Systems and methods for mapping guided automatic cardiac ablation

Abstract

Systems designed for mapping guided automatic cardiac ablation are provided. Methods for treating cardiac abnormalities in a subject by acquiring images of the heart, identifying target sites, and automatically performing ablation of cardiac tissue corresponding to the target sites are described.

Description

Summary of the Invention

[0001] In one aspect, the present invention relates to a method for mapping-guided automated ablation. The method includes acquiring an image of the heart of a subject suffering from a cardiac disorder and displaying the image on a screen display. The method also includes identifying a plurality of target sites on the image, wherein each of the plurality of target sites is cardiac tissue exhibiting electrical abnormalities. The method further includes designing a process that may interconnect two of the plurality of target sites by marking target lines on the image. The method may also include inserting a catheter comprising a plurality of ablation electrodes into the heart of the subject. The method may further include automatically selecting at least one ablation electrode from a plurality of ablation electrodes closest to the target line; and automatically ablating the cardiac tissue using at least one selected ablation electrode.

[0002] In one aspect, the present invention relates to a system for automatically ablating target tissue in the heart of a patient. The system may include a catheter comprising a plurality of ablation electrodes configured to contact the target tissue. The system may also include a navigator configured to select at least one of the plurality of ablation electrodes closest to the target tissue. The system may further include a generator adapted for automatically ablating the target site in the heart. The system may also include a screen display and a processing device adapted to drive the generator to ablate the plurality of target tissues with at least one selected ablation electrode and to store a program in memory configured to present an image of the heart on the screen display, specify the location of the target tissue in the image, and identify ablation parameters.

[0003] In one aspect, the present invention relates to computer software products. These computer software products include a non-transitory computer-readable storage medium storing computer program instructions that, when executed by a computer, cause the computer to perform the steps described herein. Attached Figure Description

[0004] The following detailed description of embodiments of the invention will be better understood by reading in conjunction with the accompanying drawings. For illustrative purposes, the drawings show presently preferred embodiments. However, it should be understood that the invention is not limited to the precise arrangements and tools shown. In the drawings:

[0005] Figure 1 This is a schematic diagram of a system used to perform automated cardiac ablation.

[0006] Figure 2 The screen displays electroanatomical mapping and the sling catheter.

[0007] Figures 3A to 3B The heart is marked with the target line. Figure 3A ) and target sites for automated cardiac ablation ( Figure 3B (view of ).

[0008] Figures 4A to 4B This is a view of the left atrium of the heart. Figure 4A A view of a basket catheter inserted into the left atrium for performing automated cardiac ablation. Figure 4B A view of the ablation line in the heart after the ablation procedure.

[0009] Figure 5 A flowchart illustrating a method for automatically performing mapping-guided cardiac ablation according to the embodiments described herein. Detailed Implementation

[0010] This disclosure relates to cardiac ablation, and more specifically, to systems and methods for automatically performing mapping-guided cardiac ablation.

[0011] Cardiac disorders, such as arrhythmias, are associated with abnormal conductivity in cardiac tissue. Procedures for treating cardiac disorders involve identifying the source of the signal causing the arrhythmia and disrupting the conductive pathways carrying the erroneous signal. By selectively ablating cardiac tissue, it is possible to interrupt the propagation of unwanted electrical signals. Cardiac ablation is typically performed by applying alternating current to electrodes to heat and destroy target tissue to create a non-conductive ablation focus. Ablation systems are known in the art. Physicians use ablation systems to track physiological and electrophysiological parameters, such as atrial chamber size, myocardial wall thickness, tissue impedance, and atrial contraction, and to adjust the ablation energy pulse by adaptively adjusting ablation parameters during electrical treatment, including pulse length and ablation time.

[0012] However, existing ablation systems rely on the knowledge and subjective assessments of medical personnel and are prone to error. A better system for identifying and ablating target sites is necessary.

[0013] This system allows physicians to manually or automatically select ablation sites using a graphical user interface (GUI) mapping of the heart, with the system automatically executing the ablation procedure. In one aspect, the system enables physicians to predefine the treatment based on specific parameters such as tissue thickness, the presence of scar tissue, and safety concerns.

[0014] Figure 1This is a schematic diagram of an exemplary system 100 for performing automated cardiac ablation in the heart of patient 103 according to one or more embodiments of the present invention. System 100 includes a console 102 including a processing unit 108. The processing unit 108 may include a processor 105 and a display device that may include a display 110 (such as a monitor and / or screen). The processing unit 108 may include one or more processors, each processor configured to process ECG signals from a catheter. Each processor 105 of the processing unit 108 may be configured to record ECG signals over time, filter ECG signals, map ECG signals, combine ECG signal information, mapping and interpolation mapping information, etc. Processor 105 may include appropriate signal processing circuitry for receiving signals from catheter 101. Catheter 101 may be coupled to the processing unit 108, which enables physician 104 to observe and adjust the function of catheter 101. The signal processing circuitry may receive, amplify, filter, and digitize signals from catheter 101. Signals may be generated by sensors and / or multiple position electrodes located in catheter 101.

[0015] The processing device 108 can also control other components of the system 100 according to the embodiments described herein. The processing device 108 is preferably programmed in software and / or hardware to perform the functions required by the system. The processing device 108 can store software data in memory. The software can be downloaded electronically to the processing device 108 via a network, or can be provided on a tangible medium, such as optical, magnetic, or other non-volatile memory media.

[0016] Catheter 101 is adapted for endocardial mapping and / or ablation of cardiac tissue and includes a catheter body and multiple electrodes. These multiple electrodes may be multiple mapping electrodes to measure electrocardiographic signals at one or more corresponding contact points with the cardiac tissue, and / or multiple ablation electrodes or electrodes capable of performing both mapping and ablation. Catheter 101 may be in any configuration that provides and / or enables coverage of the entire surface of the atrial ventricle. Catheter 101 may be a trocar catheter including multiple non-overlapping loops, such as... Figure 2 The sling catheter shown. Catheter 101 may be a basket-shaped catheter with a basket electrode array, such as the basket-shaped catheter shown in Figure 4. Basket-shaped catheters are known in the art and described in U.S. Patent No. 6,748,255, U.S. Application Publication No. 2016 / 0228023, and U.S. Application Publication No. 2006 / 0009690, all of which are incorporated herein by reference as if fully described.

[0017] The catheter 101 may also include an array of temperature sensors for monitoring local tissue heating during ablation to prevent collateral damage to the endocardium and adjacent tissues, including the lungs or esophagus. The catheter 101 can be inserted into the chambers of the heart 111 by an operator 104, typically a physician or medical professional. The catheter 101, having multiple mapping electrodes, can be used to create functional electroanatomical mappings of a patient's heart as described, for example, in U.S. Patent Nos. 6,892,091, 6,301,496, and 6,892,091, all of which are incorporated herein by reference as fully illustrated. For example, the carto... (The sentence is incomplete and requires further context to translate accurately.) TM The system can be used for electroanatomical mapping.

[0018] Processing device 108 can store mapping data in memory. Processing device 108 can be coupled to a program that operates to generate a visual display of mapping map 109 by driving monitor 110. Mapping map 109 can be an electroanatomical mapping of heart 111. Mapping map 109 can be a 3D mapping of heart 111. Physician 104 can interact with processing device 108 via graphical icons and visual indicators displayed on monitor 110, such as as described in U.S. Application Publication No. 2015 / 0057529, which is incorporated herein by reference as fully set forth. Physician 104 can view electroanatomical mapping map 109 displayed on screen of processing device 108 and identify abnormal atrial tissue that can be targeted for ablation by applying thermal energy. Abnormal atrial tissue is also referred to herein as target tissue. Target tissue can be tissue with abnormal electrical conductivity. Target tissue can be tissue that initiates or triggers atrial fibrillation. Target tissue can be located near pulmonary veins.

[0019] Physician 104 can provide parameters of the target tissue to system 100 via a visual indicator on the electroanatomical mapping. Parameters of the target tissue may include, but are not limited to, tissue thickness and the presence of scar tissue. Physician 104 can draw target lines on the mapping 109 displayed on monitor 110. As used herein, target lines may be lines drawn on the target tissue displayed on the electroanatomical mapping. Using the parameters provided by physician 104, processing device 108 can automatically adjust the ablation time, energy level, and / or temperature.

[0020] The processing device 108 can also automatically select one or more electrodes from a plurality of ablation electrodes that need to be activated based on proximity to the target line. Furthermore, critical areas can be marked on the mapping map 109 by the physician 104 and avoided by the system for safety reasons. As used herein, a “critical area, or site” refers to an area of ​​the heart that may be damaged due to an ablation procedure performed near that area. A critical area may be, for example, near the esophagus, vagus nerve, or phrenic nerve. For example, an ablation procedure involving the posterior wall of the left atrium can cause esophageal injury and lead to the formation of an atrial-esophageal fistula. If ablation must occur near a critical area, the ablation time and energy used near these critical areas can be reduced, or ablation can be avoided. Alternatively, the processing device 108 can automatically identify critical areas on the mapping map 109 and can reduce ablation energy and time limitations during treatment. The catheter 101 can be used for mapping and to deliver thermal energy during ablation. The catheter used for mapping (not shown) can be removed and replaced with the ablation catheter 101, which can be inserted into the same location on the heart using the same coordinate system. Catheter 101 is available in carto TM The system registers for ablation.

[0021] The catheter 101 may also include a position sensor that provides signals to a processing device 108 in the console 102. For example, a magnetic field sensor, typically including a coil, may be attached to the catheter 101 near the distal end 107. The position sensor may generate an electrical position signal in response to a magnetic field from the coil, thereby enabling the processing device 108 to determine the coordinates or position of the distal end 107 within the heart chamber 111, and thus the coordinates of each of the plurality of ablation electrodes. The catheter 101 may be configured to relay the coordinates of a plurality of ablation sites formed by the plurality of ablation electrodes to the processing device 108. The processing device 108 may be configured to receive signals from the magnetic field sensor indicating the coordinates of the plurality of ablation electrodes of the catheter 101. The console 102 and the positioning system may receive and use the digitized signals to calculate the position and orientation of the catheter 101, and to analyze the electrical signals from the electrodes. The processing device 108 may then calculate the position coordinates of each of the plurality of ablation electrodes. In other embodiments, the processing device 108 may be configured to receive the coordinates of the ablation sites recorded by any suitable imaging system. The processing device 108 can receive the coordinates of multiple ablation sites by any suitable method so as to use the coordinates to identify the appropriate electrode to perform ablation.

[0022] A position sensor may be included in the positioning subsystem. The positioning subsystem may be incorporated into system 100. The positioning subsystem may be a magnetic-based or impedance-based navigation system suitable for navigating the catheter. Console 102 may include drive circuitry that drives a magnetic field generator 106 placed at a known location outside the patient 103. A magnetic-based navigation system may utilize a magnetic field generating coil to determine the position and orientation of catheter 101 by generating a magnetic field at a predetermined working volume and sensing these magnetic fields at the catheter. Alternatively, an impedance-based navigation system utilizing impedance measurement may be employed. Wiring connections may connect console 102 to multiple body surface electrodes on patient 103, which are typically attached to the patient's chest above the heart. Figure 1 (Not shown in the image). Ablation electrodes and body surface electrodes can be used to measure tissue impedance at the ablation site, as described, for example, in U.S. Patent Nos. 7,536,218 and 7,756,576, both of which are incorporated herein by reference as if fully illustrated. The positioning subsystem may be, for example, a carto electrode manufactured by Biosense Webster, Inc. (Diamond Bar, California). TM System. For details, see U.S. Patent Nos. 5,391,199; 6,690,963; 6,484,118; 6,239,724; 6,618,612; 6,332,089, 6,690,963; 7,729,742; PCT Publication No. WO 1996 / 05768; and U.S. Application Publication No. 2004 / 0068178, all of which are incorporated herein by reference as if fully described. CARTO VISI TAG TM The module provides a visual representation of the ablation site and assists physicians in designing successful ablation strategies and customizing them to the anatomical location of the target tissue. VISI TAG TM The module can assist physicians in monitoring the power, contact force, and time of ablation.

[0023] Processing device 108 can use the location of the distal coordinates of the mapping points to construct a simulated surface of a portion of the heart 103. Processor 108 can then combine the potential measurement results of the mapping points with the simulated surface to generate a mapping map of the potential superimposed on the simulated surface. System 100 can use imaging techniques to synchronize images of the heart with mapping in the catheter position sensing system.

[0024] The console 102 may include one or more ablation power generators used to apply energy to multiple ablation electrodes of the catheter 101. The catheter 101 can be used to apply any ablation energy to target tissue in the heart. The power generators may selectively direct energy to electrodes positioned close to the target tissue. The ablation energy may be radiofrequency energy, ultrasound energy, and laser-generated energy, as described, for example, in U.S. Patent Nos. 6,814,733; 6,997,924 and 7,156,816, all of which are incorporated herein by reference as fully set forth herein.

[0025] When the ablation electrode contacts the heart tissue, the ablation energy locally heats and induces localized necrosis of the heart tissue at the ablation site. A localization subsystem records the locations of multiple ablation sites formed by the ablation electrode during the procedure. The locations of the ablation sites can also be observed using imaging systems such as ultrasound, fluoroscopy, or magnetic resonance imaging (MRI).

[0026] Provided solely for the purpose of conceptual clarity and not for limiting the implementation schemes described herein. Figure 1 The system shown,

[0027] Physician 104 can acquire an image 109 of the heart and display the image 109 on the screen of monitor 110. Figure 2 An exemplary screen display of the monitor 110 described herein is shown. A functional electroanatomical mapping 109 of the heart is shown, where local activation times are represented by different shading patterns. The screen displays an image including a lasso catheter 101a. The lasso catheter 101a within the heart 111 is partially obscured by details of the electroanatomical mapping 109 and target sites 112 obtained during mapping previously performed using mapping electrodes of the catheter 101a. Indications of the orientation of the catheter 101a and the state of its electrodes are visible in the image of the catheter 101a. The physician 104 may mark the electroanatomical mapping 109 with target lines, such as lines interconnecting the target sites 112.

[0028] Figures 3A to 3B The heart is marked with the target line. Figure 3A ) and target sites for automated cardiac ablation ( Figure 3B (View of) . Reference Figure 3A Electroanatomical mapping 109 can be marked with lines 112a surrounding the left superior pulmonary vein (LSPV) and left inferior pulmonary vein (LIPV), or the right superior pulmonary vein (RSPV) and right inferior pulmonary vein (LIPV), or both the left and right pulmonary veins. Electroanatomical mapping can be marked with lines 112b connecting the circles surrounding the left and right pulmonary veins, or by creating a diameter within each circle surrounding the left and right pulmonary veins.

[0029] Electroanatomical mapping can be marked using line 112c surrounding the superior vena cava (SVC). Electroanatomical mapping can be marked alone or in any combination of lines 112a, 112b, or 112c. (Reference) Figure 3B The processing device can automatically identify the target location point 112 on the electroanatomical mapping map.

[0030] Figures 4A to 4B This is a view of the left atrium of the heart. Figure 4A This is a view of an exemplary basket-shaped catheter 101b for performing automated cardiac ablation according to an embodiment disclosed herein. The catheter body includes multiple splines, and each spline contains multiple ablation electrodes 101c. The catheter is configured to activate electrodes 112d proximate to a target line of the heart 111 identified on an image of the heart 109 and perform automated ablation. The catheter may include 50 to 54 ablation electrodes. Those skilled in the art will recognize that more or fewer electrodes may be included and that the positioning and spacing of the electrodes may vary. Each of the ablation electrodes may be 4 mm in size. The distance between two ablation electrodes positioned adjacent to each other is 3 to 4 mm. Figure 4B This is a view of an example ablation line 113 in an image of the heart 109 after the ablation procedure.

[0031] Figure 5 This is a flowchart of the steps of an exemplary method for mapping-guided automated cardiac ablation according to embodiments disclosed herein. For example, the method may include step S1: acquiring an image or mapping of the heart of a patient with cardiac disorders and displaying the image on a screen display. The image may be a three-dimensional ultrasound image, an MRI image, or an image obtained by any other imaging technique known in the art. The image may be an electrical or electroanatomical mapping 109 of the heart. The electroanatomical mapping 109 can be obtained using cartometry. TM It is obtained from mapping and navigation systems.

[0032] In step S2, the electroanatomical mapping is evaluated to identify cardiac tissue exhibiting electrical abnormalities and to determine target sites on the mapping that can be targeted for ablation.

[0033] In step S3, a treatment protocol can be designed. In this step, a catheter with multiple ablation electrodes can be registered with a positioning system and inserted into a portion of the heart containing abnormal tissue.

[0034] In step S4, a decision is made as to whether to manually perform and mark the target lines for ablation, or to perform the process automatically. If the decision is made to perform the process manually (S4 = Yes), in step S5, the ablation path for ablating the identified target sites is marked, for example, by drawing target lines that interconnect two or more target sites on an image of the heart 109. In one embodiment, the system may analyze the electroanatomical mapping and recommend the location of the target lines to the physician 104. In another embodiment, the physician 104 may identify target parameters for ablation of the target tissue. Target parameters may characterize the cardiac tissue by, for example, indicating tissue thickness or the presence of scar tissue.

[0035] In step S6, physician 104 may mark one or more critical regions or sites on an image of heart 109. Because the ablation process disrupts unwanted electrical pathways by heating local tissue to temperatures that cause irreversible damage, thus creating a non-conductive ablation focus, ablation at excessive temperatures and durations can cause damage to adjacent tissues, including damage to the esophagus, lungs, phrenic nerve, or perforation of the heart wall. Therefore, to avoid or minimize damage, “mild treatment parameters” can be used to ablate the critical sites indicated in step S6. Mild treatment parameters may be, for example, reduced ablation time, lower energy, and / or lower temperature compared to treatment parameters applied to selected non-critical regions for ablation. Physician 104 may use another line to mark critical sites where ablation can be performed using mild treatment parameters, or ablation can be avoided.

[0036] If the decision is made to proceed automatically (S4 = NO), the target line for ablation can be automatically identified in step S7. Key sites can also be automatically identified in step S8.

[0037] Ablation parameters can be assigned based on the identified target line. It should be noted that the processing device 108 can be integrated with the imaging system to facilitate information processing.

[0038] The image recognition algorithm executed by the processing device 108 can identify the target line marked on the image 109 by the physician 104 in step S5, or the processing device 108 can automatically identify the target line in step S7.

[0039] In step S9, ablation parameters are calculated to facilitate automated ablation of the corresponding tissue in the patient's heart. Ablation parameters may include, but are not limited to, ablation time, ablation temperature, or ablation energy. Ablation parameters can be adjusted close to the critical site. Adjustment of ablation parameters may involve reducing ablation time, temperature, and / or energy, or completely avoiding ablation.

[0040] In step S10, the processing device identifies the ablation electrode of the catheter closest to the target line. In an embodiment, the ablation electrode closest to the target line may be selected by the physician 104.

[0041] In step S11, the selected electrode is activated and ablation is performed according to predetermined parameters. The positioning system can be adapted to compare the target site in the patient's heart after ablation with the same site before ablation.

[0042] Processing device 108 is used in all steps of the method described herein and typically includes signal processing circuitry with software and algorithms. Processing device 108 can be used to insert catheter 101 into the heart 111 of patient 103. Catheter 101 may have multiple ablation electrodes and multiple sensing electrodes. Positioning systems, such as those used in cartometry, are also employed. TM It can be used to track the location of ablation electrodes and identify ablation electrodes that are close to the target tissue.

[0043] It should be understood that many variations are possible based on the disclosure herein. Although features and elements have been described above in specific combinations, each feature or element may be used alone without other features and elements, or used together in various combinations with or without other features and elements.

[0044] It should be understood that many variations are possible based on the disclosure herein. Although features and elements have been described above in specific combinations, each feature or element may be used alone without other features and elements, or used together in various combinations with or without other features and elements.

[0045] The provided methods include implementations in general-purpose computers, processors, or processor cores. Suitable processors include, for example: general-purpose processors, special-purpose processors, conventional processors, digital signal processors (DSPs), multiple microprocessors, one or more microprocessors associated with a DSP core, controllers, microcontrollers, application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), any other type of integrated circuit (IC), and / or state machines. Such processors can be manufactured by configuring the manufacturing process using processed hardware description language (HDL) instructions and the results of other intermediate data, including netlists (such instructions can be stored on a computer-readable medium). The result of this processing can be a maskwork, which is then used in the semiconductor manufacturing process to manufacture processors capable of implementing the methods described herein.

[0046] The methods or flowcharts provided herein can be implemented in a computer program, software, or firmware incorporated in a non-transitory computer-readable storage medium, and thus executed by a general-purpose computer or processor. Examples of non-transitory computer-readable storage media include ROM, random access memory (RAM), registers, cache memory, semiconductor memory devices, magnetic media such as internal hard disks and removable disks, magneto-optical media and optical media such as CD-ROMs, and digital universal discs (DVDs).

[0047] Certain terms are used in the description herein for convenience only and not for limitation. The terms “right,” “left,” “top,” and “bottom” specify directions in the accompanying drawings for reference. The terms “a” and “one” as used in the claims and corresponding portions of the specification are defined as including one or more of the referenced items, unless otherwise specified. This term includes the words / derivatives specifically mentioned above and similarly important terms. The phrase “at least one” followed by a list of two or more items, such as “A, B, or C,” means any one of A, B, or C and any combination thereof.

[0048] Further embodiments of this document may be formed by supplementing the embodiments with one or more elements from any one or more other embodiments of this document, and / or by replacing one or more elements from one embodiment with one or more elements from one or more other embodiments of this document.

[0049] Therefore, it should be understood that the present invention is not limited to the specific embodiments disclosed, but is intended to cover all modifications within the spirit and scope of the invention as defined in the following claims; the above description; and / or the accompanying drawings.

Claims

1. A system for automatically ablating target tissue in the heart of a patient, the system comprising: A catheter comprising a plurality of ablation electrodes configured to contact target tissue; A navigator, wherein the navigator is configured to automatically select at least one ablation electrode from the plurality of ablation electrodes, the at least one ablation electrode being closest to the target tissue; A generator adapted to automatically ablate target sites in the heart; as well as A screen display and a processing device, the processing device being adapted to store a program in a memory, the program being configured to: display a heart image on the screen display; The target tissue and key sites can be selected automatically or manually, wherein each key site is an area that may be damaged due to ablation of one or more of the target sites; The location of the target tissue is specified by drawing a target line on the image of the heart and by drawing a second line to identify and mark the key sites on the image of the heart; ablation parameters are identified; And adjust the ablation parameters used for the key sites.

2. The system according to claim 1, wherein, The image includes an electroanatomical mapping of the heart.

3. The system according to claim 1, wherein, The catheter is either a lasso catheter or a basket catheter.

4. The system according to claim 1, wherein, The catheter includes one or more ablation electrodes.

5. The catheter according to claim 1, wherein, The catheter includes at least thirty ablation electrodes.

6. The system according to claim 4, wherein, The one or more ablation parameters are selected from the group consisting of: ablation time, ablation temperature, and ablation energy.

7. The system according to claim 4, wherein, The navigator is either a magneto-based navigator or an impedance-based navigator.

8. The system according to claim 4, wherein, The processing device is adapted to compare the target site after ablation with the target site before ablation and indicate the differences.

9. A non-transitory computer-readable storage medium therein storing computer program instructions, said instructions, when executed by a computer, causing the computer to perform the following steps: Acquire images of the heart of a subject with a cardiac disorder and display the images on a screen monitor; Identify multiple target sites on the image, wherein each of the multiple target sites is cardiac tissue exhibiting electrical abnormalities; Identify one or more key sites on the image of the heart, wherein each key site is an area that may be damaged due to ablation of one or more of the target sites; The process of interconnecting two of the plurality of target sites is designed by drawing target lines on the image of the heart and identifying and marking key sites on the image of the heart by drawing second lines, wherein the target lines or the second lines are drawn automatically or manually by a physician. A catheter containing multiple ablation electrodes is inserted into the heart of the subject; Automatically assign one or more ablation parameters; Automatically select at least one ablation electrode from the plurality of ablation electrodes, wherein the at least one electrode is closest to the target line; as well as The heart tissue is automatically ablated using at least one selected ablation electrode.

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