Ultrasonic sequencing system and method

Abstract

A system includes a catheter configured for delivery into a body cavity defined by surrounding tissue; a plurality of ultrasound transducers connected to the distal end of the catheter; and an electronic module configured to selectively turn each ultrasound transducer on / off according to a predetermined activation sequence, and to process signals received from each ultrasound transducer to generate at least a 2D display of the surrounding tissue. The user can selectively calculate and display various aspects of cardiac activity. The user can display dipole density (DDM), charge density (CDM), or voltage (V-V). The shape and location of the chamber (surface) and the potential recorded on the electrodes can be displayed. The system can also switch between different display modes, and the display of various types of information can be altered using post-processing tools. A method is also provided.

Description

[0001] This application is a divisional application of Chinese patent application filed on May 12, 2016, with application number 201680040709.1, entitled "Ultrasound Sequencing System and Method", and entered the Chinese national phase on January 10, 2018.

[0002] Related applications

[0003] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 160,529, filed May 12, 2015, entitled “Ultrasound Sequencing System and Method,” filed under 35 USC 119(e), the entire disclosure of which is incorporated herein by reference.

[0004] While this application does not claim priority, it may be related to U.S. Patent Application Serial No. 14 / 865,435, filed September 25, 2015, entitled “Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls,” a continuation to U.S. Patent No. 9,167,982 (hereinafter referred to as the '982 Patent), granted October 27, 2015. The '982 Patent, entitled “Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls,” is a continuation to U.S. Patent No. 8,918,158 (hereinafter referred to as the '158 Patent), granted December 23, 2014. The '158 Patent, entitled “Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls,” is also a continuation to the '158 Patent, granted December 23, 2014. "Walls" is a continuation application of U.S. Patent No. 8,700,119 (hereinafter referred to as the '119 Patent) granted on April 15, 2014. The '119 Patent, entitled "Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls," is a continuation application of U.S. Patent No. 8,417, granted on April 9, 2013.A continuation application to patent number 313 (hereinafter referred to as '313 patent'), entitled "Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls," is a national phase application (35USC 371) of PCT application CH2007 / 000380, entitled "Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls," filed on August 3, 2007, published as WO2008 / 014629, claiming priority to Swedish patent application No. 1251 / 06, filed on August 3, 2006. The entire contents of each of these applications are incorporated herein by reference.

[0005] While this application does not claim priority, it may be related to U.S. Patent Application Serial No. 14 / 886,449, filed October 19, 2015, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall,” a continuation to U.S. Patent No. 9,192,318 (hereinafter referred to as the '318 Patent), granted November 24, 2015. The '318 Patent, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall,” is a continuation to U.S. Patent No. 8,512,255 (hereinafter referred to as the '255 Patent), granted August 20, 2013. The '255 Patent, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall,” is also a continuation to the '255 Patent.” The Cardiac Wall, published as US2010 / 0298690 (hereinafter referred to as '690 Publication), is the national phase application 35USC 371 of PCT application No. PCT / IB09 / 00071, filed on January 16, 2009, entitled "A Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall," published as WO2009 / 090547, claiming priority to Swedish Patent Application No. 00068 / 08, filed on January 17, 2008. The disclosures of each of the above applications are incorporated herein by reference.

[0006] While this application does not claim priority, it may relate to U.S. Patent Application Serial No. 14 / 003,671, filed September 6, 2013, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall,” which is the national phase application of PCT Application No. PCT / US2012 / 028593, entitled “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall,” published as WO2012 / 122517 (hereinafter referred to as '517 Publication), claiming priority to U.S. Provisional Application No. 61 / 451,357. The disclosures of each of the foregoing applications are incorporated herein by reference.

[0007] While this application does not claim priority, it may relate to U.S. Design Application Serial No. 29 / 475,273, filed December 2, 2013, entitled “Catheter System and Methods of Medical Uses of Same, Including Diagnostic and Treatment Uses for the Heart,” which is a 35 USC 371 national phase application of PCT Application No. PCT / US2013 / 057579, filed August 30, 2013, entitled “Catheter System and Methods of Medical Uses of Same, Including Diagnostic and Treatment Uses for the Heart,” claiming priority to U.S. Provisional Application Serial No. 61 / 695,535, filed August 31, 2012, entitled “System and Method for Diagnosing and Treating Heart Tissue,” the disclosures of which are incorporated herein by reference.

[0008] While this application does not claim priority, it may be related to U.S. Patent Application Serial No. 14 / 762,944, filed July 23, 2015, entitled “Expandable Catheter Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways,” which is a 35 USC 371 national phase application of PCT Application No. PCT / US2014 / 15261, filed February 7, 2014, entitled “Expandable Catheter Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways,” published as WO2014 / 124231, claiming priority to U.S. Provisional Application Serial No. 61 / 762,363, filed February 8, 2013, entitled “Expandable Catheter Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways,” the disclosures of which are incorporated herein by reference.

[0009] While this application does not claim priority, it may relate to PCT application No. PCT / US2015 / 11312, filed January 14, 2015, entitled “Gas-Elimination Patient Access Device,” which claims priority to U.S. Provisional Application Serial No. 61 / 928,704, filed January 17, 2014, entitled “Gas-Elimination Patient Access Device,” the disclosure of which is incorporated herein by reference.

[0010] While this application does not claim priority, it may relate to PCT application No. PCT / US2015 / 22187, filed March 24, 2015, entitled “Cardiac Analysis User Interface System and Method,” which claims priority to U.S. Provisional Application Serial No. 61 / 970,027, filed March 28, 2014, entitled “Cardiac Analysis User Interface System and Method,” the disclosure of which is incorporated herein by reference.

[0011] While this application does not claim priority, it may be related to U.S. Patent Application Serial No. 14 / 916,056, filed March 2, 2016, entitled “Devices and Methods for Determination of Electrical Dipole Densities on a Cardiac Surface,” which is a 35 USC 371 national phase application of PCT Application No. PCT / US2014 / 54942, filed September 10, 2014, entitled “Devices and Methods for Determination of Electrical Dipole Densities on a Cardiac Surface,” published as WO2015 / 038607, claiming priority to U.S. Provisional Application Serial No. 61 / 877,617, filed September 13, 2013, entitled “Devices and Methods for Determination of Electrical Dipole Densities on a Cardiac Surface.” The disclosures of the aforementioned applications are incorporated herein by reference. Technical Field

[0012] The present invention generally relates to systems and methods that can be used to diagnose and / or treat arrhythmias or other cardiac diseases or conditions, such as systems, devices, and methods that can be used to map cardiac activity. Background Technology

[0013] To pinpoint the cause of arrhythmias, a common practice is to measure the electrical potential located on the inner surface of the heart using electrophysiological techniques within the patient's heart. One approach involves inserting an electrode catheter into the heart to record the cardiac electrical potential during normal rhythms or arrhythmias. If the arrhythmia exhibits a regular sequence of activation, the duration of electrical activation can be accumulated by moving the electrode around the periphery during the arrhythmia, measuring the voltage at the electrode location to create a three-dimensional map of electrical activation. This approach allows for the diagnosis of information about the location and mechanism of the arrhythmia's origin, i.e., re-entry circuitry, to initiate or guide treatment (radiofrequency ablation). This information can also be used to guide cardiac resynchronization therapy, where implanted pacing electrodes are placed at specific locations in the heart wall or ventricles to re-establish normal levels of coordinated cardiac activation.

[0014] Methods using external sensors employ electrocardiographic techniques, including, for example, electrocardiography (ECG) and vector electrocardiography (VCG), to measure the heart's electrical activity from the body surface. These external sensor techniques may be limited in their ability to provide information and / or data about regional cardiac electrical activity. These methods may also fail to pinpoint bioelectrical events within the heart.

[0015] Methods for locating arrhythmias using external sensors utilize body surface mapping. In this technique, multiple electrodes are attached to the entire surface of the chest, and information from an electrocardiogram (surface ECG) is measured by accumulating voltages in the cardiac activation map. This measurement can be problematic because electrical activity is time-dependent and spatially distributed throughout the myocardium, and it cannot localize bioelectrical events within the heart. Complex mathematical methods are needed to determine electrical activation on the outer surface of a cardiac model (i.e., the epicardium), such as those obtained from CT or MRI imaging, providing information about the size and orientation of the heart within the thoracic cavity.

[0016] Alternatively, potential recordings at locations on the torso, such as body surface potential maps (BSPMs) on the torso surface, can provide insights into regional cardiac electrical activity. While BSPMs can indicate regional cardiac electrical activity in a manner different from conventional ECG techniques, these BSPM techniques typically provide relatively low-resolution, smoothed projections of cardiac electrical activity, which are not conducive to visual detection or identification of the location of cardiac events (e.g., the site of onset of arrhythmias) and details of regional activity (e.g., the number and location of arrhythmogenic foci in the heart).

[0017] Because using electrical potential to locate arrhythmias is inaccurate, successful treatment of arrhythmias is difficult, and limited success and reliability have been demonstrated. Therefore, improved methods for locating, diagnosing, and treating arrhythmias are needed. Summary of the Invention

[0018] According to one aspect of the present invention, a body cavity imaging system is provided, comprising: a catheter configured for delivery into a body cavity defined by surrounding tissue; a plurality of ultrasound transducers connected to a distal end of the catheter; and an electronic module configured to selectively turn each ultrasound transducer on / off according to a predetermined activation sequence, and to process signals received from each ultrasound transducer to at least generate a 2D display of the surrounding tissue.

[0019] In various embodiments, the imaging system may be part of an electrophysiological system.

[0020] In various embodiments, the cavity may be a ventricle, and the surrounding tissue may be one or more walls of the ventricle.

[0021] In various embodiments, the display may be a 3D display of the surrounding tissue.

[0022] In various embodiments, the 3D display of the surrounding tissue can be presented on a user interface system having a display screen and a user control device that allows graphical operation of the 3D display of the surrounding tissue.

[0023] In various embodiments, graphical operations may include one or more of zooming in / out, rotating, and selecting portions or sub-portions of surrounding tissue.

[0024] In various embodiments, multiple ultrasonic transducers can be connected to a 3D array.

[0025] In various embodiments, the 3D array may be a basket array, a spiral array, an airbag, a radially deployable arm, and / or other scalable and compressible structure.

[0026] In various embodiments, the ultrasonic transducer can be positioned on multiple splines of the 3D array.

[0027] In various embodiments, the 3D array may include at least three splines.

[0028] In various embodiments, at least two ultrasonic transducers may be disposed on each spline.

[0029] In various embodiments, the system may further include multiple biopotential electrodes coupled to the distal end of the catheter.

[0030] In various embodiments, biopotential electrodes may also be disposed on multiple splines of a 3D array.

[0031] In various embodiments, at least some biopotential electrodes and at least some ultrasonic transducers may be arranged on the same spline.

[0032] In various embodiments, a biopotential electrode and an ultrasonic transducer are arranged together to form an electrode / transducer pair, and the system includes multiple electrode / transducer pairs.

[0033] In various embodiments, one or more splines may include at least one pair of electrodes / transducers.

[0034] In various embodiments, one or more splines may include multiple pairs of electrodes / transducers.

[0035] In various embodiments, multiple splines may include at least one pair of electrodes / transducers.

[0036] In various embodiments, multiple splines may include multiple pairs of electrodes / transducers.

[0037] In various embodiments, multiple splines may include at least three pairs of electrodes / transducers.

[0038] In various embodiments, each spline may include a flexible PCB, and each pair of electrodes / transducers is electrically connected to the flexible PCB.

[0039] In various embodiments, each pair of electrodes / transducers can share a common communication path on the flexible PCB.

[0040] In various embodiments, all electrode / converter pairs on the spline can share a common communication path on the flexible PCB.

[0041] In various embodiments, the common communication path can be a common ground.

[0042] In various embodiments, the system may be further configured to associate cardiac or other electrical activity with one or more images generated using an imaging device.

[0043] In various embodiments, the imaging apparatus may include imaging devices selected from the group consisting of: a fluorescence microscope; an MRI scanner; a CT scanner; an ultrasound imaging device; and combinations of two or more of these.

[0044] In various embodiments, the activation sequence can be a mode of turning multiple ultrasonic transducers on / off, which avoids the sequential activation of two adjacent ultrasonic transducers.

[0045] In various embodiments, the activation sequence can avoid the sequential activation of two transducers in two or three adjacent spaces.

[0046] In various embodiments, adjacent spaces can be considered as spaces on a single spline; spaces spanning splines, such as transducer 1 of spline 1 and transducer 1 of spline 2; and / or spaces diagonally spanning splines, such as transducer 1 of spline 1 and transducer 2 of spline 2.

[0047] In various embodiments, the activation sequence mode can be a mode that avoids the sequential activation of two transducers from a single spline.

[0048] According to another aspect of the present invention, a method for performing a diagnostic assessment is provided, comprising: providing a cardiac diagnostic system including a plurality of ultrasound transducers and a plurality of electrodes connected to an end of a diagnostic catheter; inserting the diagnostic catheter into the ventricle of a patient; placing the cardiac diagnostic system in diagnostic mode; performing a biopotential measurement procedure; performing a localization procedure; performing an ultrasound measurement procedure; and alternating the localization procedure and the ultrasound procedure.

[0049] In various embodiments, the frequency of the ultrasonic transducer does not interfere with the bioelectric potential signal, and the bioelectric potential signal does not interfere with the positioning signal.

[0050] In various embodiments, the bioelectric potential measurement process can be performed continuously.

[0051] In various embodiments, the biopotential measurement process can be interleaved with the localization process and the ultrasound measurement process.

[0052] In various embodiments, the method may include performing the positioning process for a longer time or performing the positioning process multiple times relative to a single ultrasound measurement process.

[0053] In various embodiments, the method may include performing the ultrasonic measurement process for a longer time or performing the ultrasonic measurement process multiple times, relative to a single positioning process.

[0054] In various embodiments, the biopotential measurement process may include measuring and analyzing the biopotential from the electrodes.

[0055] In various embodiments, the biopotential measurement process may include determining dipole density and / or surface charge density from biopotential data.

[0056] According to another aspect of the present invention, a method for performing a positioning process is provided, comprising: providing a cardiac diagnostic system including a plurality of biopotential electrodes connected to a distal end of a catheter, and optionally a plurality of ultrasound transducers; inserting a diagnostic catheter into the ventricle of a patient; placing one or more pairs of surface electrodes on the patient and defining a separate axis for each pair of electrodes; generating one or more positioning signals and transmitting the positioning signals to the patient via the one or more pairs of surface electrodes; recording data collected from the one or more pairs of surface electrodes; filtering the recorded data to isolate signals associated with the positioning signals generated by each pair of surface electrodes; and analyzing the filtered data to determine the position of each biopotential electrode relative to the patient in a coordinate system defined by the one or more pairs of surface electrodes.

[0057] In various embodiments, at least two pairs of electrodes may be present, and a separate axis may be defined for each pair of surface electrodes.

[0058] In various embodiments, there may be at least three pairs of electrodes, and a separate axis is defined for each pair of surface electrodes.

[0059] In various embodiments, three axes can define a three-axis positioning system.

[0060] In various embodiments, the coordinate system may be a 3D coordinate system.

[0061] In various embodiments, the origin of the coordinate system can logically be located inside the patient's heart.

[0062] In various embodiments, the method may include: placing surface electrodes from a first pair on the patient's chest and back, defining a first axis; and / or placing surface electrodes from a second pair laterally on the patient's side, defining a second axis; and / or placing surface electrodes from a third pair on the patient's neck or shoulder and thigh, thereby defining a third axis.

[0063] In various embodiments, the method may include: placing surface electrodes from a first pair of electrodes laterally on the side of the patient, defining a first axis; and / or placing surface electrodes from a second pair of electrodes on the upper chest and lower back of the patient, defining a second axis; and / or placing surface electrodes from a third pair of electrodes on the upper back and lower chest of the patient, defining a third axis.

[0064] In various embodiments, each pair of surface electrodes can be driven individually using signals of different frequencies.

[0065] In various embodiments, the positioning signal can be generated at frequencies in the range of approximately 1-100 kHz.

[0066] In various embodiments, signals from each pair of surface electrodes can be recorded individually.

[0067] In various embodiments, signals from each pair of surface electrodes can be filtered out individually.

[0068] In various embodiments, the localization process can be interleaved with the ultrasound measurement process of the cardiac diagnostic system.

[0069] In various embodiments, the localization process can be interleaved with the biopotential measurement process of the cardiac diagnostic system.

[0070] According to an aspect of the present invention, a method for performing an ultrasound measurement process is provided, comprising: providing a cardiac diagnostic system including a plurality of ultrasound transducers connected to a distal end of a catheter and optionally, a plurality of biopotential electrodes; inserting a diagnostic catheter into a ventricle; activating (or ringing) the ultrasound transducers to generate an ultrasound transducer signal; stopping the ringing of the ultrasound transducers; sensing and recording reflections of the ultrasound transducer signal emitted from a source; determining the distance from the transducer to the source based on the received reflections; repeating the above steps until all ultrasound transducers are activated; and repeating the above steps for all ultrasound transducers until the ultrasound measurement process is completed or terminated.

[0071] In various embodiments, biopotential electrodes and ultrasonic transducers can be paired to form an electrode / transducer pair.

[0072] In various embodiments, electrode / transducer pairs can be arranged on multiple splines of a 3D array.

[0073] In various embodiments, activating the ultrasonic transducer may include turning off one or more switches, thereby electrically connecting the transducer to a signal generator.

[0074] In various embodiments, one or more switches may include an optocoupler.

[0075] In various embodiments, the optical coupler may have an activation time in the range of about 0.01 μs to 500 μs.

[0076] In various embodiments, activating the transducer may include generating a pulse drive signal configured to ring, vibrate, and / or otherwise cause the transducer to generate ultrasonic pulses.

[0077] In various embodiments, the drive signal may include a signal with a frequency in the range of approximately 1 MHz to 25 MHz, such as 10 MHz.

[0078] In various embodiments, the drive signal frequency can be approximately 10 MHz.

[0079] In various embodiments, the drive signal may also include a signal with a pulse width in the range of approximately 0.1 μs to 10 μs.

[0080] In various embodiments, the pulse width of the drive signal can be approximately 2.0 μs.

[0081] In various embodiments, the duration of the ringing end can be between approximately 0.05 μs and 1 μs, used for the dissipation of vibrations in the ultrasonic transducer.

[0082] In various embodiments, the ringing end may have a duration of approximately 0.1 μs.

[0083] In various embodiments, inductive reflection can be performed over a duration ranging from approximately 1 μs to 200 μs.

[0084] In various embodiments, the sensing duration can be approximately 100 μs.

[0085] In various embodiments, the source may be the inner wall of the heart cavity.

[0086] In various embodiments, activation of the transducer can lead to deactivation of the paired biopotential electrodes.

[0087] In various embodiments, the method may further include non-sequentially activating the electrode / transducer pair so as not to extend the temporary “blind zone” of adjacent biopotential electrodes caused by the activation of the ultrasonic transducer.

[0088] In various embodiments, the patient can be biological.

[0089] In various embodiments, the patient may be a simulated biological entity or a heart.

[0090] According to various aspects of the present invention, a cavity imaging system as shown and / or described is provided.

[0091] According to various aspects of the present invention, a cardiac diagnostic system as shown and / or described is provided.

[0092] According to various aspects of the present invention, a cardiac diagnostic process shown and / or described is provided.

[0093] According to various aspects of the present invention, the positioning process shown and / or described is provided.

[0094] According to various aspects of the present invention, a bioelectric potential measurement process shown and / or described is provided.

[0095] According to various aspects of the present invention, the ultrasound imaging methods shown and / or described are provided. Brief description of the attached figures

[0096] Figure 1 A schematic diagram of an exemplary embodiment of a cardiac analysis system according to an aspect of the present invention is shown, the cardiac analysis system including a catheter having components including a plurality of electronic elements that can be configured in vivo.

[0097] Figure 2 A flowchart is provided for an embodiment of a method for performing diagnostic assessment according to aspects of the present invention.

[0098] Figure 3 A flowchart of an embodiment of a method for performing a positioning process according to aspects of the present invention is provided.

[0099] Figure 4 A flowchart is provided illustrating an embodiment of a method for performing an ultrasonic measurement process according to aspects of the present invention.

[0100] Figure 5 A perspective view of an embodiment of a diagnostic catheter according to aspects of the present invention is provided.

[0101] Figure 5A This is an aspect of the concept of the present invention. Figure 5 A perspective view of the deformed duct.

[0102] Figure 6 A diagram illustrating an embodiment of the activation sequence of an ultrasonic transducer array disposed on six splines according to aspects of the present invention is provided.

[0103] Figure 7An embodiment of a user interface system block diagram is provided that can be used with diagnostic catheters described herein, such as diagnostic catheters conceived according to the present invention.

[0104] Figures 8A-8C Different views relating to the output of a user interface system are provided according to aspects of the present invention.

[0105] Figure 9 A functional block diagram of an embodiment of a cardiac information processing system conceived according to the present invention is provided. Detailed Implementation

[0106] Various exemplary embodiments will now be described more fully with reference to the accompanying drawings, some of which illustrate exemplary embodiments. However, the inventive concept can be embodied in many different forms and should not be construed as being limited to the exemplary embodiments set forth herein.

[0107] It should be understood that although the terms first, second, etc., are used herein to describe various elements, these elements should not be limited by these terms. These terms are used to distinguish an element, but do not imply a necessary order of elements. For example, a first element may be referred to as a second element without departing from the scope of the invention, and similarly, a second element may be referred to as a first element. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. And the "combination" of the associated listed items does not need to include all of the listed items, but may include all of the listed items.

[0108] What will be understood is that when an element is described as being "on" or "attached," "connected," or "coupled" to another element, it can be directly on or connected to the other element, or there may be intermediate elements. Conversely, when an element is described as being "directly on" or "directly connected" or "directly coupled" to another element, there are no intermediate elements. Other terms used to describe the relationship between elements should be interpreted in a similar manner (e.g., "between" and "directly between," "adjacent" and "directly adjacent," etc.).

[0109] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention. Unless the context clearly indicates otherwise, the singular forms “a” and “the” are also intended to include the plural forms. It should be further understood that, as used herein, the terms “comprising” and “having” indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude one or more other features, steps, operations, elements, components, and / or combinations thereof.

[0110] Spatial terms such as “below,” “under,” “down,” “above,” and “above” can be used to describe the relationship of an element and / or feature to another element and / or feature, such as the feature shown in the figures. It should be understood that spatially related terms are intended to encompass different orientations of the device in use and / or operation, in addition to those depicted in the figures. For example, if the device in the figures is flipped, an element described as “below” and / or “under” other elements or features would be oriented “above” other elements or features. The device may be oriented in other ways (e.g., rotated 90 degrees or in other orientations), and the spatially relative descriptions used herein are interpreted accordingly.

[0111] This document describes various exemplary embodiments with reference to idealized or representative structures and intermediate structures. Therefore, variations in the illustrated shapes are expected due to factors such as manufacturing techniques and / or tolerances. Consequently, the exemplary embodiments should not be construed as being limited to specific shapes in the areas shown herein, but rather include shape deviations, for example, due to manufacturing processes.

[0112] With regard to the extent that functional features, operations, and / or steps are described herein or understood to be included within the various embodiments of the inventive concept, such functional features, operations, and / or steps may be embodied in functional blocks, units, modules, operations, and / or methods. And with regard to the scope of computer program code, such functional blocks, units, modules, operations, and / or methods, which can be stored in a computer-readable medium, such as a non-transitory memory or medium, executable by at least one computer processor, such computer program code may be used.

[0113] Now refer to Figure 1The diagram illustrates an embodiment of a cardiac analysis system consistent with the inventive concept, comprising a catheter with components including multiple electronic elements deployable within the body. System 10 includes a diagnostic catheter 100 and an electronic module 200. In some embodiments, system 10 may further include a guide 50 and / or an imaging device 80. Guide 50 includes a handle 51 and an elongated rod 55. Rod 55 includes at least one lumen, for example, configured to slidably receive the lumen of the diagnostic catheter 100 within rod 55. In some embodiments, guide 50 includes a transseptal access sheath or other device configured to provide access to a body space or cavity, such as a ventricle. Handle 51 may include a knob, lever, switch, or other controller commonly referred to herein as controller 52. Controller 52 may be configured to steer or otherwise deflect the distal end of guide 50. Imaging device 80 may include an imaging device selected from the group consisting of: fluorescein microscopes; MRI; CT scanners; ultrasound imaging devices; and combinations of two or more of these. However, other imaging devices may also be used in various embodiments.

[0114] The diagnostic catheter 100 includes a handle 110 and an elongated, flexible rod, or bar 105, extending from the handle 110. Attached to the distal end of the bar 105 is a radially expandable and / or compressible assembly, namely, an expandable assembly 130. In an alternative embodiment, the expandable assembly 130 is mounted to (e.g., around) the distal portion of the bar 105, located near the distal end of the bar 105. In some embodiments, the expandable assembly 130 is configured and arranged as described with reference to co-pending U.S. Patent Application Serial No. 14 / 422,941, filed February 5, 2015, entitled “System and Method for Diagnosing and Treating Heart Tissue,” the entire contents of which are incorporated herein by reference. The bar 105 and the expandable assembly 130 are configured and arranged for insertion into the body (e.g., an animal or human body, such as the body of patient P) and for advancement through bodily vessels such as the femoral vein, jugular vein, or other vessels. The rod 105 and the expandable component 130 may be constructed and configured such that, for example, when the expandable component 130 is in a compressed state, it is inserted through the guide 50 and slides through the lumen of the rod 55 into a body space such as a ventricle, for example, the right atrium or the left atrium.

[0115] Handle 110 may include one or more controllers, such as controller 111. Controller 111 may include a knob, switch, lever, button, slider, or other controller configured to perform a function selected from the group consisting of: a distal position of control lever 105; for example, by advancing and / or retracting the control lever (not shown in the figure, but referred to below). Figure 5 The following functions are described: controlling the expansion and / or contraction of the expandable component 130; controlling the shape of the expandable component 130, for example, by advancing or retracting a lever operably connected to the expandable component 130; closing and / or opening electrical connections, for example, to provide power to one or more components of the expandable component 130; initiating a process or otherwise sending commands or other user-activated signals to the electronic module 200; and combinations thereof.

[0116] As shown in the figure, the expandable component 130 may include a structure having multiple flexible arms or splines, namely splines 131a-c (individually or collectively referred to as splines 131). In some embodiments, the expandable component 130 may include two to ten splines 131, for example, six splines 131. Figure 1 In one embodiment, the three splines 131a-c are equidistantly spaced around the central axis of the conduit 100 (i.e., the spacing between each spline is 120° when the expandable component 130 is configured in its expanded state). In other embodiments, the splines 131 may be equally or unequally spaced, for example, two, four, eight, or twelve splines 131 with equal spacings of 180°, 90°, 60°, 45°, and / or 30°, respectively. In some embodiments, the expandable component 130 may include an airbag, a radially deployable arm, and / or other expandable and compressible structures.

[0117] The expandable component 130 may further include multiple “pairs” of electronic elements, such as at least one pair of electronic elements comprising electrodes 132 and ultrasound elements (i.e., transducers 133). Each electrode 132 may be configured to record voltages, such as voltages present at locations on the surface of the heart or within the ventricles of the heart. Each ultrasound transducer 133 may be configured to transmit and / or receive ultrasound signals, for example, to generate anatomical images of at least a portion of tissue at the heart or other patient anatomical locations. Electrodes 132 and ultrasound transducers 133 may include different shapes, such as shapes selected from the group consisting of: circular; triangular; rectangular; hexagonal; trapezoidal; and combinations of two or more of these. In some embodiments, the first electrode 132 has a different shape than the second electrode 132. In some embodiments, the first ultrasound transducer 133 has a different shape than the second ultrasound transducer 133. In some embodiments, one or more ultrasound transducers 133 each include a single element or an array of elements (e.g., a microarray of ultrasound elements), such as an array of ultrasound elements configured as a phased array (e.g., to allow steering and / or focusing of ultrasound energy). In some embodiments, one or more ultrasonic transducers 133 include elements selected from the group consisting of: bulk ceramic (thickness-mode or spherical); micromechanical ultrasonic transducers (MUTs), such as piezoelectric (pMUTs) or capacitive (cMUTs); thin films such as PVDF; shear waves; and combinations of two or more of these.

[0118] Each connection pair of electrode 132 and ultrasonic transducer 133 may share a single conductor (e.g., a wire or other communication and / or power delivery conduit), such as communication path 134 (e.g., a wire) as described below. In some embodiments, also as described below, multiple pairs of electrode 132 and ultrasonic transducer 133 may share a single conductor, communication path 135 (e.g., a wire).

[0119] Figure 1 The embodiments show that each spline 131a-c has three pairs of electrodes / transducers (i.e., nine pairs for the scalable assembly 130), each pair including an electrode 132 and an ultrasonic transducer 133. Spline 131a includes three pairs of electrodes / ultrasounds, 132... i / 133 i -132 iii / 133 iii Spline 131b includes three pairs of electrodes / ultrasound, 132 iv / 133 iv -132 vi / 133 vi The spline 131c includes three pairs of electrodes / ultrasound, 132 vii / 133 vii -132 ix / 133 ix For example, when spline 131 includes printed circuitry (e.g., flexible printed circuitry), each pair of electrodes / ultrasounds 132 / 133 is electrically connected or otherwise operatively connected to connection point 136 via communication path 134, and communication path 134 may include traces on the printed circuitry, such as those described, for example, with reference to co-pending U.S. Patent Application Serial No. 14 / 762,944, filed July 23, 2015, entitled “Expandable Catheter Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways,” the entire contents of which are incorporated herein by reference. In various embodiments, for example Figure 1 In the illustrated embodiment, one or more pairs of electrodes / ultrasounds 132 / 133 may share a common communication path 135 that is electrically connected or otherwise operatively connected to the connection point 136, such as a trace configured as a common ground.

[0120] In the illustrated embodiment, communication path 134 is connected to electrode 132, for example, electrode 132. i Electrode 132 is connected to a paired ultrasonic transducer 133, such as ultrasonic transducer 133. i The positive electrode. Ultrasonic transducer 133 i The negative terminal is connected to a common communication path 135. In some embodiments, two or more pairs of electrodes / ultrasounds 132 / 133 may share the common communication path 135. In some embodiments, each spline 131 may include two or more common communication paths 135, such as a spline including eight pairs of electrodes / ultrasounds 132 / 133, including two common communication paths 134, each common communication path 134 being shared by four pairs of electrodes / ultrasounds 132 / 133.

[0121] A conduit, such as conduit 106, including one or more electrical, optical, or electro-optical wires or cables (e.g., coaxial cables), can provide a communication path between one or more components of expandable assembly 130, such as a pair or more pairs of electrodes / ultrasounds 132 / 133, and a handle 110 of conduit 100. Conduit 106 terminates at handle 110 at connector 116. Connector 116 may include jacks, plugs, terminals, ports, or other custom or standard electrical, optical, or electro-optical connectors. Conduit 106 may extend distally from handle 110, through one or more cavities of rod 105, and terminate at one or more connection points 136. In some embodiments, such as when each pair of electrodes / ultrasounds 132 / 133 in conduit 106 has a coaxial cable, and the coaxial shield is constructed and configured to provide a common communication medium (e.g., a ground wire), conduit 106 may include multiple coaxial cables configured to extend through multiple cavities within rod 105. Two or more coaxial cables can be connected together to share a common communication medium, for example, connecting four or eight coaxial cables to create a common channel. In some embodiments, coaxial cables may be used that include a gauge greater than 36 AWG (e.g., 42 AWG or 46 AWG) and may include a rated impedance of less than or equal to 50 Ω and a capacitance of approximately 110 pF / m at 1 kHz.

[0122] Electronic module 200 includes one or more connectors 216, each connector 216 including a jack, plug, terminal, port, or other custom or standard electrical, optical, or electro-optical connector. System 10 may include cables or other conduits, such as cable 206, configured to electrically, optically, and / or electro-optically connect conduit 100 to electronic module 200 via connectors 116 and 216. In some embodiments, electronic module 200 may include patient isolation circuitry 201 configured to electrically isolate one or more components of the electronic module from patient P (e.g., to prevent the delivery of unwanted vibrations or other unwanted electrical energy to patient P). Isolation circuitry 201 may be integrated into electronic module 200, and / or it may comprise separate discrete components (e.g., a separate housing).

[0123] System 10 may also include one or more surface electrodes 225, such as patch electrodes configured to be attached to a patient's skin. The surface electrodes 225 are electrically connected to the electronics module 200 via one or more electrical, optical, or other conduits referred to as conduits 226. For example, when the surface electrodes 225 transmit electrical signals to generate one or more electric fields within the patient P, such as those used in the positioning process described herein, the surface electrodes may be constructed and configured to transmit and / or record signals from and / or to the patient P. In some embodiments, system 10 may be configured to generate one or more images based on information recorded using the diagnostic conduit 100, and to associate cardiac or other electrical activity (e.g., voltage information, dipole information, and / or surface charge information) with one or more images. Alternatively or additionally, system 10 may be configured to associate cardiac or other electrical activity with one or more images generated using imaging device 80.

[0124] Electronic module 200 includes electrode transceiver circuit 210, ultrasonic transceiver circuit 220, and user interface subsystem 230. Electrode transceiver circuit (ETC) 210 includes one or more components selected from the group consisting of: a processor, such as a computer processor configured to perform one or more calculations based on data recorded from electrode 132; at least one filter, such as one or more filters configured to filter out one or more groups of data recorded from electrode 132; at least one signal generator, such as a signal generator 211 configured to generate signals for creating a positioning field as described below; at least one memory module, such as a memory module configured to store data recorded from electrode 132; and combinations thereof.

[0125] The ultrasonic transceiver circuit (UTC) 220 includes one or more components selected from the group consisting of: a processor, such as a computer processor configured to perform one or more calculations based on data recorded from the ultrasonic transceiver 133; at least one filter, such as one or more filters configured to filter out one or more groups of data recorded from the transceiver 133; at least one signal generator, such as a signal generator 221 configured to generate a signal for driving the transceiver 133 to produce an ultrasonic signal as described below; at least one memory module, such as a memory module configured to store data recorded from the transceiver 133; and combinations thereof. However, in some embodiments, the ETC 210 and the UTC 220 may share components, such as one or more processors and / or one or more memory modules.

[0126] The user interface subsystem 230 may include one or more user input and / or user output components, such as one or more components selected from the group consisting of: a keyboard; a mouse; one or more buttons or switches; a monitor; a touchscreen; a speaker; a microphone; a foot switch; a printer; a transmitter; a receiver; and combinations thereof. The user interface subsystem 230 may be configured to allow user input, such as setting one or more parameters associated with the operation of system 10. The user interface subsystem can also be configured to display information to the user, such as information selected from the group consisting of: electrical cardiac activity information (e.g., dipole density, surface charge density, and / or voltage information, such as voltage information measured and recorded from electrode 132 and / or dipole or surface charge density information calculated from data recorded from electrode 132); device positioning (location) data, such as data calculated from data recorded from electrode 132 and / or other electrodes of system 10; cardiac geometry data, such as geometric data calculated based on signals provided by ultrasound transducer 133; one or more images, such as one or more images recorded from imaging device 80 and / or (e.g., data provided by ultrasound transducer 133) one or more images generated by electronic module 200, such as text or graphical displays of one or more calculated values ​​obtained from ETC 210 and / or UTC 220; and combinations thereof.

[0127] In some embodiments, system 10 may include systems configured and arranged to determine a dipole density map associated with a dipole density distribution on the ventricular wall, and / or a surface charge density map associated with a surface charge density distribution on the ventricular wall, such as the system described in U.S. Patent No. 8,512,255, filed August 31, 2012, entitled “Device and Method for the Geometric Determination of Electrical Dipole Density on the Cardiac Wall,” the entire contents of which are incorporated herein by reference. Alternatively or additionally, system 10 may include systems configured and arranged to determine a voltage map, or other diagnostic datasets of electrical or anatomical information recorded by catheter 100 and / or calculated by electronic module 200.

[0128] Electrode 132 may be configured to record ventricular electrical activity, for example, by means of bioelectrical energy (voltage) representing the electrical activity of the heart. Electrode 132 may be further configured to perform a localization process, including recording a voltage induced by an electric field, such as a localization field generated by surface electrode 225. Electronic module 200 and ultrasonic transducer 133 may be configured to perform ultrasound-based distance measurement, including emitting ultrasonic signals from one or more ultrasonic transducers 133 and causing similar or dissimilar ultrasonic transducers 133 to record at least a first reflection of the emitted signal.

[0129] ETC 210 can be configured to process the data recorded by electrode 132 to produce information selected from the group consisting of: the location of the individual electrode 132; the location, current geometry and / or orientation of the expandable component 130 and its corresponding parts (obtained by processing the recorded positioning data); the location of one or more additional components or devices present in the ventricle; the electrical activity of the ventricle, such as dipole density or surface charge density or voltage on the ventricular wall, obtained by processing the recorded biopotential data; and combinations thereof.

[0130] UTC 220 can be configured to process ultrasound reflection data recorded from ultrasound transducer 133 to produce information selected from the group consisting of: the distance from transducer 133 to a first surface of the ventricle; the distance from ultrasound transducer 133 to a second surface of the ventricle; the distance between the first and second surfaces of the ventricle (e.g., cardiac wall thickness including the distance between the endocardial and epicardial surfaces of the ventricle); one or more anatomical features, such as the location of pulmonary veins (e.g., pulmonary vein orifices); the location of heart valves; other anatomical geometry; tissue velocity; tissue density; the distance from transducer 133 to the surface of another component of system 10; and combinations thereof.

[0131] In some embodiments, a single component of the electrode 132 / ultrasonic transducer 133 pair (e.g., only a single electrode 132 or a single ultrasonic transducer 133) is "activated" once (e.g., by a signal provided by the electronics module 200 or by a signal recorded by the electronics module 200). For example, during the activation cycle of the ultrasonic transducer 133 (e.g., including ringing, ringing end, and / or recording), recording and / or driving of its paired electrode 132 may be disabled (e.g., not performed or ignored). Alternatively, during the activation of the electrode 132 (e.g., driving and / or recording), driving or recording of the paired ultrasonic transducer 133 may be disabled (e.g., not performed or ignored). Isolation or activation of the connected electrode 132 or ultrasonic transducer 133 can prevent problems that may be caused by interference from the ultrasonic transducer 133 driving signal (e.g., provided by the surface electrode) with the positioning driving signal and / or the biopotential signal recorded by the electrode 132. In some embodiments, one or more recorded signals are filtered out, allowing simultaneous operation of ultrasonic processing and biopotential processing. In some embodiments, system 10 may include a standard diagnostic mode, including continuous execution of bioelectric potential measurements, and staggered positioning and ultrasound measurement processes, as described below. Figure 2 The process described is 500. Ultrasonic signals may interfere with bioelectric potential signals, and / or bioelectric potential signals may interfere with positioning signals. In some embodiments, one or more processes (positioning, ultrasound, and bioelectric potential measurement) may be interleaved with one or more other processes such that a single process (or combination of processes) does not cause interference with a single process (or combination of processes).

[0132] During operation mode, for example as follows: Figure 2 In the diagnostic mode described, the activation cycle of transducer 133 causes a "blank" cycle in paired electrode 132, resulting in a temporary "blind spot" in biopotential measurement. See below for reference. Figure 4 As described, the transducers 133 can be ordered so as to activate adjacent or other neighboring 132 / 133 pairs in an orderly manner without extending the temporary “blind zone”.

[0133] In some embodiments, the following execution sequence applies. During ultrasound measurement, all electrodes 132 can actively record biopotential signals. First transducer 133 i It can be activated, see reference. Figure 4 As described below, this causes the mating electrode 132 i The "blank" in transducer 133. i After activation, transducer 133 can be activated. v Then 133 ix 133 ii 133 vi 133 viii 133iii 133 iv and 133 vii In this embodiment, the “blind zone” created by the “blank” of the mating electrode 132 follows the same pattern, moving randomly around the scalable component 130, and minimizing any potential loss of data integrity due to the created blind zone.

[0134] In some embodiments, system 10 includes one or more sensors, each sensor, such as Figure 1As shown, sensors such as sensor 59 of guide 50, sensors of diagnostic catheter 100 (e.g., sensor 119 of handle 110 or sensor 139 of array 130), sensor 209 of electronics module 200, and / or sensor 89 of imaging device 80 are configured to generate signals. In some embodiments, system 10 includes two or more of sensors 59, 119, 139, 209, and / or 89. In some embodiments, sensors 59, 119, 139, 209, and / or 89 include sensors selected from the group consisting of: force sensors; pressure sensors; strain gauges; optical sensors; imaging sensors (e.g., lenses or optical fibers); acoustic sensors such as ultrasonic sensors; Hall effect sensors; pH sensors; magnetic sensors; temperature sensors; and combinations of one or more of these. In some embodiments, sensor 59 and / or sensor 139 include patient physiological sensors, such as sensors selected from the group consisting of: blood pressure sensors; blood gas sensors; temperature sensors; blood glucose sensors; pH sensors; respiration sensors; mean clotting time (ACT) sensors; and combinations of one or more of these. In some embodiments, system 10 is configured to analyze signals generated by one, two, or more of sensors 59, 119, 139, 209, and / or 89. In some embodiments, system 10 (e.g., algorithms of electronic module 200 and / or ETC 210) is configured to perform analysis of one or more signals generated by one, two, or more of sensors 59, 119, 139, 209, and / or 89 in combination with voltage data, dipole density data, surface charge data, and / or anatomical data (e.g., anatomical data collected by one or more ultrasound transducers 133). In some embodiments, system 10 uses signals from one or more of sensors 59, 119, 139, 209, and / or 89 to perform functions selected from the group consisting of: improving anatomical images displayed by system 10; improving cardiac information displayed by system 10 (e.g., dipole density and / or surface charge information); detecting malfunctions of system 10; providing physiological data of the patient; and combinations of one or more of these. In some embodiments, (e.g., as an alternative to or in addition to a sensor) one or more of sensors 59, 119, 139, 209 and / or 89 may include transducers, such as transducers selected from the group consisting of: heating elements; cooling elements; vibration elements; drug or other agent delivery elements; magnetic field generating elements; light transmission elements; imaging elements (such as lenses and / or optical fibers); and combinations of one or more of these.

[0135] Now refer to Figure 2 This provides embodiments of a method for performing diagnostic assessments consistent with the inventive concept. In some embodiments, Figure 2The process 500 uses the method described above. Figure 1 The system 10 completes this process. In step 510, the diagnostic catheter 100 is inserted into the ventricle of patient P. Further procedures may be performed to prepare the patient for a diagnostic procedure, such as procedures selected from the group consisting of: applying one or more surface electrodes 225 to the patient; preparing one or more alternative imaging devices, such as the imaging device 80 described above; delivering one or more drugs or other agents, such as cardiac drugs or blood thinners, to the patient; preparing for use of ETC 210; and combinations of two or more of these.

[0136] In step 520, system 10 is placed in diagnostic mode. Diagnostic mode can be configured to generate one or more sets of images or information relating to the anatomical shape and / or structure of the ventricles, and / or the electrical activity of the ventricles, such as mapping information collected prior to and / or during cardiac ablation procedures. As described herein, diagnostic mode may include steps 530, 540, and 550 performed repeatedly, simultaneously, or in a specific mode.

[0137] In step 530, system 10 performs analysis of the biopotential data to determine dipole, surface charge, and / or other voltage- or charge-based information related to the electrical activity of the heart, as described in U.S. Patent No. 8,417,313 entitled “Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls,” which is incorporated herein by reference. Electrode 132 is electrically connected to ETC 210 of electronics module 200 via conduit 106 and cable 206. ETC 210 may include one or more algorithms for determining dipole density and / or surface charge based on data recorded from electrode 132. ETC 210 may also include one or more filters (e.g., hardware or software filters) configured to pass (e.g., without significantly filtering out) the biopotential signal while filtering out other signals, particularly ultrasound and / or localization signals present in the ventricles or otherwise present in the patient P. In some embodiments, the process of step 530 may be performed continuously during the completion and / or repetition of steps 540 and 550, for example, while the system 10 remains in diagnostic mode.

[0138] In step 540, a positioning process is performed, as shown below. Figure 3 The described positioning process.

[0139] In step 550, an ultrasonic measurement procedure is performed, for example, as described below. Figure 4 The ultrasonic measurement process is described.

[0140] In step 560, if system 10 remains in diagnostic mode, steps 530, 540, and 550 are repeated. In some embodiments, for example, when step 530 is performed continuously while system 10 remains in diagnostic mode, steps 540 and 550 are repeated continuously while system 10 remains in diagnostic mode. In some embodiments, step 540 may be performed for a longer period of time or multiple times for a single step 550. In some embodiments, step 550 may be performed for a longer period of time or multiple times for a single step 540.

[0141] System 10 can be placed in an alternative mode, such as a mode selected from the group consisting of: a hold mode, such as when catheter 100 remains inserted in patient P but no diagnostic procedure is performed; an alarm mode, such as when system 10 has detected an error and the diagnostic and / or other procedures are stopped; and a shutdown / completion mode, such as when system 10 is deactivated, for example, when it is removed from patient P at the end of a diagnostic or treatment procedure. In step 560, when it is determined that system 10 is no longer in diagnostic mode, process 500 proceeds to step 570. In step 570, all diagnostic procedures are stopped.

[0142] In some embodiments, system 10 may alternate between steps 540 and 550, for example, to collect positioning and ultrasound information to generate a model of the cardiac anatomy. Subsequently, steps 530 and 540 may be performed alternately or simultaneously to map the electrical activity of the heart, allowing system 10 to record the mapped electrical activity onto the previously collected simulated anatomy. In some embodiments, system 10 may again alternate between steps 540 and 550 to update the model of the anatomy.

[0143] Now for reference Figure 3 This provides embodiments of a method for performing a positioning process consistent with the inventive concept. In some embodiments, the method described above is used. Figure 1 System 10 to complete Figure 3 The process 600. In step 610, system 10 begins the positioning process. In some embodiments, this process may be associated with the following references Figure 4 The described ultrasonic measurement processes are interwoven.

[0144] In step 620, signal generator 211 generates one or more positioning signals, which are transmitted to patient P via catheter 226 through one or more surface electrodes 225. Surface electrodes 225 may include one or more pairs of electrodes 225, for example, configured to provide three pairs of electrodes 225 for a triaxial positioning system. For example, in a triaxial positioning configuration, pairs of surface electrodes 225 may be placed on patient P; a first pair placed on the chest and back of patient P defines a first axis, the X-axis; a second pair placed laterally on the side of patient P defines a second axis, the Y-axis; and a third pair placed on the neck or shoulder and thigh of patient P defines a third axis, the Z-axis. Alternatively, the first pair of electrodes may be placed laterally on the side of the patient, defining the first axis; the second pair of electrodes may be placed on the upper chest and lower back of the patient, defining the second axis; and the third pair of electrodes may be placed on the upper back and lower chest of the patient, defining the third axis. In some embodiments, signal generator 211 generates three or more signals of different frequencies, for example, to drive three or more axes (e.g., each of the X, Y, and Z axes described above), each axis being driven at a unique frequency. Three or more axes may include two or more axes orthogonal to each other. Alternatively or additionally, as described below, signal generator 211 may generate three signals with different phases or other measurable characteristics, such that each signal (axis) can be determined by filtering to perform multi-axis positioning. In some embodiments, each axis is driven individually (e.g., one at a time), and single-axis positioning may be interleaved between one or more desired axes. In embodiments of process 600, step 620 may be performed continuously throughout process 600 or throughout the diagnostic process (e.g., continuously driving positioning signals throughout the diagnostic process).

[0145] In step 630, ETC 210 simultaneously or sequentially records data collected from one or more electrodes 132, e.g., data collected from each electrode 132. In step 640, the recorded data may be filtered once or multiple times, for example, by one or more sequential filters and / or one or more parallel filters. In one embodiment, the recorded data may be initially filtered to isolate signals associated with the positioning signal generated by generator 211, e.g., signals with frequencies between 1 and 100 kHz, such as those between 10 and 100 kHz. The filtered data may then be separated and filtered by multiple (e.g., three) parallel filters, each configured to isolate a single frequency range, e.g., a frequency range associated with a single axis.

[0146] In step 650, the three separately filtered sets of data may be analyzed, for example, by a positioning algorithm, to determine the position of each electrode 132 relative to the patient P in a three-dimensional coordinate system. In some embodiments, the positioning process 600 may include the use of more or fewer axes, such as two, three, or four axes. Alternatively or additionally, the positioning process 600 may include the use of concentric surface electrodes 225. The positioning process 600 may include multiple filters and / or multiple data paths within the ETC 210, such as multiple data paths corresponding to multiple axes, and multi-level data filtering.

[0147] In step 660, if system 10 remains in the positioning process, steps 620 to 650 are repeated. In some embodiments, such as when the positioning process 600 is interleaved with the ultrasound measurement process, and each process is performed within similar or dissimilar time intervals, system 10 may remain in the positioning process for a time interval between 1 μs and 1 s (e.g., between 50 μs and 0.5 s, e.g., approximately 10 ms). In step 660, when it is determined that system 10 is no longer in diagnostic mode, process 600 proceeds to step 670. In step 670, the positioning process 600 is stopped.

[0148] Now for reference Figure 4 This invention provides a method for performing an ultrasonic measurement process consistent with the inventive concept. In some embodiments, Figure 4 The process 700 uses the method described above. Figure 1 This is accomplished by system 10. In step 710, system 10 begins the ultrasonic measurement process. In some embodiments, this process can be performed in conjunction with the above-mentioned reference. Figure 3 The positioning process is interleaved.

[0149] In step 720, UTC 220, for example, turns off one or more switches to activate the first transducer 133 (which may be referred to as 133). FIRST "Activate" – this switch will activate the first transducer 133. FIRST Electrically connected to generator 221 and / or, for example, referred to below Figure 6 Other electronic components of the described UTC 220. In some embodiments, one or more switches may include optocouplers, such as optocouplers having an activation time of approximately 0.01 μs or approximately 500 μs. Generator 221 may be configured to generate a pulsed “drive signal” configured to “ring,” vibrate, and / or otherwise cause transducer 133 to generate ultrasonic pulses. The drive signal may include a signal having one or more frequencies between 1 MHz and 25 MHz, such as a drive signal having a frequency of at least approximately 10 MHz. The drive signal may also include a signal having a pulse width between 0.1 μs and 10 μs, such as a pulse width of approximately 1.0 μs or 2.0 μs.

[0150] In some embodiments, for example Figure 1 In the paired electrode / transducer embodiment, activation of transducer 133 causes deactivation of its paired electrode 132. During the activation of transducer 133, ETC 210 does not record electrical signals received by its paired electrode 132, creating a temporary "dead zone". As described below, a non-sequential sequence of transducers 133 can be activated so that the temporary "dead zone" in the electrical recording is not prolonged by the orderly activation of adjacent pairs of 132 / 133.

[0151] In step 730, the first transducer 133 FIRST Remains active, but no longer driven by generator 221. Transducer 133 "stops ringing" (or "ringing ends") to allow the first transducer 133 to... FIRST All driving vibrations cease, and the first transducer 133 is eliminated. FIRST Any remaining vibrations within. In some embodiments, step 730 may include a duration between 0.05 μs and 1 μs, for example, a duration of approximately 0.1 μs.

[0152] In step 740, for example by recording the signal from the first transducer 133 FIRST Any ultrasonic vibrations sensed and the reflections of one or more ultrasonic pulses generated in step 720 are recorded. The UTC 220 is configured to "listen" to these reflections. These reflections may be associated with characteristics or structures of the ultrasound waves selected from the group consisting of: the inner wall of a heart chamber; the outer wall of a heart chamber; features of a heart chamber, such as a pulmonary vein or heart valve; a portion of a device inserted into a heart chamber, such as an ablation catheter and / or a second mapping catheter also inserted into a heart chamber; and combinations of two or more of these. In some embodiments, step 740 may be configured to "listen" to the reflections over a time period between 1 μs and 200 μs, for example, a time period of approximately 100 μs. Another component of the UTC 220 or electronic module 200 may be configured to determine distance measurements, for example, from the first transducer 133. FIRST The measurement distance to a first receiving reflection source, such as a reflection from the inner wall of a heart chamber. The distance measurement can be determined using techniques generally known to those skilled in the art, for example by determining the total “journey time” of the ultrasound pulse and using the velocity of sound in blood and / or (as applicable) other tissues to determine the total travel distance of the pulse.

[0153] In step 750, the subsequent transducer 133 NEXT It can be prepared electronically. Preparation may include "activating" the transducer 133 as described above. NEXT Step 750 may further include deactivating the previous transducer 133.PREV For example, transducer 133 FIRST In some embodiments, transducer 133 NEXT Activation may include a process requiring a duration between 0.01 μs and 500 μs, for example, a duration of approximately 50 μs. In these embodiments, transducer 133 NEXT The activation can be combined with the previous transducer 133 PREV And / or a portion of the deactivation interleaving in step 740, such that transducer 133 NEXT In transducer 133 PREV Activation occurs while the device is being listened to and / or deactivated. In some embodiments, these processes may overlap over time periods between 0.01 μs and 500 μs, such as approximately 100 μs. In some embodiments, the duration from the start of the activation process of transducer 133 to the end of the deactivation process may be between 1 μs and 700 μs, such as approximately 200 μs.

[0154] In steps 760 to 780, as described with reference to steps 720 to 740 above, the transducer 133 is... NEXT Ring, stop ringing, and listen and record.

[0155] In step 790, if none of the transducers 133 (or a predetermined subset thereof) have been activated since the start of process 700, steps 750 through 790 are repeated. In some embodiments, such as when two or three cycles of process 700 are required to activate all transducers 133, for example when two or three cycles are run sequentially or with one or more other processes (e.g., Figure 3 During the process 600 (interleaving), a subset of transducers 133, such as approximately half or one-third of transducers 133, is activated in process 700. In some embodiments, a complete cycle, such as a cycle in which all transducers 133 are activated, may include a duration between 500 μs and 10,000 μs, such as a duration of approximately 5,000 μs. (As described below...) Figure 5 In one embodiment, the conduit 100 may include 48 transducers 133. Each activation cycle may include a duration of approximately 200 μs, and the process 700 may include a duration of approximately 5 ms.

[0156] In step 790, if all transducers 133 (or a predetermined subset thereof) have been activated, process 700 continues to step 795. In step 795, if the measurement process is to be repeated, for example if subsequent (similar or dissimilar) subsets of transducers 133 will be activated, steps 720 to 790 are repeated. If the measurement process is complete, process 700 proceeds to step 799. In step 799, the measurement process stops.

[0157] Now for reference Figure 5 This provides a perspective view of an embodiment of a diagnostic catheter including an expandable component 130, consistent with the inventive concept. According to U.S. Patent Application No. 14 / 762,944, filed July 23, 2015, entitled "Expandable Catheter Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways," which is incorporated herein by reference, the expandable component 130 may be all or part of it. Figure 5 In one embodiment, the expandable component 130 includes a plurality of splines 131 (i.e., six radially spaced splines at 60° intervals, each spline including eight pairs of electrode transducers 132 / 133) configured as shown. In this embodiment, the transducers 133 are connected to the splines 131 via a housing 138. In other embodiments, the plurality of transducers 133 may be connected to the splines 131 in different ways (e.g., between two and twelve splines 131).

[0158] In this embodiment, as shown in the deployed state of the expandable component 130, the array of transducers 133 and electrodes 132 is substantially uniformly distributed from one side of spline 131 to the other. The proximal end of spline 131 (the nearest rod 105) is attached to the distal portion of rod 105, for example, in or within rod 105, or between rod 105 and an internally translatable (i.e., forward and retractable) control rod 107. Control rod 107 may include one or more conduits and / or channels, such as lumen 108 as shown. For example, when lumen 108 is sized to slidably accommodate a guidewire, and lumen 108 is continuous to the proximal portion of conduit 100, such as when lumen 108 exits the handle 110 of conduit 100, lumen 108 can be configured to allow conduit 100 to be inserted over the guidewire. Alternatively or additionally, the lumen 108 may be sized to slidably accommodate one or more devices, such as those selected from the group consisting of: ablation catheters; mapping catheters; cryoablation catheters; tip ablation catheters; diagnostic catheters; and combinations of two or more of these. In some embodiments, the lumen 108 may be configured to allow delivery of one or more drugs or other agents during diagnostic or other procedures.

[0159] In some embodiments, electrode 132 may be positioned inside spline 131. Optionally or additionally, electrode 132 may include some electrodes located inside spline 131 and some electrodes located outside spline 131. Optionally or additionally, electrode 132 may be a double-sided electrode with its opposing surfaces facing the inside and outside of the basket, or electrode 132 may include annular electrodes respectively surrounding each spline 131.

[0160] As shown in the figure, the distal end of spline 131 is connected to the distal end of control lever 107. Control lever 107 can be advanced and retracted to respectively compact and extend expandable assembly 130. Controls are provided via a handle at the proximal end, for example... Figure 1 The control 111 on the handle 110 allows the control lever 107 to move forward and retract. In some embodiments, the control lever 107 can be retracted from a position associated with the natural unfolded position of the expandable assembly 130 (e.g., Figure 5 As shown in the embodiment, for example, to deform the expandable component 130, for example, to invert the distal portion of the spline 131, causing at least the distal transducer 133 to align in the forward-facing direction, as shown in the embodiment. Figure 5A As shown. In this setup, the forward-facing transducer 133 can be used as a transducer array to perform a mode B scan, or other ultrasonic scanning methods known in the art.

[0161] As described in this article, Figure 5 The expandable component 130 includes forty-eight pairs of electrodes / transducers 132 / 133, which can be used to perform biopotential measurements, localization measurements, and / or ultrasonic distance measurements. During ultrasonic measurements, as described above... Figure 4 During the process of 700, please refer to the following text. Figure 6 As described, Figure 5 The transducers 133 of the scalable component 130 can be sorted.

[0162] Now refer to Figure 6 The diagram shows a view of the activation sequence of an array of 48 ultrasonic transducers arranged on six splines (eight per spline), consistent with the concept of the present invention. Figure 6 It is a specific representation of the activation order of a certain number of transducers, which is found in scalable components, such as those mentioned above. Figure 5 The scalable component 130 has a specific number of splines that are spaced substantially equidistantly. Alternatively, the scalable component 130 may have a different number of transducers and / or splines, and may perform similar or dissimilar disordered transducer activation sequences.

[0163] exist Figure 6In the embodiments, transducers 1-8 represent the farthest transducer (1) to the nearest transducer (8) from each of the six splines to the other. Each activation period depicted by a solid frame represents an activation period, and deactivation or blanking of the mating electrodes as described herein. The patterns shown represent patterns that avoid sequential activation of two adjacent transducers, for example, avoiding sequential activation of two transducers within two or three “adjacent spaces” of each other. An adjacent space can be considered as the space of a spline; the space across a spline, for example, the space of transducer 1 of spline 1 and transducer 1 of spline 2; and / or diagonally across a spline, for example, the space of transducer 1 of spline 1 and transducer 2 of spline 2. The patterns shown also represent patterns that avoid sequential activation of two transducers from a single spline.

[0164] Figure 7 An embodiment of a block diagram of a user interface (UI) system 230, for example, conceived according to the present invention, which can be used with diagnostic catheters as described herein, is provided.

[0165] UI system 230 includes a display area 240, which may include one or more windows, screens, and / or monitors, such as 2D or 3D displays, on which information can be rendered / displayed. Windows 240 in the display area do not need to... Figure 7 The settings shown do not require a relative design size. Not all windows displayed within the display area 240 need to be included. Figure 7 The descriptions in the text represent illustrative embodiments, but the UI system conceived according to the present invention is not limited to the specific embodiments shown.

[0166] A 3D display window 242 may be included to display graphical elements in a three-dimensional (3D) space, such as a heart or ventricle. The images and information presented in the 3D display window 242 may change based on the user task being performed (e.g., based on a task completed in the main application window 250). In some embodiments, the 3D display window 242 may also exist within the main application window 250. The 3D display window 242 may be user-interactive and may change in response to user interaction with it.

[0167] A two-dimensional (2D) display window 244 may be included to display graphical elements in two-dimensional space. The images and information presented in the 2D window 244 may change based on the user task being performed (e.g., based on a task completed in the main application window 250). In some embodiments, the 2D display window 244 may also exist within the main application window 250. The 2D display window 244 may be user-interactive and change in response to user interaction with it.

[0168] The main application window 250 may include the main workflow interface for creating 3D maps. The acquisition window 252 provides the tools necessary for viewing and recording bioelectrical potential signals, localization signals, and / or ultrasound signals, such as user interface tools. One tool in the acquisition window 252 allows combining ultrasound and localization data to reconstruct the compartment anatomy (i.e., to create a digital model of the surface representing the compartment anatomy). This representation of the anatomy can be displayed in the surface creation window 254. Additionally, previously reconstructed compartment anatomy (e.g., patient and / or substitute) can be loaded from one or more data repositories (e.g., files, databases, or storage) and displayed in the surface creation window 254 for use with live data. Configuration settings are available from this window 254 to correctly record / orient the compartment reconstruction to the live data.

[0169] Waveform processing window 256 can be provided and used to allow viewing, filtering, and / or analyzing recorded data. Users can use these tools to identify time periods of data to be mapped. A segment can range from one sample length to the length of the entire record. Segment selection can also take the form of directly passing data, passing one time sample by time sample to the mapping algorithm, so that the map can be formed "instantaneously" (e.g., in real-time, near-real-time, or pseudo-real-time, referred to herein as "real-time") without the need for manual segment selection. The processed waveform can be displayed in 2D display window 244, for example, as an electrocardiogram (EGM) or electrocardiogram (ECG or EKG). 3D display window 242 can display any or all of the following: voltage signals on the basket electrodes are rendered onto a three-dimensional surface of the size and shape of the basket, a colored topological surface of the electrode signals (the color of the terrain corresponding to the voltage amplitude and the "Z height"), the electrodes oriented in relative adjacency, and / or the spatial position of the basket relative to the reconstructed surface to show the location of the basket in the room of interest.

[0170] Mapping window 258 may be provided and used to allow configuration and execution of mapping algorithms, including the selection of surface source models. The resulting 3D map can be presented in 3D display window 242, while the corresponding waveform is displayed in 2D display window 244. A time cursor or window may be included to provide time indexing between display windows. The time cursor or window can be configured to slide or move from one side of the waveform to the other in the 2D window in sync with the dynamically changing display presented in the 3D window.

[0171] As an example, a system configuration and diagnostic window 246 may be provided and used to display vital signals from the catheter (e.g., processed by the electronic module 200) – biopotentials, localization, and / or ultrasound. This window 246 can be used to verify the operation of such a system or subsystem.

[0172] A surface editing window 248 may be provided and used to allow users to edit and manipulate reconstructed anatomical structures. The provided tools may include, but are not limited to: selection (single vertex / polygon, rectangle, ellipse, freeform, automatic isolation element selection and / or sharp feature selection) tools, trimming (through cut, frontal cut) tools, smoothing tools, re-interlocking tools, hole-filling tools, subdivision tools, and surface deformation tools such as push-pull tools. These tools may include shape recognition tools, component recognition tools, isolation tools, extraction tools, attachment tools, and / or merging tools. These tools may be user-interactive surface editing tools. These tools may be configured to operate manually, semi-automatically, and / or automatically.

[0173] User input module 260 may include human interface devices such as a mouse, keyboard, touch screen, digital pen, or other devices that may be used to provide user input and / or system control and their presentation.

[0174] Figures 8A-8C Different views related to the output of the user interface system are provided according to various aspects of the present invention.

[0175] refer to Figure 8A This illustrates a point cloud data structure that can be presented in a 3D display window 242. According to this embodiment, the 3D coordinate space is divided into spherical portions with quadrilateral cross-sections except for the poles on the N side. Each bin's cross-section at the same radius from the origin is configured to have similar areas. Surface point coordinates fall into one and only one bin, so they do not overlap. The bin size (e.g., the azimuth or elevation angle of the opposing direction) (e.g., at instantiation) can be settable. To change the bin size (and thus the mesh size) and / or the displacement of the surface relative to the center of the spherical bin, all surface points in the existing PointCloud can be placed into a second data structure with the desired parameters in a batch operation.

[0176] The surface representing the points in the data structure is displayed by merging all representative points or surfaces of each bin. In one embodiment, an interconnected mesh between bins can be used to draw representative vertices to form the surface. As points are added to the data structure, the bins are updated, and the representative surfaces are updated accordingly. Bins without points can be hidden and not displayed.

[0177] refer to Figure 8BA PointCloud bin is shown and described using a 3D display of the heart as a reference. All data points falling within each bin are analyzed to determine representative points (vertices) or surfaces (surface patches) of the bin. In one embodiment, the centroid of all points in the bin is used as the representative vertex. The quality of the data within each bin can be evaluated, and the vertices or polygons of the representative surface can be colored to indicate the quality of the data. In one embodiment, discrete or radial distance variations in the data can indicate the detection of heart valves, veins, or other radially oriented anatomical structures.

[0178] refer to Figure 8C The diagram illustrates a subset of neighboring bins and their relationships, where each bin is represented by a square. A non-manifold interconnect mesh is computed between neighboring bins. The orientation relationships between bins are static to avoid time-consuming recompiling of the non-manifold interconnect mesh between neighbors.

[0179] Figure 9 An embodiment of a functional block diagram of a cardiac information processing system 900 according to the present invention is provided.

[0180] use Figure 9 The described system allows the user to select what to calculate and / or display; for example, the user can display dipole density (DDM), charge density (CDM), or voltage (VV). This information is calculated based on information represented in the top three boxes 902, 904, and 906 (e.g., electrode location 902, chamber (surface) shape and location 904, and potential recorded at the electrode 906). The system can also be configured to support and allow switching between different display modes, and the way information is displayed can be altered using post-processing tools.

[0181] The process includes selecting a forward model 908. Based on this, one of three operations can be performed: dipole density mapping (DDM) 910, charge density mapping (CDM) 912, and / or voltage-to-voltage mapping (VV) 914. In dipole density mapping (DDM), a distribution of dipole sources, having amplitude and orientation, on the ventricular surface, generates an electric field measurable by electrodes inside and / or outside the ventricle, and is organized and arranged as a dipole density (DD). In charge density mapping (CDM), a distribution of scalar charge sources, having amplitude only, on the ventricular surface, generates an electric field measurable by electrodes inside or outside the ventricle, and is organized and arranged as a charge density (CD). And in voltage-to-voltage mapping (VV), no source assumption is made, and (e.g., using the Laplace equation and / or other methods known to those skilled in electromagnetic field theory) the voltage measured on the electrodes inside or outside the ventricle propagates from the voltage on the ventricular surface.

[0182] With the positions of the ventricular surface and the electrodes recorded on the surface as inputs, the transformation matrix that encodes the relationship between the DD / CD / voltage on the ventricle and the voltage measured on the electrodes is the output calculated in a forward direction.

[0183] The inverse calculation is performed using the potential and transformation matrix obtained from the mapping conduit (from the output of the forward calculation) as input. The DD / CD / voltage on the surface can be obtained by solving the linear system using a regularization method, such as the Tikhonov regularization method.

[0184] The DD / CD voltage on surface 920 is the output of the inverse calculation 916. The surface voltage can be calculated forward from the derived surface DD / CD of the DDM / CDM, and the surface DD / CD using the ventricular surface-specific transformation matrix can be derived using the surface voltage from VV.

[0185] In some embodiments, the cardiac information processing system 900 includes a post-processing tool 930. Using the post-processing tool 930, DD / CD / voltage can be post-processed to produce, for example, Coulomb plots (adaptation of the discrete Laplacian operator, or spatial secondary derivation of DDM, CDM, and / or voltage plots), isochron plots (activation time), amplitude plots (peak-to-peak amplitude or negative peak amplitude), persistence plots (activation and resting states), and / or propagation plots (wavefronts).

[0186] The 3D display 242 can be used to display the output from the post-processing tool 930. That is, for example, surface DD / CD / voltage and post-processing images can be displayed by selecting options on the display panel of the UI system 230. As an example, the user can rotate the 3D image to different viewing angles and adjust the color image.

[0187] While the content considered to be the best mode and / or other preferred embodiments has been described above, it should be understood that various modifications may be made therein, and the invention or plural inventions may be implemented in various forms and embodiments, applicable to many applications, only some of which are described herein. The appended claims are intended to claim the literal description and all equivalents, including all modifications and variations falling within the scope of each claim.

Claims

1. A method for performing a localization and imaging process, comprising: A cardiac catheter is provided, the catheter comprising a plurality of biopotential electrodes and a plurality of ultrasound transducers connected to a 3D array at the distal end of the catheter; A positioning system is provided, comprising a plurality of surface electrodes for generating one or more positioning signals and determining the position of one or more of the biopotential electrodes relative to a coordinate system by recording and analyzing data collected from the surface electrodes. An imaging system including an electronic module is provided for: Each of the plurality of ultrasonic transducers is selectively turned on / off according to a predetermined activation sequence, the predetermined activation sequence avoiding sequential activation of two adjacent transducers in two or three mutually adjacent spaces, wherein the adjacent spaces are: the space on a single spline of transducer one and transducer two including spline one; the space across the spline of transducer one including spline one and transducer one including spline one; and / or the space diagonally across the spline of transducer one including spline one and transducer two including spline one; and Signals received from each ultrasound transducer are processed to generate a 3D display of surrounding tissue, wherein the surrounding tissue is positioned relative to the coordinate system by one or more of the biopotential electrodes.

2. The method of claim 1, wherein the surrounding tissue is one or more walls of the ventricle.

3. The method of claim 1, wherein the 3D display of the surrounding tissue is presented on a user interface system having a display screen and a user control device, the user interface system allowing graphical operation of the 3D display of the surrounding tissue.

4. The method of claim 1, wherein the 3D array is a basket array, a spiral array, an airbag, a radially deployable arm, or other scalable and compressible structure.

5. The method according to claim 1, wherein the ultrasonic transducer is disposed on a plurality of splines of the 3D array.

6. The method of claim 5, wherein the 3D array comprises at least three splines.

7. The method of claim 5, wherein at least two ultrasonic transducers are disposed on each spline.

8. The method according to claim 5, wherein the biopotential electrode is also disposed on a plurality of splines of the 3D array.

9. The method of claim 8, wherein at least some of the biopotential electrodes and at least some of the ultrasonic transducers are disposed on the same spline.

10. The method of claim 8, wherein a biopotential electrode and an ultrasonic transducer are disposed together to form an electrode / transducer pair, and the system comprises multiple electrode / transducer pairs.

11. The method of claim 10, wherein one or more splines comprise multiple pairs of electrodes / transducers.

12. The method of claim 10, wherein the plurality of splines comprise at least one pair of electrodes / transducers.

13. The method of claim 10, wherein each spline comprises a flexible PCB, and each pair of electrodes / transducers is electrically connected to the flexible PCB.

14. The method of claim 10, wherein each pair of electrodes / transducers shares a common communication path.

15. The method of claim 10, wherein all electrode / transducer pairs on the spline share a common communication path.

16. The method of claim 10, wherein all electrode / transducer pairs on the spline share a common ground.

17. The method according to claim 1, further comprising: The electronic module associates electrical activity with one or more images generated using an imaging device.

18. The method of claim 17, wherein the imaging apparatus comprises an imaging apparatus selected from the group consisting of: a fluorescence microscope; an MRI scanner; a CT scanner; an ultrasound imaging apparatus; and combinations of two or more of these.

19. The method of claim 1, wherein the activation sequence avoids sequential activation of two transducers from a single spline.

20. The method of claim 1, wherein the electronic module comprises one or more switches, the method comprising selectively opening and / or closing the one or more switches to activate the one or more switches, thereby electrically connecting the transducer to a signal generator.

21. The method according to claim 20, wherein, The one or more switches include an optocoupler.

22. The method of claim 21, wherein the optical coupler has an activation time in the range of 0.01 μs to 500 μs.

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