System and device for detecting coronary artery disease using magnetic field maps

Abstract

In an aspect, the present disclosure provides a method comprising: (a) identifying first negative and positive electromagnetic dipoles in a first electromagnetic field map associated with a heart of an individual at a first time; (b) identifying second negative and positive electromagnetic dipoles in a second electromagnetic field map associated with the heart of the individual at a second time; (c) determining a first angle based on the first negative and positive electromagnetic dipoles; (d) determining a second angle based on the second negative and positive electromagnetic dipoles; and (e) determining a presence, an absence, or a likelihood of coronary artery disease in the individual based at least in part on (i) whether the first angle differs from the second angle by at least 100 degrees, or (ii) whether a third electromagnetic dipole is present in the first electromagnetic field map or the second electromagnetic field map.

Description

[0001] Cross-references

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 030,536, filed May 27, 2020, which is incorporated herein by reference in its entirety. Background Technology

[0003] Dynamic magnetic fields are associated with certain mammalian tissues, such as those with action potential-driven physiology. Changes in the structure or function of certain tissues may be reflected in changes in the magnetic fields(s) associated with and / or generated by the tissue. Summary of the Invention

[0004] This document describes systems, devices, and methods for sensing magnetic fields, such as electromagnetic fields (“EMF”) or magnetocardiograms (“MCG”), associated with an individual’s tissues, a part of an individual’s body, and / or the entire body of an individual. Non-limiting examples of tissues associated with magnetic fields and sensed using the systems, devices, and methods described herein include blood, bones, lymph, CSF, and organs including the heart, lungs, liver, kidneys, and skin. In some embodiments, the devices and systems described herein sense magnetic field signals associated with a part of an individual’s body (such as, for example, the individual’s torso), or magnetic fields associated with the entire body of an individual.

[0005] This document describes a device for sensing magnetic field data associated with an individual, comprising: a movable base component; an arm having a proximal end and a distal end, the proximal end being movably coupled to the movable base component such that the arm is movable relative to the movable base component with at least one degree of freedom; and an array of one or more optically pumped magnetometers coupled to the distal end of the arm, the optically pumped magnetometer array being configured to sense the magnetic field associated with the individual. In some embodiments, the device includes a shield configured to attenuate one or more magnetic fields associated with the environment. In some embodiments, the shield is configured to accommodate a portion of the individual's body associated with the magnetic field data. In some embodiments, the portion of the individual's body associated with the magnetic field is the individual's chest. In some embodiments, the arm of the device or system includes a contact about which the arm is configured to hinge. In some embodiments, the optically pumped magnetometer array is movably coupled to the distal end such that the optically pumped magnetometers are movable relative to the arm with at least one degree of freedom. In some embodiments, the optically pumped magnetometers are part of an array. In some embodiments, the array is arranged to conform to a specific part of the individual's body. In some embodiments, the device includes a processor and a non-transitory computer-readable medium including a computer program configured to cause the processor to: receive magnetic field data sensed by the optically pumped magnetometer; and filter the magnetic field data. In some embodiments, the device includes a gradiometer, wherein the computer program causes the processor to filter the data by canceling out magnetic fields associated with the environment. In some embodiments, the computer program causes the processor to filter the data by subtracting a frequency-based measurement from the magnetic field data. In some embodiments, the computer program causes the processor to generate a visual representation of the magnetic field data, including waveforms.

[0006] This document also describes a method for sensing magnetic field data associated with an individual, comprising: positioning a mobile electromagnetic sensing device near the individual; positioning an arm of the mobile electromagnetic sensing device near a portion of the individual's body associated with the magnetic field data, the arm being coupled to a base component near an optically pumped magnetometer; and sensing the magnetic field data. In some embodiments, the method includes shielding at least a portion of the individual from magnetic fields associated with the environment. In some embodiments, the shield is configured to accommodate the portion of the individual's body associated with the magnetic field data. In some embodiments, the portion of the individual's body associated with the magnetic field is the individual's chest. In some embodiments, the arm of the device or system includes a contact around which the arm is configured to hinge. In some embodiments, the optically pumped magnetometer is movably coupled to the arm such that the optically pumped magnetometer moves relative to the arm with at least one degree of freedom. In some embodiments, the optically pumped magnetometer is part of an array. In some embodiments, the array is arranged to conform to a specific portion of the individual's body.

[0007] In some embodiments, the method includes generating a visual representation of the magnetic field data, including waveforms. In some embodiments, the method includes generating a visual representation of the magnetic field data, the visual representation including two-dimensional cubic interpolation between two or more sensors in a magnetometer array for each timestamp of the recorded data. In some embodiments, the visual representation includes color values ​​associated with the magnetic field values ​​displayed in two-dimensional (2D) space. In some embodiments, playback of a continuous visual representation of the sensed magnetic field data includes a dynamic 2D animation summarizing electromagnetic activity detected from an individual.

[0008] A system for determining the likelihood of the presence of coronary artery disease in an individual is also described, comprising: (1) a sensing device configured to sense a magnetic field associated with the individual, wherein the device includes: a movable base component; an arm having a proximal end and a distal end, the proximal end being coupled to the movable base component via a first contact configured such that the arm is movable relative to the movable base component with at least one degree of freedom; and an array of one or more optically pumped magnetometers coupled to the distal end of the arm, the array of one or more optically pumped magnetometers being configured to sense the magnetic field associated with the individual; and (2) a non-transitory computer-readable medium encoded with a computer program including instructions executable by a processor, the instructions being configured to cause the processor to receive, at a first moment, a first magnetic field associated with the heart of the individual from the sensing device; in the first The process involves: generating a first electromagnetic field map based on the first magnetic field associated with the individual's heart; identifying a first negative electromagnetic dipole and a first positive electromagnetic dipole in the first electromagnetic field map; receiving a second magnetic field associated with the individual's heart from the sensing device at a second time; generating a second electromagnetic field map based on the second magnetic field associated with the individual's heart at the second time; identifying a second negative electromagnetic dipole and a second positive electromagnetic dipole in the second electromagnetic field map; determining a first angle based on the first negative electromagnetic dipole and the first positive electromagnetic dipole, and determining a second angle based on the second negative electromagnetic dipole and the second positive electromagnetic dipole; and determining the likelihood of the presence of coronary artery disease in the individual if the first angle differs from the second angle by at least 100 degrees, or if a third electromagnetic dipole is present in either the first or second electromagnetic field map.

[0009] In some embodiments, the coronary artery disease includes myocardial ischemia. In some embodiments, the coronary artery disease includes myocardial ischemia with associated epicardial coronary artery disease. In some embodiments, the coronary artery disease includes myocardial ischemia without associated epicardial coronary artery disease. In some embodiments, the sensing device includes a shield configured to shield the device from one or more ambient magnetic fields. In some embodiments, the shield is configured to at least partially surround a portion of the body of the individual associated with the magnetic field. In some embodiments, the portion of the body of the individual associated with the magnetic field is at least a portion of the chest of the individual. In some embodiments, the shield comprises two or more layers. In some embodiments, each of the two or more layers has a thickness from 0.1 to 10 mm. In some embodiments, the shield comprises permalloy or a high-permeability alloy. In some embodiments, the arm includes a proximal segment and a distal segment, wherein a second contact is located between the proximal segment and the distal segment and configured such that the distal segment is hinged relative to the proximal segment. In some embodiments, the array of one or more optically pumped magnetometers is movably coupled to the distal end of the arm, such that the array of one or more optically pumped magnetometers moves relative to the arm with at least one degree of freedom. In some embodiments, the array of one or more optically pumped magnetometers comprises at least three optically pumped magnetometers. In some embodiments, the array of one or more optically pumped magnetometers is arranged to match a generalized profile of a portion of the individual's body.

[0010] In some embodiments, the computer program includes instructions configured to cause the processor to further filter the sensed magnetic field. In some embodiments, the system further includes a gradiometer, and the computer program includes instructions configured to cause the processor to filter the sensed magnetic field by canceling the magnetic field sensed by the gradiometer. In some embodiments, the computer program includes instructions configured to cause the processor to filter the sensed magnetic field by subtracting a frequency-based measurement from the magnetic field. In some embodiments, the computer program includes instructions configured to cause the processor to further generate a visual representation of the magnetic field, including a waveform.

[0011] In some embodiments, the computer program includes instructions configured to cause the processor to determine, at least in part, the presence, absence, or likelihood of coronary artery disease in the individual based on (iii) parameters selected from: dipole parameters, composite MCD parameters, composite ECD parameters, average PCD parameters, isointegral parameters, field map correlation parameters, R_peak hooked dipole parameters, pseudo-current arrow parameters, extremum circle parameters, phase space embedding parameters using delta coordinates, and phase space embedding parameters using time-delay coordinates, or (iv) visualizations selected from: STAG plots, T_peak MFM plots, field map animations, pseudo-current density arrows, MCD plots, and ECD plots.

[0012] In some implementations, the computer program includes instructions configured to cause the processor to further determine, at least in part, the presence, absence, or likelihood of coronary artery disease in the individual based on the parameters.

[0013] In some implementations, the computer program includes instructions configured to cause the processor to further determine, at least in part, the presence, absence, or likelihood of coronary artery disease in the individual based on the visualization.

[0014] In some implementations, the presence of coronary artery disease in the individual is determined based on the presence of at least one of the following abnormalities: (i) whether the first angle differs from the second angle by at least 100 degrees, (ii) whether a third electromagnetic dipole is present in the first or second electromagnetic field map, (iii) the parameter, and (iv) the visualization.

[0015] In some implementations, the presence of coronary artery disease in the individual is determined based on the presence of at least two of the following abnormalities: (i) whether the first angle differs from the second angle by at least 100 degrees, (ii) whether a third electromagnetic dipole is present in the first or second electromagnetic field map, (iii) the parameter, and (iv) the visualization.

[0016] A method for determining the likelihood of coronary artery disease in an individual is also described, the method comprising: placing a mobile electromagnetic sensing device near the individual; positioning an arm of the mobile electromagnetic sensing device coupled to an array of one or more optically pumped magnetometers near the heart of the individual; receiving a first magnetic field associated with the heart of the individual from the mobile electromagnetic sensing device at a first time; generating a first electromagnetic field map based on the first magnetic field associated with the heart of the individual at the first time; identifying a first negative electromagnetic dipole and a first positive electromagnetic dipole in the first electromagnetic field map; and receiving a first magnetic field associated with the heart of the individual from the mobile electromagnetic sensing device at a second time. The method involves: receiving a second magnetic field associated with the heart of the individual; generating a second electromagnetic field map based on the second magnetic field associated with the heart of the individual at a second time; identifying a second negative electromagnetic dipole and a second positive electromagnetic dipole in the second electromagnetic field map; determining a first angle based on the first negative electromagnetic dipole and the first positive electromagnetic dipole, and determining a second angle based on the second negative electromagnetic dipole and the second positive electromagnetic dipole; and determining the likelihood of the presence of coronary artery disease in the individual if the first angle differs from the second angle by at least 100 degrees, or if a third electromagnetic dipole is present in either the first or second electromagnetic field map.

[0017] In some embodiments, coronary artery disease includes myocardial ischemia. In some embodiments, the coronary artery disease includes myocardial ischemia with associated epicardial coronary artery disease. In some embodiments, the coronary artery disease includes myocardial ischemia without associated epicardial coronary artery disease. In some embodiments, the method further includes using a shield to shield at least a portion of the individual from one or more ambient magnetic fields. In some embodiments, the shield is configured to at least partially surround a portion of the individual's body associated with the magnetic field. In some embodiments, the portion of the individual's body associated with the magnetic field is at least a portion of the individual's chest. In some embodiments, the shield comprises two or more layers. In some embodiments, each of the two or more layers has a thickness from 0.1 to 10 mm. In some embodiments, the shield comprises permalloy or a high-permeability alloy. In some embodiments, the arm includes a proximal segment and a distal segment, and wherein a second contact is located between the proximal segment and the distal segment and configured such that the distal segment is hinged relative to the proximal segment. In some embodiments, the array of one or more optically pumped magnetometers is movably coupled to the distal end of the arm, such that the array of one or more optically pumped magnetometers moves relative to the arm with at least one degree of freedom. In some embodiments, the array of one or more optically pumped magnetometers comprises at least three optically pumped magnetometers. In some embodiments, the array of one or more optically pumped magnetometers is arranged to match a generalized profile of a portion of the individual's body.

[0018] In some embodiments, the method further includes filtering the first magnetic field and / or the second magnetic field. In some embodiments, the filtering includes canceling the magnetic field sensed by the gradiometer. In some embodiments, the filtering includes subtracting a frequency-based measurement from the first magnetic field and / or the second magnetic field.

[0019] In some embodiments, the method further includes determining the presence, absence, or likelihood of coronary artery disease in the individual based at least in part on (iii) parameters selected from the group consisting of: dipole parameters, composite MCD parameters, composite ECD parameters, average PCD parameters, isointegral parameters, field map correlation parameters, R_peak hooked dipole parameters, pseudo-current arrow parameters, extremum circle parameters, phase space embedding parameters using delta coordinates, and phase space embedding parameters using time-delay coordinates, or (iv) visualizations selected from the group consisting of: STAG plots, T_peak MFM plots, field map animations, pseudo-current density arrows, MCD plots, and ECD plots.

[0020] In some embodiments, the method further includes determining, at least in part, the presence, absence, or likelihood of coronary artery disease in the individual based on the parameters.

[0021] In some embodiments, the method further includes determining the presence, absence, or likelihood of coronary artery disease in the individual based at least in part on the visualization.

[0022] In some embodiments, the method further includes determining the presence of coronary artery disease in the individual based on the presence of at least one of the following anomalies: (i) whether the first angle differs from the second angle by at least 100 degrees, (ii) whether a third electromagnetic dipole is present in the first or second electromagnetic field map, (iii) the parameter, and (iv) the visualization.

[0023] In some implementations, the method further includes determining the presence of coronary artery disease in the individual based on the presence of at least two of the following anomalies: (i) whether the first angle differs from the second angle by at least 100 degrees, (ii) whether a third electromagnetic dipole is present in the first or second electromagnetic field map, (iii) the parameter, and (iv) the visualization.

[0024] A method for determining the likelihood of the presence of coronary artery disease in an individual is also described, the method comprising: identifying a first negative electromagnetic dipole and a first positive electromagnetic dipole in a first electromagnetic field diagram associated with the heart of the individual at a first time; identifying a second negative electromagnetic dipole and a second positive electromagnetic dipole in a second electromagnetic field diagram associated with the heart of the individual at a second time; determining a first angle based on the first negative electromagnetic dipole and the first positive electromagnetic dipole; determining a second angle based on the second negative electromagnetic dipole and the second positive electromagnetic dipole; and determining the likelihood of the presence of coronary artery disease in the individual if the first angle differs from the second angle by at least 100 degrees, or if a third electromagnetic dipole is present in either the first electromagnetic field diagram or the second electromagnetic field diagram.

[0025] In some embodiments, the coronary artery disease includes myocardial ischemia. In some embodiments, the coronary artery disease includes myocardial ischemia with associated epicardial coronary artery disease. In some embodiments, the coronary artery disease includes myocardial ischemia without associated epicardial coronary artery disease. In some embodiments, the method further includes recording an individual's electrocardiogram (ECG). In some embodiments, the first angle includes a peak R depolarization angle at a first time, wherein the first time is the time when the R wave is recorded on the ECG. In some embodiments, the second angle includes a peak T repolarization angle at a second time, wherein the second time is the time when the T wave is recorded on the ECG. In some embodiments, the third electromagnetic dipole is present in the second electromagnetic field map. In some embodiments, the coronary artery disease includes occlusion of the left anterior descending artery. In some embodiments, the first angle is determined by determining a first line passing through both the first negative electromagnetic dipole and the first positive electromagnetic dipole, and by determining the angle between the first line and the horizontal axis. In some embodiments, the second angle is determined by determining a second line passing through both the second negative electromagnetic dipole and the second positive electromagnetic dipole, and by determining the angle between the second line and the horizontal axis. In some implementations, if the first angle differs from the second angle by 100 to 170 degrees, the likelihood of the presence of coronary artery disease in the individual is determined.

[0026] In some embodiments, the individual has a normal electrocardiogram or normal troponin levels when experiencing chest pain. In some embodiments, the individual has a positive stress test or abnormal echocardiographic findings. In some embodiments, the method further includes performing a stress test if the first angle differs from the second angle or if a third electromagnetic dipole is present in the first or second electromagnetic field map. In some embodiments, the method further includes sensing a first electromagnetic field associated with the individual's heart at a first time and sensing a second electromagnetic field associated with the individual's heart at a second time, wherein the first electromagnetic field map includes a representation of the first electromagnetic field and the second electromagnetic field map includes a representation of the second electromagnetic field. In some embodiments, the method further includes determining the likelihood of a conduction abnormality in the individual's heart if the first positive electromagnetic dipole and the second negative electromagnetic dipole are in the same position or the first negative electromagnetic dipole and the second positive electromagnetic dipole are in the same position. In some embodiments, the method further includes treating the individual for coronary artery disease in response to determining the likelihood of coronary artery disease (e.g., ischemia-induced pathophysiology) in the individual. In some embodiments, the treatment includes a daily aspirin regimen. In some embodiments, the treatment includes an antihypertensive drug. In some embodiments, the treatment includes a lipid-lowering drug. In some embodiments, the treatment includes cardiac catheterization. In some embodiments, the treatment includes surgical procedures. In some embodiments, the method further includes (a) to (e) being performed by a computer.

[0027] In some embodiments, the method further includes determining the presence, absence, or likelihood of coronary artery disease in the individual based at least in part on (iii) parameters selected from the group consisting of: dipole parameters, composite MCD parameters, composite ECD parameters, average PCD parameters, isointegral parameters, field map correlation parameters, R_peak hooked dipole parameters, pseudo-current arrow parameters, extremum circle parameters, phase space embedding parameters using delta coordinates, and phase space embedding parameters using time-delay coordinates, or (iv) visualizations selected from the group consisting of: STAG plots, T_peak MFM plots, field map animations, pseudo-current density arrows, MCD plots, and ECD plots.

[0028] In some embodiments, the method further includes determining, at least in part, the presence, absence, or likelihood of coronary artery disease in the individual based on the parameters.

[0029] In some embodiments, the method further includes determining, at least in part, the presence, absence, or likelihood of coronary artery disease in the individual based on the visualization.

[0030] In some embodiments, the method further includes determining the presence of coronary artery disease in the individual based on the presence of at least one of the following anomalies: (i) whether the first angle differs from the second angle by at least 100 degrees, (ii) whether a third electromagnetic dipole is present in the first or second electromagnetic field map, (iii) the parameter, and (iv) the visualization.

[0031] In some embodiments, the method further includes determining the presence of coronary artery disease in the individual based on the presence of at least two of the following anomalies: (i) whether the first angle differs from the second angle by at least 100 degrees, (ii) whether a third electromagnetic dipole is present in the first or second electromagnetic field map, (iii) the parameter, and (iv) the visualization.

[0032] This document also describes a non-transitory computer-readable medium including machine-executable code that, when executed by one or more computer processors, implements a method for determining the likelihood of the presence of coronary artery disease in an individual, the method comprising: identifying, at a first time, a first negative electromagnetic dipole and a first positive electromagnetic dipole in a first electromagnetic field map associated with the individual's heart; at a second time, identifying a second negative electromagnetic dipole and a second positive electromagnetic dipole in a second electromagnetic field map associated with the individual's heart; determining a first angle based on the first negative electromagnetic dipole and the first positive electromagnetic dipole; determining a second angle based on the second negative electromagnetic dipole and the second positive electromagnetic dipole; and determining the likelihood of the presence of coronary artery disease in the individual if the first angle differs from the second angle by at least 100 degrees, or if a third electromagnetic dipole is present in either the first or second electromagnetic field map.

[0033] In some embodiments, the coronary artery disease includes myocardial ischemia. In some embodiments, the coronary artery disease includes myocardial ischemia with associated epicardial coronary artery disease. In some embodiments, the coronary artery disease includes myocardial ischemia without associated epicardial coronary artery disease.

[0034] This document also describes a non-transitory computer-readable medium comprising machine-executable code that, when executed by one or more computer processors, implements any of the methods described above or elsewhere herein.

[0035] This document also describes a system comprising one or more computer processors and computer memory coupled thereto. The computer memory includes machine-executable code that, when executed by the one or more computer processors, implements any of the methods described above or elsewhere herein.

[0036] Other aspects and advantages of this disclosure will become readily apparent to those skilled in the art from the following detailed description, in which only illustrative embodiments of the disclosure are shown and described. As will be appreciated, this disclosure is capable of other different embodiments, and certain details thereof can be modified in various obvious ways, all without departing from this disclosure. Therefore, the drawings and descriptions should be considered illustrative in nature and not restrictive.

[0037] Incorporation

[0038] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference to the extent that each individual publication, patent, or patent application is specifically and individually indicated to be incorporated by reference. Where a publication, patent, or patent application incorporated by reference contradicts the disclosure contained in this specification, the specification is intended to supersede and / or take precedence over any such contradictory material. Attached Figure Description

[0039] The patent application documents contain at least one color drawing. The U.S. Patent and Trademark Office will, upon request and after payment of the necessary fees, provide a copy of this patent application publication with color drawings.

[0040] The novel features of the invention are set forth in the appended claims. A better understanding of the features and advantages of the invention will be obtained by referring to the following detailed description and accompanying drawings (also referred to herein as “Figures” and “graphics”) illustrating illustrative embodiments in which the principles of the invention are utilized, in which:

[0041] Figure 1 An example of a sensor array, shielding, and base component is shown.

[0042] Figure 2 An example of a shielding component is shown.

[0043] Figure 3 An example of a shielding component and a base assembly is shown.

[0044] Figure 4 An example of a sensor array operatively coupled to a base component is shown.

[0045] Figure 5 An example of a sensor array operatively coupled to an arm is shown.

[0046] Figure 6 An example of a sensor array operatively coupled to a base component is shown.

[0047] Figure 7 An example of a sensor array of an arm operatively coupled to a base component is shown.

[0048] Figure 8 A computer system is shown that is programmed or otherwise configured to implement the methods provided herein.

[0049] Figures 9A to 9B An example of a shielding component is shown. Figure 9A The shielding element is positioned to show the open end and internal volume of the shielding element. Figure 9B The shielding element is positioned to show the closed end of the shielding element having a conical or conical shape.

[0050] Figures 10A to 10B Two different cross-sectional views of the shield are shown.

[0051] Figures 11A to 11I Multiple views are shown for an example of a shield.

[0052] Figures 12A to 12B Multiple views are shown as an example of the external support of the shield.

[0053] Figure 13 An example of a hook is shown.

[0054] Figures 14A to 14B Multiple views of the mobile handcart equipment are shown.

[0055] Figures 15A to 15C Multiple views of the mobile handcart equipment are shown.

[0056] Figure 16 An example of a device used in a magnetically shielded environment is shown.

[0057] Figure 17 An example of an individual sliding into a shield is shown.

[0058] Figure 18 An example of an embodiment of a shielding device comprising three layers of high-permeability alloy (the innermost three layers) and one layer of aluminum alloy (the outer layer) is shown.

[0059] Figure 19 A graph showing the magnetic field measurements along the centerline of the shielding component is presented.

[0060] Figure 20 An example of a sensor array is shown.

[0061] Figure 21 An example of a 3D rendering of a sensor head holder mounted on a shield base is shown.

[0062] Figure 22 An exemplary layout of an inner coil located in an embodiment of a shield is shown.

[0063] Figure 23 An exemplary layout of the outer coil in an embodiment of the shielding is shown.

[0064] Figure 24 A typical balance function is shown.

[0065] Figure 25 An example method is shown for assessing the presence of coronary artery disease (e.g., myocardial ischemia with or without associated epicardial coronary artery disease) in an individual.

[0066] Figures 26A to 26B Examples of how the methods and systems of this disclosure can be used to analyze the electrical currents in an organ or tissue (e.g., the heart) of a subject and determine its associated magnetic field are illustrated, including a depiction of Ampere's law. Figure 26A ) and an example of a magnetic field diagram generated by an electric current ( Figure 26B ).

[0067] Figures 27A to 27B Examples of how the methods and systems of this disclosure can be used to analyze the electrical currents of a subject's organs or tissues (e.g., the heart) and determine their associated magnetic fields are illustrated, including a peak R depolarization angle of 27°2. Figure 27A The description of the peak T complex polarization angle 2704 ( Figure 27B The description of the increased RT angle gap indicates cardiac ischemia in the subject's heart.

[0068] Figure 28 It illustrates how the heart generates electrical currents, including depolarizing ion currents (non-energy-dependent), in which (1) sodium slows the entry of the depolarizing ion current into the cell while potassium leaves the cell, and (2) a large amount of calcium enters the cell; repolarizing ion currents (highly energy-dependent), in which (3) calcium stops entering the cell while potassium leaves the cell, and (4) the balance of ions inside and outside the cell is restored (repolarization); and heart attack / ischemic cells, in which damaged cells are stuck in zone 3 (depolarization) and can no longer contract.

[0069] Figure 29 The diagram depicts the cardiac cycle and shows ventricular volume, ventricular pressure, aortic pressure, and atrial pressure, demonstrating that electrogenic processes in the heart precede mechanical functions.

[0070] Figure 30Examples of using the systems, devices, and methods of this disclosure to assess patient intake are shown, including patients undergoing stress testing, patients who are MCG negative or MCG positive, patients who are ST negative or ST positive, and patients who are CA positive or CA negative.

[0071] Figure 31 An example of a workflow for chest pain classification based on clinical care standards is shown.

[0072] Figure 32 An example of an improved workflow for chest pain classification based on the systems, apparatus, and methods of this disclosure is shown.

[0073] Figure 33 An example of output data obtained using the methods and systems of this disclosure is shown, presenting the magnetic field strength of a set of 36 superimposed waveforms with the time of a single cardiac cycle to the interpreting physician. Each individual waveform represents the magnitude of a magnetic field perpendicular to the chest wall, measured a few inches above the torso. The system acquires data from 36 sensors arranged in a uniform 6x6 grid, so each black circle in the figure below represents a “real data point,” with color coding representing the magnetic field direction and its strength. Data from these grid points is used to interpolate all the information represented by a “sea of ​​colors” in the magnetic field map (MFM) outside the 36 grid points.

[0074] Figure 34 An example of output data obtained using the methods and systems of this disclosure after being presented as a waveform pattern is shown, which mimics the conventional format of voltage presentation of an electrocardiogram (ECG).

[0075] Figures 35A to 35B Examples of R-peak and T-peak magnetographs of subjects are shown, which are interpreted as having normal (e.g., non-ischemic) results, where the vector between the positive and negative electromagnetic dipoles is consistent during the R-peak period compared to the T-peak period.

[0076] Figures 36A to 36B Examples of R-peak and T-peak magnetic field maps of subjects are shown, which are interpreted as having normal (e.g., non-ischemic) results, where the vector between the positive and negative electromagnetic dipoles shows a 180-degree flip during the R-peak period compared to the T-peak period.

[0077] Figures 37A to 37B Examples of R-peak and T-peak magnetographs of subjects are shown, which are interpreted as having abnormal (e.g., ischemic) outcomes, in which multiple electromagnetic dipoles are present during the T-peak magnetograph, completely surrounding the positive electromagnetic dipole.

[0078] Figures 38A to 38BExamples of R-peak and T-peak magnetic field maps of subjects are shown, which are interpreted as having abnormal (e.g., ischemic) outcomes, where the vector between the positive and negative electromagnetic dipoles shows an electromagnetic dipole shift of more than 100 degrees during the R-peak period compared to the T-peak period. Detailed Implementation

[0079] While various embodiments have been shown and described herein, it will be readily understood by those skilled in the art that such embodiments are provided by way of example only. It should be understood that various alternatives to the embodiments described herein may be employed.

[0080] As used herein, the singular forms “a,” “one,” and “the” include plural references unless the context clearly indicates otherwise. Unless otherwise stated, any reference to “or” herein is intended to cover “and / or.”

[0081] As used herein, the term “about” may refer to a reference figure plus or minus 15% of that reference figure.

[0082] Devices and systems for sensing magnetic fields

[0083] This document describes devices and systems configured to sense magnetic fields associated with one or more tissues, one or more body parts, one or more organs, or the entire body of an individual. Non-limiting examples of organs and organ systems having magnetic fields sensed by the devices and systems described herein include the brain, heart, lungs, kidneys, liver, spleen, pancreas, esophagus, stomach, small intestine and colon, endocrine system, respiratory system, cardiovascular system, genitourinary system, nervous system, vascular system, lymphatic system, and digestive system. Non-limiting examples of tissues having magnetic fields sensed by the devices and systems described herein include inflamed tissue (including areas of inflamed tissue), blood vessels and blood flowing within blood vessels, lymphatic vessels and lymph flowing within lymphatic vessels, bone, and cartilage. The sensed magnetic field data is further processed to make determinations or assist users (e.g., healthcare providers) in determining one or more tissues, one or more body parts, one or more organs, or the entire body of an individual in relation to the sensed magnetic field. For example, in some embodiments, the devices described herein are used to determine the prognosis of an individual, such as, for example, predicting the likelihood of an individual developing a disease or condition based on one or more magnetic fields sensed using the device. For example, in some embodiments, devices as described herein are used to determine diagnoses, such as, for instance, confirming a diagnosis of a disease or condition based on one or more magnetic fields sensed using the device, or providing a diagnosis of a disease or condition to an individual. For example, in some embodiments, devices as described herein are used to provide monitoring, such as monitoring the progression of a disease or condition in an individual, monitoring the effectiveness of treatments provided to an individual, or combinations thereof, based on one or more magnetic fields sensed using the device. It should be understood that the devices and systems described herein are suitable for measuring magnetic fields associated with any type of tissue.

[0084] In some embodiments of the devices and systems described herein, magnetocardiograms are generated using sensed magnetic field data related to the heart. In these embodiments of the devices and systems described herein, the devices and systems are used as magnetocardiographs, for example, passive, non-invasive bioelectrical measurement tools designed to detect, record, and display magnetic fields naturally generated by the electrical activity of the heart.

[0085] In some embodiments, the devices and systems described herein are configured to measure one or more biomarkers other than a magnetic field. Non-limiting examples of biomarkers other than a magnetic field sensed using embodiments of the devices and methods described herein include body temperature, heart rate, blood pressure, echocardiography (ECG), a magnetic field, or any combination thereof.

[0086] In some embodiments, the individual whose magnetic field is sensed is in good health. In some embodiments, the individual whose magnetic field is sensed is suspected of having a condition or disease. In some embodiments, the individual whose magnetic field is sensed is an individual who has been previously diagnosed with a condition or disease.

[0087] In some embodiments, the condition or disease identified in an individual is a cardiac condition or disease. In some embodiments, the cardiac condition or disease identified in an individual includes rheumatic heart disease, hypertensive heart disease, ischemic heart disease, cerebrovascular disease, inflammatory heart disease, valvular heart disease, aneurysm, stroke, atherosclerosis, arrhythmia, hypertension, angina pectoris, coronary artery disease, coronary artery disease, ischemic heart disease, heart attack, cardiomyopathy, pericardial disease, congenital heart disease, heart failure, or any combination thereof.

[0088] In some embodiments, the device as described herein includes one or more sensors. In some embodiments, two or more sensors are arranged in a sensor array. In some embodiments, the device as described herein includes electromagnetic shielding, and in some embodiments of the device described herein, shielding is not included.

[0089] In some implementations, the system as described herein includes any device as described herein and one or more local and / or remote processors.

[0090] Sensors and sensor arrays for sensing magnetic fields

[0091] In some embodiments of the devices and systems described herein, the devices include sensors such as optically pumped magnetometers (OPMs) as measuring instruments, and in some embodiments, they utilize non-radioactive, self-contained alkali metal batteries coupled to a closed-loop pump laser and a photodetector device to measure minute magnetic fields. In some embodiments of the devices and systems described herein, the devices and systems utilize OPMs in an n×n array (or grid) or alternative geometric configuration to collect magnetic field data at n discrete locations, for example, on a part of an individual's body, such as the chest region; in some embodiments, this magnetic field data is digitized using pickup electronics.

[0092] A typical configuration of an OPM is to use a non-radioactive, self-contained alkali metal cell coupled to a closed-loop pump laser and a photodetector to measure minute magnetic fields. Compared to superconducting quantum interference devices (SQUIDs), which are also commonly used to detect these biomagnetic fields, OPM sensors are significantly smaller and typically do not require cryogenic cooling.

[0093] The Earth's magnetic field exists naturally throughout the Earth, with an amplitude of approximately 50 microtesla. Given the presence of the Earth's ambient magnetic field, OPM performance can be enhanced in at least two exemplary ways. In a first OPM enhancement technique, a reference value representing the Earth's magnetic field is used as part of a vector subtraction to isolate the signal of interest in the OPM. Another technique involves using a gradiometer for active noise cancellation in the OPM.

[0094] As utilized in some embodiments of the devices and systems described herein, the sensor array configuration includes a customized array configuration. In some embodiments, the sensor array configuration is customized for individual anatomy. In some embodiments, the sensor array configuration is customized for a location on the individual being measured, such as the chest or head position. In some embodiments, the sensor array configuration is customized so that the device is programmed to acquire the type of measurement. In some embodiments, the sensor array configuration is customized to be operatively coupled to a shield and / or an arm. In some embodiments, the sensor array configuration can be interchanged with different array configurations—users can interchange them. In some embodiments, the array configuration includes an arc (such as a generally curved shape) having a depth and a radius of about 20 cm to about 50 cm or about 10 cm to about 60 cm. In some embodiments, array configurations such as arc configurations include one or more variable magnetometer spacings and variable sensor densities. In some embodiments, the array configuration includes a recessed structure (such as a recessed structure configured to wrap around or form in a body region such as around the head or chest). One or more magnetometers are positioned on at least a portion of the surface of the recessed structure. In some implementations, the recessed array configuration includes one or more variable magnetometer spacings and variable sensor density.

[0095] In some embodiments, the sensor array comprises n×n sensors. In some embodiments, the sensor array is a 2D rectangular array, such as a 2×2 array or a 4×4 array. In some embodiments, the sensor array is a 2D non-rectangular array, such as a 2×1 array or a 4×1 array. In some embodiments, the sensor array is a circular or semi-circular array, such as a 3D array of sensors positioned in an arc or recessed structure. In some embodiments, the sensor array is a 2D array or a 3D array. In some embodiments, the sensors in the sensor array include x, y, and z coordinates. In some embodiments, the array comprises a single sensor, such as n×n = 1×1. In some embodiments, the array comprises two sensors, such as n×n = 2×1. In some embodiments, the array comprises three sensors. In some embodiments, the array comprises four sensors. In some embodiments, the array comprises nine sensors. In some embodiments, the array comprises sixteen sensors. In some embodiments, the array comprises 25 sensors. In some embodiments, the array includes 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50 or more sensors. In some embodiments, the sensor array includes 8 sensors. In some embodiments, the sensor array includes 16 sensors. In some embodiments, the sensor array includes a single sensor housed in a single housing. In some embodiments, the sensor array includes multiple sensors housed in a single housing, such as a housing with multiple sensor configurations or a variable sensor configuration. In some embodiments, the sensor array includes multiple sensors housed in multiple housings. In some embodiments, the sensor array includes multiple sensors, each housed in a separate housing. In some embodiments, the first sensor and the second sensor of the sensor array are different. In some embodiments, the first sensor and the second sensor of the sensor array are the same. In some embodiments, each sensor in the sensor array is unique. In some embodiments, each sensor in the sensor array is identical. In some embodiments, a subset of the sensor array is unique. In some embodiments, a subset of the sensor array is identical. The spatial positioning of the sensors within the sensor array is adjustable, such as by the user or automatically by the controller. In some embodiments, the spatial positioning of the sensors within the sensor array is fixed. In some embodiments, multiple sensors in the sensor array are selected based on the application. In some embodiments, multiple sensors in the sensor array are selected based on the measurement type or measurement location.In some embodiments, the array comprises a single-channel array or a multi-channel array. In some embodiments, increasing the number of sensors in the sensor array increases the resolution of the measurements performed by the array. In some embodiments, the sensor arrays are densely packed, such as being substantially adjacent to or close to each other. The sensor arrays are sparsely spaced, such as having gaps between them. In some embodiments, a subset of the sensor arrays is densely packed. In some embodiments, a subset of the sensor arrays is either sparsely spaced or densely packed. In some embodiments, the distance between the center points of any two sensors in a densely packed subset of sensors is less than about: 5, 4.5, 4, 3.5, 3, 2.5, 2, 1.5, 1, 0.5, 0.1 cm. In some embodiments, the distance between the center points of the densely packed sensors is about 0.1 cm to about 2.0 cm, or about 0.1 cm to about 1.5 cm, or about 1.0 cm to about 2.0 cm. In some embodiments, the distance between the center points of any two sensors in a sparsely packed subset of sensors is greater than approximately: 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 8, or 10 cm. In some embodiments, the distance between the center points of the sparsely packed sensors is approximately 1.5 cm to approximately 3 cm, approximately 2 cm to approximately 5 cm, or approximately 2.5 cm to approximately 8 cm. In some embodiments, the center point is the central location of the sensor, such as a central axis. In some embodiments, the center point of a circular sensor is the center point where all other edge points are equidistant.

[0096] In some implementations, densely packed arrays indicate that magnetometers are placed less than 1.5 cm apart, while magnetometers larger than about 1.5 cm apart form a sparsely arranged array.

[0097] In some embodiments, the housing is configured to house a sensor or a sensor array of sensors. In some embodiments, the housing is configured to house a single configuration of sensor spacing within the housing. In some embodiments, the housing is configured to house multiple configurations of sensor spacing within the housing. In some embodiments, the housing accommodates (i) adjusting the sensor spacing, such as dense or sparse spacing, or (ii) changing the number of sensors within an array. In some embodiments, the housing is a universal housing for multiple arrays and array configurations.

[0098] In some embodiments, the sensor is configured to sense the presence of a magnetic field or measure parameters of the magnetic field. In some embodiments, the sensor has a sensitivity of approximately 10 femtoseconds to a magnetic field per hertz (fT / √Hz). In some embodiments, the sensor has a sensitivity of approximately 1 fT / √Hz to approximately 20 fT / √Hz. In some embodiments, the sensor has a sensitivity of approximately 5 fT / √Hz to approximately 15 fT / √Hz. In some embodiments, the sensor has a sensitivity of approximately 0.1 fT / √Hz to approximately 30 fT / √Hz. In some embodiments, the sensor has a sensitivity of approximately 0.5 fT / √Hz to approximately 12 fT / √Hz. In some embodiments, the sensor has a sensitivity of approximately 1 fT / √Hz to approximately 15 fT / √Hz. In some implementations, the sensor includes a sensitivity of approximately: 0.001, 0.005, 0.01, 0.05, 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 fT / √Hz.

[0099] In some embodiments, the sensor does not require a cooling element such as cryogenic cooling to collect measurements. In some embodiments, the sensor collects measurements over a temperature range of about 30 degrees Fahrenheit (F) to about 110 degrees Fahrenheit. In some embodiments, the sensor collects measurements over a temperature range of about 50 degrees Fahrenheit to about 110 degrees Fahrenheit. In some embodiments, the sensor collects measurements over a time period of about 1 second to about 5 hours without a cooling element. In some embodiments, the sensor collects measurements over a time period of about 1 second to about 1 hour without a cooling element. In some embodiments, the sensor collects measurements over a time period of about 1 second to about 30 minutes without a cooling element.

[0100] In some embodiments, the noise source includes magnetic field strength. In some embodiments, the magnetic field strength of the noise source is measured in Tesla (T). In some embodiments, noise, such as ambient noise, includes a magnetic field strength of less than about 100 nanotesla (nT). In some embodiments, the noise includes a magnetic field strength of less than about 1000 nT. In some embodiments, the noise includes a magnetic field strength of less than about 500 nT. In some embodiments, the noise includes a magnetic field strength of less than about 200 nT. In some embodiments, the noise includes a magnetic field strength of less than about 120 nT. In some embodiments, the noise includes a magnetic field strength of less than about 80 nT. In some embodiments, a noise source, such as the Earth's magnetic field, includes a magnetic field strength of about 50 microtesla (mT). In some embodiments, the noise includes a magnetic field strength of about 40 mT to about 60 mT. In some embodiments, the noise includes a magnetic field strength of about 10 mT to about 100 mT. In some embodiments, the noise includes an amplitude component, a frequency component, or a combination thereof, and in some embodiments, the noise source includes direct current (DC), alternating current (AC), or a combination of both.

[0101] Electromagnetic shielding components

[0102] Some embodiments of the devices and systems described herein are configured to provide electromagnetic shielding to reduce or eliminate the Earth's ambient magnetic field. In some embodiments, the shielding, as described herein, comprises a metallic alloy (e.g., permalloy or a high-permeability alloy) that, when annealed in a hydrogen furnace, provides particularly high permeability, thereby isolating the area protected by the shielding (e.g., within a shield shaped as a chamber) from the Earth's magnetic field.

[0103] The chamber or shielding described herein minimizes the internal magnetic field and, in some embodiments, is configured to have a closed end and an open end. In some embodiments, the closed end takes the form of a flat, conical, or hemispherical end cap.

[0104] In some embodiments, the use of shielding for sensors, such as sensor arrays, provides noise reduction, enabling the sensors to collect measurements with substantially no noise or with significantly reduced noise. In some embodiments, the noise includes noise from noise sources. In some embodiments, noise sources include high-frequency noise such as greater than about 20 Hz, mid-frequency noise such as about 1 Hz to about 20 Hz, low-frequency noise such as 0.1 Hz to about 1 Hz, or any combination thereof. In some embodiments, the noise source includes any structure containing metal. In some embodiments, the structure containing metal includes metal implants, such as pacemakers, defibrillators, orthopedic implants, dental implants, etc. In some embodiments, the structure containing metal includes metal tools, metal doors, metal chairs, etc. In some embodiments, the noise source includes the operation of equipment such as fans, air conditioners, clinical devices, or vibrations of the building. In some embodiments, the noise source includes power supplies or the operation of electronic equipment such as computers including monitors or graphical user interfaces.

[0105] In some embodiments, the shielding element or a portion thereof comprises a single layer of material. In some embodiments, the shielding element or a portion thereof comprises multiple layers of material. In some embodiments, the shielding element or a portion thereof comprises multiple layers, wherein at least two of the multiple layers comprise different materials. In some embodiments, the shielding element or a portion thereof comprises two layers. In some embodiments, the shielding element or a portion thereof comprises three layers. In some embodiments, the shielding element or a portion thereof comprises four layers. In some embodiments, the shielding element or a portion thereof comprises five layers. In some embodiments, the shielding element or a portion thereof comprises six layers.

[0106] In some embodiments, a layer of the shielding member or a portion thereof has a thickness of about 0.1 to about 10 mm. In some embodiments, a layer of the shielding member has a thickness of about 0.5 to about 5 mm. In some embodiments, a layer of the shielding member has a thickness of about 0.1 to about 2 mm. In some embodiments, a layer of the shielding member has a thickness of about 0.8 to about 5 mm. The thickness is substantially the same along the length or circumference of the shielding member. In some embodiments, the thickness of a layer of the shielding member varies along the length or circumference of the shielding member.

[0107] In some embodiments, the shielding member includes multiple layers. In some embodiments, there is space between at least two of the multiple layers. In some embodiments, there is space between each of the multiple layers. In some embodiments, there is space between subsets of the multiple layers. In some embodiments, a first layer of the shielding member is configured to be adjacent to a second layer of the shielding member. In some embodiments, the first layer of the shielding member is configured to be attached or bonded to the second layer of the shielding member. In some embodiments, the first layer of the shielding member is configured to be positioned from about 0.1 inches to about 5 inches away from the second layer. In some embodiments, the first layer of the shielding member is configured to be positioned from about 1 inch to about 3 inches away from the second layer. In some embodiments, the first layer of the shielding member is configured to be positioned from about 1 inch to about 20 inches away from the second layer. In some embodiments, the first layer of the shielding member is configured to be positioned from about 1 inch to about 10 inches away from the second layer.

[0108] In some embodiments, the length of the shield (e.g., internal or external length) is about twice the internal diameter of the shield. In some embodiments, the length of the shield is about 0.5 to about 3 times the internal diameter of the shield. In some embodiments, the length of the shield is about 1 to about 3 times the internal diameter of the shield. In some embodiments, the length of the shield is about 1.5 to about 3 times the internal diameter of the shield.

[0109] In some embodiments, the length of the shield is configured to accommodate at least a portion of an individual. In some embodiments, the length of the shield is configured to accommodate an individual. In some embodiments, the diameter of the shield (e.g., inner diameter) is configured to accommodate at least a portion of an individual. In some embodiments, the diameter of the shield (e.g., inner diameter) is configured to accommodate an individual. In some embodiments, the individual is a human subject. In some embodiments, the human subject is an adult subject, a child subject, or a newborn subject.

[0110] In some embodiments, the shielding member is about 40 inches to about 100 inches long. In some embodiments, the shielding member is about 50 inches to about 90 inches long. In some embodiments, the shielding member is about 40 inches to about 150 inches long. In some embodiments, the shielding member is about 60 inches to about 90 inches long.

[0111] In some embodiments, the diameter of the shield is about 40 inches to about 60 inches. In some embodiments, the diameter of the shield is about 45 inches to about 55 inches. In some embodiments, the diameter of the shield is about 50 inches to about 70 inches.

[0112] In some embodiments, the shielding member or a portion thereof is configured in a substantially cylindrical shape. In some embodiments, the shielding member or a portion thereof is configured in a substantially conical shape. In some embodiments, the shielding member includes a first end and a second end. In some embodiments, the first end of the shielding member has a substantially cylindrical shape and the second end of the shielding member has a conical shape. In some embodiments, the shielding member is configured with a first end having a cylindrical shape, which tapers, such as gradually tapering, from the first end to the second end having a conical shape.

[0113] In some embodiments, the shield includes an internal volume configured to house an individual, sensor, or combination thereof within the internal volume. When an individual is placed into the internal volume of the shield, it is desirable to reduce excess internal volume. For example, providing a shield with a tapered or conical end reduces excess internal volume, improves spatial homogeneity of measurements performed by the sensor, reduces noise, or any combination thereof.

[0114] In some embodiments, measurements collected from the sensor are collected from inside the internal volume of the shield. In some embodiments, measurements are collected in the absence of the individual. In some embodiments, measurements are collected in the presence of the individual. In some embodiments, the shield includes a portion of the internal volume that has greater spatial homogeneity or greater noise reduction compared to different portions. For example, a tapered or conical end of the internal volume has greater spatial homogeneity, greater noise reduction, or both compared to a cylindrical end. In some embodiments, the individual is positioned within the internal volume of the shield such that the area of ​​the subject to be measured by the sensor is located within a portion of the internal volume that has greater spatial homogeneity, greater noise reduction, or both.

[0115] In some implementations, changing the length, diameter, or shape of the shield (e.g., tapering) alters the noise reduction and measurement quality within the internal volume of the shield. Each change is made independently or collectively to optimize noise reduction or improve the quality of measurements performed by the sensor.

[0116] In some embodiments, the shield includes a coil, such as a Helmholtz coil. In some embodiments, the coil generates a current within itself. In some embodiments, adding a coil to the shield improves the quality of the measurement (e.g., spatial homogeneity of the measurement), reduces noise, or a combination thereof. In some embodiments, the shield includes multiple coils. In some embodiments, the shield includes a single coil. In some embodiments, the shield includes two coils. In some embodiments, the shield includes three coils. In some embodiments, the shield includes 1 to 3 coils. In some embodiments, the coil is positioned within a portion of the shield. In some embodiments, the coil is positioned within a portion of the shield where the measurement occurs. In some embodiments, the position of the coil is adjustable, such as by a controller or by a user. In some embodiments, the position of the coil is adjusted for each measurement by the sensor. In some embodiments, the position of the coil is pre-programmed according to the type of measurement by the sensor. In some embodiments, the position of the coil can be adjusted with an accuracy of about 0.1 inches to about 5 inches. In some embodiments, the coil provides feedback to the user or controller, and the coil achieves the desired positioning. In some implementations, feedback from the coil to the user or controller occurs before, during, or after the sensor measurement. In some implementations, feedback from the coil confirms that a desired location has been reached (such as a location corresponding to the location of the individual to be measured).

[0117] In some embodiments, the shield is modular. In some embodiments, the shield or a portion thereof is disposable. In some embodiments, the shield is configured to receive at least a portion of an individual, at least a portion of a sensor array, or a combination thereof. In some embodiments, a portion of the individual includes a head, arm, or leg placed within the internal volume of the shield. In some embodiments, a portion of the individual includes the individual extending from the middle to the head or from the middle to the feet. In some embodiments, the shield is not modular. In some embodiments, the shield is configured to interact with one or more modular components. For example, modular components such as a base component are modular and configured to modulate relative to a fixed or non-modular shield.

[0118] In some embodiments, the shield or a portion thereof is configured for subject comfort. In some embodiments, the shield or a portion thereof is configured with illumination, such as in some embodiments where the internal volume of the shield includes an illumination source. In some embodiments, the shield or a portion thereof is configured with ventilation openings, such as one or more ports or openings, such as one or more openings located on the inner surface of the shield.

[0119] In some embodiments, the shielding element comprises a single material. In some embodiments, the shielding element comprises more than one material. In some embodiments, the shielding element or a portion thereof comprises a metal, a metal alloy, or a combination thereof. In some embodiments, the shielding element or a portion thereof comprises permalloy or a high-permeability alloy. In some embodiments, the shielding element or a portion thereof comprises aluminum, copper, gold, iron, nickel, platinum, silver, tin, zinc, or any combination thereof. In some embodiments, the shielding element or a portion thereof comprises brass, bronze, steel, molybdenum-chromium steel, stainless steel, titanium, or any combination thereof.

[0120] In some embodiments, the shielding element or a portion thereof comprises nickel, iron, or a combination thereof. In some embodiments, the shielding element or a portion thereof comprises about 70% to about 90% nickel by weight. In some embodiments, the shielding element or a portion thereof comprises about 75% to about 85% nickel by weight. In some embodiments, the shielding element or a portion thereof comprises about 10% to about 30% iron by weight. In some embodiments, the shielding element or a portion thereof comprises about 15% to about 25% iron by weight. In some embodiments, the shielding element or a portion thereof comprises about 70% to about 90% nickel and about 10% to about 30% iron by weight. In some embodiments, the shielding element or a portion thereof comprises about 40% to about 60% nickel and about 50% to about 60% iron by weight. In some embodiments, the shielding element or a portion thereof comprising permalloy and high-permeability alloys further comprises one or more additional elements, such as molybdenum.

[0121] In some embodiments, the shielding element or a portion thereof comprises a material having high magnetic permeability. For example, in some embodiments, the material comprises a relative magnetic permeability of about 50,000 to about 900,000 compared to steel, for example, having a relative magnetic permeability of about 4,000 to about 12,000. In some embodiments, the material comprises a relative magnetic permeability of about 75,000 to about 125,000. In some embodiments, the material comprises a relative magnetic permeability of about 400,000 to about 800,000. In some embodiments, the material comprises a relative magnetic permeability greater than about 50,000. In some embodiments, the material comprises a relative magnetic permeability greater than about 75,000. In some embodiments, the material comprises a relative magnetic permeability greater than about 100,000. In some embodiments, the material comprises a relative magnetic permeability greater than about 200,000. In some embodiments, the material comprises a relative magnetic permeability greater than about 300,000. In some embodiments, the material comprises a relative permeability greater than about 400,000. In some embodiments, the material comprises a relative permeability greater than about 500,000. In some embodiments, the material comprises a relative permeability greater than about 600,000. In some embodiments, the material comprises a relative permeability from about 80,000 to about 900,000. In some embodiments, the material comprises a relative permeability from about 400,000 to about 800,000.

[0122] In some embodiments, the shielding element is monolithic. In some embodiments, the shielding element is formed from multiple sub-components configured together. In some embodiments, the shielding element is 3D printed. In some embodiments, the shielding element comprises a material formed in a hydrogen furnace, such as a shielding element comprising one or more materials annealed in a hydrogen furnace.

[0123] This document describes devices and systems configured to sense magnetic fields associated with, for example, an individual's tissues, body parts, or organs. In some embodiments of the devices and systems described herein, the device for sensing the magnetic field includes a movable base component and one or more magnetic field sensors. In some embodiments of the devices and systems described herein, the device for sensing the magnetic field includes a movable base component, one or more magnetic field sensors, and a shielding element for shielding against ambient electromagnetic noise.

[0124] In some embodiments of the devices and systems described herein, the device for sensing magnetic fields includes a movable base component configured for portability. In some embodiments, the movable base component includes wheels or tracks on which the movable base component moves as it moves across a surface. In some embodiments, the movable base component is handheld. In some embodiments, the movable base component is configured to include a housing containing electronic components.

[0125] In some embodiments of the devices and systems described herein, the device for sensing magnetic fields includes one or more magnetic field sensors, such as, for example, one or more OPMs.

[0126] In some embodiments of the devices and systems described herein, the device for sensing magnetic fields includes one or more coupling mechanisms for receiving and coupling to one or more sensors. In some embodiments of the devices and systems described herein, the device for sensing magnetic fields includes one or more arms or extensions connected to a movable base component. In some embodiments of the devices and systems described herein, the device for sensing magnetic fields includes one or more extensions or arms configured to move, rotate, and / or hinge to position one or more sensors for sensing magnetic fields near the individual whose magnetic field will be sensed.

[0127] In some implementations, the device or system described herein includes a mechanical housing comprising one or more nonferrous materials, such as, for example, aluminum alloys, rubber, plastics, wood, or any combination thereof, to minimize the amount of interference seen in biomagnetic signals from the device or system itself.

[0128] Exemplary Implementation

[0129] Figure 1 An exemplary embodiment of a device for sensing a magnetic field 100, including a shield 107 as described herein, is shown. The device for sensing the magnetic field 100 includes a shield 107 and one or more sensors 106 (such as an optically pumped magnetometer). In some embodiments, two or more sensors 106 are arranged in an array.

[0130] The shield 107 includes an open end 109 and a closed end 108. In some embodiments, the open end 109 is positioned adjacent to the closed end 108. In some embodiments, the open end 109 is positioned opposite to the closed end 108. In some embodiments, the shield 107 includes one or more openings. The one or more openings of the shield 107 are configured to receive at least a portion of the base component 101, at least a portion of the individual 114, at least a portion of one or more sensors 106, or any combination thereof.

[0131] For example, shielding member 107 includes an opening, such as a recess 113 configured to receive a portion of base member 101. In some embodiments, shielding member 107 includes an opening 115 configured to receive at least a portion of base member 101, at least a portion of individual member 114, at least a portion of one or more sensors 106, or any combination thereof. Shielding member 107 includes an inner surface 110. In some embodiments, inner surface 110 includes a coating. In some embodiments, inner surface 110 of shielding member 107 defines an internal volume of shielding member. The internal volume of shielding member 107 is the volume in which a portion of individual member 114, a portion of sensor, a portion of base member 101, or any combination thereof is received. Shielding member 107 includes a shielding portion 116 configured to store components of a device for sensing magnetic fields, such as an electronic actuator. In some embodiments, shielding portion 116 includes a drawer, shelf, cabinet, compartment, or a portion of shielding member 107. In some embodiments, shielding portion 116 is positioned on a side of shielding member. In some embodiments, the shielding portion 116 is positioned on the bottom of the shield 107.

[0132] In some embodiments, the device for sensing a magnetic field 100, as described herein, includes a base component 101. Figure 1 In the exemplary embodiment shown, the base component 101 includes a bed or wheelchair on which an individual 114 lies.

[0133] In some embodiments, the device 100 for sensing magnetic fields described herein is operatively coupled to a base component 101. In some embodiments, a shield 107 is configured to receive a portion of the base component 101. For example, in some embodiments, a recess in the shield 107 is configured to receive at least a portion of the base component 101, such as... Figure 1 As shown. In some embodiments, the base component 101 is directly attached to one or more sensors 106.

[0134] In some embodiments, the base component 101 is configured as a fixed base component 101. In some embodiments, the base component 101 is configured as a movable base component 101. In some embodiments, the shield 107 is movable relative to the base component 101. In some embodiments, the base component 101 is movable relative to the shield 107. In some embodiments, the shield 107 and the base component 101 are movable relative to each other.

[0135] exist Figure 1In the exemplary embodiments shown, the base component 101 is configured as a movable base component 101. In some embodiments, the movable base component 101 is configured to move with one or more degrees of freedom (e.g., relative to the shield 107). In some embodiments, the movable base component 101 is configured to move along the x-axis, y-axis, z-axis, or any combination thereof. In some embodiments, the movable base component 101 includes one or more rotating elements, such as wheels (113a, 113b), rollers, conveyor belts, or any combination thereof, configured to provide movement of the base component 101 or a portion thereof. In some embodiments, the base component 101 includes one rotating element. In some embodiments, the base component 101 includes two rotating elements. In some embodiments, the base component 101 includes three rotating elements. In some embodiments, the base component 101 includes four rotating elements. In some embodiments, the base component 101 includes more than four rotating elements. In some embodiments, the rotating elements are positioned at one or both ends of the base component 101. In some embodiments, the base component 101 includes a non-rotating element configured to be housed in a track or channel, allowing the base component 101 to move along the track or channel. In some embodiments, the track or channel is positioned adjacent to the shield 107, allowing the base component 101 to move along the track or channel toward, away from, or toward and away from the shield.

[0136] In some embodiments, the base component 101 includes one or more pivots (102a, 102b). In some embodiments, the base component 101 includes one pivot. In some embodiments, the base component 101 includes two pivots. In some embodiments, the base component 101 includes more than two pivots. In some embodiments, pivots 102a, 102b are configured to allow movement of the base component 101, such as by accommodating an individual positioned on the base component 101. In some embodiments, pivots 102a, 102b are configured to allow movement of the base component 101 to position the base component 101 within the internal volume of the shield 107. In some embodiments, pivots 102a, 102b are configured to provide movement to the base component 101, providing one or more degrees of freedom.

[0137] In some embodiments, one or more sensors 106 are operatively coupled to arm 103. In some embodiments, arm 103 is a movable arm 103. In some embodiments, the device has an extendable arm 103 at the end of which sensor array 106 is disposed. In some embodiments, any type of OPM is used as one or more of the one or more sensors 106. In some embodiments, arm 103 is movable in at least one degree of freedom. In some embodiments, arm 103 includes contacts 104 configured to provide movement to arm 103. In some embodiments, arm 103 includes more than one contact 104. In some embodiments, arm 103 includes two contacts 104. In some embodiments, arm 103 is operatively coupled to one or more sensors 106 and base component 101, such as... Figure 1 As shown. Figure 1 As shown, arm 103 is operatively coupled to base component 101 via beam 105.

[0138] In some embodiments, the device for sensing the magnetic field 100 as described herein includes a computer processor 112, such as Figure 1 As shown. In some embodiments, the computer processor 112 includes a graphical user interface. In some embodiments, the computer processor 112 includes a touchscreen.

[0139] like Figure 1 As shown, the device for sensing the magnetic field 100 includes a stand 111 configured, for example, to house a computer processor 112. In some embodiments, the stand 111 is positioned adjacent to a shield 107 or a base component 101 of the device 100 for sensing the magnetic field. In some embodiments, the stand 111 is integrated into or attachable to the shield 107 or the base component 101 of the device 100 for sensing the magnetic field.

[0140] exist Figure 1 In some embodiments of the device 100 shown, the device is substantially fixed. It should be understood that other embodiments of the device 100 (and system) described herein are configured to be mobile.

[0141] In some embodiments, device 100 includes a compartment 116 or tabletop for housing electronics, a computer interface, and a power supply; in others, it includes separate components connected via wiring to the first component for housing these components. In some embodiments, device 100 requires a power supply via a receptacle. In some embodiments, standard operating procedures include extending the arm 103 of the device and lowering the base of the sensor unit 106 to a position, such as within 2 cm of the skin surface of an individual (e.g., the chest, head, or other area of ​​interest of individual 114). In some embodiments, device 100 is calibrated using software applications provided with the device or separately. In some embodiments, biomagnetic signals of interest are displayed and recorded for immediate or later analysis.

[0142] In some embodiments, the operation of the device 100 (or system) described herein is controlled using a software user interface (UI), a manual UI, or a combination of software and manual elements. In some embodiments, the UI is installed in-situ on a provided auxiliary computer. The use of the device is instructed by a medical professional, such as a physician, to determine more information about an individual's condition. Within the UI, user preferences and acquisition parameters, including the sampling rate and axis operation of the device or system, are selected. Magnetic field signals from the individual, such as signals corresponding to the individual's heart, are displayed from the software user interface and saved to a file. In some embodiments, the device or system is configured to measure cardiac electrical activity, producing waveforms similar to those recorded by an electrocardiograph that can demonstrate points of interest during the cardiac cycle.

[0143] One or more sensors 106 are arranged in an array, wherein one or more optically pumped magnetometers output one or more waveforms. In some embodiments, each sensor in the array outputs a single waveform. In some embodiments, individual waveforms from individual sensors are combined into a single waveform. In some embodiments, the array outputs a single waveform that includes a combination of waveforms from each sensor in the array. In some embodiments, the magnetic field data is visualized as a series of 2D images formed by interpolated magnetic field values ​​between the sensors. In some embodiments, the array includes at least one OPM and at least one other type of magnetometer. In some embodiments, the array includes only an OPM.

[0144] In some embodiments, the shield 107 is housed in a shielded structure, and in some embodiments, the total length of the device is at least about 2.25 meters (m) long, wherein the diameter of the opening (or internal opening) is about 0.8m.

[0145] In some embodiments, a base component 101, such as a bed platform, is used to position the subject in the shield 107 for insertion into the individual. During use of the device, a flexible engagement arm 103, having xyz translational motion, is configured to occupy any point within a semicircle defined by the total arm length when extended. This flexible engagement arm is used to position an array of n optically pumped magnetometers in a wide range of geometries above or near a portion of the individual (such as the chest, head, or other organs of individual 114) using a set standard operating procedure based on the organ of interest, condition or disease of interest, or a combination thereof. In some embodiments, after this point, the sensor array is opened, and at least a portion of the subject, at least a portion of the base component 101 (e.g., the bed platform), or a combination thereof, is slid into the shield 107. Using a provided computer application, the sensors are rapidly calibrated, and the magnetic field of the organ of interest, or a combination thereof, is displayed and recorded for immediate or later analysis. In some embodiments, the electronic actuators of the sensors are located below the shield 107 portion of the device 100 or in an adjacent trolley with computer control.

[0146] In some implementations, the system includes a touchscreen computer interface (such as a graphical user interface) mounted on the side of the device itself or on the adjacent trolley.

[0147] like Figure 2 As shown, in some embodiments, the shielding member includes a shielding frame 200. In some embodiments, the shielding frame 200 provides a macroscopic structure or shape for the shielding member. In some embodiments, the shielding frame 200 is positioned at an inner or outer surface of the shielding member. In some embodiments, the shielding frame 200 is configured to receive one or more portions of a base component. In some embodiments, the shielding frame 200 includes an open end 201 and a closed end 203. In some embodiments, an opening 202 is positioned on the open end 201, such as an opening configured to receive part of a base component. In some embodiments, an opening, such as a notch 204, is positioned on the open end 201 or the closed end 203 and is configured to receive part of a base component. In some embodiments, the shielding frame 200 includes individual elements operatively connected to form the shielding frame 200, or in some embodiments, the shielding frame 200 includes a single monolithic frame or a 3D-printed frame. In some embodiments, the shielding frame 200 includes one or more layers.

[0148] like Figure 3As shown, an exemplary embodiment of the device or system 300 described herein includes a shield 301. The shield 301 includes a closed end 302 and an open end 303. In some embodiments, the open end 303 of the shield 301 is positioned opposite the closed end 302 of the shield 301. In some embodiments, the open end 303 of the shield 301 is positioned adjacent to the closed end 302 of the shield 301. In some embodiments, the open end 303 is configured to position a sensor, an individual 305, a base component 306 (such as a movable base component), or any combination thereof within an internal volume of the shield 301. In some embodiments, the shield 301 includes an inner surface 304. In some embodiments, the inner surface 304 of the shield 301 spatially defines an internal volume of the shield 301. In some embodiments, the inner surface 304 is configured to contact the individual 305. In some embodiments, the inner surface 304 includes ventilation or illumination to accommodate the individual 305. In some embodiments, the base component 306 includes one or more pivots such that one or more portions of the base component 306 are adjustable. For example, in some embodiments, the base component 306 includes a first pivot 307 and a second pivot 308. In some embodiments, the pivots are configured to adjust the position of the base component 306 relative to the shield 301. In some embodiments, the pivots are configured to adjust the relative position of the base component 306 within the internal volume of the shield 301. In some embodiments, the base component 306 includes 1, 2, 3, 4, 5, 6, 7, 8, or more pivots. In some embodiments, the pivots provide movement in one or more degrees of freedom. In some embodiments, the pivots provide bending movement. In some embodiments, the pivots provide rotational movement. In some embodiments, the pivots provide extension movement. In some embodiments, the base component 306 includes a base 309. In some embodiments, the base 309 is configured to support portions of the base component 306 that hold the individual 305, a sensor, a sensor array, or a combination thereof. In some embodiments, the base 309 is configured to move into the opening 310 of the shield 301, such that a portion of the base component 306 holding the individual 305, the array, or a combination thereof moves into or out of the internal volume of the shield 301. In some embodiments, the internal volume of the shield 301 includes structures 311, such as tracks, channels, rods, or protrusions, configured to receive a portion of the base component 306 (such as a portion associated with the individual 305, a sensor, or both) when it moves into or out of the internal volume of the shield 301.

[0149] like Figure 4 As shown, the exemplary device or system 400 described herein includes a base component 412 (such as a movable base component 412) and one or more sensors including a sensor array 401 (such as an optically pumped magnetometer) in some embodiments.

[0150] In some embodiments, device 400 includes a structure 402, such as a handle, beam, rod, or protrusion, configured to allow a user to adjust the position of array 401.

[0151] In some embodiments, device 400 includes one or more pivots (such as 403 or 408). In some embodiments, the pivot adjusts the position of base component 412 or its sub-assemblies, the position of array 401, or a combination thereof. In some embodiments, the pivot (403 or 408) is adjusted manually, automatically, or in combination thereof. In some embodiments, the pivot (403 or 408) is adjusted by a user, by a controller, or a combination thereof. In some embodiments, the pivot (403 or 408) is configured to provide movement in one or more degrees of freedom. In some embodiments, the pivot (403 or 408) provides flexural movement. In some embodiments, the pivot (403 or 408) provides extension movement. In some embodiments, the pivot (403 or 408) provides rotational movement.

[0152] In some embodiments, base component 412 includes one or more compartments (such as 410 or 411). In some embodiments, base component 412 includes a single compartment. In some embodiments, base component 412 includes two compartments. In some embodiments, base component 412 includes multiple compartments. In some embodiments, base component 412 includes three compartments. In some embodiments, the first compartment and the second compartment are different. In some embodiments, the first compartment and the second compartment are the same. In some embodiments, the first compartment is larger in size than the second compartment. In some embodiments, the first compartment is positioned adjacent to the second compartment. In some embodiments, the first compartment is positioned above the second compartment. In some embodiments, the first compartment is positioned within the second compartment. In some embodiments, the compartment is configured to house one or more components. For example, the compartment is configured to house a power source such that base component 412 is not limited to maintaining proximity to a wall-mounted power outlet or external power source. In some embodiments, the compartment is configured to house a computer including an operating system, database, monitor, graphical user interface, or any combination thereof. In some implementations, the compartment is configured to house one or more sensors or sensor housings.

[0153] In some embodiments, base component 412 includes one or more compartments (such as 409 or 410). In some embodiments, base component 412 includes a single compartment. In some embodiments, base component 412 includes two compartments. In some embodiments, base component 412 includes multiple compartments. In some embodiments, base component 412 includes three compartments. In some embodiments, the first compartment and the second compartment are different. In some embodiments, the first compartment and the second compartment are the same. In some embodiments, the first compartment is larger in size than the second compartment. In some embodiments, the first compartment is positioned adjacent to the second compartment. In some embodiments, the first compartment is positioned above the second compartment. In some embodiments, the first compartment is positioned within the second compartment. In some embodiments, the compartment is configured to house one or more components. For example, the compartment is configured to house a power source such that base component 412 is not limited to maintaining proximity to a wall-mounted power outlet or external power source. In some embodiments, the compartment is configured to house a computer including an operating system, database, monitor, graphical user interface, or any combination thereof. In some implementations, the compartment is configured to house one or more sensors or sensor housings.

[0154] In some embodiments, the base component 412 includes a surface 409, such as a flat surface. Surface 409 is configured to hold other components of the computer or system. In some embodiments, the base component 412 includes one or more rotating elements (such as 414a or 414b). In some embodiments, the rotating elements include wheels (414a, 414b), rollers, conveyor belts, or any combination thereof, configured to provide movement of the base component 412. In some embodiments, the base component 412 includes an arm 413. In some embodiments, one end of the arm 413 is configured to be associated with the sensor array 401. In some embodiments, a second end of the arm 413 is configured to be associated with the base component 412 at, for example, compartments 410 or 411 or surface 409. In some embodiments, the arm 413 is adjustable. For example, the arm 413 is extendable in length, such as a first portion 405 of the arm 413 extending from a second portion 407 of the arm 413. In some embodiments, the first portion 405 or the second portion 407 of the arm 413 includes a locking element (such as a knob, protrusion, or pin slot) for securing the arm 413 or the first portion 405 or the second portion 407 of the arm 413 in an extended, flexed, or folded position.

[0155] In some embodiments, pivot 408 is positioned at a first end 405 of arm 413 and a second end 407 of arm 413 (e.g., Figure 4(as shown) or combinations thereof. In some embodiments, pivot 403 is located at one end of arm 413 adjacent to array 401. In some embodiments, pivot 408 is located at one end of arm 413 adjacent to compartment 410 or 411 or surface 409. In some embodiments, base component 412 includes wiring 404, such as one or more wires. Wiring 404 is configured to be associated with one or more sensors of array 401, one or more power supplies of base component 412, one or more computers of base component 412, or any combination thereof. In some embodiments, base component 412 includes wire securing elements 406 (such as ties, latches, or hooks) to secure one or more wires of base component 412. In some embodiments, wire securing elements 406 are located on arm 413 of base component 412. In some embodiments, wire securing elements 406 are located in compartments of base component 412. In some embodiments, the wire fixing element 406 is positioned to approach the array 401, the extension point of the arm 413, the pivot (403 or 408), or any combination thereof.

[0156] In some embodiments, device 400 is combined with a shield (not shown), such as, for example, a disposable shield or a modular shield. In some embodiments, the shield is separate from base component 412. In some embodiments, the shield is associated with base component 412, such as by attaching it to base component 412 at a location close to array 401.

[0157] In some embodiments, the shielding is integrated into device 400. In some embodiments, the shielding, array 401, arm 413, or any combination thereof are operatively connected (e.g., by wiring or wirelessly) to a controller or computer system.

[0158] like Figure 5 As shown, in some embodiments of the devices and systems described herein, the arm 500 of the mobile trolley device includes a hinge and / or extension mechanism 501. For example... Figure 5 As shown, in some embodiments, the extension mechanism 501 includes a telescopic housing for a portion of the arm 500 to extend and retract. In some embodiments, the hinge mechanism 501 includes a contact.

[0159] In some embodiments, the arm includes one or more retainers 502, such as retainers for securing the wiring assembly 503 to the arm 500. In some embodiments, the retainers 502 are located at any position along the length of the arm 500. In some embodiments, the position of the retainers 502 along the length of the arm 500 is adjustable. In some embodiments, a housing or conduit 504 is configured to house one or more wiring assemblies 503. In some embodiments, the wiring assembly 503 operatively connects the sensor array to one or more components, such as a computer or power supply. In some embodiments, the arm 500 includes a first end and a second end. In some embodiments, the first end of the arm 500 is configured to couple to the sensor array 509. The first end is coupled to the sensor array via a pivot 505. In some embodiments, the pivot 505 provides one or more degrees of freedom of movement to the sensor array 509. In some embodiments, the position of the sensor array is adjusted by employing an actuator, such as a power button 506. In some embodiments, the actuator adjusts the linear movement of the sensor array, such as toward or away from a surface of an individual. In some embodiments, the actuator has a separate power button 507. In some embodiments, the motor button 506 and the power button are the same. In some embodiments, the actuator includes a lever or handle 508. The lever is configured for manually adjusting the position of the arm 500, the sensor array position, or a combination thereof.

[0160] In some implementations, the mobile trolley device is configured to... Figure 7 The extended configuration shown is converted to, for example, Figure 6 The collapsed configuration is shown. In some embodiments, the mobile trolley device is configured to switch between the two configurations once or more. In some embodiments, the mobile trolley device is configured for a user to manually switch the device between the two configurations. In some embodiments, the mobile trolley device is configured to automatically switch between the two configurations, such as through automation via a motor system operatively coupled to a controller.

[0161] Figure 6 An exemplary mobile trolley device 600 in a collapsed configuration is shown. Figure 6As shown, the mobile trolley device 600 includes a sensor array 604, such as an optically pumped magnetometer. The sensor array 604 is coupled to a first end of an arm 608. In some embodiments, a second end of the arm 608 is coupled at position 607 to the top of a vertical beam 602 or frame. In some embodiments, the coupler includes a pivot. In some embodiments, the pivot coupler is configured to convert the device 600 from an extended configuration to a collapsed configuration. In some embodiments, a crossbeam 601 is coupled at position 609 to the arm 608 at any location between the first and second ends. In some embodiments, the crossbeam 601 is coupled to the arm 608 at the midpoint between the first and second ends. In some embodiments, the crossbeam 601 includes a pivot, such as a pivot positioned at the midpoint along the crossbeam 601. In some embodiments, the crossbeam pivot is configured to convert the device 600 from an extended configuration to a collapsed configuration. In some embodiments, the crossbeam 601 is configured to bend or pivot such that the first end coupled to the sensor array 604 moves toward the bottom end of the vertical beam 602. One or more pivots of the device 600 are locked in a configuration, such as an extended configuration or a collapsed configuration, by means of locking elements at positions 607 or 601 or both.

[0162] In some embodiments, the mobile cart device 600 includes a handle 610, such as a handle coupled to an arm 608. In some embodiments, the handle 610 facilitates actuation of the arm 608 to allow the device 600 to switch between an extended configuration and a collapsed configuration. In some embodiments, the mobile cart device 600 includes one or more rotating elements (such as wheels 605 and 606) configured to rotate, such that the mobile cart device 600 is moved. In some embodiments, the mobile cart device 600 includes one or more anchoring elements (such as rubber feet 612 and 613) configured to hold the mobile cart device 600 in a desired position. In some embodiments, the mobile cart device 600 includes a handle 611. In some embodiments, the handle 611 is configured to actuate one or more elements of the device 600. For example, the handle 611 is configured to actuate the arm 608 of the device 600 relative to a frame. In some embodiments, the handle 611 is configured to actuate a sensor array 604 relative to the arm 608. In some embodiments, the handle 611 translates the sensor array 604 with a linear movement toward or away from the arm 608. In some embodiments, the handle 611 is configured to rotate. In some embodiments, the handle 611 is operatively coupled to a drive screw 603 for converting the rotational movement of the handle 611 into linear movement of the sensor array 604.

[0163] Figure 7 It shows something similar to Figure 6An exemplary mobile trolley device 700 is described, situated in an extended configuration. Device 700 includes a sensor array 701 comprising one or more optically pumped magnetometers. The sensor array 701 is operatively coupled to a first end of an arm 706 of device 700 via one or more axes (such as a linear motion axis 702). In some embodiments, a second end of arm 706 is coupled at position 707 to one or more vertical beams (such as beams 709 and 710). In some embodiments, the coupler at position 707 includes a pivot. The coupler is configured to switch arm 706 between an extended and a collapsed configuration. In some embodiments, the coupler is configured to move sensor array 701 toward and away from the vertical beams.

[0164] In some embodiments, arm 706 includes handle 704, handle 703, or both configured to actuate at least a portion 700 of the device. For example, handle 704 is configured to move arm 706 relative to a frame. Handle 703 is configured to move sensor array 701 relative to arm 706. In some embodiments, device 700 includes crossbeam 713. In some embodiments, a first end 705 of crossbeam 713 is coupled to arm 706 at a location between a first end and a second end of arm 706, such as a midpoint location. In some embodiments, a second end 711 of crossbeam 713 is coupled to the frame, such as coupled to a vertical beam or positioned between two vertical beams. In some embodiments, crossbeam 713 includes pivot 708. In some embodiments, pivot is positioned at a midpoint on crossbeam 713. In some embodiments, pivot 708 is configured to bend. In some embodiments, pivot 708 is configured to switch the device between a collapsed configuration and an extended configuration. In some embodiments, the pivot 708 is reversibly locked. In some embodiments, the device 700 includes one or more rotating elements, such as a wheel 712, configured to move the device between positions.

[0165] Figure 8An exemplary computer system 801 is illustrated, which is programmed or otherwise configured to direct the operation of a device or system as described herein, including movement of a base component, movement of a shield, movement of a mobile trolley, movement of a sensor array, acquisition of measurements, comparison of measurements with reference measurements, or any combination thereof. The computer system 801 adjusts various aspects of: (a) movement of one or more device or system components, (b) operation of one or more sensors, (c) adjustment of one or more parameters of the sensors, (d) computational evaluation of one or more measurements of the device or system, and (e) display of various parameters, including input parameters, measurement results, or any combination thereof. In some embodiments, the computer system 801 is a user's electronic device (e.g., a smartphone, a laptop computer), or in some embodiments it relates to remote positioning of an electronic device. In some embodiments, the electronic device is a mobile electronic device.

[0166] Computer system 801 includes a central processing unit (CPU, also referred to herein as a “processor” and “computer processor”) 805, which in some embodiments is a single-core or multi-core processor or multiple processors for parallel processing. Computer system 801 also includes memory or memory location 810 (e.g., random access memory, read-only memory, flash memory), electronic storage unit 815 (e.g., hard disk), communication interface 820 for communicating with one or more other systems (e.g., network adapter), and peripheral devices 825 (e.g., cache memory, other memory, data storage, and / or electronic display adapter). Memory 810, storage unit 815, interface 820, and peripheral devices 825 communicate with CPU 805 via a communication bus (solid line) such as a motherboard. Storage unit 815 is configured as a data storage unit (or data repository) for storing data. Computer system 801 is operatively coupled to computer network (“network”) 830 by means of communication interface 820. Network 830 is the Internet, the Internet, and / or an extranet, or an intranet and / or extranet communicating with the Internet. In some embodiments, network 830 is a telecommunications network and / or a data network. Network 830 includes one or more computer servers that implement distributed computing, such as cloud computing. In some embodiments, network 830 implements a peer-to-peer network via computer system 801, which enables devices coupled to computer system 801 to act as clients or servers.

[0167] CPU 805 is configured to execute a series of machine-readable instructions embodied in a program or software. These instructions are stored in a memory location such as memory 810. The instructions direct CPU 805, which is subsequently programmed or otherwise configured to implement the methods described in this disclosure. Examples of operations performed by CPU 805 include fetching, decoding, executing, and writing back.

[0168] CPU 805 is part of a circuit (e.g., an integrated circuit). One or more other components of system 801 are included in this circuit. In some embodiments, this circuit is an application-specific integrated circuit (ASIC).

[0169] Storage unit 815 stores files, such as drivers, libraries, and saved programs. Storage unit 815 stores user data, such as user preferences and user programs. In some embodiments, computer system 801 includes one or more additional data storage units located outside computer system 801, such as on a remote server communicating with computer system 801 via an intranet or the Internet.

[0170] Computer system 801 communicates with one or more remote computer systems via network 830. For example, computer system 801 communicates with a user's remote computer system (e.g., a second computer system, a server, a smartphone, an iPad, or any combination thereof). Examples of remote computer systems include personal computers (e.g., portable PCs), tablets, or tablet PCs (e.g., [missing information]). iPad Galaxy Tab), telephone, smartphone (e.g., iPhone, Android-compatible devices (or personal digital assistant.) The user accesses the computer system 801 via network 830.

[0171] The method described herein is implemented by machine-executable code (e.g., a computer processor) stored at an electronic storage location in a computer system 801 (e.g., stored in memory 810 or electronic storage unit 815). This machine-executable code, or machine-readable code, is provided in software form. During use, the code is executed by processor 805. In some embodiments, the code is retrieved from storage unit 815 and stored in memory 810 for access by processor 805. In some cases, electronic storage unit 815 is excluded, and machine-executable instructions are stored in memory 810.

[0172] Machine-readable media, such as computer-executable code, take many forms, including but not limited to tangible storage media, carrier media, or physical transmission media. Non-volatile storage media include, for example, optical discs or magnetic disks, any storage device such as any computer, for example, a storage device used to implement a database as shown in the accompanying drawings. Volatile storage media include dynamic memory, such as the main memory of a computer platform. Tangible transmission media include coaxial cables, copper wires, and optical fibers; including wires that form a bus within a computer system. Carrier transmission media take the form of electrical or electromagnetic signals, or sound or light waves (e.g., generated during radio frequency (RF) and infrared (IR) data communications). Therefore, common forms of computer-readable media include, for example: floppy disks, flexible disks, hard disks, magnetic tapes, any other magnetic media, CD-ROMs, DVDs or DVD-ROMs, any other optical media, punched cardstock, any other physical storage media with a perforated pattern, RAM, ROM, PROM and EPROM, FLASH-EPROM, any other memory chips or cartridges, carriers for transmitting data or instructions, cables or links for transmitting such carriers, or any other medium from which a computer reads programming code and / or data. Many of these forms of computer-readable media involve loading one or more sequences of one or more instructions onto a processor for execution.

[0173] In some implementations, computer system 801 includes or communicates with an electronic display 835, the electronic display 835 including a user interface (UI) 840 for providing a graphical representation of, for example, one or more measured signals, one or more reference signals, one or more parameters input or adjusted by a user or controller, or any combination thereof. Examples of UIs include, but are not limited to, graphical user interfaces (GUIs) and web-based user interfaces.

[0174] In some embodiments, the methods and systems of this disclosure are implemented using one or more algorithms. In some embodiments, the algorithms are implemented in software and executed by a central processing unit 805. For example, the algorithm compares a signal with a reference signal.

[0175] Figures 9A to 9BExamples of shielding are shown. In some embodiments, the shielding has a first end and a second end. In some embodiments, the first end of the shielding includes a closed tapered end 901a or 901b. In some embodiments, the second end of the shielding includes an open end 904, which is substantially cylindrical in shape. In some embodiments, the opening at the second end is configured to receive at least a portion of an individual, a sensor array, a base component, or any combination thereof into the shielding. In some embodiments, the shielding is monolithic. In some embodiments, the shielding is formed of one or more segments, such as a first segment 901a or 901b, a second segment 902a or 902b, and a third segment 903. In some embodiments, the shielding includes one layer. In some embodiments, the shielding includes more than one layer. In some embodiments, the shielding includes an inner layer 905. In some embodiments, the shielding includes a gap 906 between two layers.

[0176] Figures 10A to 10B It shows Figures 9A to 9B An exemplary engineering drawing of the shielding component is shown. Figure 10A As shown, the cross-sectional view of the shielding component illustrates an example of suitable geometry. The shielding component is shown as a cylindrical portion in this figure, with the underlying support comprising nylon; however, the appendages and supports may be made of any non-ferrous material known in the art. Figure 10B A longitudinal view of the same sample shield is shown. In some embodiments, the shield has an overall length of about 2000 mm to about 2500 mm or about 2200 mm to about 2300 mm (e.g., about 2272.5 mm), an inner length of about 1500 mm to about 2000 mm or about 1700 mm to about 1800 mm (e.g., about 1750.0 mm), an inner layer with a diameter of about 500 mm to about 1000 mm or about 700 mm to about 900 mm (e.g., about 800.0 mm), a middle layer with a diameter of about 600 mm to about 1100 mm or about 800 mm to about 950 mm (e.g., about 883.0 mm), and an outer layer with a diameter of about 700 mm to about 1200 mm or about 900 mm to about 1050 mm (e.g., about 986.0 mm). Figures 10A to 10B As instructed.

[0177] In some embodiments, the shielding includes more than one layer with a gap between any two given layers. In some embodiments, the shielding has a non-uniform gap between any two layers. In some embodiments, different groups of layers have a non-uniform gap relative to each other.

[0178] In some embodiments, a layer of the shielding member or a portion thereof has a thickness of about 0.1 to about 10 mm. In some embodiments, a layer of the shielding member has a thickness of about 0.5 to about 5 mm. In some embodiments, a layer of the shielding member has a thickness of about 0.1 to about 2 mm. In some embodiments, a layer of the shielding member has a thickness of about 0.8 to about 5 mm. The thickness is substantially the same along the length or circumference of the shielding member. In some embodiments, the thickness of a layer of the shielding member varies along the length or circumference of the shielding member.

[0179] In some embodiments, the shielding member includes multiple layers. In some embodiments, there is space between at least two of the multiple layers. In some embodiments, there is space between each of the multiple layers. In some embodiments, there is space between subsets of the multiple layers. In some embodiments, a first layer of the shielding member is configured to be adjacent to a second layer of the shielding member. In some embodiments, the first layer of the shielding member is configured to be attached or bonded to the second layer of the shielding member. In some embodiments, the first layer of the shielding member is configured to be positioned from about 0.1 inches to about 5 inches away from the second layer. In some embodiments, the first layer of the shielding member is configured to be positioned from about 1 inch to about 3 inches away from the second layer. In some embodiments, the first layer of the shielding member is configured to be positioned from about 1 inch to about 20 inches away from the second layer. In some embodiments, the first layer of the shielding member is configured to be positioned from about 1 inch to about 10 inches away from the second layer.

[0180] In some embodiments, the length of the shield, such as the inner or outer length, is about twice the inner diameter of the shield. In some embodiments, the length of the shield is about 0.5 to about 3 times the inner diameter of the shield. In some embodiments, the length of the shield is about 1 to about 3 times the inner diameter of the shield. In some embodiments, the length of the shield is about 1.5 to about 3 times the inner diameter of the shield.

[0181] In some implementations, such as Figures 11A to 11I As shown, the layers of the shielding are separated using spacers of variable width, height, and length, depending on the application of interest. In some embodiments, the spacers used to separate the layers of the shielding are in the form of arcs. In some embodiments, spacers are used to cover part or the entire circumference of two consecutive layers. In some embodiments, spacers cover only part of the circumference of two consecutive layers.

[0182] In some implementations, such as Figures 12A to 12BAs shown, the shield support is manufactured from one or more parts and configured to be operatively connected (e.g., joined) by bolts, fasteners, screws, or any combination thereof. In some embodiments, the shield support is operatively connected (e.g., attached) to the shield by one or more of the following: fasteners, bolts, screws, or any combination thereof. In some embodiments, adhesive fasteners are also used to attach the support. In some embodiments, such as Figure 12A As shown, the shielding spacer is positioned at any location along the circumference of two consecutive layers. In some embodiments, a system of one or more hooks is operatively attached (e.g., attached) to any surface of any layer of the shielding by means of adhesives, fasteners, screws, bolts, or any combination thereof. The layers include a protective layer. In some embodiments, the inner layer, middle layer, outer layer, or any combination thereof includes a protective layer. In some embodiments, a portion of the layer includes the protective layer. In some embodiments, the protective layer comprises a non-ferrous material. In some embodiments, the protective layer comprises polyvinyl chloride (PVC) plastic. In some embodiments, the protective layer spans the entire inner surface of the shielding. In some embodiments, the protective layer spans a portion of the inner surface of the shielding.

[0183] Figure 13 An exemplary hook 1300 is shown, configured to span a portion or the entire volume of a shield. In some embodiments, one or more hooks 1300 are operatively connected to wiring (such as retaining wiring) and are designed to transmit analog electrical signals, digital electrical signals, or a combination thereof. In some embodiments, one or more hooks 1300 are positioned along a single plane of the shield. In some embodiments, hooks 1300 are positioned along more than one plane of the shield. Hooks are positioned along multiple planes. In some embodiments, hooks 1300 are positioned on the inner surface of the shield. In some embodiments, hooks 1300 are circumferentially positioned around the shield at a single cross-section. In some embodiments, hooks 1300 are circumferentially positioned around the shield and continuous along the length of the shield. In some embodiments, hooks 1300 are configured to retain an electronic coil system, such as an electronic coil system designed to eliminate accumulated magnetic fields. In some embodiments, hooks 1300 are configured to retain an electronic coil system, such as an electronic coil system designed to generate a uniform magnetic environment within the shield. In some embodiments, the electronic coil system is configured to employ the use of variable gauge wires. An exemplary wire gauge suitable for use with the apparatus and systems described herein is Figure 13 The 28AWG shown.

[0184] like Figures 14A to 14BAs shown, in some embodiments, the mobile trolley device is capable of operating in a non-magnetically shielded environment. In some embodiments, a computer, electronic devices, or a combination thereof are housed on the mobile trolley device itself. In some embodiments, an electronic control module is housed in a compartment (such as a cabinet) of the mobile trolley device. In some embodiments, the mobile trolley is configured to be powered by a battery (such as a portable battery). In some embodiments, the arm of the device is configured for motorized movement with one or more degrees of freedom.

[0185] Figures 14A to 14B An example of a mobile handcart device 1400 is shown. This example is related to... Figure 4The examples shown are similar. In some embodiments, the device or system described herein includes a base component (such as a movable base component) and a sensor array (such as an optically pumped magnetometer). In some embodiments, the sensor array is housed in a housing 1404. In some embodiments, the housing 1404 is interchangeable. In some embodiments, the housing 1404 is generally configured to accommodate more than one sensor array configuration. In some embodiments, the housing 1404 is configured to be removable and replaceable with a different housing. In some embodiments, the housing 1404 includes a motor feature 1403 such that the position of the sensor array is adjusted by pressing the motor feature 1403 on the housing 1404. In some embodiments, the adjustment is automated. In some embodiments, adjustment is performed manually by a user pressing the motor feature 1403. In some embodiments, the base component includes structures such as arms, beams, rods, or protrusions configured to allow a user to adjust the position of the array. In some embodiments, the arm is configured to be associated with the sensor array or housing 1404, such as with a bracket 1402. In some embodiments, the arm is extendable. In some embodiments, the arm is movable in one or more degrees of freedom. In some embodiments, the position of the arm, such as an extended arm position, is secured by a locking assembly 1401. In some embodiments, the locking assembly 1401, such as a locking solenoid, is positioned on the arm. In some embodiments, the locking assembly 1401 is operatively integrated with a motor feature 1403. In some embodiments, the base component includes a single compartment 1405. In some embodiments, the base component includes two compartments. In some embodiments, the base component includes multiple compartments. In some embodiments, the compartment 1405 is configured to house one or more components. For example, the compartment 1405 is configured to house a power source such that the base component is not limited to maintaining proximity to a wall-mounted power outlet or external power source. In some embodiments, the compartment 1405 is configured to house a computer including an operating system, database, monitor, graphical user interface, or any combination thereof. In some embodiments, the compartment 1405 is configured to house one or more sensors or sensor housings. In some embodiments, compartment 1405 is configured to house a power supply, a computer, one or more sensors, sensor housings, wiring, or any combination thereof. In some embodiments, the base component includes a surface, such as a flat surface. In some embodiments, the surface is configured to hold other components of the computer or system. In some embodiments, the base component includes one or more rotating elements. In some embodiments, the rotating elements include wheels, rollers, conveyor belts, or any combination thereof, configured to provide movement of the base component. In some embodiments, the base component includes an arm. One end of the arm is configured to be associated with a sensor array. In some embodiments, a second end of the arm is configured to be associated with the base component at, for example, compartment 1405 or a surface.In some embodiments, the arm is adjustable. For example, the arm is extendable in length, such as a first portion of the arm extending from a second portion of the arm. In some embodiments, the base component includes wiring, such as one or more wires. The wiring is configured to be associated with one or more sensors of the array, one or more power supplies of the base component, one or more computers of the base component, or any combination thereof. In some embodiments, the base component includes shielding, such as disposable shielding or modular shielding. In some embodiments, the shielding is separate from the base component. In some embodiments, the shielding is associated with the base component, such as being attached to the base component at a location close to the array. In some embodiments, the shielding is integrated into the base component. In some embodiments, the shielding, the array, the arm, or any combination thereof is operatively connected (e.g., via wiring or wirelessly) to a controller or computer system.

[0186] Figure 15A This is an enlarged view of an example of sensor array 1500a. In some embodiments, sensor array 1500a includes one or more sensor plates. For example, in some embodiments, sensor array 1500a includes a bottom sensor plate 1501. In some embodiments, the bottom sensor plate 1501 is secured to other sensor components by one or more mounting bolts, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 mounting bolts. In some embodiments, sensor array 1500a includes a top sensor plate 1502. In some embodiments, the top sensor plate 1502 is secured to other sensor components by one or more mounting bolts, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 mounting bolts. In some embodiments, sensor array 1500a includes one or more sensor plate supports 1503. For example, in some embodiments, the sensor array 1500a includes 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 sensor plate supports.

[0187] In some embodiments, sensor array 1500a includes one or more sensors 1506. In some embodiments, the sensors include magnetometer sensors. In some embodiments, the sensors include optically pumped vector magnetometers or zero-field magnetometers. In some embodiments, the sensors include superconducting quantum interference devices (SQUIDs), inductive pickup coils, vibrating sample magnetometers (VSMs), pulsed field extraction magnetometers, torque magnetometers, Faraday force magnetometers, optical magnetometers, or any combination thereof. In some embodiments, the sensors include small-scale microelectromechanical systems (MEMS) based magnetic field sensors.

[0188] In some embodiments, the sensor does not include a housing. In some embodiments, one or more sensors 1506 of sensor array 1500a include one or more sensor housings 1504a or 1504b. For example, in some embodiments, sensor array 1500a includes 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, or 24 sensor housings. In some embodiments, sensor array 1500a includes a sensor housing for each sensor in the array. In some embodiments, sensor array 1500a includes a sensor housing for at least every two sensors in the array. In some embodiments, the sensor housing is non-adjustable. In some embodiments, the sensor housing is movable within the sensor array unit to accommodate more than one sensor array configuration. In some embodiments, the sensor housing is secured in one position by one or more mounting bolts. In some embodiments, sensor array 1500a is secured in one position by a sensor housing cap 1505.

[0189] In some embodiments, the sensor array 1500a includes a handle 1510. In some embodiments, actuation of the handle 1510, such as rotational movement, causes movement of the sensor array 1500a (such as linear movement) (i) away from or toward an individual, (ii) away from or toward the arm of a moving trolley device, or (iii) a combination thereof. The handle 1510 is operated manually. In some embodiments, actuation of the handle 1510 is automated. In some embodiments, when the handle 1510 is actuated, a screw 1509, such as a lead screw, rotates. In some embodiments, rotation of the screw 1509 allows movement of one or more axes on the sensor.

[0190] In some embodiments, the sensor includes an element 1512 for coupling two or more shafts 1508a or 1508b (such as shaft 1508a (such as a linear motion shaft) and shaft 1511 (such as a square motion transmission shaft) for the transmission of motion (such as linear motion of the sensor array away from or toward an individual). In some embodiments, the shafts also include stopping elements, such as claw clutches. In some embodiments, element 1512 is operatively coupled to a handle 1510, a screw 1509, one or more shafts such as shafts 1508a and 1511, or any combination thereof.

[0191] In some embodiments, sensor array 1500a includes a bracket 1507, such as a support bracket. In some embodiments, the bracket provides spatial orientation relative to each other for one or more axes and one or more screws of the sensor array. In some embodiments, the bracket is operatively coupled to shaft 1508a, shaft 1511, screw 1509, element 1512, or any combination thereof.

[0192] In some embodiments, the sensor array 1500a includes a stop 1513, such as a separate stop. In some embodiments, the stop 1513 is configured to be positioned on the surface of an individual. In some embodiments, the stop 1513 is configured to be positioned at a specific distance from the surface of the individual. In some embodiments, the stop 1513 is configured to prevent the sensor array from advancing beyond a specific position, such as beyond the surface of the individual. In some embodiments, the stop 1513 is positioned on the surface of the sensor array so that, when in operation, the sensor array is positioned closest to the subject.

[0193] Figure 15B An example of a mobile handcart device 1500b is shown. This example is similar to... Figure 6 and Figure 7The example shown. In some embodiments, the mobile cart device 1500b includes an arm 1514. In some embodiments, the arm 1514 includes a first end and a second end. In some embodiments, a sensor array is coupled to the first end of the arm 1514. In some embodiments, the opposite end of the arm 1514 is coupled to a frame having a first support beam 1517a and a second support beam 1517b. In some embodiments, the opposite end of the arm 1514 is coupled to the frame at an upper support 1518 of the frame. In some embodiments, the mobile cart device 1500b includes a second arm. In some embodiments, the second arm includes a top support arm 1515 and a bottom support arm 1516. In some embodiments, the first end of the second arm is coupled to the arm 1514 at a location between the first and second ends of the arm 1514. In some embodiments, the second end of the second arm is coupled to the frame, such as at a support 1519 of the frame (such as a lock bracket). In some embodiments, the mobile cart device 1500b includes one or more rotating elements, such as wheels 1522. In some embodiments, the rotating elements are operatively coupled to one or more axles 1521 (e.g., two rotating elements operatively coupled to a single axle), one or more bearings 1523, or combinations thereof, such that the rotation of the two rotating elements occurs sequentially. In some embodiments, the mobile trolley device 1500b includes two rotating elements. In some embodiments, the mobile trolley device 1500b includes one rotating element. In some embodiments, the rotating element is configured to move the mobile trolley device 1500b from one location to a different location. In some embodiments, the mobile trolley device 1500b includes anchoring elements 1524, such as rubber feet, to anchor the mobile trolley device 1500b in a desired location or to prevent further movement of the rotating elements. In some embodiments, the mobile trolley device 1500b includes one anchoring element. In some embodiments, the mobile trolley device 1500b includes more than one anchoring element, such as two or three anchoring elements. One or more rotating elements, axles, anchoring elements, or any combination thereof are operatively coupled to the mobile trolley device 1500b via mounting bracket 1520.

[0194] In some embodiments, the mobile trolley device 1500b is an extended configuration ( Figure 15B Switching the configuration to a closed configuration Figure 15C In embodiments including the extended configuration, the arm 1514 collapses adjacent to the frame, allowing the mobile trolley equipment to be stored or easily moved to different locations.

[0195] In some embodiments, the performance of the magnetometer is improved through balancing. In these embodiments, a gradient of 1 nT / m is achieved within the shield. In some embodiments, balancing includes a demagnetization process.

[0196] In some embodiments, the shielding configured to utilize the balancing process includes an arrangement of coils. Typically, the coils are arranged in one or more layers. In some embodiments, the shielding includes an inner coil layer and one or more outer coil layers, an inner coil for the innermost layer, and an outer coil for each outer layer.

[0197] In some embodiments, the inner coils (for a cylinder with a diameter of 90 cm) are distributed at 45 degrees to effectively form 8 coils. Mechanical installation accuracy is approximately + / - 2 cm per wire. Typically, many different configurations are acceptable for the outer coils. In some embodiments, the shield includes 1 outer coil. In some embodiments, the shield includes 2 outer coils. In some embodiments, the shield includes 3 outer coils. In some embodiments, the shield includes 4 outer coils. In some embodiments, the shield includes 5 outer coils. In some embodiments, the shield includes 6 outer coils. In some embodiments, the shield includes 7 outer coils. In some embodiments, the shield includes 8 outer coils. In some embodiments, the shield includes 9 outer coils. In some embodiments, the shield includes 10 outer coils.

[0198] In some implementations, at least the inner layer must be electrically insulating. In some implementations, ESD PVC is used instead of conventional plastic solely to avoid disrupting the charging effect of the magnetometer.

[0199] Figure 22 An exemplary layout of an inner coil 2200 located in an embodiment of the shielding is shown. Figure 23 An exemplary layout of the outer coil 2300 positioned in an embodiment of the shielding is shown.

[0200] In some implementations, the connection to the amplifier (or transformer) is opened during measurements using a magnetic field probe. In some implementations, this is achieved using a mechanical relay.

[0201] The wire diameter is typically at least 2.5mm. 2 But 4mm 2 This would be preferred. I suggest the test setup has 3 turns at every 8th coil, resulting in 24 turns. I cannot estimate the permeability, but it should be comparable to Krupp Magnifer material (which I am more familiar with). Therefore, 24 turns would be approximately 1 ohm, and at a saturation current of 10A, it would produce 10V.

[0202] In some implementations, the balancing sequence will be a 30s sequence with an envelope that decreases linearly from the saturation of the inner layer. This sequence is needed whenever some large change is applied to the field. During normal operation, I would guess that 1-3 times per day would be meaningful. When shielding is installed, or when the external field changes direction by about 90 degrees, the external shield must be balanced only once using the same amplifier. (Therefore, in order to use the same equipment, the coils must have a similar number of turns).

[0203] In some implementations, the balancing coil is a separate wire with gold-plated contacts. Due to magnetization issues, a Ni substrate or coating cannot be used for the internal connector. In some implementations, the required accuracy level of the balancing coil in the outer shield can be arbitrarily placed without special precautions, while an inner coil with a diameter of 60 cm requires at least a 6x symmetrical current distribution to obtain a reasonably shaped residual field, and an inner coil with a diameter of 1 m requires an 8x symmetrical current distribution. For the project shown, we selected connectors from brass with a gold coating but no nickel interlayer (this is rare!) to avoid over-magnetization. All connectors must be placed outside the inner shield. Their magnetization (at this level) is independent of the residual field inside.

[0204] The balancing process employed in some embodiments of the shielding described herein is a process used to balance the magnetizable material with the surrounding magnetic field. In some embodiments, this is accomplished by applying a sinusoidal current around the magnetizable material. The oscillation is very well concentrated near zero and large enough to permeate the material in both directions. By reducing the amplitude to zero, a very low magnetic field strength is obtained outside the magnetizable material (inside the cylinder). For initial testing, a linearly decreasing envelope is useful because it is a very reliable function. This model is programmed into the balancing unit. An exponentially decreasing function may be advantageous in the future. The preset function (which can be changed by the user on a PC) is shown below:

[0205] Figure 24 A typical balance function is shown. Initially, the maximum current is maintained for 10 cycles, then decreases until zero amplitude is reached. Note that many options for modification and improvement are available at the final performance level.

[0206] In some implementations, a twisted-pair cable is used to connect the balanced coil to the power equipment. Because the shielding material and the inductance of the coil configuration (mH range) attenuate higher frequencies, RF shielding or other precautions are not required.

[0207] In some implementations, the computing device programs the sine function using an envelope function, which is then converted into a voltage signal by an NI 6281 data acquisition device. The voltage is fed to a voltage divider and subsequently drives a power amplifier. The function is user-configurable and programmable. The time resolution of the curve is 10 kHz.

[0208] In some implementations, a potentiometer enclosure is located inside the control box. These potentiometers can be manually adjusted to set the ratio of the DAC voltage to the amplifier output current. This minimizes the impact on any bit size of the residual field (for 20V = 0.3mV at 16-bit resolution). Empirically, this optimization is relevant for residual fields <0.5nT. There are two potentiometers to adjust different currents, which can then be selected via software. In noisy environments, the voltage divider enclosure is a useful place to add additional frequency filtering via capacitors. In some implementations, the amplifier's bandpass filter will be sufficient for most applications.

[0209] In some implementations, the power amplifier includes a 4-quadrant amplifier capable of operating with large inductive loads and is inherently fail-safe to prevent malfunctions such as shortcuts, numerous inductive spikes, etc. For magnetic balance, the amplifier should be used in current-controlled mode, but can also be operated in any configuration. Due to extreme noise requirements, the coils (cross-section and number of turns) around the magnetizable material are preferably varied to match the amplifier's maximum power. The power is chosen to be very small to achieve extremely low-noise operation. A bandpass filter can be manually set on the front side to reduce noise effects. The amplifier can be fully remotely controlled via a sub-D connector on the back. A unique feature of this amplifier is that the baseline can be adjusted by 1% independently of the signal input via an analog + / -10V input.

[0210] In some implementations, noise and drift of the magnetic field probe are relevant for DC measurements. In some implementations, two three-channel Bartington fluxgate Mag03-IEL-70s with a noise amplitude (peak-to-peak) of <6 pT are used. Each of the two electronics units provides three sensors, with each flying-wire sensor having a 5 m cable length. In some implementations, for example, readout of one or more fluxgates is accomplished using an NI 6281 18-bit analog input unit to provide a fluxgate analog signal (+ / -10V) with sufficient resolution. No voltage divider is required to match the range. USB control is used only for data transfer to the PC; the NI unit is independently grounded and has its own power supply. In some implementations, the readout rate is set to 625,000 samples per second.

[0211] Assessment of coronary artery disease

[0212] A method for determining the likelihood of the presence of coronary artery disease (e.g., myocardial ischemia with or without associated epicardial coronary artery disease) in an individual is also described, the method comprising: identifying a first negative electromagnetic dipole and a first positive electromagnetic dipole in a first electromagnetic field diagram associated with the individual's heart at a first time; identifying a second negative electromagnetic dipole and a second positive electromagnetic dipole in a second electromagnetic field diagram associated with the individual's heart at a second time; determining a first angle based on the first negative electromagnetic dipole and the first positive electromagnetic dipole; determining a second angle based on the second negative electromagnetic dipole and the second positive electromagnetic dipole; and determining the likelihood of the presence of coronary artery disease in the individual if the first angle differs from the second angle by at least 100 degrees, or if a third electromagnetic dipole is present in either the first or second electromagnetic field diagram.

[0213] Figure 25 An example method 2500 for assessing the presence of coronary artery disease (e.g., myocardial ischemia with or without associated epicardial coronary artery disease) in an individual is illustrated. Method 2500 may include, for each of the R-wave and T-wave electromagnetic field maps, identifying negative and positive electromagnetic dipoles in the electromagnetic field maps (as in 2502). Next, method 2500 may include determining the peak R depolarization angle and peak T repolarization angle, respectively, based on the electromagnetic dipoles in the R-wave and T-wave electromagnetic field maps (as in 2504). Next, method 2500 may include determining the RT peak angle difference based on the absolute difference between the peak R depolarization angle and the peak T repolarization angle (as in 2506). Next, method 2500 may include assessing the presence of coronary artery disease (e.g., myocardial ischemia with or without associated epicardial coronary artery disease) in an individual if the RT peak angle difference is at least 100 degrees (or either electromagnetic field map has a third electromagnetic dipole) (as in 2508).

[0214] In some embodiments, the method further includes sensing a first electromagnetic field associated with an individual's heart at a first time, and sensing a second electromagnetic field associated with an individual's heart at a second time, wherein the first electromagnetic field map includes a representation of the first electromagnetic field and the second electromagnetic field map includes a representation of the second electromagnetic field.

[0215] For example, coronary artery disease can include myocardial ischemia (e.g., occlusion of the left anterior descending artery). As another example, coronary artery disease can include demand-related ischemia (e.g., hyperthyroidism, malignant hypertension, tachycardia, and sepsis).

[0216] In some implementations, the first angle includes the peak R depolarization angle at a first time. The first time may be the time when the R wave is recorded on an electrocardiogram. For example, the peak R depolarization angle can be determined by identifying a first line passing through both the first negative electromagnetic dipole and the first positive electromagnetic dipole and determining the angle between the first line and the horizontal axis.

[0217] In some implementations, the second angle includes the peak T repolarization angle at a second time. The second time may be the time at which the T wave is recorded on an electrocardiogram. For example, the peak T repolarization angle can be determined by identifying a second line passing through both the second negative electromagnetic dipole and the second positive electromagnetic dipole and determining the angle between the second line and the horizontal axis.

[0218] In some implementations, a third electromagnetic dipole exists in either the first or second electromagnetic field diagram. This is referred to as a multiple electromagnetic dipole on the first or second electromagnetic field diagram.

[0219] In some implementations, the likelihood of coronary artery disease (e.g., myocardial ischemia with or without associated epicardial coronary artery disease) in an individual is determined to be present if the difference between the first angle and the second angle is at least 100 degrees (e.g., from 100 to 170 degrees). In other words, the likelihood of coronary artery disease (e.g., myocardial ischemia with or without associated epicardial coronary artery disease) in an individual can be identified as present based on a difference of at least 100 degrees in the peak RT angle (e.g., falling within the range of 100 to 170 degrees).

[0220] In some implementations, if the difference between the first angle and the second angle is less than 100 degrees (or either magnetic field pattern has a third electromagnetic dipole), the likelihood of the presence of coronary artery disease (e.g., myocardial ischemia with or without associated epicardial coronary artery disease) in an individual is determined to be non-existent. In other words, based on an RT peak angle of less than 100 degrees (or either magnetic field pattern having a third electromagnetic dipole), the likelihood of the presence of coronary artery disease (e.g., myocardial ischemia with or without associated epicardial coronary artery disease) in an individual can be determined to be non-existent.

[0221] In some implementations, the method also includes recording the individual's electrocardiogram (ECG). The individual may have a normal ECG or normal troponin levels when experiencing chest pain. The individual may have a positive stress test or abnormal echocardiographic results. If the likelihood of the individual having coronary artery disease (e.g., ischemic cardiomyocytes with or without associated epicardial coronary artery disease) is determined (e.g., if the first angle differs from the second angle or a third electromagnetic dipole is present in the first or second electromagnetic field map), a stress test can be performed on the individual.

[0222] In some embodiments, the method further includes determining the likelihood of a conduction abnormality in the individual's heart if the first positive electromagnetic dipole and the second negative electromagnetic dipole are in the same position or if the first negative electromagnetic dipole and the second positive electromagnetic dipole are in the same position. In some embodiments, the method further includes treating the individual with treatments for myocardial ischemia (e.g., regardless of the mechanism causing the ischemia). For example, treatment may include one or more of the following: daily aspirin or ibuprofen regimens, antihypertensive drugs, lipid-lowering drugs, cardiac catheterization, surgery, or a combination thereof.

[0223] This document also describes a non-transitory computer-readable medium comprising machine-executable code that, when executed by one or more computer processors, implements a method for determining the likelihood of the presence of coronary artery disease (e.g., myocardial ischemia with or without associated epicardial coronary artery disease) in an individual. The method includes: identifying a first negative electromagnetic dipole and a first positive electromagnetic dipole in a first electromagnetic field diagram associated with the individual's heart at a first time; identifying a second negative electromagnetic dipole and a second positive electromagnetic dipole in a second electromagnetic field diagram associated with the individual's heart at a second time; determining a first angle based on the first negative electromagnetic dipole and the first positive electromagnetic dipole; determining a second angle based on the second negative electromagnetic dipole and the second positive electromagnetic dipole; and determining the likelihood of the presence of coronary artery disease (e.g., myocardial ischemia with or without associated epicardial coronary artery disease) in the individual if the first angle differs from the second angle by at least 100 degrees, or if a third electromagnetic dipole is present in either the first or second electromagnetic field diagram.

[0224] Figures 26A to 26B Examples of how the methods and systems of this disclosure can be used to analyze the electrical currents in an organ or tissue (e.g., the heart) of a subject and determine its associated magnetic field are illustrated, including a description of Ampere's law. Figure 26A ) and an example of a magnetic field diagram generated by an electric current ( Figure 26B ). Figure 26A It shows that, according to Ampere's law, a current I passing through a long, straight wire produces a magnetic field B around the wire according to the right-hand rule. Figure 26B An example of a magnetic field map generated from an electric current according to the system, apparatus, and method of this disclosure is shown, including color-coded intensities of the current vector indicating the negative electromagnetic dipole 2602 (shown in blue), the positive electromagnetic dipole 2604 (shown in red), and the zero magnetic field region 2606 (shown in green) corresponding to the current source. Alternatively, any color may be arbitrarily chosen to represent the color-coded intensities of the current vector indicating the positive and negative electromagnetic dipoles and the zero magnetic field region corresponding to the current source.

[0225] Figures 27A to 27BExamples of how the methods and systems of this disclosure can be used to analyze the electrical currents of a subject's organs or tissues (e.g., the heart) and determine their associated magnetic fields are shown, including a peak R depolarization angle of 270°. Figure 27A The description of the peak T complex polarization angle 2704 ( Figure 27B The description of the increased RT angle gap indicates cardiac ischemia in the subject's heart.

[0226] like Figure 27A As shown, the peak R depolarization angle can be determined from the magnetograph generated during the time period when the R wave (and corresponding R peak) is measured using ECG. The R peak of the magnetograph represents the overall depolarization of the heart.

[0227] Interpreting a magnetic field diagram may include identifying positive magnetic poles (e.g., shown in red) and negative magnetic poles (e.g., shown in blue) during the duration of the R-wave. For example, a positive magnetic pole may be identified as the center of a positive magnetic field value (e.g., the center of mass), and a negative magnetic pole may be identified as the center of a negative magnetic field value (e.g., the center of mass). A first vector may be defined between the positive and negative magnetic poles to determine an angle therefrom. Alternatively, a first line, segment, or ray may be defined between the positive and negative magnetic poles to determine an angle therefrom. A second vector may be defined as a horizontal vector (e.g., having the same direction as the positive x-axis) to determine an angle therefrom. Alternatively, a second line, segment, or ray parallel to the horizontal vector (e.g., having the same direction as the positive x-axis) may be defined to determine an angle therefrom. Without loss of generality, the second vector, line, segment, or ray may pass through a negative magnetic pole (shown in blue). Alternatively, the second vector, line, segment, or ray may pass through another point (e.g., any point between the positive and negative magnetic poles) without affecting the determination of the angle therefrom. The first vector and / or the second vector can be expressed using any suitable coordinate system, including but not limited to 2-D Cartesian coordinates, 3-D Cartesian coordinates, rectangular coordinates, parametric coordinates, and polar coordinates.

[0228] After determining the first and second vectors, a vector angle can be defined based on the positive and negative magnetic poles at a given time. The vector angle can represent the angle between the first and second vectors. The vector angle can be determined as the smallest angular change between the first and second vectors. For example, the vector angle can have a value in the range of 0 to 360 degrees, or equivalently, it can have any integer multiple of 360 added to or subtracted from it to obtain a value in the range of 0 to 360 degrees. For example, the vector angle θ can be determined using the following expression: cos(θ) = a·b / (|a||b|), where a and b represent the first and second vectors respectively, "·" represents the vector dot product, and "||" represents the vector amplitude. The peak R depolarization angle can be determined as the vector angle of the magnetic field map associated with the time period during which the R-wave (and the corresponding R-peak) occurs (e.g., which can be measured using ECG).

[0229] In some implementations, a computer-implemented algorithm can be executed to determine one or more of a positive magneto-electromagnetic dipole, a negative magneto-electromagnetic dipole, a first vector, a second vector, and a vector angle based on analysis of a magneto-field diagram. The computer-implemented algorithm can determine the vector angle with or without explicitly generating one or more of the positive magneto-electromagnetic dipole, the negative magneto-electromagnetic dipole, the first vector, and the second vector.

[0230] like Figure 27B As shown, the peak T repolarization angle can be determined from the magnetograph generated during the time period when the T wave (and corresponding T peak) is measured using ECG. The T peak of the magnetograph represents the overall repolarization of the heart.

[0231] Interpreting a magnetic field diagram may include identifying positive magnetic poles (e.g., shown in red) and negative magnetic poles (e.g., shown in blue) during the duration of the T-wave. For example, a positive magnetic pole may be identified as the center of a positive magnetic field value (e.g., the center of mass), and a negative magnetic pole may be identified as the center of a negative magnetic field value (e.g., the center of mass). A first vector may be defined between the positive and negative magnetic poles to determine an angle therefrom. Alternatively, a first line, segment, or ray may be defined between the positive and negative magnetic poles to determine an angle therefrom. A second vector may be defined as a horizontal vector (e.g., having the same direction as the positive x-axis) to determine an angle therefrom. Alternatively, a second line, segment, or ray parallel to the horizontal vector (e.g., having the same direction as the positive x-axis) may be defined to determine an angle therefrom. Without loss of generality, the second vector, line, segment, or ray may pass through a negative magnetic pole (shown in blue). Alternatively, the second vector, line, segment, or ray may pass through another point (e.g., any point between the positive and negative magnetic poles) without affecting the determination of the angle therefrom. The first vector and / or the second vector can be expressed using any suitable coordinate system, including but not limited to 2-D Cartesian coordinates, 3-D Cartesian coordinates, rectangular coordinates, parametric coordinates, and polar coordinates.

[0232] After determining the first and second vectors, a vector angle can be defined based on the positive and negative magnetic poles at a given time. The vector angle can represent the angle between the first and second vectors. The vector angle can be determined as the smallest angular change between the first and second vectors. For example, the vector angle can have a value in the range of 0 to 360 degrees, or equivalently, it can have any integer multiple of 360 added to or subtracted from it to obtain a value in the range of 0 to 360 degrees. For example, the vector angle θ can be determined using the following expression: cos(θ) = a(|a||b|), where a and b represent the first and second vectors respectively, "·" denotes the vector dot product, and "||" denotes the vector amplitude. The peak T-polarization angle can be determined as the vector angle of the magnetic field map associated with the time period during which the T-wave (and the corresponding T-peak) occurs (e.g., which can be measured using ECG).

[0233] Figure 28 It illustrates how the heart generates electricity, including depolarizing ion flows (non-energy dependent), in which (1) sodium slows its entry into the cell while potassium leaves the cell, and (2) a large amount of calcium enters the cell; repolarizing ion flows (highly energy dependent), in which (3) calcium stops entering the cell while potassium leaves the cell, and (4) the balance of ions inside and outside the cell is restored (repolarization); and heart attack / ischemic cells, in which damaged cells are stuck in zone 3 (depolarization) and can no longer contract.

[0234] Figure 29 The diagram depicts the cardiac cycle using a "Viggo diagram," showing ventricular volume, ventricular pressure, aortic pressure, and atrial pressure, illustrating that electrogenesis precedes the mechanical function of the heart.

[0235] Figure 30 Examples of assessing patient intake using the systems, devices, and methods of this disclosure are shown, including patients undergoing stress testing, patients with negative or positive MCG, patients with negative or positive ST, and patients with positive or negative CA. In this example, a total of 97 patients were brought to the clinic for stress testing for further evaluation, of whom 90 had negative MCG results and 7 had positive MCG results.

[0236] Of the 90 patients with negative MCG results, 81 had negative ST results and 9 had positive ST results. Of the 9 patients with positive ST results, 4 had positive CA results and 5 had negative CA results. Furthermore, of the 7 patients with positive MCG results, 4 had positive ST results and 3 had negative ST results. Of the 4 patients with positive ST results, 3 had positive CA results and 1 had negative CA results. Of the 3 patients with negative ST results, all 3 had negative CA results.

[0237] Based on the above results, 81 patients were identified as potentially eligible for early discharge, while a small number still required stress testing for unstable angina before further treatment decisions were made. Furthermore, 16 false positive cases were eliminated, leaving only 2. The remaining cases required treatment. Therefore, there were no cases of acute ischemia suitable for early discharge and elective outpatient assessment.

[0238] Figure 31 This illustrates an example of a chest pain classification workflow based on clinical care standards. Upon arrival at the emergency department, patients with chest pain symptoms undergo clinical history and physical examination, ECG testing, and a first troponin aspiration for troponin testing. Based on a cardiac score of 7 to 10, patients have a 17% chance of being assigned a high-risk cardiac ischemia with or without epicardial coronary artery disease (CAD); based on a score of 4 to 6, patients have a 47% chance of being assigned a moderate-risk cardiac ischemia; and based on a score of 0 to 3, patients have a 36% chance of being assigned a low-risk cardiac ischemia. If a high-risk score is assigned, the patient is treated with catheterization. Conversely, if a low-risk score is assigned, the patient is discharged. However, approximately 70% of the time, patients undergo stress testing, CTA, and other cardiac imaging tests. This does not improve outcomes, as nearly 200,000 ACS patients in the United States are missed in the emergency department and develop a major adverse cardiac event (MACE) within 30 days. The average diagnostic time for cardiac risk score assessment can be 8 to 10 hours, and up to 14 hours if the patient undergoes stress testing, CTA, and other cardiac imaging tests. Therefore, patients are typically discharged 8 to 24 hours after their initial visit to the emergency department.

[0239] Figure 32An example of an improved workflow for chest pain classification according to the systems, apparatus, and methods of this disclosure is shown. Upon arrival at the emergency department with chest pain symptoms, the patient undergoes clinical history and physical examination, ECG testing, and a first troponin aspiration for troponin testing. Based on a cardiac score of 7 to 10, the patient has a 17% chance of being assigned a high risk of myocardial ischemia with or without epicardial coronary artery disease (CAD); based on a cardiac score of 4 to 6, the patient has a 47% chance of being assigned a moderate risk of myocardial ischemia; and based on a cardiac score of 0 to 3, the patient has a 36% chance of being assigned a low risk of myocardial ischemia with or without epicardial coronary artery disease. If a high-risk score is assigned, the patient is admitted, given intravenous heparin with or without nitroglycerin, and then undergoes catheterization. Conversely, if a low or moderate-risk score is assigned, the patient is confirmed to have a negative result using the MCG imaging and analysis systems, apparatus, and methods of this disclosure, and then discharged. This reduces the need for additional and often unnecessary stress tests, CTA, and other cardiac imaging tests. Therefore, the MCG imaging and analysis systems, devices, and methods disclosed herein are designed for low- and intermediate-risk chest pain patients for whom the ACC / AHA guidelines do not require observational stays and / or stress testing / CTA. This can reduce hospital discharge time by 6 to 20 hours per patient.

[0240] Example

[0241] The following provides non-limiting examples and elements of implementation of the methods, apparatus and systems described herein.

[0242] Example 1

[0243] · Magnetic shielding environment The minimum dimensions include approximately 7 feet wide × approximately 7 feet deep × approximately 7 feet high. In some embodiments, the magnetically shielded environment includes a DC shielding factor of at least approximately 500 at all points at least approximately 1 foot away from each surface of the magnetically shielded environment, wherein the minimum shielding factor is approximately 56 dB over a bandwidth of approximately 0.1 Hz to approximately 500 Hz.

[0244] · Handcart with computer Located outside the magnetically shielded environment. Connected to the computer is the sensor's electronic control module, which is part of the provided device. In some embodiments, each module provides power and control commands to one sensor in an array located on the device arm. In an exemplary embodiment, 1600 is set as follows: Figure 16 As shown.

[0245] ·like Figure 16As shown, the individual lies supine on a base component (such as a bed) 1607. The sensor array 1606 is positioned adjacent to the subject's location, such as the chest area, by adjusting the arm 1605 of the movable trolley device. A shield 1603 is positioned between (i) the subject and the sensor array 1606 and (ii) one or more additional devices 1601 (such as electrical equipment, a power supply, a computer, or any combination thereof). One or more sub-components 1602 (such as wiring) required for operatively connecting one or more additional devices and the sensor array 1606 are housed in conduits or covers. An opening 1604 in the shield 1603 is configured to receive one or more sub-components 1602 for passage therethrough.

[0246] ·like Figure 17 As shown, in some embodiments, the shielding member 1700 includes more than one layer, such as a first layer 1701 and a second layer 1702. In some embodiments, the first layer 1701 and the second layer 1702 are adjacent to each other. In some embodiments, the first layer 1701 and the second layer 1702 are separated by a gap.

[0247] · Base components (e.g., a hospital bed), in some embodiments, is positioned in a magnetically shielded environment in which the individual is positioned (e.g., supine) prior to use of the device. The bed is constructed of non-ferromagnetic materials (e.g., entirely of non-ferromagnetic materials) and non-permanent magnets to minimize the amount of interference that the device can read.

[0248] Setup: To set up the device for use, perform one or more of the following exemplary steps:

[0249] • Ensure the device frame and sensor housing are located within the magnetically shielded chamber. Keep the device in storage mode, where the device's arms are collapsed.

[0250] • Ensure that the control unit is connected to the sensor housing and device frame through one or more entrances to the magnetically shielded chamber.

[0251] • Open the computer interface and launch the software application (such as Maxwell).

[0252] Turn on the power to the electronic control module.

[0253] • Position the individual on the base component 1704 (i.e., the bed), wherein the individual's head is aligned with one side of the base component 1704 and the individual's feet are aligned with a second side of the base component 1704, such as Figure 17 As shown. The magnetic shielding chamber has sufficient clearance to position the magnetocardiograph along at least one side of the base component 1704.

[0254] The individual component is positioned on a base component 1704, which is configured such that at least a portion of the base component 1704 can slide into or out of the shielding opening. The base component 1704 is configured to slide on a track 1705 or to slide on one or more rollers or wheels. At least a portion of the sub-assembly 1703, such as wiring, is configured to operatively connect the sensor array to one or more other devices and is configured to enter at least a portion of the shielding 1700. The sub-assembly 1703 is associated with a hook or latch or track structure within the shielding 1700.

[0255] • Extend the arm of the frame so that the arm forms an angle of approximately 90 degrees with the vertical portion of the frame having a handle (such as an arc handle).

[0256] • Move the device toward the subject by pulling the handle on the frame. Position the device so that the sensor housing is above the area of ​​interest on the subject (e.g., the chest area). Make minor adjustments to place the square platform in the optimal position.

[0257] Align the left side of the housing with the rightmost side of the sensor array platform that is above or near the center line of the individual and parallel to the center line of the individual.

[0258] • Use the lifting mechanism located at the end of the arm on the frame to adjust the height of the sensor housing. Lower the sensor housing to a position above or near the area of ​​interest on the individual (e.g., chest). Rotate the handle in a first direction to lower the sensor housing. Rotate the handle in a second direction to raise the sensor housing.

[0259] Startup: After the frame is in place, activate one or more sensors to prepare for recording signals, such as cardiac magnetic activity. To begin startup, the user logs into a software application (such as Maxwell) and selects the data acquisition module. If any of the following steps fail, close the application and try reopening it. If the problem persists, restart the computer interface. To start the device for use, follow one or more of the following:

[0260] • Ensure that there is a connection to all sensors (e.g., 8 sensors) by checking the sensor status in the data acquisition software user interface.

[0261] • Initiate the automatic start procedure via the software application by pressing "Auto Start" in the data acquisition software user interface. This process calibrates one or more sensors for use. Before continuing, ensure that the readiness indicator found in the software UI has turned green and the status reads "Ready".

[0262] Log: After startup is complete, the device is ready to capture signals, such as cardiac magnetic field data. First, perform one or more of the following:

[0263] • Select the "Acquire" button in the software application. Selecting this option will draw the magnetic field collected from the sensor in the observation window located on the acquisition software UI.

[0264] • Ensure that the collected magnetic field is characteristic of signals such as cardiac electrical activity.

[0265] • To save data to a file, select the "Record" option. Choose your preferred data collection period length, filename, and file save location. Select "Save" to begin saving to the file. In some implementations, the application automatically stops saving after a selected time period. Name the file according to policy guidelines to protect subject identification information.

[0266] Power off and store: After you are finished using the device, shut down the system using one or more of the following methods:

[0267] • Close applications on your computer.

[0268] • Power is cut off to the electronic control module by turning the toggle switch to the "off" position.

[0269] • Turn off the computer.

[0270] Inside the magnetically shielded enclosure, the device's handle is rotated in a first direction to raise the sensor platform. The device is reset by pulling the handle (e.g., an arc handle) so that the arm does not intersect with the subject or base component (e.g., a bed). The extension arm is moved downward toward the ground to return the device to its storage mode. The subject is assisted to rise from the base component. The user, subject, or a combination thereof has the magnetically shielded enclosure.

[0271] Example 2

[0272] Setup: To set up the device for use, perform one or more of the following exemplary steps:

[0273] • Ensure that the equipment frame and sensor housing are free from defects or damage.

[0274] • Open the computer interface and launch the software application.

[0275] Turn on the power to the electronic control module.

[0276] • Pull the base component (such as the bed) out of the magnetic shielding chamber until the bed is completely outside the shielding chamber.

[0277] • Ensure that the locking components of the sensor array and the arm (such as an extension arm) are unlocked. Remove the sensor array from the base component so that the sensor array or any part thereof is not above the base component.

[0278] • Assist the individual onto the surface of the base component. Position the individual on the base component with its head aligned towards one opening of the hole and its feet aligned towards the other opening, as shown. Figure 17 As shown.

[0279] • Move the sensor array over an area of ​​interest on the individual (such as the individual's chest).

[0280] Adjustments are made to ensure the sensor array platform is correctly positioned. Align the housing with the subject's left side, with the rightmost side of the sensor array platform above and parallel to the subject's center line.

[0281] • Lower the sensor array platform to adjust the height of the sensor housing. Lower the housing to a point where it can rest on or near the location of interest on the subject (e.g., the chest).

[0282] • Lock the pivot, joint, or extension point of the sensor array to restrict the movement of the array.

[0283] • Slide the base component into the recess of the shield until external light on the device is indicated (such as turning on, or changing color such as turning green).

[0284] Startup: After the frame is in place, activate one or more sensors to prepare for recording signals, such as cardiac magnetic activity. To begin startup, log in to the software application and select the data acquisition module. If any of the following steps cause problems, close the application and try reopening it. If the problem persists, restart the computer interface. To start the device for use, follow one or more of the following:

[0285] • Ensure there is a connection to one or more sensors (such as 8 sensors) by checking the sensor status in the data acquisition software user interface.

[0286] • Initiate the automatic start procedure via the software application by pressing "Auto Start" in the data acquisition software user interface. This process calibrates one or more sensors for use. Before continuing, ensure that the readiness indicator found in the software UI has turned green and the status reads "Ready".

[0287] Record: After startup is complete, the device is ready to capture signals such as cardiac magnetic field data. First, attach one or more of the following:

[0288] • Select the "Acquire" button in the software application. Selecting this option will draw the magnetic field collected from the sensor in the observation window located on the acquisition software UI.

[0289] • Ensure that one or more of the collected magnetic fields are characteristic of signals such as cardiac electrical activity.

[0290] • To save data to a file, select the "Record" option. Choose your preferred data collection period length, filename, and file save location. Select "Save" to begin saving to the file. The application will automatically stop saving after the selected time period. Name the file according to policy guidelines to protect participant identification information.

[0291] Power off and store: After you are finished using the device, shut down the system using one or more of the following methods:

[0292] • Close applications on your computer.

[0293] • Power is cut off to the electronic control module by turning the toggle switch to the "off" position.

[0294] • Turn off the computer.

[0295] Remove the base component (such as a bed) from the magnetically shielded chamber. Unlock one or more connectors, pivots, or extensions of the sensor array or arm, or combinations thereof, and remove them from the base component so that the path of motion is not in the individual's path. Assist the subject to leave the base component. Clean and disinfect one or more sensor arrays, sensor housings, the inner surfaces of the shield, the surfaces of the base component, or any combination thereof, between the use of the first and second subjects.

[0296] Example 3

[0297] Setup: To set up the device for use, perform one or more of the following exemplary steps:

[0298] • Open the computer interface and launch the software application.

[0299] Turn on the power to the electronic control module.

[0300] • Position the individual on a base component (such as a standard hospital bed), with the individual's head aligned with one side of the base component and the individual's feet aligned with a second side of the base component, for example... Figure 17 As shown. The operating chamber has sufficient clearance to position a sensor array (such as a magnetocardiograph) along at least one side of the base component.

[0301] • Extend the arm of the device and increase its height by pulling up the arm or using the “raise / lower” button on the sensor array, so that the sensor array is positioned above the individual.

[0302] • Move the device toward the individual by pushing a mobile trolley. Position the device so that the sensor housing is above the subject (e.g., above the subject's chest).

[0303] • Use the lifting mechanism located at the end of the arm of the frame to adjust the height of the sensor housing. Lower the sensor housing to a position above or near the inspiratory point of a normal subject (e.g., the individual's chest).

[0304] Adjustments are made to ensure the sensor array platform is correctly positioned. Align the housing with the subject's left side, with the rightmost side of the sensor array platform above and parallel to the subject's center line.

[0305] Startup: After the frame is in place, activate one or more sensors to prepare for recording signals, such as cardiac magnetic activity. To begin startup, the user logs into the software application and selects the data acquisition module. If any of the following steps fail, close the application and try reopening it. If the problem persists, restart the computer interface. To start the device for use, follow one or more of the following:

[0306] • Ensure there is a connection to one or more sensors (e.g., 8 sensors) by checking the sensor status in the data acquisition software user interface.

[0307] • Initiate the automatic start procedure via the software application by pressing "Auto Start" in the data acquisition software user interface. This process calibrates one or more sensors for use. Before continuing, ensure that the readiness indicator found in the software UI has turned green and the status reads "Ready".

[0308] Log: After startup is complete, the device is ready to capture signals, such as cardiac magnetic field data. First, perform one or more of the following:

[0309] • Select the "Acquire" button in the software application. Selecting this option will draw the magnetic field collected from the sensor in the observation window located on the acquisition software UI.

[0310] • Ensure that one or more of the collected magnetic fields are characteristic of signals such as cardiac electrical activity.

[0311] • To save data to a file, select the "Record" option. Choose your preferred data collection period length, filename, and file save location. Select "Save" to begin saving to the file. The application will automatically stop saving after the selected time period. Name the file according to policy guidelines to protect participant identification information.

[0312] Power off and store: After you are finished using the device, shut down the system using one or more of the following methods:

[0313] • Close applications on your computer.

[0314] • Power is cut off to the electronic control module by turning the toggle switch to the "off" position.

[0315] • Turn off the computer.

[0316] Raise the arm of the device by pushing it up or using the "Raise / Lower" button on the sensor array until the sensor array is above the subject's chest level. Assist the subject to rise from the base component.

[0317] Example 4

[0318] Figure 18 An example implementation of a shielding device comprising three layers of high-permeability alloy (the innermost three layers) and one layer of aluminum alloy (the outer layer) is shown. The truncated end is on the left, and the open end is on the right. Although one end of the shielding tube is completely open, if the sensor assembly is located sufficiently far from this open end, the EM noise entering the shielding aperture through the open end will be attenuated to a sufficiently low level so as not to affect the accuracy of any magnetic field measurements obtained from the individual located within the shielding device.

[0319] Figure 19 It shows the following: Figure 18 The graph shows the measured magnetic field values ​​along the centerline of the shielding component. A field level of less than 50 nT is acceptable for system operation. Ambient noise attenuation has been measured and... Figure 19 As shown in the diagram, since the patient's head will be roughly positioned at the point where the cylinder begins to taper, organs of interest within the EM shield, such as, for example, the individual's heart, can be expected to be comfortably positioned within a background noise level (<50 nT) considered acceptable for reliable device performance.

[0320] Example 5

[0321] Figure 20 An example of a sensor array is shown (sensors are shown in black, cables cut off for clarity). To precisely position the sensor array above the patient's heart, the housing can be raised, lowered, and translated laterally (shoulder to shoulder) via a manually operated gear mechanism.

[0322] Figure 21 It shows installation in, such as Figure 18 An example of a 3D rendering of a sensor head holder on a shielding base, such as a shielding device (the patient's head will be on the left and the chest below the inner arch of the shielding device).

[0323] Example 6

[0324] Using the systems, apparatus, and methods of this disclosure, a magnetocardiography (MCG) device (Genetesis, Inc., Mason OH) was used to assess potential acute coronary syndrome patients under observation following normal continuous troponin and electrocardiogram (ECG) assessments. Compared to cardiac stress test-guided coronary angiography, the data showed a sensitivity of 33%, a specificity of 78%, a positive predictive value (PPV) of 13%, and a negative predictive value (NPV) of 92%, where a positive result was defined as at least one epicardial coronary artery stenosis greater than 50%. These results were based on the use of nonparametric qualitative interpretation (NPQI) rules taught to researchers interpreting the magnetocardiograms. These data are consistent with the diagnostic accuracy of MCG reported using similar patient populations in terms of sensitivity (73% to 98%) and specificity (41% to 95%). Importantly, despite the considerable diversity in interpretation rules across the various devices (as shown in Table 1), the ischemia diagnostic pattern of MCG appeared similar across these different reports and was highly sensitive to both acute and subacute levels of cardiac ischemia. In fact, in the absence of traditional negative diagnostic methods, many MCG studies may focus on patients with ischemic MCG patterns.

[0325] Table 1: MCG Equipment Interpretation Rules

[0326]

[0327]

[0328] MCG stands for a non-invasive technique that involves measuring and recording the cardiac magnetic field generated by the electrical currents produced during the depolarization and repolarization processes of cardiomyocytes. Although various detectors were used during the development of MCG devices, the final output uses measurements of the cardiac magnetic field at multiple points simultaneously to generate a magnetic field map, which can be analyzed as an indicator of normal and abnormal cardiac physiology. While ECG uses voltage to assess cardiac electrical function, MCG appears to have a unique sensitivity to tangential and eddy currents generated in the subepicardial and deeper layers of myocardium due to the electrical property gradient between normal and ischemic tissue, partly because such currents lack electrical counterparts.

[0329] These results are based on the use of nonparametric qualitative interpretation (NPQI) rules taught to researchers interpreting magnetograms. Due to the unique potential advantages of MCGs and the variability in MCG interpretation, magnetograms were re-evaluated to develop parametric interpretation (PBI) rules based on actual clinical outcomes for MCGs generated using the systems, devices, and methods of this disclosure for patients with and without myocardial ischemia. Furthermore, accuracy statistics among experienced MCG interpreters were compared, and interpretation rules based on Delphi process-derived parameters were identified, along with reliability ratings among evaluators.

[0330] method

[0331] The MCG study was conducted as follows. In short, 101 patients with potential acute coronary syndrome were admitted for observational evaluation after a series of negative troponin and ECG results for acute myocardial infarction. Four patients underwent direct coronary angiography for clinical reasons, while the remaining 97 patients underwent cardiac stress testing, with positive patients further assigned to coronary angiography for either revascularization or non-revascularization, as determined by a treating cardiologist. Magnetogram results assessed by researchers (study reads) using the NPQI method based on their pre-trial training were retrieved. The magnetograms were blinded (overread) by experienced individuals using the same NPQI method. The Delphi process involved three rounds of review by a group of individual individuals comparing the magnetograms to the actual results to establish the PBI rule criteria outlined below.

[0332] Three groups of interpretations (study, overread, and PBI) were compared for sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, PPV, NPV, and accuracy. Cohen Kappa scores were calculated for PBI against each of the other two groups of interpretations. Magnetic field interpretations were defined as non-ischemic or ischemic using the following rules. Clinical ischemia was redefined using the decision to perform coronary angiography-ascertained revascularization as a comprehensive assessment of epicardial coronary artery lesions associated with cardiac ischemia. No patients had troponin levels or ECG diagnoses of cardiac ischemia.

[0333] Nonparametric Qualitative Interpretation (NPQI) rules are based on the following outputs obtained from various MCG devices: a magnetic field map, which is generated as a superimposed waveform of 36 magnetic field intensities and the time of a single cardiac cycle and presented to the interpreting physician (e.g., Figure 33(As shown). The magnetic field map is evaluated for interpretation (instead of or in conjunction with waveform analysis). The magnetic field map represents a two-dimensional (2D) representation of the current vector sum. Each individual waveform represents the magnitude of the magnetic field perpendicular to the chest wall, measured a few inches above the individual's torso. The MCG imaging and analysis system was used to acquire data from 36 sensors arranged in a uniform 6x6 grid, so each black circle shown in the figure below represents a "true data point," and the color coding indicates the direction and intensity of the magnetic field. For example, red indicates a current vector with a positive amplitude, while blue indicates a current vector with a negative amplitude. All information in the "sea of ​​colors" representation of the magnetic field map (MFM) outside the 36 grid points is interpolated using data from these grid points (e.g., ...). Figure 33 (As shown). For example, interpolation can be performed to upsample an image from a 6x6 pixel grid to a 50x50 pixel grid. The magnetic field can be in waveform mode (e.g., Figure 34 (As shown) (which can mimic the traditional format of ECG voltage representation) and / or a separate magnetograph (which shows normal or ischemic patterns) is presented as a visual representation of the sensed magnetic field data. For example, the waveform pattern can include a superposition of data acquired at multiple (e.g., 1,000) discrete time points over a single cardiac cycle. For each discrete time point, the most positive and most negative values ​​of the MCG data can be determined and used for further analysis. For example, the waveform pattern can include the R peak depolarization time 3402 and the T peak repolarization time 3404 (as shown) Figure 34 (As shown).

[0334] Nonparametric Qualitative Interpretation (NPQI)

[0335] The following nonparametric qualitative interpretation (NPQI) rules can be applied to magnetographs. First, assess the scan quality to evaluate readability. Second, examine the MCG waveform to identify P-wave deflection (potentially small deflection), QRS complex deflection, and T-wave deflection. Available time intervals on the horizontal baseline can be used to measure PR, QRS, and QT intervals as appropriate. Readers may specifically look for evidence of interval prolongation (e.g., QRS intervals to find evidence of bundle branch block / conduction delay), which may indicate conduction disorders and could affect interpretation.

[0336] Third, the interval between the onset of T-wave deflection and the peak of the T-wave is assessed as follows. During this T-wave interval, the reader assesses whether the magnetic pole cores (e.g., red electromagnetic dipoles versus blue electromagnetic dipoles) are well-defined. For example, poorly defined magnetic pole cores indicate abnormal myocardial electrical function (e.g., characteristic of myocardial ischemia in an individual). Furthermore, the stability of the vector angle between the positive and negative magnetic pole cores is determined. For example, a vector angle stability of less than 30 degrees indicates a normal finding; conversely, a shift or rotation of the vector angle during the T-wave interval indicates an abnormal finding. Additionally, any significant gaps in the magnetic field distribution (e.g., areas without net magnetic inflow or outflow) are identified. For example, any asymmetric gaps in the cardiac magnetogram indicate myocardial injury (e.g., characteristic of myocardial ischemia in an individual). Furthermore, magnetic pole splitting is assessed. For example, the presence of distinct positive and negative magnetic poles during repolarization indicates a normal finding; conversely, splitting of either positive or negative magnetic poles during this interval indicates an abnormal finding.

[0337] Fourth, the NPQI rules are used to determine the diagnostic conclusion as follows. A non-ischemic outcome (e.g., a normal outcome) is specified based on a combination of the following: the presence of a well-defined magnetic core during the T wave; vector angular stability between positive and negative magnetic cores of less than 30 degrees; and the presence of distinct positive and negative magnetic poles during repolarization. Conversely, an ischemic outcome (e.g., an abnormal outcome) is specified based on any of the following: the presence of an indistinct magnetic core, indicating abnormal myocardial electrical function; a vector angle of at least 30 degrees, or a shift or rotation vector angle through the T wave interval; an asymmetric gap in the cardiac magnetic field map; and the splitting of a positive or negative electromagnetic dipole.

[0338] Parameter-Based Interpretation (PBI)

[0339] Using the systems, apparatus, and methods of this disclosure, magnetographs can be interpreted according to the following parametric-based interpretation (PBI) rules. First, the scan quality is evaluated to assess the readability of the scan. Second, the duration of the QRS complex wave is evaluated to identify bundle branch conduction block (e.g., with a duration greater than 120 milliseconds (ms)). This allows for the identification of the initial R-wave peaks (since these two peaks are visualized using bundle branch blocks), which can be used to calculate the angles as described below. Third, the peak values ​​of the R-wave and T-wave are determined.

[0340] Third, the R-angle and T-angle are then calculated using the peak values ​​of the R-wave and T-wave, as follows. First, corresponding to the R-wave ( Figure 27A ) and T wave ( Figure 27BOn the magnetic field diagram, identify the centers of the negative electromagnetic dipole (shown in blue) and the positive electromagnetic dipole (shown in red), respectively. For example, the centers of the negative or positive electromagnetic dipoles can be identified by determining their centroids. Next, using the center of the negative electromagnetic dipole (blue), define an X vector extending horizontally to the right side of the magnetic field diagram, and define a Y vector extending from the center of the negative electromagnetic dipole (blue) through the center of the positive electromagnetic dipole (red).

[0341] Next, the peak R-wave depolarization angle is determined, which involves determining the angle of the R-wave from the X vector to the Y vector. When the Y vector is positioned counterclockwise relative to the X vector, a negative angle is assigned to the R-wave; conversely, when the Y vector is positioned clockwise relative to the horizontal X vector, a positive angle is defined for the R-wave.

[0342] Similarly, determining the peak T repolarization angle involves determining the angle of the T wave from the X vector to the Y vector. A negative angle is assigned to the T wave when the Y vector is positioned counterclockwise relative to the X vector; conversely, a positive angle is defined for the T wave when the Y vector is positioned clockwise relative to the horizontal X vector.

[0343] Next, the peak angle difference of RT is determined, which involves determining the absolute difference between the two angles (peak R depolarization angle and peak T repolarization angle). For example, if the peak R angle is -45 degrees and the peak T angle is -30 degrees, then the peak angle difference of RT is 15 degrees.

[0344] Fourth, assess the entire duration of the T-wave to identify single electromagnetic dipoles and multiple electromagnetic dipoles (positive or negative) that appear during the T-wave process on the magnetograph.

[0345] Fifth, the PBI rules are used to determine the diagnostic conclusion as follows: A non-ischemic result is specified when the RT peak angle difference is less than 100 degrees, or when the RT peak angle difference is between 170 and 190 degrees and a single electromagnetic dipole is present in the magnetic field map. An ischemic result is specified when the RT peak angle difference is between 100 and 170 degrees (with or without multiple electromagnetic dipoles in the magnetic field map), or when multiple electromagnetic dipoles are present in the magnetic field map (regardless of the RT peak angle difference value).

[0346] Statistical analysis included calculations of sensitivity, specificity, positive and negative likelihood ratios, PPV, NPV, and accuracy. Cohen Kappa scores were calculated for each of the PBI and the other two groups of explanations.

[0347] result

[0348] Demographic and raw outcome data reported in the Pena study were obtained. Accuracy indices and Kappa scores for composite ischemia measurements of coronary angiography-guided revascularization were calculated for the three reader groups, as shown in Table 2. The results indicate that assessments using the PBI rule generally outperformed those using the other two interpretations, particularly in terms of NPV and overall accuracy, which is important when considering tests to “exclude” diagnostic criteria for cardiac ischemia. The Kappa score for PBI versus overreading was 0.82, and for PBI versus study reading was 0.72. These scores are consistent with high correlation, indicating that the overall MCG imaging and analysis apparatus of this disclosure can be used to produce high-quality magnetographs with consistent, identifiable elements that can differentiate between ischemic and non-ischemic conditions. However, the incremental improvement in accuracy favoring experienced readers over study readers suggests a steeper learning curve. The superior accuracy of the discrete PBI rule could provide greater consistency and a shallower learning curve.

[0349] Table 2: Accuracy Indicators of PBI, NPQI (Overreading), and NPQI (Study Reading)

[0350]

[0351]

[0352] discuss

[0353] Data suggests that a simple set of structured PBI rules can provide accurate interpretation of cardiac magnetograms for diagnosing or ruling out myocardial ischemia in individuals. A consistent key element for effective analysis of magnetograms appears to be the inquiry into the depolarization phase of cardiac cell function and the T-wave-dominated repolarization phase. These data are consistent with studies examining diagnostic patterns caused by ischemic changes in the current vector and the resulting magnetic field. Other studies may rely on different interpretation rules, and many rule sets are inherently relatively subjective, making consistent assessment across providers more difficult to implement (as shown in Table 1). This study provides a narrow set of magnetogram data required for diagnosing ischemia, much of which is visually interpretable but can also be precisely determined using mathematical algorithms. The proposed set of rules focuses on comparative depolarization, which is energy-independent and represented by the peak of the R-wave, automatically provided to the reader by software analysis and evaluation of the magnetic field waveform. Alternatively, the reader can override this displayed data element (determined using mathematical algorithms) and manually select his or her own determination of the peak R-wave location (determined based on the reader's visual assessment), then use that location to define the “peak R” and the subsequent “R angle” (as described above). The reader then turns to the peak T wave, which has been automatically provided through software analysis and evaluation of the magnetic field waveform. Alternatively, the reader can override this displayed data element (determined using mathematical algorithms) and manually select his or her own determination of the peak T wave location (determined based on the reader's visual perception), then use that location to define the "peak T" and the subsequent "T angle" (as described above). The difference between these angles is defined as the "RT angle difference." These indicators are important because cardiac cell depolarization begins at the endocardial surface and continues to the epicardial surface, with repolarization only occurring in the opposite direction. Therefore, while the gap should theoretically be zero, the data indicating a physiological non-ischemic pattern can range from 0 to 100 degrees. It should be noted that left bundle branch block produces a double R peak phenomenon; by convention, the initial peak is selected to determine the "RT angle difference," which is normally defined in the same way. Alternatively, the MCG has identified a conduction abnormality that is not identified on the ECG, but an assessment of the MFM indicates an "RT angle difference" of 180 degrees ± 10 degrees.

[0354] Other important criteria identified in the analysis as being clearly associated with myocardial ischemia were the presence of multiple electromagnetic dipoles (positive or negative) during the T-wave. In fact, regardless of etiology, this was determined to be almost universally associated with cellular-level ischemia because it is linked to poorly controlled heart failure and epicardial coronary artery disease. This phenomenon was also presented in the work of Hailer et al. Abnormal MCG patterns appear to persist in the early recovery phase following both ST-segment elevation and non-ST-segment elevation myocardial infarctions and are associated with higher morbidity and mortality. This suggests that persistent microvascular ischemia represents an unmet need to guide post-discharge medical management of cardiac patients. Similarly, because ischemic magnetic field mapping diagnostic patterns represent cellular-level ischemia, this technique has the potential to expand the patient population beyond those at risk of severe epicardial coronary artery occlusive disease, regardless of the device used.

[0355] Statistical accuracy can be confirmed in different patient groups at risk of ischemic cardiomyocytes (including STEMI, NSTEMI, microvascular ischemia, and type 2 myocardial infarction). Developing diagnostic pathways including MCG to inform early assessment of patients with potential acute coronary syndromes and uncertain troponin levels is another useful application of magnetofluidography. Furthermore, the systems, devices, and methods disclosed herein can be used as alternatives to other methods of assessing patients with cardiac stress without requiring trained technicians or radiopharmaceuticals.

[0356] in conclusion

[0357] Using the systems, apparatus, and methods of this disclosure, magnetocardiography imaging and analysis devices have been demonstrated to generate magnetocardiograms that can be evaluated using a structured PBI rule set, thereby effectively diagnosing cardiac ischemia caused by multiple mechanisms without the need for trained technicians, radiopharmaceuticals, or exposure to external beam radiation. Further validation of specific diagnostic criteria related to the evaluation of both QRS complexes and T waves can be achieved through wider use of this technique in various patient populations. Therefore, the systems, apparatus, and methods of this disclosure enable rapid and safe assessment of cardiac patients based on the evaluation of cardiac magnetocardiograms, without the need for expensive shielded rooms located near service points.

[0358] References

[0359] [Pena ME, Pearson CL, Goulet MP, Kazan VM, DeRita AL, Szpunar SM, Dunne RB. A 90-second magnetocardiogram using a novel analysis system to assess forcoronary artery stenosis in emergency department observation unit chest pain patients Int J Cardiol Heart Vasc. 2020 Jan8;26:100466. doi:10.1016 / j.ijcha.2019.100466.eCollection 2020 Feb.] This article is incorporated in its entirety by reference.

[0360] [Hailer B, Van Leeuwen P. Detection of coronary artery disease with MCG. Neurol Clin Neurophysiol 2004; 2004:82] is incorporated herein by reference in its entirety.

[0361] [Park JW, Leithauser B, Vrsansky M, et al. Dobutamine stressmagnetocardiography for the detection of significant coronary arterystenoses–a prospective study in comparison with simultaneous 12-lead electrocardiography. Clin Hemorheol Microcirc. 2008; 39(1–4):21–32.4] is incorporated herein by reference in its entirety.

[0362] [Lim HK, Kwon H, Chung N, Ko YG, Kim JM, Kim IS, Park YK. Usefulness of magnetocardiogram to detect unstable angina pectoris and non-ST elevationmyocardial infarction. Am J Cardiol. 2009 Feb 15; 103(4): 448-54] is incorporated herein by reference in its entirety.

[0363] [Gapelyuk A, Schirdewan A, Fischer R, et al. Cardiac magnetic field mapping quantified by kullback-leibler entropy detects patients with coronary artery disease. Physiol Meas. 2010; 31(10): 1345–1354] is incorporated herein by reference in its entirety.

[0364] [Tolstrup K, Madsen BE, Ruiz JA, et al. Non-invasive resting magnetocardiographic imaging for the rapid detection of ischemia in subjects presenting with chest pain. Cardiology. 2006; 106(4):270–276] is incorporated herein by reference in its entirety.

[0365] [Steinberg BA, Roguin A, Watkins SP 3rd, et al. Magnetocardiogram recordings in a nonshielded environment–reproducibility and ischemia detection. Ann Noninvasive Electrocardiol. 2005; 10(2):152–160] is incorporated herein by reference in its entirety.

[0366] [Kandori A, Ogata K, Miyashita T, et al. Subtraction magnetocardiogram for detecting coronary heart disease. Ann Noninvasive Electrocardiol. 2010; 15(4):360–368] is incorporated herein by reference in its entirety.

[0367] [Baule G, McFee R. Detection of the magnetic field of the heart. AmHeart J. 1963; 66:95–96.8] is incorporated herein by reference in its entirety.

[0368] [Moshage W, Achenbach S, Weikl A, et al. Clinical magnetocardiography: Experience with a biomagnetic multichannel system. Int J Card Imaging. 1991; 7(3–4): 217–223] is incorporated herein by reference in its entirety.

[0369] [Hopenfeld B, Stinstra JG, Macleod RS. Mechanism for ST depression associated with contiguous subendocardial ischemia. J Cardiovasc Electrophysiol. 2004; 15(10): 1200–1206] is incorporated herein by reference in its entirety.

[0370] [Lim HK, Kwon H, Chung N, Ko YG, Kim JM, Kim IS, et al. Usefulness of magnetocardiogram to detect unstable angina pectoris and non-ST elevationmyocardial infarction. Am J Cardiol 2009; 103:448-54] is incorporated herein by reference in its entirety.

[0371] [Kyoon Lim H, Kim K, Lee YH, Chung N. Detection of non-ST-elevation myocardial infarction using magnetocardiogram: new information from spatiotemporal electrical activation map. Ann Med. 2009; 41(7):533-46] is incorporated herein by reference in its entirety.

[0372] [Van Leeuwen P,Hailer B,Beck A,Eiling G, D. Changes indipolar structure of cardiac magnetic field maps after ST elevation myocardial infarction. Ann Noninvasive Electrocardiol 2011; 16:379-87] is incorporated herein by reference in its entirety.

[0373] Example 7

[0374] Using the systems, apparatus, and methods of this disclosure, a magnetocardiography (MCG) device (Genetesis, Inc., Mason OH) was used to assess individuals under observation for potential acute coronary syndrome following normal continuous troponin and electrocardiogram (ECG) assessments. As described herein, the MCG device generates magnetocardiograms and interprets them using PBI rules.

[0375] Interpretation of a magnetic field map can include pattern recognition. For example, the initial focus of the interpretation might be the duration of the R-peak and T-wave. In some implementations, interpretation of the magnetic field map involves viewing the map in time series and frozen images during the waveform segments of interest (e.g., the time periods corresponding to the R-peak and T-peak). This approach provides global and granular data in the MCG mode and enables static and dynamic views of the magneto-electromagnetic dipole within the magnetic field map.

[0376] Interpreting a magnetic field diagram may include identifying positive magnetic poles (e.g., shown in red) and negative magnetic poles (e.g., shown in blue) during the duration of the R-peak and T-wave. For example, a positive magnetic pole may be identified as the center of a positive magnetic field value (e.g., the center of mass), and a negative magnetic pole may be identified as the center of a negative magnetic field value (e.g., the center of mass). A first vector may be defined between the positive and negative magnetic poles to determine an angle therefrom. Alternatively, a first line, segment, or ray may be defined between the positive and negative magnetic poles to determine an angle therefrom. A second vector may be defined as a horizontal vector (e.g., having the same direction as the positive x-axis) to determine an angle therefrom. Alternatively, a second line, segment, or ray parallel to the horizontal vector (e.g., having the same direction as the positive x-axis) may be defined to determine an angle therefrom. Without loss of generality, the second vector, line, segment, or ray may pass through a negative magnetic pole (shown in blue). Alternatively, the second vector, line, segment, or ray may pass through another point (e.g., any point between the positive and negative magnetic poles) without affecting the determination of the angle therefrom. The first vector and / or the second vector can be expressed using any suitable coordinate system, including but not limited to 2-D Cartesian coordinates, 3-D Cartesian coordinates, rectangular coordinates, parametric coordinates, and polar coordinates.

[0377] After determining the first and second vectors, a vector angle can be defined based on the positive and negative magnetic poles at a given time. The vector angle can represent the angle between the first and second vectors. The vector angle can be determined as the smallest angular change between the first and second vectors. For example, the vector angle can have a value in the range of 0 to 360 degrees, or equivalently, it can have any integer multiple of 360 added to or subtracted from it to obtain a value in the range of 0 to 360 degrees. For example, the vector angle θ can be determined using the following expression: cos(θ) = a(|a||b|), where a and b represent the first and second vectors respectively, "·" denotes the vector dot product, and "·" denotes the vector magnitude.

[0378] For example, the peak R depolarization angle can be determined as the vector angle of the magnetic field map associated with the time period during which the R wave (and the corresponding R peak) occurs (e.g., which can be measured using ECG). As another example, the peak T repolarization angle can be determined as the vector angle of the magnetic field map associated with the time period during which the T wave (and the corresponding T peak) occurs (e.g., which can be measured using ECG).

[0379] Such vector angles can be determined at two distinct time points (e.g., during the R-peak and T-peak periods), and the differences, variations, or migration rates of vector angles from two different magnetographs (e.g., from the R-peak compared to the T-peak) can be used to perform magnetograph assessments of coronary artery disease (e.g., positive or negative results for ischemia). The differences, variations, or migration rates of vector angles can be determined based on the positive clockwise angle between two vector angles (e.g., from the R-peak compared to the T-peak). Alternatively, the differences, variations, or migration rates of vector angles can be determined based on the positive counterclockwise angle between two vector angles (e.g., from the R-peak compared to the T-peak).

[0380] As an example, the presence of a movement or rotation vector angle with a difference of no more than 100 degrees indicates that the magnetic field map does not show evidence of ischemia (e.g., negative or non-ischemic result). Conversely, as another example, the presence of a movement or rotation vector angle with a difference of more than 100 degrees indicates that the magnetic field map shows evidence of ischemia (e.g., positive or ischemic result).

[0381] As another example, the presence of a complete 180-degree reversal of the vector angle difference between the positive and negative magnetic poles (e.g., comparing an R-peak magnetograph with a T-peak magnetograph) indicates that the magnetograph shows a conduction abnormality in the subject's heart, rather than ischemia; the subject receives a positive result for the abnormality but a negative result for ischemia. As another example, the presence of multiple electromagnetic dipoles in the magnetograph during any part of the T wave indicates that the magnetograph shows an abnormality.

[0382] A magnetograph associated with a normal outcome (e.g., no cardiac abnormality detected in the subject) may have one or more of the following characteristics. First, there may be a normal QRS duration and morphology, but no evidence of any waveform variation that could indicate an underlying abnormality. Second, the vector difference between the electromagnetic dipoles in the magnetographs at the R-peak and T-peak phases is 100 degrees or less. When viewing the polar orientation in the magnetograph during the T-wave phase, the positive pole is typically located near the upper right quadrant (RUQ) of the screen, while the negative pole is typically located near the lower left quadrant (LLQ). As an example, a complete 180-degree reversal of the vector angle difference between the R-peak and T-peak phases indicates no evidence of ischemia (e.g., a negative or non-ischemic outcome). Third, only one positive electromagnetic dipole and one negative electromagnetic dipole may be present during the T-wave duration.

[0383] Figures 35A to 35B Examples of R-peak and T-peak magnetographs for subjects are shown, which are interpreted as having normal (e.g., non-ischemic) outcomes, where the vector between positive and negative electromagnetic dipoles is consistent during the R-peak period compared to the T-peak period. Here, the R-peak appears in the waveform representation corresponding to the peak R depolarization ( Figure 35AThe peak T occurs at a time of 400 ms on the waveform, while the peak T peak appears in the waveform representation corresponding to the peak T repolarization. Figure 35B At time 703ms on the time scale.

[0384] Figures 36A to 36B Examples of R-peak and T-peak magnetographs for subjects are shown, interpreted as having normal (e.g., non-ischemic) outcomes, where the vector between positive and negative electromagnetic dipoles shows a 180-degree flip during the R-peak compared to the T-peak. Here, the R-peak appears in the waveform representation corresponding to the peak R depolarization ( Figure 36A The peak T occurs at a time of 400 ms on the waveform, while the peak T peak appears in the waveform representation corresponding to the peak T repolarization. Figure 36B At time 717ms on the time scale.

[0385] Furthermore, the magnetograph associated with abnormal outcomes (e.g., cardiac abnormalities detected in the subject, such as ischemia or conduction abnormalities) may have one or more of the following characteristics: First, multiple poles are present in the magnetograph during the T-band. Second, when comparing the R-peak magnetograph and the T-peak magnetograph, the positive and negative magnetic poles of the magnetographs are rotated more than 100 degrees relative to each other.

[0386] Figures 37A to 37B Examples of R-peak and T-peak magnetographs of subjects are shown, which are interpreted as having abnormal (e.g., ischemic) outcomes, wherein multiple electromagnetic dipoles are present during the T-peak magnetograph, completely surrounding the positive electromagnetic dipole. Here, the R-peak appears in the waveform representation corresponding to the peak R depolarization ( Figure 37A The peak T occurs at 399 ms, while the peak T appears in the waveform representation corresponding to the peak T repolarization. Figure 37B At time 609ms on the time scale.

[0387] Figures 38A to 38B Examples of R-peak and T-peak magnetographs of subjects are shown, interpreted as having abnormal (e.g., ischemic) outcomes, where the vector between the positive and negative electromagnetic dipoles shows electromagnetic dipole motion exceeding 100 degrees during the R-peak period compared to the T-peak. Here, the R-peak appears in the waveform representation corresponding to the peak R depolarization ( Figure 38A The peak T occurs at a time of 400 ms on the waveform, while the peak T peak appears in the waveform representation corresponding to the peak T repolarization. Figure 38B At time 690ms on the time scale.

[0388] Example 8

[0389] Using the systems, apparatus, and methods of this disclosure, a set of one or more of the following parameters and / or graphs is determined using an individual's magnetograph, and this set of parameters and / or graphs is analyzed to assess cardiac ischemia in the individual. For parameter classification, parameters can be quantitatively measured (e.g., using dipole parameters, integrated MCD parameters, integrated ECD parameters, average PCD parameters, isointegral parameters, field map-related parameters, R_peak hooked dipole parameters, pseudo-current arrow parameters, extremum circle parameters, phase space embedding parameters using incremental coordinates, and / or phase space embedding parameters using time-delay coordinates). Alternatively or in combination, for visual classification (e.g., manually or using computer-based machine vision techniques), graphs (e.g., STAG graphs, T_peak MFM graphs, field map animations, pseudo-current density arrows, MCD graphs, and / or ECD graphs) can be qualitatively determined.

[0390] In some implementations, dipole parameters are determined by measuring the angle and amplitude parameters of a magnetic field map over a specified time range and at the peak of T. These parameters may include measurements of Ts / 3, Tp, Te / 3, etc. For example, dipole parameters (e.g., peak angle, maximum angle, minimum angle, angular dynamics, distance dynamics, and minimum-maximum ratio) can be measured from a magnetic field map. As another example, dipole parameters (e.g., peak angle, minimum angle, maximum angle, and angular dynamics) can be measured from a current map. Dipole parameters can be described, for example, by Lim et al., “Detection of non-ST-elevation myocardial infarction using magnetocardiogram: New information from spatiotemporal electricalactivation map,” Annals of Medicine, 2009, DOI:10.1080 / 07853890903107883, the entire contents of which are incorporated herein by reference.

[0391] In some implementations, the parameters are determined using the integrated maximum current density (MCD) method, which involves determining the average measurement of the current vector with the maximum amplitude at each time point from the start to the end of the T-wave. This can include measurements of PCD, Ts, Te, etc. For example, integrated MCD parameters (e.g., amplitude, angle, perimeter, and area) can be measured from a magnetic field map (e.g., of size 4x4, 6x6, or 50x50). Integrated MCD parameters can be described, for example, by Zhao et al., “An Integrated Maximum Current Density Approach for Noninvasive Detection of Myocardial Infarction,” IEEE Journal of Biomedical and Health Informatics, 2016, DOI10.1109 / JBHI.2017.2649570, the entire contents of which are incorporated herein by reference.

[0392] In some implementations, the parameters are determined using an equivalent current density (ECD) method, which involves determining the average measurement of the equivalent current vector calculated at each time point from the start to the end of the T-wave. This can include measurements of ECD, Ts, Te, etc. For example, integrated ECD parameters (e.g., amplitude, angle, perimeter, and area) can be measured from a magnetic field diagram (e.g., of size 4x4, 6x6, or 50x50). Integrated ECD parameters can be described, for example, by Zhao et al., “An Integrated Maximum Current Density Approach for Noninvasive Detection of Myocardial Infarction,” IEEE Journal of Biomedical and Health Informatics, 2016, DOI 10.1109 / JBHI.2017.2649570, the entire contents of which are incorporated herein by reference.

[0393] In some implementations, the parameters are determined using an average pseudo-current density (PCD) method, which involves determining the average measured value of the current vector arrow at each time point from the start to the end of the T-wave. This can include measurements of PCD, Ts, Te, etc. For example, average PCD parameters (e.g., amplitude, angle, perimeter, and area) can be measured from a magnetic field diagram (e.g., of size 4x4, 6x6, or 50x50). Average PCD parameters can be described, for example, by Kandori et al., “A method for detecting myocardial abnormality by using a total current-vector calculated from ST-segment deviation of amagnetocardiogram signal”, Med. Biol. Eng. Comput., 2000, 38, 21-28, the entire contents of which are incorporated herein by reference.

[0394] In some implementations, the parameters are determined using an isointegration method, which involves determining an integral measurement of the current vector arrow at each spatial point in the QRS complex or T wave, which may include measurements of PCD, Q, S, Te, etc. For example, isointegration parameters (e.g., QS maximum integrated current, ST maximum integrated current diff integrated current, and QS MIC>STMIC) can be measured from a magnetic field diagram. Isointegration parameters can be described, for example, by Watanabe et al., “Magnetocardiography in Early Detection of Electromagnetic Abnormality in Ischemic Heart Disease,” J Arrhythmia, Vol. 24, No. 1, 2008, the entire contents of which are incorporated herein by reference.

[0395] In some implementations, field map correlation methods are used to determine parameters. These methods involve determining the correlation of a magnetic field map at a specific time point within other time ranges, which may include measurements of T_peak, R_peak, etc. For example, field map correlation parameters (e.g., the mean and / or standard deviation of the T_peak correlation on T_wave, the T_peak correlation on R-wave, the T_peak correlation on T-wave, and / or the R_peak correlation on R-wave) can be measured from 100Hz low-pass and 20Hz low-pass filtered data. Field map correlation parameters can be described, for example, by Goernig et al., “Magnetocardiography Based Spatiotemporal Correlation Analysis is Superior to Conventional ECG Analysis for Identifying Myocardial Injury,” Annals of Biomedical Engineering, Vol. 37, No. 1, 2009, the entire contents of which are incorporated herein by reference.

[0396] In some implementations, the parameters are determined using the R_peak hooked dipole parameter method, which involves determining measurements of angular and / or amplitude parameters of a magnetic field map over a specified time range, where many angular parameters are calculated relative to the R_peak field map angle; this may include measurements of T_peak, R_peak, etc. For example, R_peak hooked dipole parameters (e.g., R_peak_FMA, T_peak_FMA–R_peak_FMA, TT_CAmax, TT_CAmax–R_peak_FMA, and JT_CMD (indicating the change in maximum current amplitude over 20 ms from J_point to T_end)) can be measured from 100 Hz low-pass and 20 Hz low-pass filtered data. R_peak hooked dipole parameters can be described, for example, by Kwon et al., “Non-Invasive Magnetocardiography for the Early Diagnosis of Coronary Artery Disease in Patients Presenting With Acute Chest Pain,” Circulation Journal, Vol. 74, 2010, the entire contents of which are incorporated herein by reference.

[0397] In some implementations, a pseudo-current arrow parameter method is used to determine the parameters. This method involves determining the measured values ​​of the average current arrow plot at the T-peak of the magnetic field plot using all arrows (global) or any one of the four plot limits (Q1, Q2, Q3, Q4); this can include measurements of PCD, T_peak, etc. For example, the pseudo-current arrow parameters can be related to the amplitude (e.g., mean, variance, kurtosis, and / or skewness) and / or the angle (mean, variance, kurtosis, and / or skewness) at T_peak. Pseudo-current arrow parameters can be described, for example, by Udovychenko et al., “Binary Classification of Heart Failures Using k-NN with Various Distance Metrics,” International Journal of Electronics and Telecommunications, Vol. 61, Issue 4, 2015, the entire contents of which are incorporated herein by reference.

[0398] In some implementations, the parameters are determined using an extrema circle parameter method, which includes determining measurements of the ratio of positive to negative areas and the curvature of the zero profile within a circle drawn with the edges of the contacting positive and negative electrodes; this may include measurements of T_end, T_begin, etc. For example, the extrema circle parameters may be related to the area ratio and / or profile curvature of a magnetocardiogram. Extrema circle parameters can be described, for example, by Wu et al., “Noninvasive Diagnosis of Coronary Artery Disease Using Two Parameters Extracted in an Extrema Circle of Magnetocardiogram,” 35th Annual International Conference of the IEEE EMBS, 2013, the entire contents of which are incorporated herein by reference.

[0399] In some implementations, the parameters are determined using a phase space embedding parameter method, which includes using incremental computation to determine a reconstruction of a multidimensional phase space approximation of the signal; this may include measurements of incremental coordinates, etc. For example, the phase space embedding parameters may be related to dimensions (M) such as 2, 3, or 6, such as binning parameters bound to 10^M bins, or even the count for each bin, and a Gaussian mixture model with 20 mixtures.

[0400] In some implementations, a phase space embedding parameter method is used to determine the parameters, which includes using time delays to determine a reconstruction of a multidimensional phase space approximation of the signal; this can include measurements of incremental coordinates, etc. For example, the phase space embedding parameters may be related to dimensions (M) such as 2, 3, or 6, such as binning parameters bound to 10^M bins, or even the count per bin, and a Gaussian mixture model with 20 mixtures.

[0401] In some implementations, the STAG plot is generated by drawing average current arrows in the base-to-top direction and from left to right; this can include measurements of PCD, S, Te, etc. For example, one or more of the following visual indicators can be evaluated: no separation or discontinuity in the core, no left-hand tail, consistent centering of the red core, smooth shape of the comet head, good core-T-wave matching, compressed excitation shape and region, and / or compression on the y-axis.

[0402] In some implementations, a T-peak MFM curve is generated by plotting the MFM at the T-peak. For example, one or more of the following visual metrics can be evaluated: compressed dipole, stretched dipole, disconnected dipole, and / or rotating dipole.

[0403] In some implementations, field map animation is generated by evaluating the animation of the MFM at the T-peak based on certain visual metrics. For example, one or more of the following visual metrics may be evaluated: dipole drift, dipole rotation, and / or multipole.

[0404] In some implementations, pseudo-current density arrows are generated by evaluating the pseudo-current arrow diagram based on certain visual indicators (e.g., to classify MFM into one of five categories). For example, one or more of the following visual indicators can be evaluated: dipole presence, dipole orientation, majority vector direction, and / or eddy current uniformity. Pseudo-current density arrows can be described, for example, by Hailer et al., “The Value of Magnetocardiography in the Course of Coronary Intervention,” Annals of Noninvasive Electrocardiology, Vol. 10, No. 2, 2005, the entire contents of which are incorporated herein by reference.

[0405] In some implementations, the MCD curve is generated by evaluating the magnetic field map based on the maximum current density vector. In some implementations, the ECD curve is generated by evaluating the magnetic field map based on the equivalent current density vector. In some implementations, the magnetic field map is evaluated based on one or more of the following visual metrics: Q, S, Ts, Ts / 3, Tp, Te / 3, Te, and / or Rp.

[0406] While preferred embodiments of the invention have been shown and described herein, it will be readily understood by those skilled in the art that such embodiments are provided by way of example only. Many modifications, alterations, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein will be employed in the practice of the invention. The following claims are intended to define the scope of the invention and therefore cover the methods and structures within the scope of these claims and their equivalents.

Claims

1. A system for determining the presence, absence, or likelihood of coronary artery disease in an individual, comprising: (1) A sensing device configured to sense a magnetic field associated with an individual, wherein the device comprises: a. Movable base component; b. An arm having a proximal end and a distal end, the proximal end being coupled to the movable base member via a first contact, the first contact being configured such that the arm moves relative to the movable base member with at least one degree of freedom; and c. An array of one or more optically pumped magnetometers coupled to the distal end of the arm, the array of one or more optically pumped magnetometers being configured to sense the magnetic field associated with the individual; and (2) A non-transitory computer-readable medium encoding a computer program, said computer program including instructions executable by a processor, said instructions being configured to cause the processor to: i. Receive a first magnetic field associated with the individual's heart from the sensing device at a first time, wherein the first time is the time when the R wave is recorded on the electrocardiogram; ii. At the first time, a first electromagnetic field map is generated based on the first magnetic field associated with the heart of the individual; iii. Identify the first negative electromagnetic dipole and the first positive electromagnetic dipole in the first electromagnetic field diagram; iv. Receive a second magnetic field associated with the heart of the individual from the sensing device at a second time, wherein the second time is the time when the T wave is recorded on the electrocardiogram; v. At the second time, a second electromagnetic field map is generated based on the second magnetic field associated with the heart of the individual; vi. Identify the second negative electromagnetic dipole and the second positive electromagnetic dipole in the second electromagnetic field diagram; vii. Determining a first angle based on the first negative electromagnetic dipole and the first positive electromagnetic dipole, and determining a second angle based on the second negative electromagnetic dipole and the second positive electromagnetic dipole, wherein the first angle is the peak depolarization angle R at the first time, and the second angle is the peak repolarization angle T at the second time; and viii. The presence, absence, or likelihood of coronary artery disease in the individual is determined at least in part based on (i) whether the first angle differs from the second angle by at least 100 degrees, or (ii) whether a third electromagnetic dipole exists in the first or second electromagnetic field diagram. The first angle is determined by determining a first line passing through both the first negative electromagnetic dipole and the first positive electromagnetic dipole and by determining the angle between the first line and the horizontal axis. The second angle is determined by determining a first line passing through both the first negative electromagnetic dipole and the first positive electromagnetic dipole and by determining the angle between the first line and the horizontal axis.

2. The system of claim 1, wherein the sensing device includes a shield configured to protect the device from one or more ambient magnetic fields.

3. The system of claim 2, wherein the shield is configured to at least partially surround a portion of the body of the individual associated with the magnetic field.

4. The system of claim 3, wherein the portion of the body of the individual associated with the magnetic field is at least a portion of the chest of the individual.

5. The system of claim 2, wherein the shielding comprises two or more layers.

6. The system of claim 5, wherein each of the two or more layers has a thickness from 0.1 to 10 millimeters.

7. The system of claim 2, wherein the shielding component comprises permalloy or a high-permeability alloy.

8. The system of claim 1, wherein the arm comprises a proximal segment and a distal segment, and wherein a second contact is located between the proximal segment and the distal segment and configured such that the distal segment is hinged relative to the proximal segment.

9. The system of claim 1, wherein the array of one or more optically pumped magnetometers is movably coupled to the distal end of the arm, such that the array of the one or more optically pumped magnetometers moves relative to the arm with at least one degree of freedom.

10. The system of claim 1, wherein the array of one or more optically pumped magnetometers comprises at least three optically pumped magnetometers.

11. The system of claim 10, wherein the array of one or more optically pumped magnetometers is arranged to match a generalized profile of a portion of the individual's body.

12. The system of claim 1, wherein the computer program includes instructions configured to cause the processor to further filter the sensed magnetic field.

13. The system of claim 12, further comprising a gradient meter, wherein the computer program includes instructions configured to cause the processor to filter the sensed magnetic field by canceling the magnetic field sensed by the gradient meter.

14. The system of claim 12, wherein the computer program includes instructions configured to cause the processor to filter the sensed magnetic field by subtracting a frequency-based measurement from the magnetic field.

15. The system of claim 1, wherein the computer program includes instructions configured to cause the processor to further generate a visual representation of the magnetic field, including a waveform.

16. The system of claim 1, wherein the coronary artery disease includes myocardial ischemia.

17. The system of claim 1, wherein the coronary artery disease includes myocardial ischemia with associated epicardial coronary artery disease.

18. The system of claim 1, wherein the coronary artery disease includes myocardial ischemia without associated epicardial coronary artery disease.

19. The system of claim 1, wherein the computer program includes instructions configured to cause the processor to determine, at least in part, the presence, absence, or likelihood of coronary artery disease in the individual based on (iii) parameters selected from the group consisting of: dipole parameters, integrated MCD parameters, integrated ECD parameters, average PCD parameters, isointegral parameters, field map correlation parameters, R_peak hooked dipole parameters, pseudo-current arrow parameters, extremum circle parameters, phase space embedding parameters using delta coordinates, and phase space embedding parameters using time-delay coordinates, or (iv) visualizations selected from the group consisting of: STAG plots, T_peak MFM plots, field map animations, pseudo-current density arrows, MCD plots, and ECD plots.

20. The system of claim 19, wherein the computer program includes instructions configured to cause the processor to further determine, at least in part, the presence, absence, or likelihood of the coronary artery disease in the individual based on the parameters.

21. The system of claim 19, wherein the computer program includes instructions configured to cause the processor to further determine, at least in part, the presence, absence, or likelihood of the coronary artery disease in the individual based on the visualization.

22. The system according to any one of claims 19-21, wherein the presence of the coronary artery disease in the individual is determined based on the presence of at least one of the following abnormalities: (i) whether the first angle differs from the second angle by at least 100 degrees, (ii) whether a third electromagnetic dipole is present in the first electromagnetic field diagram or the second electromagnetic field diagram, (iii) the parameter, and (iv) the visualization.

23. The system according to any one of claims 19-21, wherein the presence of the coronary artery disease in the individual is determined based on the presence of at least two of the following abnormalities: (i) whether the first angle differs from the second angle by at least 100 degrees, (ii) whether a third electromagnetic dipole is present in the first electromagnetic field diagram or the second electromagnetic field diagram, (iii) the parameter, and (iv) the visualization.

24. A non-transitory computer-readable medium comprising machine-executable code, said machine-executable code, when executed by one or more computer processors, implementing a method for determining the presence, absence, or likelihood of coronary artery disease in an individual, said method comprising: a. Place the mobile electromagnetic sensing device near the individual; b. Positioning the arm of the mobile electromagnetic sensing device, coupled to an array of one or more optically pumped magnetometers, near the heart of the individual; c. Receive a first magnetic field associated with the heart of the individual from the mobile electromagnetic sensing device at a first time, wherein the first time is the time when the R wave is recorded on the electrocardiogram; d. At the first time, a first electromagnetic field map is generated based on the first magnetic field associated with the heart of the individual; e. Identify the first negative electromagnetic dipole and the first positive electromagnetic dipole in the first electromagnetic field diagram; f. Receiving a second magnetic field associated with the heart of the individual from the mobile electromagnetic sensing device at a second time, wherein the second time is the time when the T wave is recorded on the electrocardiogram; g. At the second time, a second electromagnetic field map is generated based on a second magnetic field associated with the heart of the individual; h. Identify the second negative electromagnetic dipole and the second positive electromagnetic dipole in the second electromagnetic field diagram; i. Determining a first angle based on the first negative electromagnetic dipole and the first positive electromagnetic dipole, and determining a second angle based on the second negative electromagnetic dipole and the second positive electromagnetic dipole, wherein the first angle is the peak depolarization angle R at the first time, and the second angle is the peak repolarization angle T at the second time; and j. The presence, absence, or likelihood of coronary artery disease in the individual is determined at least in part based on (i) whether the first angle differs from the second angle by at least 100 degrees, or (ii) whether a third electromagnetic dipole exists in the first or second electromagnetic field diagram. The first angle is determined by determining a first line passing through both the first negative electromagnetic dipole and the first positive electromagnetic dipole and by determining the angle between the first line and the horizontal axis. The second angle is determined by determining a first line passing through both the first negative electromagnetic dipole and the first positive electromagnetic dipole and by determining the angle between the first line and the horizontal axis.

25. The non-transitory computer-readable medium of claim 24, wherein the method further comprises using a shielding element to shield at least a portion of the individual from one or more ambient magnetic fields.

26. The non-transitory computer-readable medium according to claim 25, wherein, In the method, the shield is configured to at least partially surround a portion of the body of the individual associated with the magnetic field.

27. The non-transitory computer-readable medium according to claim 26, wherein, In the method, the part of the individual's body associated with the magnetic field is at least a portion of the individual's chest.

28. The non-transitory computer-readable medium according to claim 25, wherein, In the method, the shielding element comprises two or more layers.

29. The non-transitory computer-readable medium according to claim 28, wherein, In the method, each of the two or more layers has a thickness from 0.1 to 10 millimeters.

30. The non-transitory computer-readable medium according to claim 25, wherein, In the method, the shielding component comprises permalloy or a high-permeability alloy.

31. The non-transitory computer-readable medium according to claim 24, wherein, In the method, the arm includes a proximal segment and a distal segment, and a second contact is located between the proximal segment and the distal segment and configured such that the distal segment is hinged relative to the proximal segment.

32. The non-transitory computer-readable medium according to claim 24, wherein, In the method, the array of one or more optically pumped magnetometers is movably coupled to the distal end of the arm, such that the array of the one or more optically pumped magnetometers moves relative to the arm with at least one degree of freedom.

33. The non-transitory computer-readable medium according to claim 24, wherein, In the method, the array of one or more optically pumped magnetometers includes at least three optically pumped magnetometers.

34. The non-transitory computer-readable medium according to claim 33, wherein, In the method, the array of one or more optically pumped magnetometers is arranged to match a generalized profile of a part of the individual's body.

35. The non-transitory computer-readable medium of claim 24, wherein the method further comprises filtering the first magnetic field and / or the second magnetic field.

36. The non-transitory computer-readable medium according to claim 35, wherein, In the method, the filtering includes counteracting the magnetic field sensed by the gradient meter.

37. The non-transitory computer-readable medium according to claim 35, wherein, In the method, the filtering includes subtracting frequency-based measurements from the first magnetic field and / or the second magnetic field.

38. The non-transitory computer-readable medium according to claim 24, wherein, In the method, the coronary artery disease includes myocardial ischemia.

39. The non-transitory computer-readable medium according to claim 24, wherein, In the method, the coronary artery disease includes myocardial ischemia with associated epicardial coronary artery disease.

40. The non-transitory computer-readable medium according to claim 24, wherein, In the method, the coronary artery disease includes myocardial ischemia without associated epicardial coronary artery disease.

41. The non-transitory computer-readable medium of claim 24, wherein the method further comprises determining the presence, absence, or likelihood of the coronary artery disease in the individual based at least in part on (iii) parameters selected from the group consisting of: dipole parameters, composite MCD parameters, composite ECD parameters, average PCD parameters, isointegral parameters, field map correlation parameters, R_peak hooked dipole parameters, pseudo-current arrow parameters, extremum circle parameters, phase space embedding parameters using delta coordinates, and phase space embedding parameters using time-delay coordinates, or (iv) visualizations selected from the group consisting of: STAG plots, T_peak MFM plots, field map animations, pseudo-current density arrows, MCD plots, and ECD plots.

42. The non-transitory computer-readable medium of claim 41, wherein the method further comprises determining, at least in part, the presence, absence, or likelihood of the coronary artery disease in the individual based on the parameters.

43. The non-transitory computer-readable medium of claim 41, wherein the method further comprises determining, at least in part, the presence, absence, or likelihood of the coronary artery disease in the individual based on the visualization.

44. The non-transitory computer-readable medium according to any one of claims 41-43, wherein the method further comprises determining the presence of the coronary artery disease in the individual based on the presence of at least one of the following anomalies: (i) whether the first angle differs from the second angle by at least 100 degrees, (ii) whether a third electromagnetic dipole is present in the first electromagnetic field diagram or the second electromagnetic field diagram, (iii) the parameter, and (iv) the visualization.

45. The non-transitory computer-readable medium according to any one of claims 41-43, wherein the method further comprises determining the presence of the coronary artery disease in the individual based on the presence of at least two of the following anomalies: (i) whether the first angle differs from the second angle by at least 100 degrees, (ii) whether a third electromagnetic dipole is present in the first electromagnetic field diagram or the second electromagnetic field diagram, (iii) the parameter, and (iv) the visualization.

46. ​​A non-transitory computer-readable medium comprising machine-executable code, said machine-executable code, when executed by one or more computer processors, implementing a method for determining the presence, absence, or likelihood of coronary artery disease in an individual, said method comprising: (a) Identify, at the first moment, the first negative electromagnetic dipole and the first positive electromagnetic dipole in the first electromagnetic field diagram associated with the heart of the individual; (b) Identifying, at a second time, a second negative electromagnetic dipole and a second positive electromagnetic dipole in a second electromagnetic field diagram associated with the heart of the individual; (c) Determine the first angle based on the first negative electromagnetic dipole and the first positive electromagnetic dipole; (d) Determine the second angle based on the second negative electromagnetic dipole and the second positive electromagnetic dipole; as well as (e) The presence, absence, or likelihood of coronary artery disease in the individual is determined at least in part based on (i) whether the first angle differs from the second angle by at least 100 degrees, or (ii) whether a third electromagnetic dipole is present in the first or second electromagnetic field diagram. The method further includes recording the individual's electrocardiogram; In the method, the first angle includes the peak R depolarization angle at the first time, wherein the first time is the time when the R wave is recorded on the electrocardiogram; In the method, the second angle includes the peak T repolarization angle at the second time, wherein the second time is the time when the T wave is recorded on the electrocardiogram; In this method, the first angle is determined by determining a first line passing through both the first negative electromagnetic dipole and the first positive electromagnetic dipole, and by determining the angle between the first line and the horizontal axis; and In this method, the second angle is determined by determining a second line passing through both the second negative electromagnetic dipole and the second positive electromagnetic dipole, and by determining the angle between the second line and the horizontal axis.

47. The non-transitory computer-readable medium according to claim 46, wherein, In the method, the third electromagnetic dipole exists in the second electromagnetic field diagram.

48. The non-transitory computer-readable medium according to claim 46, wherein, In the method, the coronary artery disease includes occlusion of the left anterior descending artery.

49. The non-transitory computer-readable medium according to claim 46, wherein, In the method, if the first angle differs from the second angle by 100 to 170 degrees, the likelihood of the presence of the coronary artery disease in the individual is determined.

50. The non-transitory computer-readable medium according to claim 46, wherein, In the method, the individual has a normal electrocardiogram or normal troponin levels when experiencing chest pain.

51. The non-transitory computer-readable medium according to claim 46, wherein, In the method, the individual has a positive stress test or abnormal echocardiographic findings.

52. The non-transitory computer-readable medium of claim 46, wherein the method further comprises performing a stress test if the first angle is different from the second angle or if a third electromagnetic dipole is present in the first electromagnetic field diagram or the second electromagnetic field diagram.

53. The non-transitory computer-readable medium of claim 46, further wherein the method includes sensing a first electromagnetic field associated with the heart of the individual at a first time, and sensing a second electromagnetic field associated with the heart of the individual at a second time, wherein the first electromagnetic field map includes a representation of the first electromagnetic field and the second electromagnetic field map includes a representation of the second electromagnetic field.

54. The non-transitory computer-readable medium of claim 46, wherein the method further comprises determining the likelihood of a conduction abnormality in the heart of the individual if the first positive electromagnetic dipole and the second negative electromagnetic dipole are at the same position or the first negative electromagnetic dipole and the second positive electromagnetic dipole are at the same position.

55. The non-transitory computer-readable medium of claim 46, wherein the method further comprises treating the individual for coronary artery disease in response to determining the likelihood of the presence of the coronary artery disease in the individual.

56. The non-transitory computer-readable medium according to claim 55, wherein, In the method, the treatment includes a daily aspirin regimen.

57. The non-transitory computer-readable medium according to claim 55, wherein, In the method, the treatment includes an antihypertensive drug.

58. The non-transitory computer-readable medium according to claim 55, wherein, In the method, the treatment includes lipid-lowering drugs.

59. The non-transitory computer-readable medium according to claim 55, wherein, In the method, the treatment includes cardiac catheterization.

60. The non-transitory computer-readable medium according to claim 55, wherein, In the method, the treatment includes surgical procedures.

61. The non-transitory computer-readable medium of claim 46, wherein the method further comprises being performed by a computer (a) to (e).

62. The non-transitory computer-readable medium according to claim 46, wherein, In the method, the coronary artery disease includes myocardial ischemia.

63. The non-transitory computer-readable medium according to claim 46, wherein, In the method, the coronary artery disease includes myocardial ischemia with associated epicardial coronary artery disease.

64. The non-transitory computer-readable medium according to claim 46, wherein, In the method, the coronary artery disease includes myocardial ischemia without associated epicardial coronary artery disease.

65. The non-transitory computer-readable medium of claim 46, wherein the method further comprises determining the presence, absence, or likelihood of the coronary artery disease in the individual based at least in part on (iii) parameters selected from the group consisting of: dipole parameters, composite MCD parameters, composite ECD parameters, average PCD parameters, isointegral parameters, field map correlation parameters, R_peak hooked dipole parameters, pseudo-current arrow parameters, extremum circle parameters, phase space embedding parameters using delta coordinates, and phase space embedding parameters using time-delay coordinates, or (iv) visualizations selected from the group consisting of: STAG plots, T_peak MFM plots, field map animations, pseudo-current density arrows, MCD plots, and ECD plots.

66. The non-transitory computer-readable medium of claim 65, wherein the method further comprises determining, at least in part, the presence, absence, or likelihood of the coronary artery disease in the individual based on the parameters.

67. The non-transitory computer-readable medium of claim 65, wherein the method further comprises determining, at least in part, the presence, absence, or likelihood of the coronary artery disease in the individual based on the visualization.

68. The non-transitory computer-readable medium according to any one of claims 65-67, wherein the method further comprises determining the presence of the coronary artery disease in the individual based on the presence of at least one of the following anomalies: (i) whether the first angle differs from the second angle by at least 100 degrees, (ii) whether a third electromagnetic dipole is present in the first electromagnetic field diagram or the second electromagnetic field diagram, (iii) the parameter, and (iv) the visualization.

69. The non-transitory computer-readable medium according to any one of claims 65-67, wherein the method further comprises determining the presence of the coronary artery disease in the individual based on the presence of at least two of the following anomalies: (i) whether the first angle differs from the second angle by at least 100 degrees, (ii) whether a third electromagnetic dipole is present in the first electromagnetic field map or the second electromagnetic field map, (iii) the parameter, and (iv) the visualization.

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