e.g., for processing by the algorithm 255) one or more tissue parameter information 80.

[0079] In some embodiments, heart motion during systole can be determined by measuring impedance changes between internal electrodes (e.g., one or more internal electrodes) and surface electrodes (e.g., one or more surface electrodes). The measured impedance changes can represent actual changes in the position, geometry, and / or other characteristics of the heart, and the measured impedance changes can be used to monitor heart function (e.g., tissue contractility, ejection fraction) during clinical operations (such as monitoring left ventricular volume over time).

[0080] In some embodiments, for example, during the transfer matrix 290 creation process described below, the transfer matrix 290 is determined based on information (e.g., electrical activity) recorded from patient P1. Alternatively or additionally, also described below, the transfer matrix 290 may be determined based on information (e.g., electrical activity) recorded from a different patient, namely patient P2 (e.g., a different mammalian subject having similar physiological attributes as patient P1).

[0081] In some embodiments, the volume V X An intermediate volume V may be included I2 and one or more drive positions (e.g., drive position 412 described below), the intermediate volume V I2 The volume V is defined by the space within the convex hull of the set of points represented by the recording locations 312; a drive signal (e.g., drive signal 413, also described below) is emitted from one or more drive locations while determining the transfer matrix 290. The transfer matrix 290 may be determined as follows. In some embodiments, the convex hull of the recording locations 312 encompasses each drive location 412, and the volume V I2 is defined only by the convex hull of the recording locations 312. The transfer matrix 290 depends primarily on the volume V I2 The volume V X It can also include volume V I1 External but with volume V I1 Approximate volume V P2 The transfer matrix 290 also depends (although less so) on the volume V P2 In some embodiments, the volume V may be defined for the first patient P1 as described above. XP1 , while the volume V of the second patient P2 XP2 It can be approximated by the volume V XP1(For example, approximately V XP1 size, shape and physiological characteristics).

[0082] In some embodiments, the volume V X Including the intermediate volume V I2 , the intermediate volume V I2 The volume V is defined by the space between an arbitrary distribution of a set of points represented by recording locations 312 and one or more drive locations 412 from which drive signals 413 are emitted while determining transfer matrix 290. Transfer matrix 290 may be determined as described herein. In some embodiments, the arbitrary distribution of recording locations 312 includes each drive location 412, and volume V I2 is limited only by the distribution of the recording locations 312. The transfer matrix 290 depends primarily on the volume V I2 The volume V X It can also be included in the volume V I1 Outside but close to volume V I1 The volume V P2 The transfer matrix 290 also depends (although less so) on the volume V P2 In some embodiments, a volume V may be defined for a first patient P1. XP1 (eg, as described above), and the volume V of the second patient P2 XP2 It can be approximated by the volume V XP1 (For example, approximately V XP1 size, shape and / or physical characteristics).

[0083] In some embodiments, the console 200 or other components of the system 10 include an electronic assembly configured to deliver electrical energy (e.g., deliver a drive signal), such as a signal generator 400 as shown. In these embodiments, the system 10 also includes a set of one or more energy delivery transducers, i.e., drive electrodes 411, which deliver drive signals 413 to the patient's tissue at one or more drive locations 412. The drive locations 412 may include one or more locations external to the patient (e.g., on the patient's skin), such as the drive locations 412 shown in the figure. S ), and / or one or more locations within the patient's body (eg, under the patient's skin) (eg, drive location 412 as shown in FIG. 4 ). i). The drive signal 413 emitted by the drive electrode 411 can be used to determine and / or adjust (herein "determine" or "calculate") the transfer matrix 290 (e.g., as described below), to perform a positioning operation (e.g., as described below), to correct a positioning coordinate system (e.g., an impedance field for locating one or more devices within the field), and / or to perform another function. The drive signal (e.g., drive signal 413) may include a signal selected from the following: a continuous wave, an impulse, a pattern sequence, an amplitude modulated signal, a frequency modulated signal, a chirp, and combinations thereof. In some embodiments, one or more drive signals (e.g., drive signal 413) are implemented based on electrical properties or other characteristics of applicable tissue.

[0084] In some embodiments, system 10 includes one or more patient-insertable devices, such as device 100 as shown. Device 100 may include a catheter or other patient-insertable device, for example, including drive electrode 411 (e.g., Figure 1 shown).

[0085] In some embodiments, system 10 includes one or more patient-attachable garments or other patient-attachable components, such as garment 50 shown in the figure, which can be used to position one or more sensors of system 10 at one or more locations associated with patient P1, such as positioning recording electrode 311 relative to the patient. Recording electrode 311 can be positioned on and / or within garment 50.

[0086] In some embodiments, the system 10 is configured to generate, receive and / or process information using two or more modalities (e.g., drive signal and / or received signal modalities), such as: potential and ultrasound, potential and impedance (e.g., complex impedance such as dielectric properties), and / or other combinations of modalities (e.g., combinations of drive signal and / or received signal forms). One or more transfer matrices of the present invention can then be generated and subsequently used (e.g., two or more transfer matrices used in combination) to distinguish local, regional and / or global differences (e.g., temporal and / or spatial differences) measured via a subset of each modality employed (e.g., insensitive versus sensitive measurements). For example, spatial or temporal variations in breathing pattern and / or respiratory volume may be sensitive to both impedance and ultrasound modalities, and less sensitive to cardiac potential modalities, while spatial and / or temporal variations in tissue conductivity will be sensitively measured via impedance, while measurements using ultrasound are less sensitive.

[0087] The system 10 may include one or more sensors (e.g., electrodes configured to record electrical activity as defined herein), one or more sensors being positioned on the patient's skin and / or under the patient's skin. The system 10 may also include one or more energy delivery elements (e.g., electrodes configured to deliver electrical signals as defined herein), one or more energy delivery elements being positioned on the patient's skin and / or under the patient's skin. In some embodiments, the system 10 includes a vest or other garment (garment 50) that positions one or more sensors, transducers, and / or other functional elements relative to the patient's anatomical structure. For example, the functional elements positioned in the garment 50 may be used to perform one or more diagnostic and / or one or more therapeutic operations on the patient. In some embodiments, the garment 50 includes one or more sensors configured to record patient physiological data for generating diagnostic information, the diagnostic information being selected from: ECG and other electrocardiographic information, blood pressure measurements, blood flow measurements, respiration measurements, heart sound measurements, p02 measurements, pCO2 measurements, ejection fraction measurements, organ function measurements, brain activity measurements, epileptic seizure activity measurements, and combinations thereof. In some embodiments, the system 10 also includes one or more sensors positioned under the patient's skin (e.g., near the heart, brain, and / or other organs), wherein data from the skin contact sensors and internal sensors are processed (e.g., by the algorithm 255) to generate a diagnostic output. In some embodiments, for example, when the Einthoven triangle is used as a coordinate system, the system 10 creates a coordinate system to identify the anatomical location of the patient. In some embodiments, the system 10 creates a coordinate system based on the location of one or more surface electrodes (e.g., based on the location of the garment 50 including the one or more surface electrodes).

[0088] In some embodiments, the coordinate system is based on the location of one or more internal electrodes (e.g., a coordinate system based on one or more drive electrodes positioned within the heart). In these embodiments, the coordinate system can be configured relative to the drive electrodes used as a coordinate reference or origin. Alternatively or additionally, the coordinate system can be configured relative to one or more surface electrodes used as a coordinate reference (e.g., an origin). Alternatively or additionally, the coordinate system can be configured relative to an anatomical location (e.g., a structure or boundary) used as a coordinate reference (e.g., an origin).

[0089] In some embodiments, system 10 includes one or more sensors (e.g., electrodes 311) on the patient's skin. S ,321 S ,411 S and / or electrode-based functional elements 99 S) and one or more sensors (e.g., electrodes 311 ) positioned in the patient's heart I ,321 I ,411 I and / or electrode-based functional elements 99 I ). In these embodiments, the sensors (e.g., electrodes) positioned in the patient's heart may include at least one sensor on the endocardial surface of a heart chamber (e.g., a contact electrode on the endocardial surface of the left atrium), and at least one sensor positioned in a heart chamber offset from the endocardial wall (e.g., a non-contact electrode in the left atrium or other heart chamber in flowing blood offset from all endocardial surfaces). Patient information 95 may be determined based on signals (data) received from one or more of at least one skin surface sensor, at least one endocardial surface contact sensor, and / or at least one non-contact sensor.

[0090] The electrodes and / or other sensors of system 10 may include a variety of shapes, surface areas, and materials of construction. In some embodiments, one or more skin contact electrodes (e.g., electrode 311) for recording electrical activity and / or delivering electrical energy may include: S ,321 S ,411 S and / or electrode-based functional elements 99 S ) includes one or more materials selected from the group consisting of platinum-iridium, gold, carbon, polymers (e.g., polymer coatings), and combinations thereof. In some embodiments, one or more electrodes (e.g., electrode 311) positioned under the patient's skin to record electrical activity and / or deliver electrical energy I ,321 I ,411 I and / or electrode-based functional elements 99 I ) includes one or more materials selected from the group consisting of platinum-iridium, gold, carbon, polymers (e.g., polymer coatings), copper, silver-silver chloride, conductive gels, and combinations of these.

[0091] In some embodiments, the electrodes and / or other sensors (e.g., electrodes 311 S ,321 S ,411 S and / or electrode-based functional elements 99 S ) are positioned on the patient's skin in a vertical arrangement, a horizontal arrangement, a diagonal arrangement, and / or a spiral arrangement relative to the patient. For example, the sensors can be positioned and in these and / or other geometric arrangements via the garment 50 (e.g., via a fixed attachment to the garment 50 and / or via a pocket of the garment 50 that receives the sensor).

[0092] The console 200 may include one or more discrete components, such as when the console 200 includes one or more housings, these housings together surround the components of the processing unit 250, the user interface 260, the recording assembly 300 and / or the signal generator 400. The console 200 may include multiple discrete components (e.g., each component includes a discrete housing) that transmit information, signals and / or power between these components via wired and / or wireless connections. The console 200 may include components configured to be transported from one room to another (e.g., between a warehouse and a clinical operating room in a hospital).

[0093] The processing unit 250 may include one or more components that receive, store, analyze and / or otherwise process information (e.g., information recorded by the recording component 300). The processing unit 250 may include one or more components that generate and / or otherwise provide information (e.g., information provided to the signal generator 400) and is used by the signal generator 400 to generate a drive signal (e.g., a drive signal 413 for driving the electrode 411). The processing unit 250 may include one or more central processing units, such as a CPU 251 as shown. The processing unit 250 may include one or more electronic memory modules, such as a memory 252 as shown.

[0094] CPU 251 may include one or more digital signal processors (DSPs), which, as described herein, may analyze signals received from one or more electrodes or other sensors of system 10 for calculating patient information (e.g., patient electrical information, patient motion, etc.).

[0095] The console 200 may include a user interface, such as the user interface 260 shown in the figure, which can receive information and / or provide information to a user of the system 10 (e.g., a clinician of the patient P1 and / or P2 described herein). The user interface 260 may include one or more user input components, such as an input component selected from the following: a keyboard, a mouse, a touch screen, a joystick, a tactile controller, a microphone, a switch, a button, and a combination of these. The user interface 260 may include one or more user output components, such as an output component selected from the following: a display (e.g., a video monitor), a speaker, a tactile transducer, and a combination of these.

[0096] The transfer matrix 290 may include characteristics of electrical properties of tissue (e.g., bone, fat, skin, lung, blood, and / or connective tissue) between a first set of recording locations (e.g., first set of recording locations 312) and a set of target locations (e.g., a set of target locations 90).

[0097] Based on the one or more recorded locations 312 (eg, one or more patient skin locations 312 S and / or one or more locations within the patient, internal location 312 i ), the transfer matrix 290 of the system 10 can be used to calculate one or more patient locations 90 (e.g., one or more patient skin locations 90 S and / or one or more locations within the patient's body, internal location 90 i ) at the address provided by the patient.

[0098] The transfer matrix 290 represents a matrix in which a series of measurements at a first location (e.g., a set of first locations) can be related to a feature at a second location (e.g., a set of second locations) determined by applying the transfer matrix to the series of measurements at the first location. The transfer matrix 290 can be generated by delivering a drive signal (e.g., from an area proximate to the second location or otherwise) and by performing a recording at the first location. Multiple recordings can be performed at one or more similar or dissimilar anatomical locations to create the transfer matrix 290.

[0099] The transfer matrix 290 represents the mathematical correspondence between the measurements made in two separate domains. For example, the two separate domains may include: a first domain within the patient's body and a second domain outside the patient's body, a first domain on a specific area of ​​the patient's body and a second domain on another area of ​​the patient's body, a first domain inside an organ within the patient's body and a second domain outside the organ within the patient's body, and / or a combination of these. The transfer matrix 290 mathematically describes the relationship between the measurements made in the first domain and the features (e.g., tissue features and / or electrical conditions) in the corresponding second domain. Such a transfer matrix 290 may also describe the relationship between the measurements made in the second domain and the features of the first domain. The application of the transfer matrix 290 may be used to account for the differences in features between the two domains in terms of calculations (such as both static and dynamic imposed by physiology and the environment as described above), and the application of the transfer matrix 290 enables the combined use of measurements from the two domains.

[0100] In some embodiments, a known electrical signal (potential or current) is emitted from a first drive electrode (e.g., an internal electrode) and recorded by one or more (e.g., all) recording electrodes (e.g., surface electrodes). Subsequently, a known signal is emitted from a second drive electrode (e.g., an internal electrode), and the known signal is recorded by one or more (e.g., all) recording electrodes (e.g., surface electrodes). In some embodiments, subsequently, a known signal is emitted from a third, fourth, etc. drive electrode (e.g., until all drive electrodes have been used). This embodiment provides a set of drive signals (voltage or current) from all drive electrodes (e.g., all internal electrodes) for each recording electrode (e.g., each surface electrode). In these embodiments, intrinsic cardiac signals (e.g., atrial electrograms) can be recorded using the same recording electrodes (e.g., body surface electrodes).

[0101] As described herein, the relationship (e.g., ratio) of the drive signal to the recorded second signal is used as the basis for the transfer matrix 290 and can be used to determine the calculated patient information 95. The transfer matrix 290 can be continuously updated (e.g., between measurements taken to generate the calculated patient information 95), for example, to account for changes in fluid status, electrolyte concentrations, skin resistance, and / or electrode position (e.g., recording electrode positions).

[0102] In some embodiments, such as the following reference Figure 3 As described, the system 10 is configured to create a transfer matrix 290. For example, the system 10 may include one or more electrodes or other transducers configured to deliver electrical energy (e.g., deliver drive signals), such as drive electrodes 411 as shown. The drive electrodes 411 may be positioned at various drive locations 412 from which drive signals 413 are emitted. The system 10 may include a set of recording electrodes 321 that may be positioned at a plurality of recording locations 322 and create a set of recorded signals 323. Figure 1 In some embodiments, (e.g., when recording electrodes 311 and 321 are the same set of electrodes or at least one is a subset of the other, such as when patients P1 and P2 are the same patient, such as when electrode 311 is used to determine both transfer matrix 290 and calculated patient information 95) recording location 322 is the same as recording location 312 described above. In other embodiments, such as when location 322 includes locations on different mammalian subjects (e.g., used to create universal transfer matrix 290) or location 322 includes different locations on the same patient, recording location 322 and recording location 312 include different locations (e.g., all locations are different or at least one location is different).

[0103] The transfer matrix 290 may be determined by comparing the set of recorded signals 323 to the set of drive signals 413 emitted from the drive locations 412 (e.g., by the algorithm 255). In some embodiments, the drive locations 412 include locations within the patient's body and the recorded locations 322 include locations on the patient's surface (skin). Alternatively or additionally, the drive locations 412 may include locations on the patient's surface and / or the recorded locations 322 include locations within the patient's body. In some embodiments, at least one of the drive locations 412 and / or the recorded locations 322 includes both locations on the patient's surface and within the patient's body. In some embodiments, at least one of the drive locations 412 and / or the recorded locations 322 is limited to locations on the patient's surface (i.e., is limited to only include locations on the patient's surface). In some embodiments, at least one of the drive locations 412 and / or the recorded locations 322 is limited to locations within the patient's body (i.e., is limited to only include locations within the patient's body).

[0104] When the drive signal 413 is used to determine the transfer matrix 290, the drive electrode 411 may include at least 1 electrode, at least 2 electrodes, and / or at least 48 electrodes, and the recording electrode 321 may include at least 4 electrodes, at least 10 electrodes, and / or at least 200 electrodes. In some embodiments, the drive electrodes 411 may be positioned at the drive positions 412 at least 1 mm apart from each other (such as at least 2 mm apart, and / or at least 4 mm apart, and / or at least 10 mm apart), and the recording electrodes 321 may be positioned at the recording positions 322 at least 2 mm apart from each other (such as at least 3 mm apart, at least 10 mm apart, and / or at least 20 mm apart).

[0105] In some embodiments, the drive location 412 includes one or more locations within the patient, such as a drive location selected from the following: within a chamber of the heart, on the endocardial surface of a heart chamber, on the epicardial surface of the heart, in a blood vessel (e.g., a vein or artery) of the heart, in the pericardial cavity, in the esophagus, in and / or near the brain, in a blood vessel (e.g., a vein or artery) of the brain, and combinations thereof. In these embodiments, the device 100 may include one or more drive electrodes 411 (e.g., on a distal expandable basket or other distal portion of the device 100), such as when the distal portion of the device 100 is inserted into the patient's heart, resulting in the drive electrode 411 being positioned on the endocardial surface of a heart chamber and / or within a heart chamber. In these embodiments, the associated set of recording locations 322 may include locations within the patient's body, on the patient's skin, or both. The recording electrode 321 may be positioned at one or more recording locations 322 selected from the following: chest, back, torso, shoulder, abdomen, thorax, head, and combinations thereof. In some embodiments, the system 10 includes at least 6 recording electrodes.

[0106] In some embodiments, the recording electrodes 321 include surface electrodes 321s positioned to cover an area around the heart in all three dimensions (e.g., anterior-posterior, cranial-caudal, and right-to-left). S Configured to deliver signals or other energy to perform localization, cardioversion, etc. (e.g., to avoid location conflicts with separate electrodes used to perform those additional functions).

[0107] Alternatively or additionally, the drive signals 413 used to determine the transfer matrix 290 may be delivered from one or more drive locations 412 on the patient's skin, such as one or more drive locations selected from the group consisting of: chest, back, torso, shoulder, abdomen, thorax, head, and combinations thereof. In these embodiments, the associated set of recording locations 322 may include locations within the patient, on the patient's skin, or both. The recording electrodes 321 may be positioned at one or more recording locations 322 selected from the group consisting of: within a chamber of the heart, on the endocardial surface of a chamber of the heart, on the epicardial surface of the heart, in a blood vessel (e.g., a vein or artery) of the heart, in the pericardial cavity, in the esophagus, in and / or proximal to the brain, in a blood vessel (e.g., a vein or artery) of the brain, and combinations thereof.

[0108] In some embodiments, at least 4 surface electrodes are used to cover a 3-dimensional volume (e.g., to fully provide a drive signal to and / or record a signal from a 3-dimensional volume). For example, a set of surface electrodes may include: 4 surface electrodes, 4 surface electrodes are positioned to form a tetrahedron that crosses the body; 5 surface electrodes, 4 of which form a tetrahedron, and the fifth surface electrode is used as a distinguishing electrode that is not coplanar with any tetrahedron surface; 6 surface electrodes, forming 3 orthogonal or approximately orthogonal Cartesian coordinate axes; 6 surface electrodes, 3 of which form a triangle on one side of the body, and the other 3 surface electrodes form an inverted triangle on the other side of the body (e.g., the chest and back).

[0109] In some embodiments, the transfer matrix 290 is determined by one or more drive electrodes 411a that deliver a drive signal 413a comprising a first frequency and one or more drive electrodes 411b that deliver a drive signal 413b comprising a different second frequency. In these embodiments, the drive signals 413a and 413b may be delivered simultaneously (e.g., and correspondingly received simultaneously by the recording electrode 321).

[0110] In some embodiments, the transfer matrix 290 is determined by one or more drive electrodes 411a that deliver a drive signal 413a comprising a first frequency and one or more drive electrodes 411b that deliver a drive signal 413b comprising a similar or different second frequency. In these embodiments, the drive signals 413a and 413b may be delivered sequentially (e.g., and correspondingly received sequentially by the recording electrodes 321).

[0111] In some embodiments, transfer matrix 290 is determined by evaluating the amplitude and / or phase of a set of recorded signals 323 (e.g., recorded by recording electrode 321 positioned at recording location 322). For example, transfer matrix 290 may include numerical scaling factors based on a comparison of the amplitude and / or phase of the set of recorded signals 323 with the amplitude and / or phase of a set of drive signals 413 (e.g., delivered by drive electrode 411 positioned at drive location 412), respectively. In some embodiments, the comparison is based on both the amplitude and phase of each set of signals.

[0112] In some embodiments, the emission of the drive signal 413 and the associated recording of the recording signal 323 occur over at least one physiological cycle of the patient, and the resulting transfer matrix 290 includes a time-dependent (e.g., cycle-time-dependent) transfer matrix. The associated physiological cycle may include the patient's cardiac cycle (e.g., a cycle including contraction and relaxation), respiratory cycle, pressure change cycle (e.g., cyclically changing blood pressure), and / or other repeating physiological cycles. The recording may be performed over multiple cycles (e.g., at least 2 cycles, at least 3 cycles, or at least 5 cycles). The transfer matrix 290 may include one or more parameters that adapt proportionally over time. The transfer matrix 290 may include information related to changes within a physiological cycle, such as when the transfer matrix 290 includes a time-dependent transfer matrix, the time-dependent transfer matrix including one or more components that vary relatively consistently with the signal recorded by the electrode 311, such as to correlate these recordings made by the electrode 311 over similar physiological cycles (e.g., compensation performed when calculating patient information 95 and compensating for changes within a physiological cycle). In some embodiments, the algorithm 255 can be configured to compensate for: the cardiac cycle (e.g., to compensate for heart motion), the respiratory cycle (e.g., to compensate for lung motion and / or other patient respiratory parameters), or both the cardiac cycle and the respiratory cycle. In some embodiments, the algorithm 255 calculates the patient information 90 by aligning the time-dependent transfer matrix 290 with the patient's physiological cycle. The parameters of the transfer matrix 290 can vary according to a functional and / or biological process, such as a cyclically and / or spatially varying process (e.g., blood flow or other cyclically varying cardiovascular process). In some embodiments, one or more parameters of the transfer matrix 290 can vary in time, linearly, and / or exponentially. These parameters can include values ​​that are expanding and / or drifting. The changes over time and / or across space do not need to be completely periodic. These non-cyclic changes can also be modeled, such as creating a model via a learning algorithm and training the model to compensate for the changes. Changes can also be compensated by extrapolating from previous change data (e.g., data recorded in patient P1 or a different mammal such as patient P2), such as data configured and used as a comparison model.

[0113] In some embodiments, signals recorded during respiratory cycles (e.g., at a frequency of 10-15 breaths / minute) and / or signals recorded during cardiac cycles (e.g., due to changes in the heart and / or contractile movement of the heart and heart walls and electrodes) are averaged (e.g., at a frequency corresponding to the heart rate) to create a transfer matrix 290 (e.g., averaging results in a more stable transfer matrix 290, such as a transfer matrix 290 with improved stability over one or more respiratory and / or cardiac cycles).

[0114] In some embodiments, the system 10 considers one or more physiological and / or anatomical parameters of a patient (e.g., patient P1 and / or patient P2), such as parameters selected from the following: rotation of the heart (e.g., toward the right or left side of the patient), circumference of the chest relative to the heart, position of the heart in the chest (e.g., low-weight patients have a relatively high-positioned diaphragm, emphysema and COPD patients have a relatively low-positioned diaphragm), and combinations of these. These parameters can be determined by analyzing the patient's geometric characteristics, such as chest circumference (as an example, chest circumference can be calculated based on the distance between surface electrodes, where impedance-based measurements can be used to determine the distance), the number and angle between surface electrodes around the body, and / or the rotation and / or position of the heart relative to the surface electrodes. For example, standardized positions of surface electrodes (e.g., electrodes for providing ECG recordings) can be used as a reference, and diagnostic bioelectric signals measured from the surface electrodes can be used to assess the patient's physiological and / or anatomical conditions. As an example, on a standard 12-lead ECG, the presence of certain signal features in leads V1 or V2 can indicate a rightward deviation of the heart position. Alternatively, the signal features in V4-5 may indicate a leftward deviation of the heart position, while other signal features may indicate a higher or lower heart position.

[0115] In some embodiments, the system 10 modifies the transfer matrix 290 at least once, for example, at least once during a single operation on a single patient. For example, the system 10 may modify the transfer matrix 290 intermittently and / or relatively continuously ("continuously" herein) (such as in a closed-loop manner) over time. The modifications performed by the system 10 may be based on at least one patient parameter that varies over time. In some embodiments, the modifications performed by the system 10 may be based on at least two or at least three patient parameters that vary over time. The modifications performed by the system 10 may be based on one or more patient parameters that vary periodically over time, such as parameters that vary in relation to the patient's respiratory cycle and / or cardiac cycle. The patient parameters may vary linearly and / or exponentially. In these embodiments, the system 10 may include one or more sensors (e.g., electrodes 311, 321, and / or 411, and / or functional element 99 described below) configured to generate a signal associated with a patient parameter that is used to adjust the change in the transfer matrix 290. Monitoring may be performed continuously (eg, when transfer matrix 290 is continuously modified) and / or intermittently (eg, when transfer matrix 290 is intermittently modified).

[0116] In some embodiments, the transfer matrix 290 for patient P1 (e.g., patient information 95 is determined based on the recorded signals 313) includes or at least includes information incorporated from previously calculated (e.g., from at least one other mammalian subject (e.g., patient P2)) and / or other standardized transfer matrices (standardized transfer matrix 290'). As used herein, the transfer matrix 290 may include a standardized transfer matrix 290' (e.g., a transfer matrix based on one or more individual mammals (patient P2)). The transfer matrix 290 may include a transfer matrix based only on data from patient P2, only on data from patient P1, or a transfer matrix based on data from patient P2 and data from patient P1. In some embodiments, the standardized transfer matrix 290' (or a portion thereof) may be selected based on the characteristics of the patient (characteristics of patient P1) for which the standardized transfer matrix 290' (or a portion thereof) is to be used. For example, a plurality of different standardized transfer matrices 290' may be determined, each based on one or more mammalian subjects (e.g., patient P2) having one or more specific patient characteristics (e.g., one or more similar patient parameter levels). In some embodiments, a single standardized transfer matrix 290' can accommodate a variety of patient characteristics, such as when the standardized transfer matrix 290' is customized based on one or more specific patient characteristics. A standardized transfer matrix 290' can be selected and / or customized for use as the transfer matrix 290 based on the parameter levels of a patient P1 similar to the subject used to create the standardized transfer matrix 290'. In some embodiments, the applicable patient parameters for selection and / or customization include parameters selected from the following: gender, weight, height, body or body part size, body mass index (BMI), chest circumference (e.g., determined by functional element 99 including an imaging device such as a CT scanner or MRI), location of the esophagus, size of the atrium, filling of the atrium volume, atrium pressure, fat to water ratio, air to water to fat ratio, bone location (e.g., determined by MRI), medications taken, medication levels, electrolyte levels, pH, pO2, pCO2, weight of water, and combinations thereof.

[0117] In some embodiments, the transfer matrix 290 includes a standardized transfer matrix 290' (e.g., based on a transfer matrix of one or more mammals (patient P2) different from patient P1), wherein differences in the positions of recording electrodes on patient P2 used to create the standardized transfer matrix 290' and the positions of recording electrodes on patient P1 used to generate the calculated patient information 95 are taken into account by the system 10.

[0118] In some embodiments, the standardized transfer matrix 290' can be obtained by analyzing the collection of data sets from multiple (i.e., two or more) patients P2. In some embodiments, the data set includes measurement information from each individual patient P2, such as position information (e.g., the position of anatomical structures and / or sensors and other objects), tissue information (e.g., tissue characteristics, features, and / or qualitative categories), information related to physiological processes (e.g., respiration and / or cardiac motion, and respiration and / or cardiac motion may include records from sensors over a period of time and / or data calculated based on these records), environmental information (e.g., background electrical noise or device interconnections) and / or cardiac information (e.g., electrical activation time, conduction pattern, surface charge, dipole density, (measured as voltage) cardiac potential electrogram, etc.). In some embodiments, the data set includes the transfer matrix 290 calculated based on the measurement results in each individual patient P2 and image data (e.g., CT and / or MRI data) from each individual patient P2. The memory 252 can be used to store the collection of data sets from multiple patients P2. The collection of data sets from multiple patients may include different groups of P2 patients with different characteristics (eg, gender, size, presence of a disease such as emphysema, age, heart location), which may also be included in the patient data sets.

[0119] Analysis of the collection of data sets from multiple patients P2 can be performed to identify patterns, correlations, correspondences, and / or other similar relationships between data set elements (such as measured information, measured transfer matrices 290, varying patient characteristics, and / or the entire collected image data). This analysis of the collection of data sets can be a "training" or "learning" step in a computational and / or algorithmic (e.g., machine learning method) process. The analysis produces one or more quantitative entities (e.g., a system of equations or a computational "model") that describe the complex relationships between data set elements throughout the population of patients P2. In some embodiments, the analysis can be performed using computational methods such as classification, collaborative filtering, regression, clustering, and / or dimensionality reduction. The quantitative entities can be applied in a second step, where one or more data set elements from patient P1 are provided as input and then used to calculate, select, customize, optimize, update, and / or predict the standardized transfer matrix 290' for patient P1. In some embodiments, the data set elements from patient P1 are only a subset of the data set elements used to calculate the quantitative entities, thereby reducing or eliminating the acquisition or measurement steps of patient P1.

[0120] In some embodiments, the standardized transfer matrix 290' calculated, selected, customized, optimized, updated, and / or predicted for patient P1 has improved accuracy or reduced artifacts compared to a transfer matrix directly measured in P1 due to potential imperfections or measurement limitations (e.g., environmental interference or human error). In some embodiments, the data set elements from patient P1 may be provided once to generate a single standardized transfer matrix 290', and / or may be provided multiple times in succession (e.g., provided in an interval or continuous manner), such as to generate multiple standardized transfer matrices 290' that are applied in succession to provide dynamic updates of time-varying relationships. In some embodiments, the data set elements used to generate the quantitative entity may contain time-varying information, and the data set elements from patient P1 need only be applied once or a limited number of times to generate multiple standardized transfer matrices 290', thereby providing dynamic updates more frequently than providing information from P1, thereby providing greater temporal resolution when updating the standardized transfer matrices 290'. In these embodiments, the system 10 can use the standardized transfer matrix 290' (e.g., the transfer matrix 290 only includes the standardized transfer matrix 290') to generate the calculated patient information 95. In some embodiments, for example, if an appropriate standardized transfer matrix 290' can be selected and / or customized based on characteristics of the patient P1 (e.g., characteristics such as size, weight, chest circumference, and / or rotation and / or position of the heart), a patient image (e.g., an MRI or CT scan) is not used (e.g., not required).

[0121] In some embodiments, the system 10 utilizes dynamic feedback and / or machine learning to determine the transfer matrix 290 and / or uses the transfer matrix 290 to determine the calculated patient information 95 based on the recorded signals 313. In some embodiments, the collection of data sets from one or more patients P2 (e.g., to create a standardized transfer matrix 290') may include treatment information. For example, the standardized transfer matrix 290' may be based on one, two or more treatment parameters selected from the following: duration (e.g., duration of energy delivery), intensity (e.g., intensity of energy delivery), amplitude (e.g., amplitude of energy delivery), temperature (e.g., temperature of tissue receiving energy), power (e.g., power of energy delivery), impedance (e.g., impedance of tissue), and combinations thereof. Each parameter may be analyzed in absolute, relative, and / or differential form. The standardized transfer matrix 290' may be based on tissue parameters associated with the applied treatment (e.g., tissue parameter information 80 stored by the system 10), such as one, two or more tissue parameters selected from the following (e.g., parameters of tissue receiving ablation energy and / or other treatment): size, depth, thickness, density, composition, and combinations thereof. The standardized transfer matrix 290' can be based on the effectiveness of a treatment (e.g., an ablation treatment) on local and / or regional electrical properties of tissue. The standardized transfer matrix 290' can be based on the acute (i.e., short-term) effectiveness and / or the chronic (e.g., long-term) effectiveness of the treatment. Applicable short-term and / or long-term treatment effectiveness parameters include, but are not limited to: elimination of conduction, changes in the conduction, velocity, amplitude, and / or direction of electrical signals in tissue, changes in the amplitude, frequency, and / or rate of measured electrical signals, changes in the rate, pattern, and / or frequency of the cardiac cycle, conversion of cardiac rhythms, changes in duty cycle and / or duration of intermittent rhythms, maintenance of a desired cardiac rhythm, conversion to an alternative rhythm (e.g., a desired or undesired rhythm), and / or duty factor of a resulting rhythm (e.g., a desired or undesired rhythm). The standardized transfer matrix 290' can be based on short-term and / or long-term treatment effectiveness parameters associated with changes in local, regional, and / or global mechanical and / or functional properties of tissue, such as parameters associated with: changes or maintenance of cardiac output and function; and / or changes in tissue stiffness, contractility, displacement, and / or strain. As described above, analysis of the collection of data sets from one or more patients P2 can be performed by the system 10 (e.g., by the algorithm 255), and the results are used to provide calculated patient information 95 to calculate, select, customize, predict, update and / or otherwise enhance treatment (e.g., therapeutic energy delivery and / or drug therapy strategy) for patient P1. In some embodiments, the delivery matrix 290 is based on a reduced data set (a subset of the full data set) recorded from patient P1, which is used in conjunction with data (e.g., the full set) recorded from one or more patients P2.In these embodiments, enhancements to treatment can be achieved without acquiring or performing other measurements on the remaining data set from the P1 patient, thereby reducing cost, time, and / or operational complexity. For example, based on the included patient P2 data, the assessment of one or more impairments incurred during the treatment procedure can be eliminated or at least reduced.

[0122] In some embodiments, the system 10 utilizes machine learning such as described above. The system 10 can be configured to obtain sequential measurements from one or more (e.g., all) surface electrodes, the surface electrodes being configured to record signals sequentially emitted from each of the one or more internal electrodes, and to track changes over time (e.g., physiological changes associated with changes in the signals). The system 10 can evaluate the respiratory and / or cardiac cycle, and the system 10 can perform compensation (e.g., subtraction and / or cancellation) to reduce the undesirable effects of these changes (e.g., as described above). The system 10 can determine the motion of the heart throughout the cardiac cycle by evaluating the impedance changes between the internal electrodes and the surface electrodes. The determination of the cardiac motion can be used to calculate mechanical, dynamic and / or other functional characteristics of the heart (such as contractility, volume, volume changes over time, ejection fraction, wall motion, wall displacement, strain and / or pressure), and the determination of the cardiac motion can be used to monitor cardiac function during clinical operation (e.g., to assess the safety of the operation). In some embodiments, the function of the ventricle can be measured, for example, by measuring the impedance across the thoracic cavity (e.g., in combination with the signals provided and / or recorded by the internal electrodes). Atrial and ventricular function can be separated by a time window: for example, when evaluating ventricular function from 200ms to 500ms after the QRS complex, when systole occurs. In some embodiments, the geometry of the chest (e.g., diameter, circumference, volume, etc.) is determined based on measurements made by two or more surface electrodes and changes in geometry relative to respiration (e.g., changes related to respiratory excursion and / or respiratory rate). In some embodiments, the position of the heart relative to surface electrodes (e.g., a 12-lead ECG positioned on the skin, electrodes 311, 321, and / or 411), as well as the rotation, position, and / or displacement (e.g., up and down) of the heart are measured during respiration and systole. Heart motion during systole can be determined in different heart rhythms (e.g., sinus rhythm, flutter, and / or fibrillation). The system 10 can integrate anatomical information (e.g., from CT, MRI, ultrasound, and / or other imaging devices) into a transfer matrix 290 (e.g., information related to air / fat / water ratios; the location of bones, spine, and / or ribs; the size of the chest diameter; and / or the angle and / or rotation of the heart) along with other information (e.g., ECG information and / or signal axes of body surface electrodes). The system 10 can be configured to create the transfer matrix 290, and the system 10 can also be configured to update (e.g., adapt or otherwise modify) the transfer matrix 290 (e.g., continuously or at least repeatedly update the transfer matrix 290). The system 10 can be configured to perform positioning operations, such as determining the position of one or more electrodes (e.g., internal drive and / or internal recording electrodes) relative to a positioning coordinate system.

[0123] In some embodiments, system 10 is configured to direct vector pulses of energy from one or more electrodes (e.g., electrode 311) positioned on the patient's skin. S ,321 S ,411 S and / or electrode-based functional elements 99 S One or more of the electrodes 311 and 312 are delivered to one or more electrodes (e.g., electrodes 311 ) positioned within the patient. I ,321 I ,411 I and / or electrode-based functional elements 99 I In some embodiments, one or more of the skin electrodes may be integrated into the distal portion of the device 100, such as one or more electrodes integrated into the distal portion of the device 100. In these embodiments, after the vector pulse is delivered, one or more skin electrodes may begin recording (and / or a separate skin electrode may record), such as to determine characteristics of the tissue based on the recording, such as to determine electrical conductivity characteristics and / or physical characteristics (e.g., scarring, fibrosis, fiber orientation, etc.) based on the response of the tissue to the vector pulse. Electrical activation of the tissue can be immediately detected in the tissue region surrounding the intracardiac catheter. The method is similar to a CRT device that uses an electrical vector to activate tissue from a housing (e.g., an implantable metal housing) to a lead. Amplitude and phase information may also be acquired to determine whether the pulse activated the tissue region in the direction of the vector. This determination may be performed for a subset of the surface electrodes of the intracardiac electrodes to determine whether the tissue in the direction of the vector is viable. The vector is rotated around the patient's body and / or modulated by creating a vector using different subsets of the surface electrodes of the intracardiac catheter electrodes to create a 3D map of the vitality of the tissue. Alternatively or additionally, the system 10 may be configured to deliver vector pulses of energy between the surface electrodes.

[0124] Recording assembly 300 may be integrated into console 200 and / or recording assembly 300 may include a second separate console operably attached to console 200 .

[0125] The recording component 300 can be configured to record signals from one or more electrodes or other sensors of the system 10, such as the recording electrode 311. The recording component 300 can record signals from one or more other electrodes of the system 10, such as electrodes that are also configured as drive electrodes, such as the drive electrode 411 including one or more drive electrodes on the patient's skin. S , and / or a drive electrode 411 including one or more electrodes positioned within the patient (eg, when included on a device 100 inserted into a patient) I The recording component 300 can be recorded via Figure 1Wired or wireless connections are shown (connections to recording electrodes 311 and 321 are shown via solid lines, and connections to drive electrode 411 are shown via dashed lines connected to the solid lines), connected to one or more electrodes.

[0126] The recording component 300 may include circuits, such as the patient isolation circuit 301 shown in the figure, which is configured to isolate the patient (e.g., patient P1 or P2 as shown) from undesired electric shock or other undesired interactions with the recording component 300. The recording component 300 may include one or more analog-to-digital converters, such as A2D 302 as shown, which may be configured to convert the recorded analog signal into a digital signal (e.g., a digital signal received from the recording component 300 by the processing unit 250). The recording component 300 may include one or more signal filters, such as the filter 303 as shown, which may be configured to filter out undesired noise or other undesired signals. The recording component 300 may include other signal recording and / or other signal processing circuits known to those skilled in the art, such as a wireless receiver configured to receive wireless signals from the garment 50, a wireless transmitting electrode of the system 10, and / or another wireless transmitter.

[0127] In some embodiments, recording component 300 is configured to multiplex (e.g., include multiplexing circuits) connections to multiple sensors so that a first group of one or more sensors (e.g., electrodes configured to record electrical activity) are recorded during a first time period, followed by a second group of one or more sensors (e.g., electrodes configured to record electrical activity) being recorded during a subsequent second time period. In some embodiments, three or more groups of sensors are multiplexed.

[0128] As described above, recording component 300 can be configured to perform dynamic impedance and / or dynamic voltage measurements associated with changes in the patient's respiratory cycle and / or physiological cycle.

[0129] The recording assembly 300 can be configured to record from multiple electrodes collectively (e.g., via multiplexing or other schemes) to form a "macroelectrode," e.g., to exploit the electrical and / or geometric advantages of more than one electrode and / or more than one recording channel. Examples of some advantages include greater effective electrode surface area (from multiple electrodes) and lower input impedance (through multiple parallel recording channels).

[0130] The recording electrode 311 may include one or more electrodes placed on the patient's skin (electrode 311 as shown in FIG. S ), and / or one or more electrodes placed in the patient's body (electrode 311 as shown in the figure) i). The recording electrode 311 may include two or more electrodes, for example, at least 2, at least 4, at least 6 or at least 10 electrodes.

[0131] In some embodiments, recording electrodes 311 include at least 3 electrodes (e.g., 3 electrodes included in a standard 6 limb leads for ECG recording). In some embodiments, recording electrodes 311 include at least 9 electrodes (e.g., 9 electrodes included in a standard 12-lead ECG). In some embodiments, recording electrodes 311 include no more than 1000 electrodes (e.g., up to 1000 surface electrodes included in garment 50, such as at least 50 electrodes, at least 100 electrodes, and / or at least 250 electrodes positioned in garment 50). In some embodiments, recording electrodes 311 are positioned on the surface of the patient in a relatively uniform pattern (e.g., a uniform pattern provided by garment 50). For example, when at least 2 electrodes 311 (e.g., at least 2 surface electrodes) are used for each axis of the coordinate system used, the number of recording electrodes 311 can be determined by using the coordinate system used.

[0132] The recording electrodes 311 may include one, two or more electrodes positioned on the patient's skin, for example at a location 312 selected from the following: S In some embodiments, the target location 90 may include one or more locations within the patient's body, such as one or more locations on an organ of the patient and / or within an organ of the patient. For example, the recording location 312 may include one or more locations selected from the following: the chest, back, torso, shoulder, and / or abdomen; the target location 90 may include one or more cardiac locations, such as cardiac locations selected from the following: the epicardial surface of the heart, within the cardiac tissue (subendocardial), the endocardial surface of the cardiac chamber, within the cardiac chamber, the pericardial cavity, the pericardium, and combinations thereof. In some embodiments, the recording electrode 311 includes at least one electrode positioned in each of the following locations: in the cardiac chamber, on the skin, and in the esophagus. In some embodiments, the recording electrode 311 includes an internal location and at least one non-intracardiac location (e.g., a location on the skin surface, a location on the epicardial surface, and / or a location on the pericardial surface). In some embodiments, recording electrodes 311 include at least 9 or at least 12 recording electrodes 311 (eg, the 9 or 12 electrodes are further configured as a 12-lead EKG device).

[0133] The recording electrodes 311 may include one, two or more electrodes that are connected via the garment 50 at positions 312. SThe garment 50 may be configured to position the recording electrodes 311 at various locations relative to each other and / or relative to the patient's anatomy.

[0134] The recording electrodes 311 may include one, two or more electrodes positioned within the patient's body, such as at a recording location 312 positioned on and / or within an organ of the patient. I In some embodiments, the recording location 312 I The recording location 312 includes a location within a chamber of the heart, a location on the endocardial surface of the heart, a location on the epicardial surface of the heart, and a combination thereof. I The recording location 312 includes one or more locations selected from the group consisting of: esophagus, epicardium (e.g., via a transthoracic or subxiphoid incision), pericardium (e.g., via a subxiphoid incision), near the heart but outside the heart, and combinations thereof. I In some embodiments, the recording location 312 includes locations containing interstitial fluid (e.g., tissue surrounding the heart and / or subcutaneous tissue locations). I This includes locations within the spine and / or at least close to the spine, and / or locations within the brain and / or at least close to the brain.

[0135] In some embodiments, recording electrodes 311 include at least one recording electrode positioned on the patient's skin and at least one recording electrode positioned within the patient's body. In these embodiments, recording electrodes 311 positioned externally (e.g., on the skin) may be reused. S and a recording electrode 311 placed internally (e.g., within a patient's body) I , to provide a source (e.g., to provide a function as a recording electrode) and / or a sink (e.g., to provide a function as a drive electrode). Multiplexing of electrodes (e.g., recording electrode 311) can be performed to form a group of electrodes that act as a single source and / or a single sink.

[0136] In some embodiments, the recording electrode 311 includes one, two, three or more electrodes selected from the following: surface electrodes, internal body electrodes (e.g., electrodes placed inside the body, under the patient's skin), transcutaneous electrodes, subcutaneous electrodes, epicardial electrodes, pericardial electrodes, spinal electrodes, brain electrodes, and combinations of these.

[0137] In some embodiments, the recording electrode 311 includes one, two, three or more electrodes selected from the following: one or more electrodes configured to transmit and / or receive positioning signals; multiple electrodes configured to generate ECG signals, such as at least 9 electrodes of a 12-lead ECG device; multiple electrodes configured to generate high-density ECGi signals; one or more electrodes configured to deliver cardiac pacing energy; one or more electrodes configured to deliver defibrillation energy; one or more electrodes configured to deliver therapeutic energy; and combinations of these (e.g., to avoid the need for standard ECG patch electrodes, pacing components and / or defibrillation components).

[0138] In some embodiments, the recording electrode 311 is configured to transmit and / or receive a localization signal, such as a localization signal for identifying the position of one or more devices (e.g., the device 100 described herein) positioned within the patient's body. For example, the signal generator 400 can provide a localization signal to the drive electrode 411 that is received by the recording electrode 311. Additionally or alternatively, the signal generator 400 can be electrically attached to the recording electrode 311 (e.g., via a catheter represented by a dotted line), and the signal generator 400 can provide a localization signal to the recording electrode 311 (e.g., received by the drive electrode 411, the electrode 321, and / or other electrodes of the system 10).

[0139] In some embodiments, recording electrodes 311 are positioned (relative to the patient) in a defined pattern (e.g., a standardized pattern), such as a pattern defined by a coordinate system. For example, one or more recording electrodes 311 can be positioned in garment 50, and garment 50 can be positioned relative to the patient to position recording electrodes 311 relative to the patient in a particular pattern (e.g., the coordinate system can be standardized via garment 50).

[0140] In some embodiments, recording electrode 311 includes one or more electrodes, one or more electrodes are further configured to record the patient's ECG signal, for example, when recording electrode 311 includes: at least 9 electrodes of a 12-lead ECG device and / or multiple electrodes configured to produce a high-density ECGi signal. Recording electrode 311 can be configured to provide arrhythmia monitoring of the patient. In these embodiments, recording electrode 311 can be specifically positioned relative to the patient's anatomical structure by garment 50.

[0141] In some embodiments, recording electrodes 311 are also configured to deliver pacing energy and / or defibrillation energy to the patient, such as pacing energy and / or defibrillation energy provided by signal generator 400. In these embodiments, recording electrodes 311 may be specifically positioned relative to the patient's anatomy by garment 50.

[0142] The recording electrode 321 may include one or more electrodes placed on the patient's skin (electrode 321 as shown in FIG. S ), and / or one or more electrodes placed in the patient's body (electrode 321 as shown in the figure) i ). Recording electrode 321 may include two or more electrodes, for example, at least 2, at least 4, or at least 10 electrodes. In some embodiments, recording electrode 321 includes at least twice the number of coordinate axes present in the coordinate system used by system 10, and / or recording electrode 321 includes a number of electrodes, the number of which is at least one more than the number of coordinate axes present in the coordinate system (e.g., 4 electrodes for a 3-axis coordinate system). In some embodiments, recording electrode 321 includes at least 9 electrodes (e.g., further configured as at least 9 electrodes of a standard 12-lead ECG device). In some embodiments, recording electrode 321 includes at least 3 electrodes (e.g., 3 electrodes further configured as a standard 6-limb lead ECG).

[0143] The recording electrodes 321 may include one, two or more electrodes positioned on the patient's skin, for example at a location 322 selected from the following: S The recording electrodes 321 may be located at: chest, back, torso, shoulder, abdomen, skull, face, arm, leg, groin, and combinations of these. In some embodiments, the recording electrodes 321 include at least one electrode located in each of the following locations: the patient's limbs (e.g., on the patient's legs or arms) and the patient's torso (e.g., at least 2, 4, or 6 electrodes across the patient's torso).

[0144] The recording electrodes 321 may include one, two or more electrodes that are connected via the garment 50 at positions 322. S The garment 50 may be configured to position the recording electrodes 321 at various locations relative to each other and / or relative to the patient's anatomy.

[0145] The recording electrodes 321 may include one, two or more electrodes positioned within the patient's body, such as at a recording location 322 positioned on and / or within an organ of the patient. I In some embodiments, the recording location 322 I The recording location 322 includes a location selected from the group consisting of a location within a chamber of the heart, a location on the endocardial surface of the heart, a location on the epicardial surface of the heart, and combinations thereof. I The recording location 322 includes one or more locations selected from the group consisting of: esophagus, epicardium (e.g., via a transthoracic or subxiphoid incision), pericardium (e.g., via a subxiphoid incision), near the heart but outside the heart, and combinations thereof.I In some embodiments, the recording location 322 includes locations containing interstitial fluid (e.g., tissue surrounding the heart and / or subcutaneous tissue locations). I This includes locations within the spine and / or at least close to the spine, and / or locations within the brain and / or at least close to the brain.

[0146] In some embodiments, recording electrodes 321 include at least one recording electrode positioned on the patient's skin and at least one recording electrode positioned within the patient's body. In these embodiments, recording electrodes 321 positioned externally (e.g., on the skin) may be reused. S and internally placed (e.g., within a patient's body) recording electrodes 321 I , to provide a source (e.g., to provide a function as a recording electrode) and / or a sink (e.g., to provide a function as a drive electrode). Multiplexing of electrodes (e.g., recording electrode 321) can be performed to form a group of electrodes that act as a single source and / or a single sink.

[0147] In some embodiments, the recording electrodes 321 include one, two, three or more electrodes selected from the group consisting of: surface electrodes, internal body electrodes, transcutaneous electrodes, subcutaneous electrodes, epicardial electrodes, pericardial electrodes, spinal electrodes, brain electrodes, and combinations thereof.

[0148] The signal generator 400 can be electrically attached to the recording electrode 321 (e.g., via a catheter represented by a dashed line), and the signal generator 400 can provide a drive signal (e.g., drive signal 413) or other electrical energy (e.g., received by the drive electrode 411, the electrode 311 and / or other electrodes of the system 10) to the recording electrode 321.

[0149] In some embodiments, recording electrodes 321 are positioned (relative to the patient) in a defined pattern (e.g., a standardized pattern), such as a pattern defined by a coordinate system. For example, one or more recording electrodes 321 can be positioned in garment 50, which is positioned relative to the patient to position recording electrodes 321 relative to the patient in a particular pattern (e.g., the coordinate system can be standardized via garment 50).

[0150] Signal generator 400 may be integrated into console 200 and / or signal generator 400 may comprise a second separate console operably attached to console 200 .

[0151] Signal generator 400 is configured to generate signals that are provided to one or more electrodes or other transducers of system 10 (eg, drive electrode 411 ).

[0152] The signal generator 400 may include a circuit (such as a patient isolation circuit 401 shown in the figure) configured to isolate a patient (such as the patient P1 or P2 shown) from an undesired electric shock or other undesired interaction with the signal generator 400. The signal generator 400 may include one or more digital-to-analog converters (such as D2A 402 shown in the figure), which may be configured to convert a digital signal (such as digital information received from the processing unit 250) into an analog signal. The signal generator 400 may include one or more signal filters (such as filter 403 shown in the figure), which may be configured to filter out undesired noise or other undesired signals. The signal generator 400 may include other signal generators and / or other signal processing circuits known to those skilled in the art.

[0153] In some embodiments, signal generator 400 is configured to provide positioning signals, such as positioning signals provided to drive electrode 411 , recording electrode 311 (eg, recording electrode 311 positioned in garment 50 ), and / or other electrodes of system 10 .

[0154] In some embodiments, the signal generator 400 is configured to provide energy to pace and / or defibrillate the patient's heart, such as pacing and / or defibrillation energy provided to a recording electrode 311 (e.g., a recording electrode 311 positioned in a garment 50 ), a drive electrode 411 , a functional element 99 , and / or other electrodes of the system 10 .

[0155] In some embodiments, the signal generator 400 is configured to multiplex (e.g., include multiplexing circuits) connections to multiple transducers so that a first group of one or more transducers (e.g., electrodes configured to deliver electrical signals and / or other electrical energy) are energized during a first time period, after which a second group of one or more transducers (e.g., electrodes configured to deliver electrical signals and / or other electrical energy) are energized during a subsequent second time period. In some embodiments, three or more groups of transducers are multiplexed. As described above, the drive electrodes may be configured (e.g., by multiplexing or another approach) to be interconnected to form macroelectrodes. The grouping of drive electrodes may be patterned to provide geometric and / or electrical advantages, such as shaping the source field in the body, maximizing the linearity of the source field, maximizing the field curvature of the source field, and / or maximizing or minimizing edge effects by creating or eliminating "holes" in the electrode groups.

[0156] In some embodiments, the signal generator 400 generates a signal from a first set of electrodes (eg, electrodes 411) positioned within the patient. I ) is transmitted, and at the same time, the recording component 300 simultaneously records the second set of electrodes (e.g., electrodes 311) positioned on the patient's skin. S), and then the signal generator 400 generates a signal from a second set of electrodes (e.g., electrodes 311) positioned on the patient's skin. S ) to transmit, and simultaneously record from a first group of electrodes (e.g., electrodes 411 I ) signal. This alternating signal source and receiver can continue for multiple cycles. In some embodiments, the algorithm 255 is configured to determine the time of each part of the cycle, and / or determine in which electrodes the signal is delivered and recorded. The combination of multiplexing of the signal source and receiver variations of the electrodes implementing the system 10 allows flexibility in establishing, shaping and / or modulating the geometric orientation and shape of the signal source and receiver signal paths (e.g., fields) through the body. The geometric orientation and shape of the signal paths through the body can vary according to time to produce a sequence or pattern that varies in time and space.

[0157] In some embodiments, at least one drive electrode 411 is positioned on the patient's skin (e.g., via garment 50) and potentially held in place by garment 50 (e.g., garment 50 includes one or more drive electrodes 411). In these embodiments, drive electrode 411 may be configured to deliver drive signals 413 for determining transfer matrix 290 (as described herein), deliver positioning signals, deliver cardiac pacing energy, deliver defibrillation energy, deliver therapeutic energy (e.g., deliver energy to suppress epileptic seizures, headaches or other neurological conditions and / or otherwise treat an adverse patient condition), and / or perform another function.

[0158] Device 100 may include one or more devices configured to be inserted into a patient's body (e.g., inserted into the patient's vasculature and / or otherwise inserted under the patient's skin). In some embodiments, device 100 includes a distal portion configured to be inserted into a chamber of the heart of patient P1. Device 100 may include a set of electrodes (drive electrodes 411) configured to provide a drive signal.

[0159] Device 100 may include a mapping and / or ablation device, such as an ablation device that is localized via a localization signal provided by system 10 (eg, a localization signal delivered by recording electrode 311 ).

[0160] The garment 50 may include one or more different forms for positioning one or more recording electrodes 311 relative to the patient's anatomy (e.g., at a specific anatomical location on the patient's skin). The garment 50 may include a garment selected from the group consisting of a vest, a shirt, a belt, a waistband, and combinations thereof.

[0161] The garment 50 may include a wireless transmitter (e.g., a functional element 99 configured as a wireless transmitter). S), for example a wireless transmitter configured to wirelessly transmit recordings made by one or more electrodes and / or other sensors of garment 50 to a receiving element of recording assembly 300.

[0162] In some embodiments, the system 10 utilizes one or more electrodes (eg, one or more electrodes 311) of the garment 50 to provide a sense of the present invention. S ,321 S ,411 S and / or electrode-based functional elements 99 S ) to perform impedance tomography of the patient's torso.

[0163] In some embodiments, garment 50 is configured simply as a template, such as when garment 50 is placed on a patient to mark sensor placement locations, and / or when garment 50 includes openings through which sensors are placed on the patient's skin (e.g., after garment 50 is removed).

[0164] The calculated patient information 95 may include a map of the electrical activity of an organ (e.g., heart or brain) of the patient. The mapped electrical activity may include voltage information, dipole density information, and / or surface charge information. In cardiac applications, the target location 90 associated with the calculated patient information 95 may include a location on the endocardial surface, a location within cardiac tissue, and / or a location on the epicardial surface. In brain applications, the target location 90 associated with the calculated patient information 95 may include a location on the brain surface and / or within the brain (e.g., in the cerebral cortex and / or within the deep brain).

[0165] The calculated patient information 95 may include information types selected from the following: electrical information (e.g., voltage information, surface charge information, tissue charge information, and / or dipole density information); tissue; structural or mechanical information (e.g., density, and / or differences in mechanical properties (e.g., density), size and / or shape of areas of change in mechanical properties (e.g., density); tissue composition information (e.g., damaged tissue, inflamed tissue, and / or degenerated tissue, such as degenerated proteins, collagen, fibrosis, fat, and / or nerves); electrogram flow information; impedance information; phase information (e.g., for phase mapping), and combinations of these. For example, the calculated patient information 95 may include tissue density information that has been modified in a tissue ablation procedure (e.g., an RF or other cardiac tissue ablation procedure for treating arrhythmias), for example, in order to assess the quality of the ablation performed. In some embodiments, the calculated patient information 95 may include a combination of electrical information of the tissue (such as surface charge information) and mechanical and / or compositional properties (density or presence of denatured proteins, or other indications of structural formation of ablation lesions or other treated tissues) so that the effectiveness of the delivered treatment can be classified as complete or incomplete. For example, the electrical information collected by the system 10 may indicate a loss of electrical conduction, while the structural formation of a lesion (e.g., a lesion produced via the delivery of ablation energy) remains incomplete, which may indicate a lesion that is only temporarily effective (e.g., undesirable conduction may occur again in the future). The collected electrical information may indicate continuous conduction through the treatment area, and the mechanical and / or compositional information may suggest the formation of edema rather than a completely transmural (ablation) lesion, which may prompt a change in treatment strategy. The collected electrical information may indicate the elimination of electrical conduction through the area, and the structural and / or compositional information may indicate the formation of a completely transmural (ablation) lesion, which may increase the probability that the lesion will remain effective for a long time, which increases the confidence in the delivered treatment.

[0166] As described above, the calculated patient information 95 may include tissue composition information. Tissue composition may be locally assessed by the system 10 via optical measurements (e.g., spectroscope or perspective). The system 10 may be configured to determine (e.g., using a catheter enabled by an optical fiber or CCD camera) the fluorescence, reflectivity, and / or absorptivity from the tissue. The system 10 may assess the extent to which the tissue fluoresces, reflects light, and / or absorbs light via the algorithm 255. These responses to specific two or more wavelengths of light may increase further specificity, because different biomaterial compositions fluoresce, reflect light, and / or absorb light in a specific manner. In some embodiments, the system 10 analyzes damage by monitoring the fluoroscopic markers of NADH. NADH is a coenzyme present in all intact cells that fluoresces when irradiated with certain wavelengths of light (e.g., UV). Once a cell (e.g., by RF ablation) is damaged, NADH is released from the mitochondria of the cell and / or converted into an oxidized form of NADH, and its fluorescence decreases significantly. In some treatment methods, cellular damage is a desired outcome of a clinical procedure (e.g., an ablation procedure configured to treat an arrhythmia such as atrial fibrillation). However, under some conditions, the response of tissue and / or other body to treatment can vary. For example, when attempting to deliver RF ablation to cardiac tissue, the body's inflammatory response accumulates extracellular fluid to the affected area (edema), thereby protecting the cells from further damage. This edema prevents the effective delivery of further RF energy, thereby reducing the effectiveness of subsequent delivery of ablation energy. When edema forms, the cells remain intact and the fluoroscopic markers of NADH remain unchanged, so this fluoroscopic measurement performed by system 10 is highly specific to the desired response of the tissue to the delivered ablation energy (e.g., situations where cellular damage is associated with lesion formation). This analysis can be performed in conjunction with an assessment of tissue density (also at the energy delivery location) to further refine the assessment of cellular damage relative to healthy tissue. In some embodiments, the system 10 creates a standardized transfer matrix 290' based on one or more patients P2 by recording treatment information associated with an ablation procedure (e.g., a cardiac ablation procedure) performed on the patient P2. The treatment information may include: electrical information, anatomical information (e.g., recorded by an imaging device), tissue impedance information. This information may be combined with measurements of tissue composition, and the system 10 (e.g., using a machine learning algorithm) may then sensitively and specifically identify a signature of tissue composition that may be associated with the procedure performed on the patient P1 without having to perform actual measurements of the composition directly in the patient P1.

[0167] In some embodiments, the calculated patient information 95 includes dipole density and / or surface charge information, which is determined using devices and methods (e.g., via algorithm 255) such as those described in applicant's co-pending U.S. patent application serial number 16 / 533,028, filed on August 6, 2019, entitled “Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls,” and / or in applicant's co-pending U.S. patent application serial number 16 / 568,768, filed on September 12, 2019, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall,” the contents of each of which are incorporated herein by reference in their entirety for all purposes.

[0168] In some embodiments, the calculated patient information 95 includes information types selected from the group consisting of: medication information, electrolyte information, pH information, and combinations thereof.

[0169] In some embodiments, system 10 is configured to collect other physiological data of the patient (e.g., data other than the data recorded by recording electrodes 311, 321 and / or drive electrodes 411). In these embodiments, system 10 may include functional element 99, which includes one, two, three or more sensors or other data acquisition components. In some embodiments, functional element 99 may include one or more sensors or other functional elements (functional element 99) positioned within the patient's body. I ), and / or one or more sensors or other functional elements (functional element 99) positioned on the patient's skin. S ), each as shown in the figure. Functional element 99 S The garment 50 may include one or more functional elements (e.g. Figure 1 Functional element 99 I One or more functional elements positioned on and / or within the device 100 (eg, on a basket or other distal portion of the device 100 as shown) may be included.

[0170] In some embodiments, functional element 99 includes one or more components configured to collect data selected from the group consisting of: circadian data, cardiac data, respiratory data, patient medication data, skin impedance data, perspiration data, thoracic and / or abdominal space data (e.g., as measured manually and / or by an imaging device such as CT or MRI), water weight data, hematocrit level data, wall thickness data (e.g., cardiac wall thickness data), and combinations thereof. For example, functional element 99 may include a manual measurement device (e.g., a tape measure or ruler) and / or an imaging device (e.g., CT or MRI) for collecting thoracic measurement information used by system 10 to determine transfer matrix 290 and / or calculated patient information 95. In some embodiments, the functional element 99 includes one, two, three or more sensors selected from the group consisting of a magnetic sensor, a water sensor, a perspiration sensor, a skin impedance sensor, a glucose sensor, a pH sensor, a PO2 sensor, a pCO2 sensor, a SpO2 sensor, a heart rate sensor, a pressure sensor, a blood pressure sensor, a spinal sensor, a brain electrode, a brain sensor, a flow sensor, a blood flow sensor, a motion sensor, and combinations thereof. In these various embodiments, the algorithm 255 may be configured to include this additional patient information, such as calculating the patient information 95 in the analysis to determine and / or modify the transfer matrix 290 (e.g., modify the transfer matrix 290 in a continuous and / or intermittent manner), to determine and / or modify system 10 parameters, and / or to perform another function. In some embodiments, the transfer matrix 290 is used to measure cardiac function (e.g., changes in blood volume over time) as described herein, such as during cardiac ablation or other cardiac procedures.

[0171] In some embodiments, functional element 99 includes one or more electrodes or other transducers configured to deliver electrical signals and / or electrical energy to a patient. For example, functional element 99 may include one or more electrodes configured to: deliver a drive signal (e.g., similar to drive signal 413) used to determine transfer matrix 290 (as described herein); deliver a localization signal; deliver cardiac pacing energy; deliver defibrillation energy; and / or perform another function.

[0172] In some embodiments, functional element 99 includes one or more magnets used for spatial tracking (e.g., respiration tracking and / or other patient motion tracking) by system 10. In these embodiments, garment 50 may include one or more magnets, such as to position the one or more magnets at one or more predetermined locations relative to the patient.

[0173] In some embodiments, functional element 99 includes one or more ultrasonic elements (e.g., sensors and / or transducers) for measuring distances, for example, to create a 2D or 3D image of patient tissue and / or a device of system 10 positioned on and / or within the patient. In these embodiments, garment 50 may include one or more ultrasonic elements, such as to position the one or more ultrasonic elements at one or more predetermined locations relative to the patient.

[0174] In some embodiments, functional element 99 includes a microphone for recording heart sounds, such as a microphone integrated into patient garment 50 to position the microphone at a specific location relative to the patient.

[0175] In some embodiments, functional element 99 includes an accelerometer, such as an accelerometer configured to track movement of a portion of the patient (e.g., when integral with garment 50) and / or an accelerometer included in another component of system 10 (e.g., included in device 100 to track movement of patient tissue and / or movement of device 100).

[0176] In some embodiments, one or more drive electrodes of system 10 are positioned at one or more known locations (e.g., in the blood in a chamber offset from the heart wall) in the patient's body (e.g., in the patient's heart), emitting drive signals of known amplitude (e.g., one or more drive signals). System 10 includes one or more recording electrodes, one or more recording electrodes are positioned at one or more locations (e.g., one or more arbitrary locations) on the patient's skin surface, and one or more recording electrodes measure the response to the drive signals. The ratios of these recorded signals to the drive signals can be used by system 10 to generate transfer matrix 290. These ratios depend on various patient characteristics (e.g., obesity, size of the heart, conduction of the lungs, organs and other tissues, skin resistance, orientation of the heart, respiratory changes, diaphragm position, etc.). Subsequently, electrical activity (e.g., electrical activity of the heart) is measured simultaneously using both internal electrodes and surface electrodes (e.g., previously used or otherwise used). Using transfer matrix 290, system 10 transforms the electrical activity measured by the surface electrodes to generate a first potential map on the heart wall (e.g., scaled as a ratio by the scaling of transfer matrix 290 itself).

[0177] In some embodiments, system 10 generates a potential map on the heart wall while avoiding the use of an inverse solution, such as when the voltage V at a point "i" on the heart wall is i The voltage value W on the body surface k The voltage V is determined by a linear relationship (e.g., via algorithm 255) i When, for example, by using the following equation (1):

[0178] Equation (1):

[0179] The driving signal is applied to “k” surface electrodes (SE k ), and at the “i” heart wall electrodes (HW i ) on the measured response V i In the sum of equation (1), there is only one term for which:

[0180]

[0181] Therefore, W k is measured, and according to equation (1), by ik Multiply it by itself to get V i In these embodiments, system 10 may include a minimum number of surface electrodes (eg, electrodes 312 configured as drive electrodes) that provide drive signal k. S and / or 322 S ), for example at least 3, at least 6, at least 9 or at least 12 surface electrodes.

[0182] In some embodiments, the system 10 applies the transfer matrix 290 to the first set of recorded signals 313 including applying a ratiometric function of the transfer matrix 290 to the first set of recorded signals 313. The ratiometric function may include an "identity function" for which the resulting set of recorded values ​​(e.g., the calculated patient information 95) is determined (e.g., by the transfer matrix 290 alone). The ratiometric function may also be configured to linearly scale the transfer matrix 290 as a "linear scaling function." Alternatively or additionally, the ratiometric function may be configured to nonlinearly scale the transfer matrix 290 (e.g., as a "nonlinear scaling function").

[0183] In some embodiments, system 10 applying the transfer matrix 290 to the first set of recorded signals 313 includes applying a non-linear geometric function of the transfer matrix 290 to the first set of recorded signals 313 .

[0184] In some embodiments, the system 10 transforms the electrical activity measured by the internal electrodes to produce a second potential map on the heart wall (e.g., using an inverse solution). The system 10 can be configured to generate a third potential map on the heart wall based on the first map and the second map, wherein the third map is more accurate than the first map or the second map alone. Alternatively, avoiding the use of internal electrodes, the system 10 is configured to generate a heart wall potential data map using only surface electrodes. For example, the transfer matrix 290 can be determined using patient P2, and the cardiac electrical activity is calculated for a separate patient P1, such as when patient P2 has a similar heart size or other similar features to patient P1. The similarity between patients P2 and P1 can be assessed, and correction factors can be used to account for differences (e.g., differences in weight, size, heart size, etc.).

[0185] In some embodiments, the system 10 records voltage information at a first α location and determines electrical activity information at a different second β location. For example, a recording electrode 311 (e.g., positioned on the patient's skin) can record voltages, and the system 10 can generate calculated patient information 95 including electrical activity information at a target location 90, including a location within the patient's body, such as a location on and / or within an organ of the patient (such as the heart or brain). In some embodiments, the electrical activity information includes voltage information, surface charge information, and / or dipole density information, such as described in applicant's co-pending U.S. patent application serial number 16 / 533,028, filed on August 6, 2019, entitled "Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls," and / or applicant's co-pending U.S. patent application serial number 16 / 568,768, filed on September 12, 2019, entitled "Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall," the contents of each of which are incorporated herein in their entirety for all purposes. In these embodiments, an inverse solution may be used to determine the calculated patient information 95, such as using an inverse solution in conjunction with the transfer matrix 290 to improve the accuracy of the calculated patient information 95. System 10 may use transfer matrix 290 to compensate for spatial and / or temporal anisotropy.

[0186] In some embodiments, system 10 includes a device 100 including one or more electrodes (eg, one or more electrodes 411 ) configured to record electrical activity from within a patient's heart. I and / or electrode-based functional elements 99 I ); one or more electrodes, the one or more electrodes being positioned on the patient's skin (e.g., via garment 50) and configured to record electrical activity on the surface of the patient; and an algorithm 255, the algorithm 255 being configured to calculate electrical information of the heart (e.g., voltage information, dipole density information, and / or surface charge information). In these embodiments, the algorithm 255 can use the recorded electrical activity from inside the patient's heart and from the surface of the patient to calculate an inverse solution to determine the electrical information. In some embodiments, the inverse solution is constrained (limited to) the normal, strictly tangential, and / or strictly scalar density magnitudes of the dipoles. In these embodiments, additional recorded data (surface data) can be used for a "double-constrained" inverse solution, or to provide a confirmation or correction data set to improve the accuracy of the inverse solution. Alternatively or additionally, the additional recorded data (surface data) sufficiently constrains the inverse solution so that the inverse solution can allow for vector dipoles (i.e., linear combinations of normal dipoles and tangential dipoles) whose directions are not constrained. In some embodiments, by applying the algorithm 255 at a location on the surface of the heart (e.g., on a three-dimensional shell without thickness), additional recorded data (surface recorded data) can be used to calculate the electrical information of the heart. In some embodiments, applying the algorithm 255 within and / or throughout the tissue (through or throughout the transmural thickness of one or more heart chambers, and / or within a three-dimensional structure including variations in tissue thickness representing structural anatomy (such as myocardial tissue between the endocardium and epicardium, atrial septum, ventricular septum, etc.) can be used to calculate the electrical information of the heart. In some embodiments, the algorithm 255 can use the additional recorded data (surface data) to improve the accuracy of the inverse solution at one or more heart locations (e.g., one or more left atrial locations (e.g., locations near the pulmonary veins, left atrial appendage, and / or mitral valve)). In some embodiments, internal and surface recorded data can be recorded simultaneously and used by the algorithm 255 to improve modeling of the ventricular component of the electrical information, such as for V wave (QRST) removal.

[0187] As described above, system 10 can be configured to perform localization operations, such as operations to determine the location of one or more portions of device 100 and / or operations to determine the location of another device that has been inserted into a patient. In these embodiments, system 10 can be configured to improve the accuracy of location information using transfer matrix 290. In some embodiments, system 10 can be configured to improve accuracy in real time or at least near real time (referred to herein as "real time") throughout a patient operation (e.g., a patient mapping and / or ablation operation). In some embodiments, system 10 is configured to use skin-placed electrodes (e.g., electrodes 311) to determine the location of another device that has been inserted into a patient. S ,321 S ,411 S and / or electrode-based functional elements 99 S ) and performs real-time updating of positioning data by continuously transmitting and recording determined electrical information from internal and external electrodes.

[0188] In some embodiments, system 10 includes a distribution of electrodes that are configured for multiple purposes, such as multiple electrodes positioned at specific locations relative to the patient's anatomy on and / or near the patient's skin (hereinafter "on the patient's skin") via garment 50. In some embodiments, multiple electrodes are used to determine electrical information related to the patient's heart, such as a voltage map, a dipole density map, and / or a surface charge map of the heart surface, such as described herein. In some embodiments, one or more of the electrodes (e.g., electrodes 311, 321 and / or electrode-based functional elements 99) are configured to deliver electrical signals and / or electrical energy, such as to perform positioning operations, deliver cardiac pacing energy, deliver cardiac defibrillation energy, and / or deliver therapeutic energy. In some embodiments, one or more electrodes are configured to provide an electrical ground (e.g., a return path for one or more signals, such as a return path for delivering ablation energy) and / or a reference signal (e.g., a reference voltage).

[0189] In some embodiments, system 10 includes a first set of one or more electrodes for positioning on the patient's skin (e.g., via garment 50) to perform a first function, and a second, different set of one or more electrodes for positioning on the patient's skin (e.g., via garment 50) to perform a second, different function. For example, one set of electrodes may include a size and / or a set of materials configured to perform cardiac pacing and / or fibrillation, while a different set of electrodes includes a size and / or a set of materials configured to record electrical signals.

[0190] In some embodiments, system 10 includes a set of multiple electrodes that are multiplexed (e.g., via a switching network) such that a first subset of one or more electrodes is used for a first function, and one or more different additional subsets of one or more electrodes can be used for different functions. For example, one subset can be used to record signals to create a voltage, surface charge, and / or dipole density map of the surface of the heart, one subset can be used to create an ECG (e.g., ECGi and a subset for a 12-lead ECG), one subset can be used to pace a patient's heart, one subset can be used to defibrillate a patient's heart, one subset can be used as an electrical ground, and / or one subset can be used as a reference signal. In some embodiments, the subset of electrodes used for a particular function can be modified by an operator of system 10, such as during operation to improve recording and / or energy delivery.

[0191] In some embodiments, one or more functions of the system 10 (e.g., positioning, defibrillation, and / or other functions described above) can be optimized or at least improved (herein "optimized") during patient operation, such as to adjust for patient-specific and / or environment-specific conditions. In some embodiments, the system 10 may include a plurality of electrodes interconnected (grouped) in one or more groups of electrodes, such as one or more electrode groups each performing a function (e.g., a diagnostic function and / or a therapeutic function). In some embodiments, a particular electrode group (e.g., an electrode group for a particular function) is predefined and / or automatically adjusted by the system 10. Alternatively or additionally, a particular electrode group can be selected and / or adjusted by a user of the system 10 (e.g., a patient's clinician). Different groups can be configured to perform different functions. Additionally or alternatively, different groups can be configured to perform the same function, such as when a first group of electrodes is used to perform a function, after which a second group is used to perform the same function, such as to optimize the performance of the function. In some embodiments, a combination of multiple groups of electrodes is configured to perform a single function, such as multiple groups of one or more electrodes are configured as a "positioning patch".

[0192] For example, the system 10 can be configured such that multiple groups of one or more electrodes are configured as positioning patches that are dynamically adjustable without having to remove and reapply electrodes. These groups of electrodes can be set and / or adjusted (e.g., selecting or adjusting electrodes at specific anatomical locations), such as modifying orthogonal axes and / or including additional axes in the adjustment. For example, in a cardiac operation, a lateral shift of 1-2 pairs of electrode groups can be performed, such as to account for dextrocardia (heart more to the right).

[0193] In another example, the system 10 may be configured so that multiple groups of one or more electrodes are configured as cardiac pacing electrodes and / or defibrillation electrodes, and these groups of electrodes can be dynamically adjusted to optimize pacing and / or defibrillation without having to remove and reapply electrodes. In some embodiments, pacing and / or defibrillation electrode placement is selected based on physician preference. In some embodiments, before delivering pacing and / or defibrillation energy, one or more pacing and / or defibrillation electrodes that are also used for (one or more) different functions are disconnected from other functional circuits. For example, after delivering pacing and / or defibrillation, the system 10 can be configured to quickly switch one or more of the electrodes (and / or other electrodes) to a mapping mode, such as recording ECG information shortly after pacing and / or defibrillation, thereby allowing the creation of pacing recovery, defibrillation recovery and / or arrhythmia attack (e.g., atrial fibrillation attack) maps. Alternatively or additionally, the system 10 can be configured to deliver electrical energy to a patient's non-cardiac organs, such as the patient's brain, such as to treat neurological diseases such as epilepsy, migraine, depression, etc.

[0194] In another example, the system 10 can be configured so that multiple groups of one or more electrodes can be selected to deliver energy in a specific pattern, such as to optimize energy delivery to a location (e.g., the patient's heart, brain, and / or another organ). For example, one or more groups of energy delivery electrodes can be switched and / or adjusted to successfully cardiovert the patient's heart, and / or prevent or at least reduce epileptic seizures. In some embodiments, the pattern of electrodes is selected to reduce the required energy delivery. In some embodiments, a spiral pattern of electrodes can be included. In some embodiments, the pattern of electrodes can be adjusted (adjusted) based on mapped electrical activity (e.g., of the heart or brain) and / or a physiological substrate (e.g., of the heart or brain).

[0195] In some embodiments, the system 10 is configured to determine transmural conduction within cardiac tissue (e.g., endocardium to epicardium or vice versa), such as when the algorithm 255 analyzes signals from sensors (e.g., electrodes 311 ) placed on the patient's skin (e.g., via the garment 50 ). S ,321 S ,411 S and / or electrode-based functional elements 99 S ) and data recorded by sensors in the patient (e.g., via device 100, such as electrodes 311 I ,321 I ,411 I and / or electrode-based functional elements 99 I) recorded data. The algorithm 255 may use one or more boundary conditions such as (e.g., as measured directly and / or determined indirectly by the system 10) endocardial, epicardial, and / or pericardial voltages to make the determination. As described above, the algorithm 255 may utilize additional recorded data (e.g., surface data) to "double constrain" the mathematical transformation (e.g., inverse solution) and / or provide a confirmation or correction data set to improve the accuracy of the output of the algorithm 255.

[0196] Reference now Figure 1A , a schematic diagram of a system for calculating information related to one or more parameters of a patient's heart consistent with the present inventive concept is shown. Figure 1A The system 10 may have the same Figure 1 The system 10 is similarly constructed and arranged, and may include similar components. Figure 1A In an embodiment of the present invention, the system 10 is arranged and configured to calculate patient information 95 related to the patient's heart, such as information related to one or more target locations 90 in the patient's left atrium. The patient information 95 can be determined using the transfer matrix 290 and can be based on signals 313 recorded by one or more recording electrodes 311 positioned at one or more skin-based recording locations 312. The recorded signals 313 can be recorded by the recording component 300 (e.g., and stored in the memory 252 of the processing unit 250). The recording electrodes 311 can be included in the patient garment 50, and / or the patient garment 50 can simply be used as a template to position the electrodes 311 at specific anatomical locations on the patient's skin.

[0197] In some embodiments, system 10 is configured to determine transfer matrix 290, such as when system 10 includes one or more drive electrodes 411 positioned at one or more drive positions 412 and configured to deliver drive signals 413 (e.g., drive signals 413 provided by signal generator 400). In these embodiments, a set of recording electrodes 321 is included and positioned at positions 322 to record signals 323. Figure 1A In the illustrated embodiment, drive electrode 411 is positioned at drive location 412 within the patient's body (e.g., drive electrode 411 is included in an expandable cage or other distal portion of device 100 that is inserted into the body, such as at a location within a chamber of the patient's heart), and recording electrode 321 is positioned at location 322 on the patient's skin. In some embodiments, recording location 322 is located at a location 414 of the patient's heart. Figure 1AThe recording locations 322 shown are the same or at least similar (e.g., recording electrode 321 is the same or at least similar to recording electrode 311). Alternatively, recording electrode 321 includes different electrodes and / or recording locations 322 include locations that are different from recording electrode 311 and recording locations 312, respectively. Algorithm 255 can generate transfer matrix 290 based on an analysis of recording signal 323 compared to drive signal 413.

[0198] Reference now Figure 2 , showing a flow chart of a method for determining patient information at a target location consistent with the concept of the present invention. Figure 2 The method 2000 provides a method of recording electrical activity at one or more recording locations and applying a transfer matrix to the recording to determine patient information at one or more target locations. Figure 1 Various components of system 10 are described to describe method 2000 .

[0199] In step 2100, a transfer matrix 290 is determined. The transfer matrix 290 may be based on a sample collected from a single patient (e.g., as described above with reference to Figure 1 The patient P1 described above and / or multiple patients (e.g., patients P1, P2 and / or other mammal patients) are determined by the recorded information. Figure 1 As described above, the transfer matrix 290 can be determined by generating a drive signal 413 from one or more recording locations 322 via a set of one or more recording electrodes 321. In some embodiments, the transfer matrix 290 is as follows with reference to Figure 3 Determined as described.

[0200] In step 2200, the potential is recorded. For example, the first set of recording electrodes (recording electrodes 311) records the potential at the first set of recording locations (recording locations 312) to create a set of recording signals (recording signals 313 stored in the console 200), as described above with reference to Figure 1 described.

[0201] In step 2300, patient information is calculated. For example, patient information 95 may be calculated for a set of target locations, such as target locations 90 including one or more locations on and / or within a patient. Patient information 95 may be calculated by applying transfer matrix 255 to recorded signal 313, such as described above with reference to Figure 1 as described.

[0202] Reference now Figure 3 , shows a flow chart of a method for determining a transfer matrix and then using the transfer matrix to determine patient information at a target location consistent with the concept of the present invention. Figure 3Method 3000 provides a method for determining a transfer matrix. The method also provides recording electrical activity at one or more recording locations, and applying the transfer matrix to the recording to determine patient information at one or more target locations. Figure 1 Various components of system 10 are described to describe method 3000.

[0203] In step 3050, a drive signal is emitted or otherwise delivered to the tissue from one or more drive locations 412, for example via a set of one or more drive electrodes 411. The drive signal 413 is recorded, for example via a set of one or more recording electrodes 321 from one or more recording locations 322, to create a set of recorded signals 323 that can be stored in the console 200, for example as described above with reference to Figure 1 As described.

[0204] In step 3100 , the transfer matrix 290 is determined based on the recorded signal 323 recorded in step 3050 .

[0205] In step 3200, the potential is recorded. For example, the first set of recording electrodes (recording electrodes 311) records the potential at the first set of recording locations (recording locations 312) to create a set of recording signals (recording signals 313 stored in the console 200), as described above with reference to Figure 1 and / or Figure 2 described.

[0206] In step 3300, patient information is calculated. For example, patient information 95 may be calculated for a set of target locations, such as target locations 90 including one or more locations on and / or within a patient. Patient information 95 may be calculated by applying transfer matrix 255 to recorded signal 313, such as described above with reference to Figure 1 and / or Figure 2 As described.

[0207] The above embodiments should be understood as being intended only as illustrative examples; further embodiments are contemplated. Any feature described herein with respect to any one embodiment may be used alone or in combination with other features described, and may also be used in combination with one or more features of any other embodiment, or in any combination of any other embodiment. In addition, equivalents and modifications not described above may also be employed without departing from the scope of the invention as defined in the appended claims.

Claims

1. A patient information processing system, comprising: a recording assembly configured to record electrical potentials via a first set of recording electrodes at a first set of recording locations on and / or in the patient to create a first set of recorded signals; a processing unit configured to calculate patient information for a set of target locations within the patient by applying a transfer matrix to the first set of recorded signals, wherein the transfer matrix comprises features of electrical properties of tissue between the first set of recorded locations and the set of target locations, wherein the recording component is further configured to record the voltage of the patient at the second set of recording locations, and the processing unit is further configured to determine the electrical information of the first set of recording locations, wherein the calculated patient information is based on the output of the inverse solution, and a transfer matrix is ​​applied to improve the quality of the calculated patient information, and Therein, the system is configured to apply the transfer matrix to the first set of recorded signals by applying a nonlinear geometric function of the transfer matrix to the first set of recorded signals.

2. The system according to claim 1, wherein: The transfer matrix takes into account spatial anisotropy and / or temporal anisotropy.

3. The system according to claim 1, wherein: The calculated patient information includes information selected from the group consisting of voltage information, surface charge information, tissue charge information, dipole density information, tissue density information, impedance information, phase information, and combinations thereof.

4. The system according to claim 3, wherein: The tissue density information includes information related to changes in tissue density over time.

5. The system according to claim 4, wherein: The change in tissue density over time includes changes caused by ablation of the tissue.

6. The system according to claim 1, further comprising: a signal generator configured to cause a set of driving electrodes located at a set of driving positions to emit a set of driving signals; wherein the recording component is configured to record the emitted drive signal via a second set of recording electrodes located at a second set of recording positions to create a second set of recorded signals; and Wherein, the processing unit is configured to determine the transfer matrix by comparing the second set of recorded signals with a set of emitted drive signals.

7. The system according to claim 6, wherein: The transfer matrix is ​​determined using the amplitude and / or phase of the second set of recorded signals.

8. The system according to claim 7, wherein: The transfer matrix includes numerical scaling factors based on a comparison of the amplitude and / or phase of the second set of recording signals with the amplitude and / or phase of the set of drive signals.

9. The system according to claim 6, wherein: The set of drive signals are emitted during at least one physiological cycle of the patient and the emitted drive signals are recorded.

10. The system according to claim 9, wherein: The physiological cycle comprises a cycle selected from the group consisting of a cardiac cycle, a respiratory cycle, a pressure cycle, and combinations thereof.

11. The system according to claim 6, wherein: The transfer matrix is ​​determined by calculating and / or selecting a normalized transfer matrix.

12. The system according to claim 11, wherein: The standardized transfer matrix is ​​selected based on patient parameters.

13. The system of claim 1, wherein: modifying the transfer matrix over time; and / or modifying the transfer matrix based on at least one changing patient parameter, and / or modifying the transfer matrix to compensate for the patient's breathing, and / or The transfer matrix is ​​modified to compensate for cardiac motion of the patient.

14. The system according to claim 13, wherein: The system is also configured to monitor at least one changing patient parameter.

15. The system of claim 14, wherein: Monitoring includes: continuously monitoring the at least one changing patient parameter; and / or The transfer matrix is ​​continuously modified.

16. The system of claim 14, wherein: Monitoring includes: intermittently monitoring the at least one changing patient parameter; and / or The transfer matrix is ​​intermittently modified.

17. The system of claim 1, wherein: Applying the transfer matrix to the first set of recorded signals includes a processing unit applying a linear geometric function of the transfer matrix to the first set of recorded signals.

18. The system of claim 1, wherein: The system is configured to collect patient physiological data, and The patient physiological data includes data selected from the following: physiological cycle data, heart data, respiratory data, patient medication data, skin impedance data, perspiration data, chest and / or abdominal space data, water weight data, hematocrit level data, wall thickness data and combinations thereof.

19. The system of claim 1, wherein: The system is also configured to execute a device positioning procedure to determine device location information.

20. A patient information processing system, comprising: a recording assembly configured to record electrical potentials via a first set of recording electrodes at a first set of recording locations on and / or in the patient to create a first set of recorded signals; a processing unit configured to calculate patient information for a set of target locations within the patient by applying a transfer matrix to the first set of recorded signals, wherein the transfer matrix comprises features of electrical properties of tissue between the first set of recorded locations and the set of target locations, wherein the recording component is further configured to record the voltage of the patient at the second set of recording locations, and the processing unit is further configured to determine the electrical information of the first set of recording locations, and wherein the calculated patient information is based on the output of the inverse solution, and a transfer matrix is ​​applied to improve the quality of the calculated patient information, and a signal generator configured to transmit a set of drive signals using a set of drive electrodes located at a set of drive positions; wherein the recording component is configured to record the emitted drive signal via a second set of recording electrodes located at a second set of recording positions to create a second set of recorded signals; and wherein the processing unit is configured to determine the transfer matrix by comparing the second set of recorded signals with a set of emitted drive signals, and Wherein, the driving signal includes: a first drive signal at a first frequency from a first drive electrode; and a second drive signal at a second frequency from a second drive electrode; The first frequency and the second frequency are different.

21. The system of claim 20, wherein: The first drive signal and the second drive signal are delivered simultaneously.

22. A patient information processing system, comprising: a recording assembly configured to record electrical potentials via a first set of recording electrodes at a first set of recording locations on and / or in the patient to create a first set of recorded signals; a processing unit configured to calculate patient information for a set of target locations within the patient by applying a transfer matrix to the first set of recorded signals, wherein the transfer matrix comprises features of electrical properties of tissue between the first set of recorded locations and the set of target locations, wherein the recording component is further configured to record the voltage of the patient at the second set of recording locations, and the processing unit is further configured to determine the electrical information of the first set of recording locations, and wherein the calculated patient information is based on the output of the inverse solution, and a transfer matrix is ​​applied to improve the quality of the calculated patient information, and a signal generator configured to transmit a set of drive signals using a set of drive electrodes located at a set of drive positions; wherein the recording component is configured to record the emitted drive signal via a second set of recording electrodes located at a second set of recording positions to create a second set of recorded signals; and wherein the processing unit is configured to determine the transfer matrix by comparing the second set of recorded signals with a set of emitted drive signals, and Wherein, the driving signal includes: a first drive signal at a first frequency from a first drive electrode; and a second drive signal at a second frequency from a second drive electrode, Wherein, the first driving signal and the second driving signal are delivered sequentially.

23. The system of claim 22, wherein: The first frequency and the second frequency are the same frequency.

24. A patient information processing system, comprising: a recording assembly configured to record electrical potentials via a first set of recording electrodes at a first set of recording locations on and / or in the patient to create a first set of recorded signals; a processing unit configured to calculate patient information for a set of target locations within the patient by applying a transfer matrix to the first set of recorded signals, wherein the transfer matrix comprises features of electrical properties of tissue between the first set of recorded locations and the set of target locations, wherein the recording component is further configured to record the voltage of the patient at the second set of recording locations, and the processing unit is further configured to determine the electrical information of the first set of recording locations, and wherein the calculated patient information is based on the output of the inverse solution, and a transfer matrix is ​​applied to improve the quality of the calculated patient information, and a signal generator configured to transmit a set of drive signals using a set of drive electrodes located at a set of drive positions; wherein the recording component is configured to record the emitted drive signal via a second set of recording electrodes located at a second set of recording positions to create a second set of recorded signals; and wherein the processing unit is configured to determine the transfer matrix by comparing the second set of recorded signals with a set of emitted drive signals, and Wherein, the determining of the transfer matrix comprises calculating and / or selecting a standardized transfer matrix based on patient parameters, and Wherein, the patient parameters include parameters selected from the following: gender, weight, height, body mass index (BMI), chest circumference, esophageal position, atrium size, atrial volume filling, atrial pressure, fat to water ratio, air to water to fat ratio, bone position, drug level, electrolyte level, pH, pO2, pCO2, water weight and their combinations.

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