Organizational processing system

Abstract

The present invention provides tissue processing systems, apparatus, and methods. [Solution] Provided herein is a system for treating patient tissue. The system comprises an energy delivery console and at least one energy delivery device. The energy delivery console can deliver a first dose of energy and a second dose of energy. The energy delivery device comprises a first delivery element configured to deliver a first dose of energy to target tissue and a second delivery element configured to deliver a second dose of energy to target tissue. The first dose of energy may include the delivery of energy that reversibly alters the target tissue, and the second dose of energy may include the delivery of energy that irreversibly alters the target tissue. The first dose of energy is delivered to enhance the therapy provided by the second dose of energy.

Description

[Technical Field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 939,412, entitled “Tissue Treatment Systems, Devices, and Methods,” filed on 22 November 2019, and to U.S. Provisional Patent Application No. 63 / 075,280, entitled “Tissue Treatment Systems, Devices, and Methods,” filed on 7 September 2020, each of which is incorporated herein by reference.

[0002] This application does not claim priority to U.S. application No. 16 / 335,893, entitled “Ablation System with Force Control,” filed on 22 March 2019, but may be related to this application. This application is a national phase application under Section 371 of the U.S. Patent Cooperation Treaty application PCT / US2017 / 056064, entitled “Ablation System with Force Control,” filed on 11 October 2017, published as International Publication No. 2018 / 071490, claiming priority to U.S. Provisional Application No. 62 / 406,748, entitled “Ablation System with Force Control,” filed on 11 October 2016, and U.S. Provisional Application No. 62 / 504,139, entitled “Ablation System with Force Control,” filed on 20 May 2017. Each of these applications is incorporated herein by reference.

[0003] This application does not claim priority to U.S. application No. 16 / 097,955, filed October 31, 2018, entitled "Cardiac Information Dynamic Display System and Method," but may be related to this application. This application is a national phase application under Section 371 of the U.S. Patent Cooperation Treaty application PCT / US2017 / 030915, filed May 3, 2017, entitled "Cardiac Information Dynamic Display System and Method," published as International Publication No. 2017 / 192769, claiming priority to U.S. Provisional Application No. 62 / 331,351, filed May 3, 2016, entitled "Cardiac Information Dynamic Display System and Method." Each of these applications is incorporated herein by reference.

[0004] This application does not claim priority to U.S. Patent Application No. 16 / 861,814, filed on April 29, 2020, entitled "Catheter, System and Methods of Medical Uses of Same, including Diagnostic and Treatment Uses for the Heart," but may be related to this application. This application is a continuation of U.S. Patent No. 10,667,753, filed on June 19, 2018, entitled "Catheter, System and Methods of Medical Uses of Same, Including Diagnostic and Treatment Uses for the Heart," which is a continuation of U.S. Patent No. 10,004,459, filed on February 20, 2015, entitled "Catheter, System and Methods of Medical Uses of Same, Including Diagnostic and Treatment Uses for the Heart," which is a national phase application under Section 371 of the U.S. Patent Cooperation Treaty application PCT / US2013 / 057579, filed on August 30, 2013, entitled "Catheter System and Methods of Medical Uses of Same, Including Diagnostic and Treatment Uses for the Heart," which has been published as International Publication No. 2014 / 036439, and is a continuation of U.S. Patent No. 10,667,753, filed on June 19, 2018, entitled "Catheter, System and Methods of Medical Uses of Same, Including Diagnostic and Treatment Uses for the Heart," which was filed on August 31, 2012, entitled "System and Method for We claim priority to U.S. Provisional Patent Application No. 61 / 695,535, entitled “Diagnosing and Treating Heart Tissue.” Each of these applications is incorporated herein by reference.

[0005] This application does not claim priority to U.S. Patent Application No. 16 / 242,810, filed on January 8, 2019, entitled "Expandable Catheter Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways," but may be related to that application. This application is a continuation of U.S. Patent Application No. 14 / 762,944, filed on 23 July 2015, entitled "Expandable Catheter Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways," which is a national phase application under Section 371 of the U.S. Patent Cooperation Treaty Application PCT / US2014 / 015261, entitled "Expandable Catheter Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways," filed on 7 February 2014, published as International Publication No. 2014 / 124231, and claims priority to U.S. Provisional Patent Application No. 61 / 762,363, entitled "Expandable Catheter Assembly with Flexible Printed Circuit Board (PCB) Electrical Pathways," filed on 8 February 2013. Each of these applications is incorporated herein by reference.

[0006] This application does not claim priority to U.S. Patent Application No. 16 / 533,028, filed on August 6, 2019, entitled "Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls," but may be related to that application. This application is a continuation of U.S. Patent Application No. 16 / 014,370, filed on June 21, 2018, entitled "Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls," which is a continuation of U.S. Patent Application No. 15 / 435,763, filed on February 17, 2017, entitled "Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls," which is a continuation of U.S. Patent No. 9,610,024, filed on September 25, 2015, entitled "Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls," which is a continuation of U.S. Patent Application No. 9,610,024, filed on November 19, 2014, entitled "Method and Device for Determining and Presenting Surface Charge and Dipole Densities on This is a continuation application to U.S. Patent No. 9,167,982 titled "Cardiac Walls," which is a continuation application to U.S. Patent No. 8,918, published on December 23, 2014, titled "Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls."This is a continuation application of Patent No. 158 (hereinafter referred to as '158 patent), which is a continuation application of U.S. Patent No. 8,700,119 (hereinafter referred to as '119 patent), issued on April 15, 2014, entitled "Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls," which is a continuation application of U.S. Patent No. 8,417,313 (hereinafter referred to as '313 patent), issued on April 9, 2013, entitled "Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac Walls," which is a continuation application of Patent No. 158 (hereinafter referred to as '158 patent), issued on August 3, 2007, entitled "Method and Device for Determining and Presenting Surface Charge and Dipole Densities on Cardiac The Patent Cooperation Treaty application PCT / CH2007 / 000380, entitled “Walls,” is a national phase application under Section 371 of the United States Patent Act, published as International Publication 2008 / 014629, claiming priority to Swiss Patent Application 1251 / 06, filed 3 August 2006. Each of these applications is incorporated herein by reference.

[0007] This application does not claim priority to U.S. Patent Application No. 16 / 568,768, filed on September 12, 2019, entitled "Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall," but may be related to that application. This application is a continuation of U.S. Patent Application No. 15 / 882,097, filed on January 29, 2018, entitled "Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall," which is a continuation of U.S. Patent No. 9,913,589, filed on December 25, 2016, entitled "Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall," which is a continuation of U.S. Patent No. 9,504,395, filed on October 19, 2015, entitled "Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall," which is a continuation of U.S. Patent No. 9,504,395, filed on July 19, 2013, entitled "Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall This is a continuation application to U.S. Patent No. 9,192,318 titled "Wall," which is a continuation application to U.S. Patent No. 8,512, published on August 20, 2013, titled "Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall."This is a continuation application of patent application 255, published as US2010 / 0298690 (published '690), which is a national phase application under Section 371 of the United States Patent Act, of Patent Cooperation Treaty application PCT / IB2009 / 000071, filed on 16 January 2009, entitled "A Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall," published as International Publication 2009 / 090547, claiming priority to Swiss patent application 00068 / 08, filed on 17 January 2008. Each of these applications is incorporated herein by reference.

[0008] This application does not claim priority to U.S. Patent Application No. 16 / 389,006, “Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall,” filed on 19 April 2019, but may be related to that application. This application is a continuation of U.S. Patent Application No. 15 / 926,187, filed on March 20, 2018, entitled "Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall," which is a continuation of U.S. Patent No. 9,968,268, filed on August 8, 2017, entitled "Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall," which is a continuation of U.S. Patent No. 9,757,044, filed on September 6, 2013, entitled "Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall," which was published as International Publication No. 2012 / 122517 (text below, '517 publication) entitled "Device and Method for the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall This is a national phase application under Section 371 of the United States Patent Act, entitled "Wall," which is a Patent Cooperation Treaty application PCT / US2012 / 1212517, claiming priority to U.S. Provisional Patent Application No. 61 / 451,357. Each of these applications is incorporated herein by reference.

[0009] This application does not claim priority to U.S. design patent application No. 29 / 681,827, “Set of Transducer-Electrode Pairs for a Catheter,” filed on 28 February 2019, but may be related to that application. This application is a divisional application of U.S. Design Patent Application No. 29 / 593,043, filed on February 6, 2017, entitled "Set of Transducer-Electrode Pairs for a Catheter," which is a divisional application of U.S. Design Patent No. D782,686, filed on December 2, 2013, entitled "Transducer-Electrode Pair For a Catheter," which is a national phase application under Section 371 of the U.S. Patent Act, entitled PCT / US2013 / 057579, filed on August 30, 2013, entitled "Catheter System and Methods of Medical Uses of Same, Including Diagnostic and Treatment Uses for the Heart," which claims priority to U.S. Provisional Patent Application No. 61 / 695,535, filed on August 31, 2012, entitled "System and Method for Diagnosing and Treating Heart Tissue." Each of these applications is incorporated herein by reference.

[0010] This application does not claim priority to U.S. Patent Application No. 16 / 111,538, titled “Gas-Elimination Patient Access Device,” filed on 24 August 2018, but may be related to this application. This application is a continuation of U.S. Patent No. 10,071,227, titled “Gas-Elimination Patient Access Device,” filed on 14 July 2016, which is a national phase application under Section 371 of the U.S. Patents Act to Patent Cooperation Treaty Application PCT / US2015 / 11312, titled “Gas-Elimination Patient Access Device,” filed on 14 January 2015, which claims priority to U.S. Provisional Patent Application No. 61 / 928,704, titled “Gas-Elimination Patient Access Device,” filed on 17 January 2014. Each of these applications is incorporated herein by reference.

[0011] This application does not claim priority to U.S. Patent Application No. 15 / 128,563, entitled “Cardiac Analysis User Interface System and Method,” filed on 23 September 2016, but may be related to this application. This is a national phase application under Section 371 of the U.S. Patent Act, which is a patent cooperation treaty application PCT / US2015 / 22187 entitled “Cardiac Analysis User Interface System and Method,” filed on 24 March 2015, and claims priority to U.S. Provisional Patent Application No. 61 / 970,027, entitled “Cardiac Analysis User Interface System and Method,” filed on 28 March 2014, and is incorporated herein by reference.

[0012] This application does not claim priority to U.S. Patent Application No. 17 / 063,901, “Devices and Methods for Determination of Electrical Dipole Densities on a Cardiac Surface,” filed on October 6, 2020, but may be related to that application. This is a continuation application of U.S. Patent No. 10,828,011, filed on 2 March 2016, entitled "Devices and Methods for Determination of Electrical Dipole Densities on a Cardiac Surface," which is a national phase application under Section 371 of the U.S. Patents Act of Patent Cooperation Treaty application PCT / US2014 / 54942, entitled "Devices and Methods for Determination of Electrical Dipole Densities on a Cardiac Surface," filed on 10 September 2014, claiming priority to U.S. Provisional Patent Application No. 61 / 877,617, filed on 13 September 2013, entitled "Devices and Methods for Determination of Electrical Dipole Densities on a Cardiac Surface," which is incorporated herein by reference.

[0013] This application does not claim priority to U.S. Patent Application No. 16 / 849,045, “Localization System and Method Useful in Acquisition and Analysis of Cardiac Information,” filed on 15 April 2020, but may be related to that application. This application is a continuation of U.S. Patent No. 10,653,318, filed on 26 October 2017, entitled “Localization System and Method Useful in the Acquisition and Analysis of Cardiac Information,” and is a national phase application under Section 371 of the United States Patent Act, which claims priority to U.S. Provisional Patent Application No. 62 / 161,213, filed on 13 May 2015, entitled “Localization System and Method Useful in the Acquisition and Analysis of Cardiac Information,” and is incorporated herein by reference.

[0014] This application does not claim priority to U.S. Patent Application No. 15 / 569,231, “Cardiac Virtualization Test Tank and Testing System and Method,” filed on 25 October 2017, but may be related to this application. This application is a national phase application under Section 371 of the U.S. Patent Act, PCT / US2016 / 031823, filed on 11 May 2016, which claims priority to U.S. Provisional Patent Application No. 62 / 160,501, “Cardiac Virtualization Test Tank and Testing System and Method,” filed on 12 May 2015, and is incorporated herein by reference.

[0015] This application does not claim priority to U.S. Patent Application No. 15 / 569,185, “Cardiac Virtualization Test Tank and Testing System and Method,” filed on 25 October 2017, but may be related to this application. This application is a national phase application under Section 371 of the U.S. Patent Act, pursuant to Patent Cooperation Treaty Application PCT / US2016 / 032017, filed on 12 May 2016, which claims priority to U.S. Provisional Patent Application No. 62 / 160,529, “Ultrasound Sequencing System and Method,” filed on 12 May 2015, and is incorporated herein by reference.

[0016] This application does not claim priority to U.S. Patent Application No. 16 / 097,959, entitled “Cardiac Mapping System with Efficiency Algorithm,” filed on 31 October 2018, but may be related to this application. This application is a national phase application under Section 371 of the U.S. Patent Act, which claims priority to U.S. Provisional Patent Application No. 62 / 413,104, entitled “Cardiac Mapping System with Efficiency Algorithm,” filed on 3 May 2017, and is incorporated herein by reference.

[0017] This application does not claim priority to U.S. Patent Application No. 16 / 961,809, filed July 13, 2020, entitled “System for Identifying Cardiac Conduction Patterns,” but may be related to this application. This application is a national phase application under Section 371 of the U.S. Patent Act, which claims priority to U.S. Provisional Patent Application No. 62 / 619,897, filed January 21, 2018, entitled “System for Recognizing Cardiac Conduction Patterns,” and U.S. Provisional Patent Application No. 62 / 668,647, filed May 8, 2018, each of which is incorporated herein by reference.

[0018] This application does not claim priority to U.S. Patent Application No. 17 / 048,151, entitled "Cardiac Information Processing System," filed on October 16, 2020, but may be related to this application. This application is the national stage application under 35 U.S.C. § 371 of Patent Cooperation Treaty Application PCT / US2019 / 031131, entitled "Cardiac Information Processing System," filed on May 7, 2019, which claims priority to U.S. Provisional Application No. 62 / 668,659, entitled "Cardiac Information Processing System," filed on May 8, 2018, and U.S. Patent Provisional Application No. 62 / 811,735, entitled "Cardiac Information Processing System," filed on February 28, 2019, and each of these applications is incorporated herein by reference.

[0019] This application does not claim priority to Patent Cooperation Treaty Application PCT / US2019 / 060433, entitled "Systems and Methods for Calculating Patient Information," filed on November 8, 2019, but may be related to this application. This application claims priority to U.S. Provisional Application No. 62 / 757,961, entitled "Systems and Methods for Calculating Patient Information," filed on November 9, 2018, and each of these applications is incorporated herein by reference.

[0020] This application does not claim priority to Patent Cooperation Treaty application PCT / US2020 / 028779, entitled "System for Creating a Composite Map", filed on April 17, 2020, but may be related to this application. This application claims priority to U.S. Provisional Application No. 62 / 835,538, entitled "System for Creating a Composite Map", filed on April 18, 2019, and U.S. Provisional Application No. 62 / 925,030, entitled "System for Creating a Composite Map", filed on October 23, 2019, and each of these applications is incorporated herein by reference.

[0021] This application does not claim priority to Patent Cooperation Treaty application No. PCT / US2020 / 036110, entitled "Systems and Methods for Performing Localization Within a Body", filed on June 4, 2020, but may be related to this application. This application claims priority to U.S. Provisional Application No. 62 / 857,055, entitled "Systems and Methods for Performing Localization Within a Body", filed on June 4, 2019, and each of these applications is incorporated herein by reference.

[0022] The concepts of the present invention generally relate to systems, devices, and methods for ablating (excising) tissue, particularly for ablating tissue of a patient's heart.

Background Art

[0023] Many medical procedures involve the delivery of energy for ablating tissue or treating it in other ways. Achieving the desired specificity and effectiveness of tissue treatment is difficult and the desired results may not be obtained.

Summary of the Invention

Problems to be Solved by the Invention

[0024] Systems, methods, and apparatus are needed to achieve improved tissue therapy through energy delivery. [Means for solving the problem]

[0025] According to one aspect of the concept of the present invention, a system for treating a patient's tissue comprises an energy delivery console for providing a first dose of energy and a second dose of energy, and an energy delivery device including a first delivery element configured to deliver the first dose of energy to a target tissue, and a second delivery element configured to deliver the second dose of energy to the target tissue. The first dose of energy may include the delivery of energy that reversibly alters the target tissue. The second dose of energy may include the delivery of energy that irreversibly alters the target tissue. The first dose of energy may be delivered to enhance the treatment provided by the second dose of energy.

[0026] In some embodiments, the target tissue includes cardiac tissue.

[0027] In some embodiments, the target tissue includes nerve tissue.

[0028] In some embodiments, the target tissue includes vascular wall tissue.

[0029] In some embodiments, the target tissue includes organ tissue.

[0030] In some embodiments, the target tissue includes tissues selected from the group consisting of cardiac tissue, nerve tissue, vascular wall tissue, organ tissue, brain tissue, lung tissue, kidney tissue, liver tissue, stomach tissue, muscle tissue, and combinations thereof.

[0031] In some embodiments, the energy delivery device includes a catheter.

[0032] In some embodiments, the energy delivery device includes a device selected from the group consisting of catheters, surgical tools, laparoscopic tools, endoscopic tools, and combinations thereof.

[0033] In some embodiments, the first energy delivery element and the second energy delivery element include the same components.

[0034] In some embodiments, the first energy delivery element and the second energy delivery element include different components.

[0035] In some embodiments, the first energy delivery element includes a plurality of energy delivery elements. The second energy delivery element may include a single energy delivery element. The second energy delivery element may include a plurality of energy delivery elements that are identical components to the first energy delivery element.

[0036] In some embodiments, the second energy delivery element includes a plurality of energy delivery elements. The first energy delivery element may include a single energy delivery element.

[0037] In some embodiments, the energy delivery device includes a first energy delivery device and a second energy delivery device, wherein the plurality of energy delivery elements include a first device element of the first energy delivery device and a second device element of the second energy delivery device. The first device element may be configured to be positioned on the endocardial surface of the patient's heart during the delivery of the second dose, and the second device element may be configured to be positioned on the epicardial surface of the patient's heart.

[0038] In some embodiments, the energy of the first dose includes the delivery of energy insufficient to ablate, necrotize, and / or otherwise permanently alter the target tissue, and the energy of the second dose includes the delivery of energy sufficient to ablate, necrotize, and / or otherwise permanently alter the target tissue. In some embodiments, the parameters of the energy of the first dose and / or the energy of the second dose are determined by an algorithm of the system, for example, an artificial intelligence-based algorithm.

[0039] In some embodiments, the system is configured to deliver the energy of the first dose and / or the energy of the second dose to the surface of the endocardial tissue.

[0040] In some embodiments, the system is configured to deliver the energy of the first dose and / or the energy of the second dose to the epicardial tissue surface.

[0041] In some embodiments, the system is configured to deliver the energy of a second dose after the energy of the first dose has been delivered. The energy of the second dose may be configured to irreversibly electroperforate the target tissue.

[0042] In some embodiments, the system is configured to deliver the energy of the second dose during at least a portion of the energy delivery of the first dose.

[0043] In some embodiments, the energy of the first dose includes RF energy delivered at a level insufficient to ablate the tissue.

[0044] In some embodiments, the energy of the first dose includes a form of energy selected from the group consisting of thermal energy, heat energy, cryogenic energy, electromagnetic energy, radio frequency (RF) energy, microwave energy, optical energy, laser light energy, sound energy, subsonic energy, ultrasonic energy, chemical energy, and combinations thereof.

[0045] In some embodiments, the energy of the second dose includes a form of energy selected from the group consisting of thermal energy, heat energy, cryogenic energy, electromagnetic energy, radio frequency (RF) energy, microwave energy, optical energy, laser light energy, sound energy, subsonic energy, ultrasonic energy, chemical energy, and combinations thereof.

[0046] In some embodiments, the energy of the first dose and the energy of the second dose include different forms of energy.

[0047] In some embodiments, the energy of the second dose includes a pulse of energy for irreversible electroporation. The second dose may include parameters selected from the group consisting of a dose delivered by electrodes having a length of at least 1.46 mm and / or 8 mm or less, a dose delivered by a pair of electrodes separated by a distance of at least 1 mm and / or 11 mm or less, a dose based on a supply voltage of at least 500 V and / or 5000 V or less, a dose including an electric field strength of at least 200 V / cm and / or 1000 V / cm or less, a dose including a pulse width of at least 0.1 μs and / or 200 μs or less, a dose including a series of pulses with a pulse repetition interval of at least 1 μs, and combinations thereof.

[0048] In some embodiments, the energy of the first dose is delivered over a set period of time. The system may be configured to monitor the patient's cardiac cycle, and the energy of the second dose may be initiated when the cardiac cycle reaches a desired cardiac cycle point. The system may be configured to enter an alert mode if a timeout period is reached after the energy of the first dose has been delivered and before the second dose is delivered.

[0049] In some embodiments, the system is configured to monitor the patient's cardiac cycle during the delivery of the first dose and / or the delivery of the second dose. The system is configured to monitor the patient's cardiac cycle during both the delivery of the first dose and the delivery of the second dose. The first dose may be delivered until the patient's cardiac cycle reaches a desired cardiac cycle point or until a timeout is reached.

[0050] In some embodiments, the system is configured to monitor the patient's heart before the delivery of the first dose of energy. The system may be configured to predict time T1 of the next desired cardiac cycle point after receiving an energy delivery signal. The energy of the first dose includes energy delivery parameters based on a target amount of energy to be delivered and the time to reach T1. If the system determines that the patient's cardiac cycle is equal to the desired cardiac cycle point at time T1, the energy of the second dose may be delivered. The energy of the second dose may not be delivered if the system determines that the patient's cardiac cycle is different from the desired cardiac cycle point at time T1.

[0051] In some embodiments, the energy of the first dose is configured to raise the temperature of the target tissue by at least 2°C.

[0052] In some embodiments, the system is configured to deliver the energy of a third dose and the energy of a fourth dose to additional target tissue, wherein the energy of the first dose includes the delivery of energy that reversibly alters the target tissue, and the energy of the second dose includes the delivery of energy that irreversibly alters the target tissue. The energy of the third dose may be similar to the energy of the first dose, and the energy of the fourth dose may be similar to the energy of the second dose.

[0053] In some embodiments, the system further comprises a monitoring device configured to provide physiological information of a patient, the energy delivery console providing the energy of the first dose and / or the energy of the second dose based on the provided physiological information. The physiological information may include cardiac cycle information. The physiological information may include information on physiological parameters selected from the group consisting of cardiac cycle, heart rate, blood pressure, blood flow velocity, respiratory rate, brain activity, electrogram amplitude, tissue impedance, and combinations thereof.

[0054] According to another aspect of the concept of the present invention, a method for delivering energy to cardiac tissue includes: (1) inserting a device comprising at least one electrical energy delivery element into the patient's ventricle; (2) positioning the at least one electrical energy delivery element in close proximity to a target location including target tissue to receive energy; and (4) delivering a dose of energy to the target tissue sufficient to irreversibly electroperforate the target tissue. The method may further include predicting a time T1 of a subsequent desired cardiac cycle point, wherein step (4) is performed at time T1. Prior to step (4), the method may further include performing a step of (3) delivering an additional dose of energy to raise the temperature of the target tissue. The additional dose of energy may include the delivery of RF energy. The RF energy may be delivered over a period of time. If the patient's cardiac cycle is not equal to the desired cardiac cycle point, step (4) may not be performed at time T1.

[0055] According to another aspect of the concept of the present invention, a method for delivering energy to cardiac tissue includes (1) inserting a device comprising at least one electrical energy delivery element into the patient's ventricle; (2) positioning the at least one electrical energy delivery element in close proximity to a target location including target tissue to receive energy; (3) heating the target tissue; and (4) subsequently delivering a second energy to the target tissue configured to irreversibly electroperforate the target tissue.

[0056] According to another aspect of the concept of the present invention, a system for treating patient tissue comprises an energy delivery console for providing electrical pulses configured to perform pulsed field ablation of target tissue, an energy delivery device including two or more electrodes, and a graphical user interface. The electrical pulses are delivered between the two or more electrodes, and the graphical user interface is configured to provide information regarding the intensity of the electric field generated by the electrical pulses.

[0057] According to another aspect of the concept of the present invention, a system for treating a patient's tissue comprises an energy delivery console for providing electrical pulses configured to perform pulsed electric field ablation of a target tissue, an energy delivery device including two or more electrodes, and an irrigation fluid having a conductivity different from that of blood. The electrical pulses are delivered between the two or more electrodes, and the system is configured to control the electric field generated by the electrical pulses via the delivery of the irrigation fluid.

[0058] The technologies described herein, along with their attributes and associated advantages, will be best understood in conjunction with the following detailed description, which includes the accompanying drawings illustrating typical embodiments.

[0059] Embedding by reference All publications, patents, and patent applications referenced herein are incorporated herein by reference to the same extent as individual publications, patents, or patent applications are specifically and individually incorporated by reference. The entire contents of all publications, patents, and patent applications referenced herein are incorporated herein by reference for all purposes. [Brief explanation of the drawing]

[0060] [Figure 1] This is a schematic diagram of a system for performing medical procedures on a patient, consistent with the concept of the present invention. [Figure 2]This is a flowchart of a method for delivering energy to a patient's tissue, consistent with the concept of the present invention. [Figure 3] This is a flowchart of another method for delivering energy to a patient's tissue, consistent with the concept of the present invention. [Figure 3A] This figure shows a graph of the cardiac cycle including a desired cycle point, consistent with the concept of the present invention. [Figure 4] This is a flowchart of another method for delivering energy to a patient's tissue, consistent with the concept of the present invention. [Figure 5] This is a flowchart of another method for delivering energy to a patient's tissue, consistent with the concept of the present invention. [Figure 6] This is a flowchart of another method for delivering energy to a patient's tissue, consistent with the concept of the present invention. [Figure 7] This is a flowchart of another method for delivering energy to a patient's tissue, consistent with the concept of the present invention. [Figure 8] This is a side view of an energy delivery device consistent with the concept of the present invention. [Figure 8A] This is a graph showing lesion depth created with various energy delivery geometries consistent with the concept of the present invention. [Figure 8B] This graph shows the surface area of ​​lesions created with various energy delivery geometries consistent with the concept of the present invention. [Figure 9A] This is one of the graphs showing lesion volume created with various energy delivery geometries consistent with the concept of the present invention. [Figure 9B] This is one of the graphs showing lesion volume created with various energy delivery geometries consistent with the concept of the present invention. [Figure 9C] This is one of the graphs showing lesion volume created with various energy delivery geometries consistent with the concept of the present invention. [Figure 9D] This is one of the graphs showing lesion volume created with various energy delivery geometries consistent with the concept of the present invention. [Figure 10A] This is one anatomical cross-sectional view of the distal portion of an energy delivery device in contact with a tissue surface at different orientation angles, consistent with the concept of the present invention. [Figure 10B] This is one anatomical cross-sectional view of the distal portion of an energy delivery device that contacts a tissue surface at different orientation angles, consistent with the concept of the present invention. [Figure 11A] This is one of the user views of a graphical user interface that displays information related to different orientation angles of an energy delivery device, consistent with the concept of the present invention. [Figure 11B] This is one of the user views of a graphical user interface that displays information related to different orientation angles of an energy delivery device, consistent with the concept of the present invention. [Figure 12] This is a perspective view of the distal portion of an energy delivery device including multiple ports for delivering an irrigation fluid, consistent with the concept of the present invention. [Figure 13] This is an anatomical side view of the distal portion of an energy delivery device that delivers an irrigation fluid in contact with a tissue surface, consistent with the concept of the present invention. [Modes for carrying out the invention]

[0061] Hereafter, we will refer in detail to embodiments of the technology illustrated in the accompanying drawings. Similar reference numerals may be used to indicate similar components. However, this description is not intended to limit the disclosure to any particular embodiment and should be construed as including various modifications, equivalents, and / or substitutes of the embodiments described herein.

[0062] It will be understood that, when used herein, the terms “comprising” (and any form of “comprising,” e.g., “comprise” and “comprises”), “having” (and any form of “having,” e.g., “have” and “has”), “including” (and any form of “including,” e.g., “includes” and “include”), or “containing” (and any form of “containing,” e.g., “contains” and “contain”), when used herein, indicate the existence of a described feature, complete, step, action, element, and / or component, and do not preclude the existence or addition of one or more other features, complete, step, action, element, component, and / or group thereof.

[0063] The terms “first,” “second,” “third,” etc., are used herein to describe various limitations, elements, components, areas, layers, and / or sections, but it will be further understood that these limitations, elements, components, areas, layers, and / or sections should not be limited by these terms. These terms are used solely to distinguish one limitation, element, component, area, layer, or section from another limitation, element, component, area, layer, or section. Accordingly, the first limitation, element, component, area, layer, or section discussed below may also be termed the second limitation, element, component, area, layer, or section, and this does not depart from the scope of the invention.

[0064] When an element is described as being "on" another element, "attached," "connected," or "coupled" to it, it is either directly on or above the other element, or can be connected to or coupled to it, or there may be one or more intervening elements. Conversely, when an element is described as being "directly on" another element, "directly attached," "directly connected," or "directly coupled" to it, there are no intervening elements. Other words used to describe relationships between elements should be interpreted similarly (e.g., "between" versus "directly between," "adjacent" versus "directly connected").

[0065] When the first element is referred to as being "in," "on," and / or "within" the second element, it will be further understood that the first element may be located inside the internal space of the second element, inside a portion of the second element (e.g., inside the walls of the second element), on the outer surface and / or inner surface of the second element, or in one or more combinations thereof.

[0066] As used herein, the term “proximate” should be interpreted as including one or more locations close to the second component or location, as well as locations inside, above, and / or inside the second component or location, when used to describe the proximity of a first component or location to a second component or location. For example, a component located in proximity to an anatomical site (e.g., the location of a target tissue) includes components located near the anatomical site, as well as components located inside, above, and / or inside the anatomical site.

[0067] Spatial terms, such as “beneath,” “below,” “lower,” “above,” and “upper,” may be used to describe the relationship of an element and / or feature to another element and / or feature, for example, as shown in the drawings. It will be further understood that spatial terms are intended to include various orientations of the device in use and / or operation, in addition to the orientation shown in the drawings. For example, if the device in the drawing is inverted, the element described as “below” and / or “directly below” another element or feature will be oriented “above” another element or feature. The device may be oriented in other ways (e.g., rotated 90 degrees or in other directions), and spatial descriptions used herein shall be interpreted accordingly.

[0068] The terms “reduce,” “reducing,” and “reduction,” as used herein, include reductions in quantity, including reductions to zero. Reducing the likelihood of occurrence includes preventing occurrence. Similarly, the terms “prevent,” “preventing,” and “prevention” include the actions of “reducing,” “reducing,” and “reducing,” respectively.

[0069] The term "and / or," when used herein, should be interpreted as referring to each of two specific features or components, with or without the other. For example, "A and / or B" should be interpreted as referring to (i) A, (ii) B, and (iii) A and B, each of which is described herein separately.

[0070] The term "one or more," as used herein, may mean any number from 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or any number greater than or equal to 1.

[0071] The terms “and combination thereof” and “and combination of these” may, in this specification, be used after a list of items to be included individually or collectively. For example, a component, process, and / or other item selected from the group consisting of A, B, C, and combinations thereof shall include one, two, or three or more items A, one, two, or three or more items B, and / or one, two, or three or more items C.

[0072] In this specification, unless otherwise specified, “and” may mean “or,” and “or” may mean “and.” For example, if a feature is described as having A, B, or C, that feature may have A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A, B, and C, that feature may have only one or two of A, B, or C.

[0073] When used herein, if a quantifiable parameter is described as having a value "between" a first value X and a second value Y, it shall include a parameter having a value of at least X, Y or less, and / or at least X and Y or less. For example, the length between 1 and 10 shall include a length of at least 1 (including values ​​greater than 10), a length less than 10 (including values ​​less than 1), and / or a value greater than 1 and less than 10.

[0074] The expression “configured (or set) to” as used in this disclosure may be used interchangeably with expressions such as “suitable for,” “having the capacity to,” “designed to,” “adapted to,” “made to,” and “capable of,” depending on the context. The expression “configured (or set) to” does not only mean “specifically designed to” in hardware. Alternatively, depending on the context, the expression “a device configured to” may mean that the device “can” work with another device or component.

[0075] As used herein, the term “threshold” means the maximum level, minimum level, and / or range of a value that correlates to a desired or undesirable state. In some embodiments, system parameters are maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and / or outside a threshold range of values, to produce a desired effect (e.g., an effective treatment) and / or prevent or otherwise reduce (hereinafter, “prevent”) an undesirable event (e.g., a device and / or a clinical adverse event). In some embodiments, system parameters are maintained above a first threshold (e.g., above a first temperature threshold to produce a desired therapeutic effect on tissue) and below a second threshold (e.g., below a second temperature threshold to prevent undesirable tissue damage). In some embodiments, thresholds are determined to include a safety margin, taking into account, for example, patient variability, system variability, tolerance, etc. As used herein, “exceeding a threshold” refers to a parameter that is above a maximum threshold, below a minimum threshold, within a threshold range, and / or outside a threshold range.

[0076] Where used herein, “room pressure” means the pressure of the environment surrounding the system and apparatus of the concept of the present invention. Positive pressure includes pressures higher than room pressure, or simply pressures greater than another pressure, and is, for example, a positive differential pressure across a fluid path component such as a valve. Negative pressure includes pressures lower than room pressure, or pressures less than another pressure, and is, for example, a negative differential pressure across a fluid path component such as a valve. Negative pressure may include a vacuum, but does not mean pressure lower than a vacuum. Where used herein, the term “vacuum” may be used to refer to a complete vacuum, a partial vacuum, or any negative pressure as described above.

[0077] As used herein to describe non-circular shapes, the term “diameter” should be understood as the diameter of a hypothetical circle approximating the shape being described. For example, when describing a cross-section, such as the cross-section of a component, the term “diameter” shall be interpreted as representing the diameter of a hypothetical circle having the same cross-sectional area as the cross-section of the component being described.

[0078] As used herein, the terms “major axis” and “minor axis” refer to the length and diameter of the smallest hypothetical cylindrical body that can completely enclose the component, respectively.

[0079] As used herein, the term “functional element” should be interpreted as including one or more elements configured and arranged to perform a certain function. A functional element may include a sensor and / or transducer. In some embodiments, a functional element is configured to deliver energy and / or treat tissue in other ways (e.g., a functional element configured as a therapeutic element). Alternatively or additionally, a functional element (e.g., a functional element including a sensor) may be configured to record one or more parameters, e.g., a patient’s physiological parameters, a patient’s anatomical parameters (e.g., parameters of tissue shape), a patient’s environmental parameters, and / or system parameters. In some embodiments, a sensor or another functional element is configured to perform a diagnostic function (e.g., to collect data used to perform a diagnosis). In some embodiments, a functional element is configured to perform a therapeutic function (e.g., to deliver therapeutic energy and / or therapeutic drugs). In some embodiments, a functional element includes one or more elements configured and arranged to perform a function, the function being selected from the group consisting of: That is, delivering energy, extracting energy (for example to cool components), delivering drugs or other agents, manipulating system components or patient tissue, recording or otherwise sensing parameters such as patient physiological parameters or system parameters, and one or more combinations thereof. Functional elements may include fluids and / or fluid delivery systems. Functional elements may include reservoirs such as expandable balloons or other fluid-holding reservoirs. A "functional assembly" may include an assembly constructed and arranged to perform a function such as a diagnostic and / or therapeutic function. A functional assembly may include an expandable assembly. A functional assembly may include one or more functional elements.

[0080] The term “transducer,” as used herein, should be interpreted to include any component or combination of components that receive energy or any input and produce an output. For example, a transducer may include electrodes that receive electrical energy and distribute it to tissue (for example, based on the size of the electrodes). In some configurations, a transducer converts an electrical signal into any output. These outputs are, for example, light (e.g., a transducer including a light-emitting diode or a light bulb), sound (e.g., a transducer including a piezoelectric crystal configured to deliver ultrasonic energy), pressure (e.g., applied pressure or force), thermal energy, cryogenic energy, chemical energy, mechanical energy (e.g., a transducer including a motor or a solenoid), magnetic energy, and / or a different electrical signal (e.g., different from the input signal to the transducer). Alternatively or additionally, a transducer may convert a physical quantity (e.g., a variation of a physical quantity) into an electrical signal. A transducer may include any components that deliver energy and / or drugs to tissue, for example, a transducer may be configured to deliver one or more of the following: In other words, these include electrical energy to the tissue (e.g., a transducer including one or more electrodes), optical energy to the tissue (e.g., a transducer including a laser, light-emitting diode, and / or optical components such as a lens or prism), mechanical energy to the tissue (e.g., a transducer including a tissue manipulation element), acoustic energy to the tissue (e.g., a transducer including a piezoelectric crystal), chemical energy, electromagnetic energy, magnetic energy, and one or more combinations thereof.

[0081] As used herein, the term “fluid” may refer to a liquid, gas, gel, or any fluid material, such as a material that can be propelled through a lumen and / or opening.

[0082] As used herein, the term "material" may refer to a single material or a combination of two, three, four, or more materials.

[0083] For clarity, it will be understood that any features of the present invention described in relation to a separate embodiment may also be provided in combination in a single embodiment. Conversely, for simplicity, various features of the present invention described in relation to a single embodiment may also be provided separately or in any suitable subcombination. For example, it will be understood that all features described in any of the claims (whether independent or dependent) may be combined in any given manner.

[0084] At least some of the drawings and descriptions of this invention have been simplified to focus on elements that relate to a clear understanding of the concept of the invention, but it will be understood that other elements, namely elements that those skilled in the art will understand may also include part of the concept of the invention, have been omitted for the sake of clarity. However, since such elements are known in the art and do not necessarily facilitate a better understanding of the concept of the invention, a description of such elements is not provided herein.

[0085] The terms defined herein are used solely to describe specific embodiments of the disclosure and are not intended to limit the scope of the disclosure. Terms provided in the singular form are intended to include the plural form unless the context explicitly indicates otherwise. All terms used herein, including technical or scientific terms, have the same meaning as commonly understood by those skilled in the art unless otherwise defined herein. Terms defined in commonly used dictionaries should be interpreted as having the same or similar meaning as in the context of the art and not as having an ideal or exaggerated meaning unless explicitly defined herein. In some cases, terms defined herein should not be interpreted as excluding embodiments of the disclosure.

[0086] Provided herein are systems, apparatus, and methods for treating patient tissue. An energy delivery console can be configured to deliver various "doses" of energy to be delivered by one or more energy delivery devices, such as catheters or surgical tools containing electrodes or other energy delivery elements. In some embodiments, multiple interdependent energy doses are delivered to a common tissue location to provide, for example, an improved therapeutic benefit to the patient. An initial dose may be configured to warm the tissue, such as by delivering radio frequency (RF), heat, and / or other energy. Subsequent doses may include doses of energy configured to irreversibly electroperforate tissue that has already been warmed, for example, while the tissue is in a high-temperature state (e.g., above body temperature).

[0087] Referring here to Figure 1, a schematic diagram of a system for performing medical procedures on a patient (e.g., a human or other living mammal) is shown, consistent with the concept of the present invention. This medical procedure may include a diagnostic procedure, a therapeutic procedure, or a procedure combining diagnosis and therapy. System 10 may include one or more ablation catheters and / or other energy delivery devices, EDD100, one or more mapping devices, mapping catheters 200, one or more sheaths, sheaths 12, one or more patient patches, patches 60, and / or an energy delivery console, EDC300. EDC300 is operably mounted (e.g., electrically, mechanically, fluidly, sonicly, and / or optically) to one or more devices 100,200 (e.g., two, three or more devices 100,200) and / or one or more patient patches 60.

[0088] The EDC300 may include a console or other device configured to deliver one or more forms of energy (e.g., to deliver energy to tissue via a catheter or other energy delivery device of System 10). As used herein, energy delivery to tissue includes not only the transfer of energy to the tissue (e.g., to heat, ablate, and / or act on the tissue) but also the extraction of energy from the tissue (e.g., to cool, freeze, and / or cryoablate the tissue). The EDC300 may be configured to deliver energy to tissue (e.g., via EDD100) to form lesions within the tissue. This is for example, to form one or more therapeutic lesions in cardiac tissue to treat a patient's atrial fibrillation (AF) and / or other arrhythmias.

[0089] The EDC300 can deliver one or more forms of energy to one or more electrodes and / or other energy delivery elements 130 (hereinafter also referred to as electrodes 130) of the EDD100. In Figure 1, the EDD100 includes four energy delivery elements 130, an element at the distal end of the EDD100 (e.g., “tip electrode”), and three more proximal elements 130, elements 130b to 130d (e.g., “ring electrode”). In some embodiments, the EDD100 includes 1 to 64 energy delivery elements 130, for example, 1 to 12 elements 130 arranged in a linear or curved configuration.

[0090] In some embodiments, the EDC300 can be configured to deliver dose DOE1, which is the energy of a first dose, and dose DOE2, which is the energy of a second dose, where dose DOE2 is different from dose DOE1 (for example, dose DOE1 and DOE2 include different types of energy, energy levels, energy delivery waveforms, energy delivery durations, and / or other different energy parameters). In some embodiments, dose DOE1 and DOE2 have multiple differences in energy delivery parameters. In some embodiments, dose DOE1 is delivered to a first part of the tissue, and dose DOE2 is delivered to a second part of the tissue. The first and second parts of the tissue may be the same part of the tissue. At least a portion of the first part of the tissue may be included in the second part of the tissue.

[0091] Dose DOE1 may include the delivery of energy that reversibly alters the target tissue (e.g., the volume of tissue intended to be reversibly altered by dose DOE1), while dose DOE2 may include the delivery of energy that irreversibly alters the target tissue (e.g., the volume of tissue intended to be irreversibly altered by dose DOE2). Changes to or lack thereof in the tissue (e.g., target tissue) will be described herein in terms of the effects that the target tissue experiences, though not all, most. For example, as used herein, "reversibly altering tissue" may refer to the reversible alteration of all of the tissue, or merely a large portion of the tissue (e.g., a large portion of the target tissue). In other words, a small portion (e.g., less than 30%, 20%, or 10%) of the target tissue (e.g., the tissue intended to be reversibly altered by dose DOE 1) may be irreversibly altered or not altered at all by energy delivery, while the majority of the target tissue (e.g., at least 70%, 80%, or 90%, respectively) may be reversibly altered. Similarly, as used herein, "reversibly altering tissue" may refer to the irreversible alteration of all of the target tissue, or merely a large portion of the tissue (e.g., a large portion of the tissue intended to be altered by dose DOE 2). In other words, a small portion of the target tissue (e.g., less than 30%, 20%, or 10%) can be reversibly altered or remain unchanged by energy delivery, while the majority of the target tissue (e.g., at least 70%, 80%, or 90%, respectively) can be irreversibly altered.

[0092] Dose DOE1 may be configured to enhance the effects (e.g., tissue effects) caused by Dose DOE2, as described herein (for example, if at least a portion of Dose DOE2 is delivered after the completion of delivery of Dose DOE1).

[0093] Dose DOE1 may include energy delivery below a threshold, such as the energy threshold for delivery. This energy threshold is the value required to change the target tissue (e.g., the tissue receiving the energy, and potentially some adjacent tissue) from its initial state (e.g., initial temperature, pressure, cell membrane permeability level, viability level, health status, and / or other tissue state) and then return it to that initial state over time (e.g., within 10 minutes, within 1 hour, or within 1 day). For example, Dose DOE1 may include energy delivery that simply cools or warms the target tissue from body temperature, in which case the target tissue returns to body temperature relatively quickly after the energy delivery stops. This is the case, for example, when Dose DOE1 includes energy delivery that is insufficient to ablate, necrotize, and / or otherwise permanently alter the target tissue (e.g., RF energy delivery having amplitude, frequency, duration, and / or other parameters insufficient to ablate, necrotize, and / or otherwise permanently alter the target tissue). Dose DOE1 may include delivery of RF energy delivered in unipolar mode (e.g., between energy delivery element 130a and / or another energy delivery element 130 and the return electrode 130' of EDD100) and / or RF energy delivered in bipolar mode (e.g., between the two delivery elements 130 of EDD100). Dose DOE1 may include delivery of non-electrical energy (e.g., optical energy, ultrasonic energy, and / or thermal energy) that causes a temperature increase in the tissue receiving Dose DOE1 (e.g., the same tissue receiving Dose DOE2).

[0094] Dose-DOE2 may include the delivery of energy exceeding a threshold, such as the energy threshold of delivery. This energy threshold is such that the target tissue (e.g., the tissue receiving the energy, and potentially some adjacent tissue) changes from its initial state (e.g., initial pressure, level of cell membrane permeability, level of viability, health status, and / or other tissue state) and the target tissue does not return to its initial state over time (e.g., not within 4 hours, 1 week, 1 month, 3 months, 6 months, 1 year, or 2 years). For example, dose-DOE2 may include the delivery of energy that brings about irreversible changes and / or other desirable long-term effects on the target tissue. These include, for example, cases where the dose DOE2 contains an energy level sufficient to ablate, necrotize, and / or otherwise permanently alter the target tissue (for example, energy delivered in the form of an IEP dose, as described below, having sufficient amplitude, frequency, duration, and / or other parameters to create a desired lesion within the tissue, for example, to treat a patient's AF or other arrhythmia).

[0095] Dose DOE1 and DOE2 may be delivered sequentially, for example, when dose DOE2 is delivered immediately after or at least immediately after the completion of delivery of dose DOE1. In some embodiments, at least a portion of the delivery of dose DOE2 (e.g., the initial portion of dose DOE2) is delivered during at least a portion of the delivery of dose DOE1 (e.g., the final portion of dose DOE1), for example, in an overlapping and / or alternating configuration.

[0096] In some embodiments, the dose DOE2 includes the delivery of energy that causes irreversible electroporation of target tissue. For example, the dose DOE2 may include the delivery of an "IEP" dose. An IEP dose as used herein may include one or more electrical pulses delivered between two or more electrodes, the pulses configured to generate an electric field in the tissue adjacent to the two electrodes. The parameters of the electrical pulses may be selected such that the resulting electric field causes irreversible electroporation of the tissue, for example, while avoiding significant thermal damage to the tissue (e.g., avoiding the delivery of excessive heat to the tissue). For example, an IEP dose may be configured to prevent the temperature of the tissue receiving the dose from exceeding 50°C. In some embodiments, an IEP dose is configured to limit the temperature rise occurring in the tissue (e.g., the tissue receiving the IEP dose) to not exceed 13°C, 11°C, 9°C, or 7°C.

[0097] In some embodiments, the IEP dose is delivered by an EDD100 having electrode-based energy delivery elements 130, the delivery elements 130 having a length of at least 1.46 mm and / or 8 mm or less. In some embodiments, the IEP dose is delivered by an EDD100 having two electrode-based energy delivery elements 130, these delivery elements 130 being spaced at least 1 mm apart from each other and / or 11 mm or less. In some embodiments, the IEP dose is delivered based on a supply voltage (e.g., provided by an EDC300) of at least 500 V and / or 5000 V or less. In some embodiments, the IEP dose includes an electric field strength of at least 200 V / cm and / or 1000 V / cm or less. In some embodiments, the IEP dose includes a pulse width of at least 0.1 μsec and / or 200 μsec or less. In some embodiments, the IEP dose includes a series of pulses having a pulse repetition interval of at least 1 μsec.

[0098] In some embodiments, the IEP dose of the concept of the present invention includes an energy delivery parameter level selected from the group consisting of: a voltage gradient of at least 50 V / cm, at least 100 V / cm, at least 300 V / cm, or at least 400 V / cm; a voltage gradient of 8000 V / cm or less, or 800 V / cm or less; an amplitude of 5000 V or less, an amplitude of 2000 V or less, an amplitude of 1000 V or less; a set of at least two pulses; a set of 15 pulses or less, each pulse having a duration of at least 1 microsecond; an IEP duration of at least 5 microseconds, an IEP duration of 30 seconds or less, and combinations thereof. In some embodiments, the dose DOE2 includes an IEP dose delivered between two electrode-based energy delivery elements 130 positioned at least 2 mm, 5 mm, 7 mm, or 10 mm apart. In some embodiments, one of the delivery elements 130 that receive and / or deliver the IEP dose is located at the distal end (tip) of the EDD 100 (for example, element 130a is shown). In some embodiments, one or both of the delivery elements 130 that receive and / or deliver the IEP dose include a circular electrode (for example, a ring electrode).

[0099] In some embodiments, Dose DOE2 includes an IEP dose, and Dose DOE1 includes the delivery of energy (e.g., RF energy) to warm the target tissue (e.g., tissue warming, which takes place prior to the delivery of Dose DOE2). The warming induced by Dose DOE1 may result in one or more benefits. These include, for example, reducing the required amplitude of the IEP dose in Dose DOE2, reducing the duration of the IEP dose, modifying the frequency of the IEP dose, modifying the waveform shape of the IEP dose, and / or improving the potency (ablation effect) of the IEP dose to ensure successful energy delivery (successful lesion formation). In some embodiments, Dose DOE1 is configured such that the tissue receiving the dose is raised by at least 2°C, for example, at least 3°C, or at least 4°C.

[0100] In some embodiments, the dose DOE2 includes an IEP dose delivered by one or more pairs of electrode-based energy delivery elements 130, where, for example, one of each pair of elements 130 is configured as a cathode and the other as an anode. The system 10 (e.g., EDC300) can be configured to select (e.g., via algorithm 335 as described herein) which elements 130 should deliver the IEP dose (e.g., which pair of three or more sets of elements 130) and which elements 130 should be the cathode and which should be the anode. In some embodiments, an element 130 located at the tip (e.g., element 130a in Figure 1 located at the distal end of the shaft 110) is configured as the cathode, and a more proximal element 130 (e.g., a ring electrode, e.g., one or more of elements 130b-130d in Figure 1) is configured as the anode. In some embodiments, the dose DOE1 and / or DOE2 includes delivering electrical energy between a pair of electrodes, each including one or more elements 130 configured as an anode and one or more elements 130 configured as a cathode. For example, system 10 (e.g., one or more EDDs 100) may include a plurality of energy-delivering elements 130 configured to function as anodes, cathodes, or both.

[0101] Dose DOE2 may include an IEP dose delivered while the impedance of the tissue receiving the dose is being monitored by system 10. This may occur, for example, when system 10 delivers the IEP dose in a closed-loop manner and / or when the success of irreversible electroporation of the tissue is confirmed via impedance measurement (e.g., when system 10 automatically stops the IEP dose upon confirmation).

[0102] Dose DOE1 and / or DOE2 may be delivered to one or more types of target tissue by one or more energy delivery elements 130. These target tissues are, for example, cardiac tissue, nerve tissue, vascular wall tissue, and / or organ tissue. In some embodiments, dose DOE1 and / or DOE2 may be configured to be delivered to tissue selected from the group consisting of cardiac tissue, nerve tissue, vascular wall tissue, organ tissue, brain tissue, lung tissue, kidney tissue, liver tissue, stomach tissue, muscle tissue, and combinations of these tissues. Dose DOE1 and / or DOE2 may be delivered to the surface of an organ (e.g., the endocardial surface and / or epicardial surface of the heart), and / or within the tissue of an organ (e.g., within cardiac wall tissue and / or within another type of organ tissue).

[0103] The EDC300 may include an energy delivery module, the drawing of which shows an energy delivery module 360. The energy delivery module 360 ​​is configured to deliver ablation energy to the EDD100 (for example, to deliver the energy of doses DOE1 and DOE2 and / or other energy to one or more energy delivery elements 130, which include one or more electrodes and / or other energy delivery elements). The energy delivery module 360 ​​can deliver energy to the EDD100 via a patient interface unit, PIU310 (as shown and described herein), or by other means. As described herein, the energy delivered by module 360 ​​may include energy selected from the group consisting of thermal energy such as thermal energy or cryogenic energy, electromagnetic energy such as radio frequency (RF) energy and / or microwave energy, optical energy such as light energy delivered by a laser, sound energy such as subsonic energy or ultrasonic energy, chemical energy (for example, as delivered by a pharmaceutical drug or other drug), and combinations of these energies. The energy delivery module 360 ​​may include an energy delivery module selected from the group consisting of an RF generator, an optical energy delivery unit, a cryogenic energy delivery unit, an ultrasonic energy delivery unit, a microwave energy delivery unit, an electroporation energy delivery unit, and combinations thereof. In some embodiments, the energy delivery module 360 ​​includes an RF generator configured to deliver RF ablation energy to one or more energy delivery elements 130 (i.e., each energy delivery element 130 includes an electrode). The doses DOE1 and DOE2 may include similar or dissimilar forms of energy (e.g., RF energy and another form of energy).

[0104] In some embodiments, the EDC300 includes one or more functional elements, such as the functional element 309 shown and described herein.

[0105] The EDD100 may include one or more devices configured to deliver energy, which are energy delivery devices including, for example, catheters, surgical tools, laparoscopic tools, and / or endoscopic tools. The EDD100 may include a shaft 110, which is generally a flexible shaft, and the shaft 110 includes a proximal end 111. The EDD100 includes a distal portion 102 as shown in the figure. A handle 120, which is an operator-graspable portion, may be positioned on the proximal end 111 of the shaft 110. The handle 120 may include one or more controls (e.g., one or more buttons, switches, levers, etc.), for example, a control 121 is shown in the figure. In some embodiments, the distal portion 102 of the EDD100 has a configuration and arrangement similar to that of the EDD100 in Figure 8 as described herein.

[0106] The EDD100 includes one or more elements configured to deliver energy to tissue, such as the energy delivery elements 130a to 130d shown in Figure 1. In some embodiments, one or more energy delivery elements 130 are configured to deliver a dose DOE1, which is the energy of a first dose (e.g., RF energy delivered in a unipolar or bipolar configuration, as provided by and described herein for EDC300), and a pair of energy delivery elements 130 are configured to deliver a dose DOE2, which is the energy of a second dose (e.g., as also provided by and described herein for EDC300). In some embodiments, dose DOE1 and dose DOE2 are delivered by the same set of components (e.g., the same pair of elements 130). Alternatively, an energy delivery element 130 used to deliver dose DOE1 may not be included in the set of elements 130 used to deliver dose DOE2, and vice versa. In some embodiments, dose DOE1 is delivered by one or more energy delivery elements 130 (e.g., at least element 130a), and dose DOE2 is delivered by at least two energy delivery elements 130 (e.g., at least element 130a and one or more of elements 130b to 130d).

[0107] Each energy delivery element 130 may include one or more elements configured to deliver one, two or more forms of energy, selected from the group consisting of thermal energy such as thermal or cryogenic energy, electromagnetic energy such as radio frequency (RF) energy and / or microwave energy, optical energy such as light energy provided by a laser, sound energy such as subsonic or ultrasonic energy, chemical energy, and combinations thereof. In some embodiments, the energy delivery element 130 delivers at least two forms of energy, which are selected from the group consisting of thermal energy such as thermal or cryogenic energy, electromagnetic energy such as radio frequency (RF) energy and / or microwave energy, optical energy such as light energy provided by a laser, sound energy such as subsonic or ultrasonic energy, chemical energy, and combinations thereof. The energy delivery element 130 may include one or more energy delivery elements located on the distal portion of the EDD 100, for example, the distal portion 102 of the illustrated device. The energy delivery element 130 may include at least one energy delivery element (e.g., at least one electrode, at least one optical element configured to deliver light energy, and / or at least one cryogenic fluid delivery element), which are arranged on the distal end of the EDD 100 in a “tip electrode” configuration. In some embodiments, the EDD 100 may include two, three, or more energy delivery elements 130, which are, for example, multiple electrodes configured to deliver unipolar and / or bipolar electromagnetic (e.g., RF) energy to heat, ablate, and / or act on tissue in other ways (e.g., to form a desired lesion within the tissue). One or more energy delivery elements 130 may each include an electrode, for example, an electrode configured to deliver radio frequency (RF) and / or other electromagnetic energy. Two or more energy delivery elements 130 may be configured as a pair of electrodes delivering pulses of irreversible electroporation energy (e.g., provided by the EDC 300 as dose DOE 2).The energy delivery element 130 may include one or more electrodes (e.g., element 130a shown in Figure 1) positioned at the end of the EDD 100. The energy delivery element 130 may include an array of energy delivery elements (e.g., an array of electrodes) as shown in Figures 1 and 8. In some embodiments, the energy delivery element 130 includes an electrode 130' which is a return electrode pad shown in Figure 1. Element 130' may include an electrode configured as a return electrode for energy delivery between one or more elements 130 of the EDD 100 (e.g., for the delivery of unipolar RF energy by the EDD 100).

[0108] In some embodiments, the EDD100 includes two or more devices for delivering energy to tissue, which are, for example, a first EDD100' including one or more energy delivery elements 130, and a second EDD100” including one or more energy delivery elements 130 (EDD100' and EDD100” are similar or dissimilar energy delivery devices, each including one or more delivery elements 130, though not shown). In these embodiments, dose DOE1 and / or dose DOE2 may include doses delivered between the elements 130 of EDD100' and the elements 130 of EDD100”. For example, an RF energy dose and / or IEP dose may be delivered between the elements 130 of EDD100' positioned on the endocardial surface of the heart and the elements 130 of EDD100” positioned on the epicardial surface of the heart (e.g., an epicardial surface location relatively close to the endocardial surface location of the elements 130 of EDD100').

[0109] The EDD100 may include an assembly configured to measure, monitor, react to, and / or maintain a force (e.g., a force between tissue and one or more parts of the EDD100), which is illustrated, for example, as a force-maintaining assembly 150. The force-maintaining assembly 150 may be located within the handle 120, within a portion of the shaft 110 (e.g., within the distal portion 102 of the EDD100), and / or on the distal end of the shaft 110 (e.g., within the distal portion 102 of the EDD100 as illustrated). The force-maintaining assembly 150 may include one or more elements configured to provide or maintain a force, i.e., a force-maintaining element 160 as illustrated and described herein. For example, such a force-maintaining element 160 may be one or more of the following: a hydraulic element, a spring, a magnet, a compressible fluid, a memory material, etc., or may include these. The force-maintaining element 160 may be located at the distal end, proximal end, or intermediate portion of the EDD100, or two or more combinations thereof. Furthermore, the force-holding assembly 150 may include one or more sensing elements, the illustrated sensing element 158, which may take the form of one or more sensors and / or may include one or more sensors. In some embodiments, the force-holding assembly 150 may include a structure and arrangement and similar components to those described in the present applicant's concurrently pending U.S. Patent Application No. 16 / 335,893, filed March 22, 2019, entitled “Ablation System with Force Control”.

[0110] The force-maintaining assembly 150 can be axially aligned with the shaft 110, for example, when the assembly 150 is aligned with the distal portion 102 (for example, the main axis of the force-maintaining assembly 150 is aligned with the central axis of the distal portion 102). The force-maintaining assembly 150 may be configured to absorb mechanical shock and / or to respond dynamically (e.g., dynamically and automatically) to the movement of the cardiac wall or other cardiac tissue (for example, to avoid reliance on clinicians to manually respond to the movement of the endocardial surface in cardiac ablation procedures). The force-maintaining assembly 150 can tolerate and / or compensate for high-frequency and / or low-frequency movements, various ranges of motion, etc. The force-maintaining assembly 150 may be configured to compress over a predetermined maximum distance ("maximum compression distance" or "maximum travel distance") over a "travel distance" (also called the "compression distance," which is equal to the distance the force-maintaining assembly 150 compresses when a force is applied). "Maximum compression distance" is, for example, the maximum distance including lengths from 0.1 mm to 10 mm, the maximum distance including lengths from 0.1 mm to 5 mm, and / or any other predetermined distance range and / or limit.

[0111] The force-maintaining assembly 150 may be configured to provide a predetermined force range over all or part of the travel distance. This force range is, for example, a predetermined constant and / or variable force (e.g., a force of 0.1 gmf to 100 gmf, 5 gmf to 30 gmf, and / or a force of 10 gmf to 30 gmf). In some embodiments, the force-maintaining assembly 150 may be configured to provide a relatively constant force over all or part of the travel distance. This force is, for example, a predetermined constant force of 0.1 gmf to 100 gmf, e.g., 5 gmf to 30 gmf, or 10 gmf to 30 gmf. Additionally or alternatively, in some embodiments, the force-maintaining assembly 150 is configured to provide a variable force over all or part of the travel distance, which is, for example, a variable force that changes within a predetermined range of force (e.g., a range of force proportional to the amount of compression). For example, the force maintenance assembly 150 may be configured to apply a force that varies from 5 gmf to 30 gmf, for example, a force that varies from 10 gmf to 30 gmf.

[0112] As described above, the force-maintaining assembly 150 may include one or more sensing elements or sensors, for example, the illustrated sensing element 158, which may be configured to generate a signal correlated with the amount of compression of the force-maintaining assembly 150. Additionally or alternatively, the sensing element 158 ​​may be configured to generate a signal correlated with the maximum compression of the force-maintaining assembly 150 (e.g., the maximum force achieved during compression).

[0113] The energy delivery element 130 may be positioned on the distal end of the shaft 110, for example, when the force maintenance assembly 150 is positioned inside the shaft 110. Alternatively, the energy delivery element 130 may be positioned on the distal end of the force maintenance assembly 150.

[0114] The EDD100 may be configured for atrial ablation of the heart (e.g., to form one or more lesions for the treatment of atrial fibrillation or right atrial flutter) and / or ventricular ablation of the heart (e.g., for the treatment of ventricular tachycardia). For atrial ablation, the force maintenance assembly 150 may be configured to have a first maximum compression distance, e.g., 10 mm or less, 5 mm or less, or 3 mm or less. Alternatively, for ventricular ablation, the force maintenance assembly 150 may be configured to have a second maximum compression distance. The second maximum compression distance is, for example, a greater distance than the first maximum compression distance, e.g., at least 1 mm greater than the first maximum compression distance, e.g., the second (ventricular) maximum compression distance is at least 3 mm or at least 6 mm. In some embodiments, the first (atrial) maximum compression distance includes a distance of about 2 mm to 3 mm. In some embodiments, the second (ventricular) maximum compression distance includes a distance of about 4 mm to 6 mm.

[0115] The system 10 may include at least a second energy delivery device, EDD 100', for example, a second EDD 100' configured for use in the atria and / or ventricles of the heart (e.g., EDD 100' includes the patient's vascular system and a catheter for insertion into the ventricles of the patient's heart). In some embodiments, the first EDD 100 is configured for use in the atria (e.g., not the ventricles), and the second EDD 100' is configured for use in the ventricles (e.g., not the atria). In these embodiments, the first EDD 100 may include a force maintenance assembly 150 having a shorter maximum compression distance compared to the maximum compression distance of a force maintenance assembly 150 located within the second EDD 100'. In some embodiments, the dose DOE 2 includes an IEP pulse configured to form an effective lesion in the ventricles of the patient's heart, for example, when the IEP dose is based on a voltage of 5 kV or less. In some embodiments, the dose DOE2 includes an IEP pulse configured to form an effective lesion in the atrium of the patient's heart, for example, when the IEP dose is based on a voltage of 2 kV or less.

[0116] The EDD100 may include one or more electrodes, a mapping electrode 135 as shown in the figure, which may be configured to record biopotential information (e.g., cardiac electrical activity data, etc.) and / or positional information (e.g., data regarding the position of the EDD100 within the patient's anatomical structure). The mapping electrode 135 may include one or more electrodes positioned on the distal portion 102 of the EDD100, as shown in the figure. The mapping electrode 135 may include a ring electrode. In some embodiments, the mapping electrode 135 includes at least one sensor or sensing element (hereinafter referred to as "sensor"), which are, for example, electrode-based sensors and / or non-electrode-based sensors (e.g., light sensors, temperature sensors, pH sensors, physiological sensors, e.g., blood sensors, blood gas sensors, etc.). In some embodiments, one or more mapping electrodes 135 and one or more energy delivery elements 130 include the same components.

[0117] The EDD100 is configured to be operably mounted to the EDC300. The EDD100 includes a conduit 125 which is one or more wires, filaments, and / or other conduits, and a connector 126 which is one or more accessory connectors. The connector 126 is operably mounted to the mating connector 301b of the EDC300. The conduit 125 includes one or more wires or conductive traces (hereinafter referred to as "wires"), optical fibers, tubes (e.g., hydraulic, pneumatic, irrigation, or other fluid delivery tubes), waveguides, and / or mechanical connections (e.g., translating filaments), each of which may be used to operably mount one or more components of the EDC300 to one or more components of the EDD100.

[0118] System 10 may include one or more functional elements, for example, functional elements 119, 129, 219, 229, and / or 309 shown in Figure 1 and described in detail herein. Each of the functional elements 119, 129, 219, 229, and / or 309 may include one or more sensors and / or one or more transducers, as described herein. In some embodiments, functional elements 119, 129, 219, 229, and / or 309 include transducers selected from the group consisting of: heating elements, cooling elements, vibration transducers, ultrasonic transducers, electrodes, optical delivery elements, drug or other drug delivery elements, and one or more combinations thereof. In some embodiments, functional elements 119, 129, 219, 229, and / or 309 include sensors selected from the group consisting of: These include physiological sensors, blood pressure sensors, blood gas sensors, pressure sensors, strain gauges, force sensors, chemical sensors, impedance sensors, magnetic sensors, electrodes, displacement sensors (e.g., a sensor configured to determine the distance over which the force-maintaining assembly 150 is compressed), flow sensors, and one or more combinations thereof. In some embodiments, functional elements 129 and / or 229 include functional elements configured to provide feedback and / or functional elements otherwise configured to warn the user of the state of one or more components of the system 10 (e.g., when an undesirable state exists). Functional elements 129 and / or 229 may include elements selected from the group consisting of tactile transducers, light sources such as LED light sources, sound transducers such as speakers, and one or more combinations thereof.

[0119] The mapping catheter 200 of system 10 includes a shaft 210, which is typically a flexible shaft containing one or more lumens. A basket assembly 230 is positioned on the distal end 213 as shown, or on at least the distal portion of the shaft 210. A handle 220, which is the portion that the operator can grasp, is positioned on the proximal end 211 of the shaft 210. The handle 220 may include one or more control units, such as the control unit 221 shown.

[0120] The basket assembly 230 may include an expandable assembly. This assembly is configured to be elastically biased, for example, into a radially expanded or compressed state, and to be compressed or expanded accordingly. This compression or expansion is performed via control 221 by advancing from the distal end of a sheath (radially expanding) and / or by being retracted into a sheath such as sheath 12 (radially compressing). The basket assembly 230 includes an array of filaments, a spline 231, which may include elastically biased (e.g., biased in an expanded state and / or compressed state) metal (e.g., stainless steel and / or nickel-titanium alloy) and / or plastic filaments. The basket assembly 230 may include electrodes 232, which are a plurality of electrodes connected to the spline 231. Additionally or alternatively, the basket assembly 230 may include transducers 233, which are a plurality of ultrasonic transducers, which may also be connected to the spline 231. In some embodiments, the basket assembly 230 and / or the mapping catheter 200 have a similar structure and arrangement to the similar components described in the concurrently pending U.S. Patent Application No. 16 / 389,006, filed April 19, 2019, “Device and Method For the Geometric Determination of Electrical Dipole Densities on the Cardiac Wall,” and / or the concurrently pending U.S. Patent Application No. 16 / 242,810, filed January 8, 2019, by the applicant of the present invention. In some embodiments, one or more electrodes 232 and / or ultrasonic transducers 233 additionally or alternatively include sensors such as physiological sensors and / or other sensors as described herein.

[0121] The mapping catheter 200 of system 10 may include one or more functional elements, such as functional elements 219, 229 as illustrated and described herein. In some embodiments, one or more functional elements 219 and / or 229 are arranged on the basket assembly 230 (for example, on one or more splines 231).

[0122] The mapping catheter 200 may be configured to be operably attached to the EDC 300. The mapping catheter 200 includes one or more wires, filaments, and / or other conduits, conduit 225, and one or more accessory connectors, connector 226, as shown. Connector 226 is operably attached to connector 301a, which is the mating connector of the EDC 300. Conduit 225 may include one or more wires, optical fibers, tubes (e.g., hydraulic, pneumatic, irrigation, or other fluid delivery tubes), waveguides, and / or mechanical connections (e.g., translation filaments), each of which may be used to operably attach one or more components of the EDC 300 to one or more components of the mapping catheter 200.

[0123] System 10 may include one or more patch electrodes, namely the illustrated patch electrode 60, which may include a standard skin electrode and / or another electrode configured to adhere to the patient's skin and transmit and / or receive electrical signals through the patient. In some embodiments, the patch electrode 60 is configured to record the patient's electrocardiogram (ECG) and / or transmit and / or receive localized signals from System 10. The patch electrode 60 may be configured to be operably attached (e.g., electrically attached) to the EDC 300. Each patch electrode 60 may include one or more conduits, a conduit 65 (e.g., one or more electrical wires), and a connector 66 which is one or more attached connectors. The connector 66 is operably attached to the mating connector 301c of the EDC 300.

[0124] The EDC300 includes one or more internal components configured to control and / or interface with one or more energy delivery devices, EDD100s, one or more mapping catheters 200s, and / or one or more patient patches 60s. The EDC300 includes conduits 302, e.g., conduits 302a, 302b, 302c, which are one or more wires, filaments, and / or other conduits, and which are operably connected to one or more EDD100s, one or more mapping catheters 200s, and / or one or more patient patches 60s, respectively, via connectors 301a, 301b, and / or 301c. The conduits 302 may include one or more wires, optical fibers, tubes (e.g., hydraulic, pneumatic, irrigation, or other fluid supply tubes), waveguides, and / or mechanical connections (e.g., parallel-transfer filaments).

[0125] The EDC300 may include a patient interface unit (PIU310). The PIU310 may be connected (e.g., electrically connected) via a bus 305 to one or more of the units 320, 330, 340, 350, 360, and / or 370, each of which is described in detail herein. The bus 305 may include one or more wires, optical fibers, and / or other conduits configured to supply power, transmit data, and / or receive data. In some embodiments, the bus 305 includes one or more fluid delivery tubes configured to provide hydraulic fluid, irrigation fluid, and / or other fluids, as described herein. The PIU310 may be operably mounted to units 340, 350, 360, 330, and / or 320 so that power, data, fluids, and / or mechanical connections can pass between the PIU310 and one or more of the EDD100, mapping catheter 200, and / or patch 60. In some embodiments, the PIU310 can reduce undesirable electrical interactions between two or more modules of the EDC300. For example, the PIU310 may include one or more filters (e.g., one, two or more parallel LC notch filters and / or low-pass filters) configured to reduce electrical interference between the mapping module and the RF generator, e.g., interference from signals transmitted to and received by the patient. The PIU310 may include one or more components selected from the group consisting of filters, transformers, buffers, amplifiers, pass-throughs (e.g., conduits not filtered by or otherwise modified by the PIU310, e.g., fluid conduits) and one or more combinations thereof. In some embodiments, the PIU310 includes an electrical protection circuit configured to protect the EDC300 from damage by high-energy signals such as defibrillation pulses and / or RF ablation energy delivered to the patient.

[0126] The EDC300 may include a user interface unit 320, shown in the illustration, which is a clinician or other user interface, and which includes one or more user input and / or user output components. In some embodiments, the user interface unit 320 includes a joystick, keyboard, mouse, touchscreen, and / or other human interface device, such as the HID321 shown in the illustration. In some embodiments, the user interface unit 320 includes a display, such as the display 322, also shown in the illustration.

[0127] The EDC300 may include a processor 330, which is a signal processing assembly. In some embodiments, the processor 330 includes one or more algorithms, such as algorithm 335 shown in the figure. The processor 330 can receive signals, for example, from one or more sensors (as described herein) of the EDD100 and / or mapping catheter 200. The processor 330 may be configured to perform one or more mathematical operations on the received signals to derive results that correlate to quantitative or qualitative measurements of the force that the EDD100 exerts on the tissue, the amount of compression of the force-holding assembly 150, the orientation of the EDD100, the proximity of part of the EDD100 to the cardiac tissue, and / or the level or quality of contact between part of the EDD100 and the cardiac tissue. The one or more mathematical operations may include arithmetic operations, statistical operations, linear and / or nonlinear functions, operations as a function of time, operations as a function of space or distance, comparisons with thresholds, comparisons with ranges, and operations of functions selected from a group consisting of one or more combinations thereof. In some embodiments, algorithm 335 includes machine learning or other artificial intelligence (AI) algorithms. In some embodiments, algorithm 335 is configured to monitor, evaluate and / or control (as "control" herein) the force-maintaining assembly 150 (for example, by adjusting one or more parameters of the force-maintaining assembly in a closed-loop or semi-closed-loop manner), for example, by controlling based on sensor signals. In some embodiments, algorithm 335 is configured to determine and / or evaluate at least one of the contact, force, or pressure applied to the tissue by the EDD 100. In some embodiments, algorithm 335 processes one or more signals received from one or more sensors of the system 10, for example, signals correlated with: the temperature of the energy-delivering element, the temperature of the tissue surrounding the energy-delivering element, the duration of energy delivery to the tissue, the level of energy delivered to the tissue, the force and / or pressure applied to the tissue, and one or more combinations thereof.Algorithm 335 can be configured to modify energy delivery based on these signals, for example, to stop energy delivery when a sufficient combination of parameter levels is reached, for example, when sufficient energy delivery is reached with sufficient pressure for a sufficient amount of time. In some embodiments, system 10 is configured to deliver an increased energy level in order to reduce the duration of energy delivery to the tissue. Alternatively or additionally, system 10 may be configured to increase the duration of energy delivery to the tissue in order to reduce the energy level. In some embodiments, system 10 controls the force between one or more energy delivery elements 130 and the tissue to adjust one or more of the duration of energy delivery and / or the level of energy delivery (e.g., voltage level, current level and / or power level). In some embodiments, system 10 adjusts the duration of energy delivery and / or the level of energy delivery based on a measured and / or controlled level of the force between one or more energy delivery elements 130 and the tissue.

[0128] In some embodiments, algorithm 335 (e.g., AI algorithm) is configured to define, adjust, and / or otherwise control the delivery of energy by EDC 300 to EDD 100 to control dose DOE1 and / or DOE2. In some embodiments, algorithm 335 is configured to modify the delivery of dose DOE1 and / or DOE2 (e.g., in a closed-loop configuration). This modification is, for example, based on the patient's tissue impedance and / or other physiological parameters. In some embodiments, algorithm 335 is configured to modify dose DOE2 based on parameters (e.g., measured parameters) related to the previously delivered dose DOE1.

[0129] Algorithm 335 can be used to determine the orientation angle of the EDD 100, as described herein with reference to Figures 10-11, and this determination is based, for example, on data provided by the sensors of system 10 and / or another imaging device.

[0130] Algorithm 335 may be used to measure electric field strength, for example, the electric field strength used to perform pulsed electric field ablation as described herein with reference to Figures 10 to 13.

[0131] Algorithm 335 may be used to provide information about the lesion, for example, the predicted size of the lesion to be created (e.g., length, width, depth, and / or volume), as described herein with reference to Figures 10 to 13.

[0132] The EDC300 may include a fluid delivery module, module 370 as shown, which may be configured to deliver a fluid (e.g., hydraulic fluid and / or irrigation fluid as described herein) to the EDD100 and / or mapping catheter 200, for example, via PIU310. In an alternative embodiment, the fluid delivery module 370 is connected to the EDD100 and / or mapping catheter 200 without going through PIU310. The fluid delivery module 370 may include one or more fluid delivery devices (e.g., peristaltic pumps, syringe pumps, gravity feed flow controllers and / or other fluid delivery devices), which may be attached to one or more sources of the fluid 70 shown, which is saline and / or other fluids.

[0133] The fluid 70 may include fluids with known conductivity (e.g., relatively low conductivity and / or conductivity at least lower than that of blood). These are fluids delivered, for example, for the manipulation of electric current and / or electromagnetic fields (e.g., to surround one or more electrodes during the delivery of energy to produce pulsed field ablation of target tissue).

[0134] The EDC300 may include a force-maintaining module, module 340, as shown in the illustration. The force-maintaining module 340 may be configured to provide control signals to a force-maintaining assembly 150, for example, to provide signals that enable the system 10 to adjust the force applied to the tissue by the EDD100. In some embodiments, the force-maintaining module 340 is configured to deliver and / or at least control (e.g., control its pressure) a supply of hydraulic fluid to the EDD100 (e.g., via a fluid delivery module 370).

[0135] In some embodiments, the force maintenance module 340 is configured to automatically adjust the force between the electrode 130 and the tissue to form a desired electric field during pulsed electric field ablation of the target tissue.

[0136] The EDC300 may include a mapping module, module 350, as shown in the illustration. In some embodiments, the mapping module 350 includes a module configured to record and / or process ultrasound information, for example, the ultrasound module 351 shown in the illustration. In some embodiments, the mapping module 350 includes a module configured to record and process biopotential information, for example, the biopotential module 352 shown in the illustration. The mapping module 350 can transmit energy and / or signals to the EDD100, the mapping catheter 200, and / or the patch 60, via the PIU310 (as shown) or otherwise. The mapping module 350 may be configured to transmit one or more signals into the patient (for example, via one or more patches 60) to form a localized field within the patient. Furthermore, the mapping module 350 can receive signals from one or more electrodes (or other sensors) of the EDD100 and / or the mapping catheter 200. These signals are, for example, signals correlated with localization signals, and are signals for determining the localization of one or more electrodes within a localization field (for example, for determining the position and / or orientation of the relevant catheter(s) in the patient). In some embodiments, two or more localization fields may be used simultaneously. Components used to generate and / or sense localization fields (e.g., patch 60 and / or one or more electrodes of EDD 100 or mapping catheter 200) may be configured to transmit (as "source" herein), receive (as "sink" herein), and / or transmit and receive localization signals interchangeably. For example, components may be multiplexed to source and sink localization signals between each other in a pattern configured to augment localization information received by mapping module 350. Localization information is, for example, information relating to the relative position between a component of system 10 and cardiac tissue or other structures within the ventricle and / or another component of system 10.

[0137] For example, the direction of current flow between two or more components used to perform localization measurements can be reversed. For example, in an impedance-based system, multiple frequency ranges can be used to generate multiple (e.g., three or four) localization fields simultaneously. All electrodes and / or sensors in the field can be used to sense the localization field. The components used for source (e.g., transmission of localization signals) and sink (e.g., sensing of localization signals) of the localization field can be fixed and static, and these are, for example, a patch 60 placed on the body surface used as the source of the localization field, and electrodes placed on one or more components of the system 10 and electrodes placed in the patient used as the sink for the localization signals. Alternatively, the components can be time-multiplexed and / or frequency-multiplexed, which is done, for example, by source and sink currents from different sets of components at various frequencies and / or various times. As an example of a time-multiplexed localization method, the system may include three source / sink components A-C. In the first configuration, component A is used as the source and component B is used as the sink. In the second configuration, B can be used as the source and A as the sink. In the third configuration, C can be used as the source and B as the sink. Multiplexing these three configurations can provide an enhanced localization method. Using all possible permutations, it would be possible to provide a complete complement of the information available through the source-sink configuration. A subset of these configurations can be selected to reduce electronic and algorithmic complexity while still providing enough information to determine the number of required conditions and / or states. In some embodiments, the electronics are configured to minimize current leakage (e.g., through the ground path) within a frequency range (e.g., 10 kHz to 100 kHz), which is done via sensors and / or electrodes present in and / or used to measure the localized field. For example, current leakage can be minimized by designing a sufficiently high input impedance in the target localization frequency range.

[0138] In some embodiments, the ultrasound module 351 of the mapping module 350 is configured to transmit and receive ultrasound signals via one or more ultrasound transducers 233 of the mapping catheter 200 to determine the distance between the ultrasound transducers 233 and cardiac tissue, and, for example, in conjunction with localization data, to generate an anatomical model of cardiac tissue. The biopotential module 352 of the mapping module 350 may be configured to record one or more biopotential signals, for example, via electrodes 232 of the mapping catheter 200, thereby creating an electrical activity map of the ventricles. In some embodiments, the mapping module 350, including an ultrasound module 351 and a biopotential module 352, has a configuration and arrangement similar to that described in the applicant's concurrently pending U.S. Patent Application No. 15 / 569,185, filed October 25, 2017, entitled "Ultrasound Sequencing System and Method," and / or the applicant's concurrently pending U.S. Patent Application No. 16 / 849,045, filed April 15, 2020, entitled "Localization System and Method Useful in the Acquisition and Analysis of Cardiac Information."

[0139] One or more sensors of the EDD100 (e.g., one or more of the functional elements 119 or 129 configured as one or more sensors, and / or other sensors described herein) may be configured to generate signals relating to the level of contact between one or more energy delivery elements 130 and tissue (e.g., cardiac tissue). The signals provided can easily distinguish between minimum (sufficient) levels of contact and insufficient levels of contact (e.g., no contact) and / or provide data that distinguishes between various levels of contact (e.g., a quantitative assessment of the force between one or more energy delivery elements 130 and tissue). The EDC300 can provide qualitative and / or quantitative contact information to a user (e.g., a clinician) via, for example, a display 322, which indicates the level of contact between one or more energy delivery elements 130 and tissue (e.g., ventricular wall and / or other cardiac tissue). In some embodiments, the system 10 is configured to provide information (through the display 322) including: This information includes sufficient contact achieved (e.g., sufficient contact to allow for effective energy delivery to the tissue), insufficient contact achieved, the level of force achieved, the level of pressure achieved, the distance or proximity to the boundary, the orientation or angle of attack relative to the position of the boundary or other tissue, the topology of the adjacent boundary, the contact efficiency, and one or more combinations thereof.

[0140] Referring to Figures 2-7, the tissue treatment methods described below relate to a catheter, for example, the EDD100 energy delivery device for delivering the two forms of energy described herein to the patient's target tissue. It should be considered within the spirit and scope of this application that other types of energy delivery devices, such as surgical tools, laparoscopic tools, endoscopic tools, and / or other energy delivery tools may also be used. Referring to Figures 2-7, the methods described below relate to cardiac tissue, for example, target tissue including ventricular tissue to which energy is delivered to the endocardial surface of the heart. It should be considered within the spirit and scope of this application that energy may alternatively be delivered within the cardiac wall and / or to the epicardial surface, and that other tissues of the patient may be treated using the systems, apparatus, and methods of the concept of the present invention. The energy doses DOE1 and DOE2, as described with reference to Figures 2-7, may include similar forms of energy (e.g., both including RF energy delivery) or different forms of energy (e.g., DOE2 including RF or other electromagnetic energy delivery and DOE1 including non-electromagnetic energy delivery). DOE1 may include the delivery of energy configured to reversibly warm the target tissue, and DOE2 may include the delivery of energy configured to irreversibly electroperforate the target tissue. This electroperforation is performed, for example, via the delivery of IEP as described herein, for example, to form a desired lesion within the tissue (e.g., to treat a patient's AF or other arrhythmia). This pre-warming of the tissue may offer numerous advantages, as described herein. For example, if DOE2 includes the delivery of energy (e.g., RF energy) with a lower amplitude than what would have been required to irreversibly electroperforate the target tissue if the target tissue was at body temperature (e.g., not pre-warmed by DOE1).

[0141] In some embodiments, the EDC300 is configured as a monitoring device, for example, when one or more sensors in the system 10 provide information relating to the patient's physiological condition and / or the patient's environment. In some embodiments, the EDC300 configures dose DOE1 and / or dose DOE2 based on this information. For example, the EDC300 may be configured to provide dose DOE1 and / or dose DOE2 based on physiological information of the patient selected from the group consisting of: cardiac cycle, heart rate, blood pressure, blood flow velocity, respiratory rate, brain activity, electrogram amplitude (e.g., measured in unipolar and / or bipolar modes), tissue impedance, and combinations thereof.

[0142] Referring now to Figure 2, a flowchart of a method for delivering energy to tissue, consistent with the concept of the present invention, is shown. Method 2000 will be described using System 10 and its components as described herein.

[0143] In step 2010, the distal portion of the EDD100 is inserted into the patient's ventricle. In some embodiments, the distal portion of the catheter 200 is also inserted into the patient's ventricle to provide bioelectric potential, anatomical visualization, and / or other cardiac mapping functions.

[0144] In step 2020, one or more energy delivery elements 130 of the EDD100 are moved to the vicinity (proximity) of the tissue site for treatment (hereinafter referred to as the "target tissue").

[0145] In step 2030, the energy of the first dose, dose DOE1 as described herein, is provided to EDD100 by EDC300 and delivered to the target tissue by one or more energy delivery elements 130.

[0146] In step 2040, the energy of the second dose, dose DOE2 as described herein, is provided to EDD100 by EDC300 and delivered to the target tissue by one or more energy delivery elements 130 (for example, the same and / or different energy delivery elements 130 that delivered dose DOE1 in step 2030).

[0147] In step 2050, the completeness of the procedure is checked. If the procedure is not complete, for example, if additional tissue (e.g., additional target tissue) should be treated, the method returns to step 2020. If the procedure is complete, the procedure ends in step 2070.

[0148] Referring now to Figure 3, a flowchart of a method for delivering energy to tissue, consistent with the concept of the present invention, is shown. Method 3000 will be explained using System 10 and its components as described herein.

[0149] In step 3010, the distal portion of the EDD100 is inserted into the patient's ventricle. In some embodiments, the distal portion of the catheter 200 is also inserted into the patient's ventricle to provide bioelectric potential, anatomical visualization, and / or other cardiac mapping functions.

[0150] In step 3020, one or more energy delivery elements 130 of the EDD100 are moved near the target tissue.

[0151] In step 3030, the dose DOE1 described herein, which is the energy of the first dose, is supplied to the EDD100 by the EDC300 and delivered to the target tissue by one or more energy delivery elements 130. In some embodiments, the dose DOE1 includes the delivery of energy (e.g., RF energy) over a period of time.

[0152] In step 3032, the patient's cardiac cycle is monitored by the EDC300 or other components of system 10.

[0153] In step 3033, a check is performed to determine if a "timeout" has been reached, for example, by checking the timeout period, which includes the time since the delivery of dose DOE1 was completed. If the timeout period has been reached, step 3060 is performed, system 10 enters warning mode, and method 3000 continues to step 3050, which is described later. If the timeout period has not been reached, step 3035 is performed.

[0154] In step 3035, the patient's cardiac cycle reaches the desired cycle point, cycle point CP. D A check is performed to determine if the patient's cardiac cycle is at point CP. D If not, method 3000 returns to step 3033. The patient's cardiac cycle is at point CP. D If it is in that state, step 3040 is executed.

[0155] In step 3040, the energy of the second dose, dose DOE2 as described herein, is provided to EDD100 by EDC300 and delivered to the target tissue by one or more energy delivery elements 130 (for example, the same and / or different energy delivery elements 130 that delivered dose DOE1 in step 3030).

[0156] In some embodiments, cycle point CP D This is selected in step 3035, and this selection is made so that in step 3040, dose DOE2 is delivered between 50 and 200 milliseconds after the R wave occurs (see Figure 3A).

[0157] In step 3050, the completeness of the procedure is checked. If the procedure is not complete, for example, if additional tissue (e.g., additional target tissue) should be treated, the method returns to step 3020. If the procedure is complete, the procedure ends in step 3070.

[0158] Referring now to Figure 4, a flowchart of a method for delivering energy to tissue, consistent with the concept of the present invention, is shown. Method 4000 will be described using System 10 and its components as described herein.

[0159] In step 4010, the distal portion of the EDD100 is inserted into the patient's ventricle. In some embodiments, the distal portion of the catheter 200 is also inserted into the patient's ventricle to provide, for example, bioelectric potential, anatomical visualization, and / or other cardiac mapping functions.

[0160] In step 4020, one or more energy delivery elements 130 of the EDD100 are moved near the target tissue.

[0161] In step 4030, delivery of the first dose energy, dose DOE1 as described herein, is initiated. The energy is delivered to EDD100 by EDC300 and then delivered to the target tissue by one or more energy delivery elements 130.

[0162] In step 4032, the patient's cardiac cycle is monitored by the EDC300 or other components of system 10.

[0163] In step 4033, a check is performed to determine if a "timeout" has been reached, for example, by checking the timeout period, which includes the time since the delivery of dose DOE1 was completed. If the timeout period has been reached, step 4060 is performed, system 10 enters warning mode, delivery of dose DOE1 is stopped, and method 4000 continues to step 4050, which is described later. If the timeout period has not been reached, step 4035 is performed.

[0164] In step 4035, the patient's cardiac cycle reaches the desired cycle point, cycle point CP. D A check is performed to determine if the patient's cardiac cycle is at point CP. DIf not, method 4000 returns to step 4033. The patient's cardiac cycle is at point CP. D If it is in that state, step 4040 is executed.

[0165] In step 4040, the delivery of dose DOE1 is stopped, and dose DOE2, which is the energy of the second dose as described herein, is delivered to EDD100 by EDC300 and delivered to the target tissue by one or more energy delivery elements 130 (for example, the same and / or different energy delivery elements 130 that delivered dose DOE1 in step 4030).

[0166] In step 4050, the completeness of the procedure is checked. If the procedure is incomplete, for example, if additional tissue (e.g., additional target tissue) should be treated, the method returns to step 4020. If the procedure is complete, the procedure is completed in step 4070.

[0167] Referring now to Figure 5, a flowchart of a method for delivering energy to tissue, consistent with the concept of the present invention, is shown. Method 5000 will be explained using System 10 and its components as described herein.

[0168] In step 5010, the distal portion of the EDD100 is inserted into the patient's ventricle. In some embodiments, the distal portion of the catheter 200 is also inserted into the patient's ventricle to provide, for example, bioelectric potential, anatomical visualization, and / or other cardiac mapping functions.

[0169] In step 5020, one or more energy delivery elements 130 of the EDD100 are moved near the target tissue.

[0170] In step 5022, the patient's cardiac cycle is monitored by the EDC300 or other components of system 10.

[0171] In step 5024, the time T1 of a desired future cardiac cycle point CP D is predicted by the system 10 (e.g., via algorithm 335).

[0172] In step 5030, the option step of delivering the dose DOE1 described herein, which is the first dose of energy, can be provided by the EDC 300 to the EDD 100 and can be delivered to the target tissue by one or more energy delivery elements 130. In some embodiments, the dose DOE1 includes delivery of energy (e.g., RF energy) over a fixed time period (e.g., a fixed time period that ends before time T1).

[0173] In step 5035, a check is performed (e.g., at time T1 or immediately before it) to determine whether the patient's cardiac cycle at time T1 is at the desired cycle point, cycle point CP D . If the patient's cardiac cycle is at point CP D , step 5040 is executed. If the patient's cardiac cycle is not at point CP D , step 5060 is executed, the system 10 enters the warning mode, the delivery of the dose DOE1 is stopped (if delivered via the optional step 5030), and the method 5000 continues to step 5050, which will be described later.

[0174] In step 5040, the dose DOE2 described herein, which is a dose of energy (e.g., the first dose of energy or the second dose of energy), is provided by the EDC 300 to the EDD 100 and is delivered to the target tissue by one or more energy delivery elements 130 (e.g., the same and / or different energy delivery elements 130 that may have delivered the dose DOE1 in the optional step 5030).

[0175] In step 5050, the completeness of the procedure is checked. If the procedure is incomplete, for example, if additional tissue (e.g., additional target tissue) should be treated, the method returns to step 5020. If the procedure is complete, the procedure ends in step 5070.

[0176] Referring now to Figure 6, a flowchart of a method for delivering energy to tissue, consistent with the concept of the present invention, is shown. Method 6000 will be explained using System 10 and its components as described herein.

[0177] In step 6010, the distal portion of the EDD100 is inserted into the patient's ventricle. In some embodiments, the distal portion of the catheter 200 is also inserted into the patient's ventricle to provide, for example, bioelectric potential, anatomical visualization, and / or other cardiac mapping functions.

[0178] In step 6020, one or more energy delivery elements 130 of the EDD100 are moved near the target tissue.

[0179] In step 6022, the patient's cardiac cycle is monitored by the EDC300 or other components of system 10.

[0180] In step 6024', after receiving a "go" signal (e.g., a start request) from the operator of system 10 (e.g., the patient's clinician, provided via the user interface 320 of EDC 300), the system then determines the future desired cardiac cycle point CP D The time T1 is predicted by system 10 (for example, via algorithm 335).

[0181] In step 6026, the dose DOE1, which is the energy of the first dose, is determined in order to achieve a target amount of energy (e.g., a target amount in joules) to be delivered by time T1 (e.g., delivered continuously until time T1 and / or delivered in intermittent pulses until time T1). This target amount of energy may be determined by the system 10 and / or the patient's clinician.

[0182] In step 6030, a dose DOE1 as described herein and defined in step 6026 is provided to the EDD100 by the EDC300 and delivered to the target tissue by one or more energy delivery elements 130.

[0183] In step 6035, the patient's cardiac cycle at time T1 reaches the desired cycle point, cycle point CP. D A check is performed (for example, at or immediately before time T1) to determine if the patient's cardiac cycle is at point CP. D If the patient's cardiac cycle is at point CP, step 6040 is performed. D If not, step 6060 is performed, system 10 enters warning mode, delivery of dose DOE1 is stopped, and method 6000 continues to step 6050 described later.

[0184] In step 6040, the energy of the second dose, dose DOE2 as described herein, is provided to EDD100 by EDC300 and delivered to the target tissue by one or more energy delivery elements 130 (for example, the same and / or different energy delivery elements 130 that delivered dose DOE1 in step 6030).

[0185] In step 6050, the completeness of the procedure is checked. If the procedure is incomplete, for example, if additional tissue (e.g., additional target tissue) should be treated, the method returns to step 6020. If the procedure is complete, the procedure ends in step 6070.

[0186] Referring now to Figure 7, a flowchart of a method for delivering energy to tissue, consistent with the concept of the present invention, is shown. Method 7000 will be explained using System 10 and its components as described herein.

[0187] In step 7010, the distal portion of the EDD100 is inserted into the patient's ventricle. In some embodiments, the distal portion of the catheter 200 is also inserted into the patient's ventricle to provide, for example, bioelectric potential, anatomical visualization, and / or other cardiac mapping functions.

[0188] In step 7020, one or more energy delivery elements 130 of the EDD100 are moved near the target tissue.

[0189] In step 7030, a dose DOE1 as described herein is supplied to the EDD100 by the EDC300 and delivered to the target tissue by one or more energy delivery elements 130.

[0190] In step 7040, the energy of the second dose, dose DOE2 as described herein, is provided to EDD100 by EDC300 and delivered to the target tissue by one or more energy delivery elements 130 (for example, the same and / or different energy delivery elements 130 that delivered dose DOE1 in step 7030).

[0191] In step 7045, a check is performed to determine whether additional energy should be delivered to the current target tissue. If additional energy should be delivered (for example, as manually determined by the operator of system 10 and / or automatically by algorithm 335, for example if algorithm 335 includes an AI algorithm), method 7000 returns and repeats step 7030. Otherwise, step 7050 is performed.

[0192] In step 7050, the completeness of the procedure is checked. If the procedure is incomplete, for example, if additional tissue (e.g., additional target tissue) should be treated, the method returns to step 7020. If the procedure is complete, the procedure ends in step 7070.

[0193] In method 7000 of Figure 7, the energy delivery in steps 7030 and 7040 may include alternating delivery of dose DOE1 and dose DOE2 (e.g., at least a portion of dose DOE1 is delivered during step 7040 and / or at least a portion of dose DOE2 is delivered during step 7030). For example, a portion of dose DOE1 may be delivered between a portion of dose DOE2, or vice versa. In some embodiments, dose DOE1 includes energy delivered in a pulse configuration (e.g., RF energy), which, for example, dose DOE1 is delivered during an "off-time" period (DOE1TP OFF ) One or more "on time" (DOE1TP ON This includes the period of ) and in this case the energy is DOE1TP ON It will be delivered during the period, DOE1TP OFF No delivery during the period (e.g., pulse width modulation configuration). In these embodiments, dose DOE2 is DOE1TP of dose DOE1. OFF It can be delivered during the period. In some embodiments, the dose DOE2 includes energy delivered in a pulsed configuration (e.g., IEP dose). This is, for example, when the dose DOE2 has an "off-time" period (DOE2TP OFF ) One or more "on-time" periods separated by (DOE2TP ON This is the case when it includes ). In this case, the energy is DOE2TP ON During the period, it is delivered, and during the DOE2TPOFF period, it is not delivered (e.g., pulse width modulation configuration). In these embodiments, dose DOE1 is DOE2TP of dose DOE2. OFFIt can be delivered during the period. In some embodiments, dose DOE1 and dose DOE2 may each include energy delivered in a pulse configuration. In these embodiments, the energy delivered in dose DOE1 and dose DOE2 may be delivered in an alternating configuration. For example, the energy delivery of dose DOE1 may be in the same configuration as the DOE2TP of dose DOE2. OFF During the period, the energy delivery of dose DOE2 is equivalent to that of dose DOE1. OFF This applies if it is delivered within the specified period.

[0194] Referring here to Figure 8, a side view of the distal portion of an energy delivery device consistent with the concept of the present invention is shown. Figures 8A and 8B are two graphs of lesion depth versus electrode pairs during an electroporation experiment using the device in Figure 8, consistent with the concept of the present invention. Furthermore, referring to Figures 9A to 9D, four graphs representing lesion volume versus electrode pairs during an electroporation experiment using the device in Figure 8 are shown, which are also consistent with the concept of the present invention. The applicant performed an in silico experiment. In this experiment, an EDD100, such as the EDD100 shown in Figure 8, delivers a dose of energy containing an IEP as defined herein (a dose of IEP provided by the EDC300 as described herein with reference to Figure 1) to tissue. The EDD100 in Figure 8 includes four electrodes 130 (e.g., four electrode-based energy delivery elements 130) located in the distal portion 102. The EDD100 includes electrode 130a positioned on the distal end of shaft 110 and three electrodes positioned more proximal to shaft 110, arranged in a continuous linear configuration. Electrode 130b is positioned closest to the tip electrode 130a, electrode 130c is positioned distal to electrode 130b, and electrode 130d is positioned distal to electrode 130c, all of which are shown in Figure 8. In silico experiments showed that the shape and size of lesions within tissue can be controlled by selecting specific pairs of electrodes 130 and delivering IEP to those pairs. Figures 8A and 8B show tests with three pairs of electrodes 130: pair "1-2" consisted of electrodes 130a and 130b, pair "1-3" consisted of electrodes 130a and 130c, and pair "1-4" consisted of electrodes 130a and 130d. In the simulation, the distal portion of the EDD100 was positioned approximately perpendicular (90 degrees) to the tissue surface receiving the energy, electrode 130a had a length of 3.46 mm, and the amplitude of the electric field was kept constant. The test was repeated for each of the three pairs with different voltages of 500V, 1000V, 1500V, and 2000V, as shown in the figure. Figure 8A is a graph showing the lesion depth for each pair of electrodes 130, and Figure 8B is a graph showing the lesion surface area for each pair of electrodes 130. Figures 9A to 9C are graphs of the lesion volume created using pairs 1-2, 1-3, and 1-4, respectively, with the distal portion of the EDD100 positioned on the tissue (for example, at an angle of approximately 0 degrees).Figure 9D is a graph that combines (overlays) the lesion areas shown in Figures 9A to 9C.

[0195] As demonstrated by experiments, system 10 may be configured to switch between pairs of electrodes 130 receiving and / or delivering IEP (without modifying the amplitude), thereby modifying the depth of the lesion and / or creating a lesion with a desired geometric volume. For example, as shown in Figure 8A, a lesion created with 1000V IEP creates a deeper lesion when delivered by pair 1-3 than when delivered by pair 1-2. As shown in Figures 9A-9D, longer lesions (approximately 1.5 cm as shown) can be created by delivering the IEP dose between multiple pairs of electrodes (without repositioning, for example, the distal portion of EDD 100).

[0196] Referring here to Figures 10A and 10B, two anatomical cross-sectional views of the distal portion of an energy delivery device in contact with a tissue surface at different orientation angles, consistent with the concept of the present invention. As described herein, the system 10 may be configured to deliver one or more electrical pulses via the EDD 100 between two or more electrodes 130 (e.g., one or more electrodes 130 configured to supply current, and one or more electrodes 130 configured to sink current). The parameters of each pulse (e.g., voltage, current, frequency, pulse width, etc.) may be selected to generate a high-voltage electric field in the tissue adjacent to the two or more electrodes to perform “pulsed field ablation” for ablation of the tissue. Energy is delivered to the EDD 100 by the EDC 300, as described herein. The parameters of the electrical pulse may further be selected so that the resulting electric field causes reversible or irreversible electroperforation of the tissue. The spatial extent (e.g., the complete volume) of the tissue to be ablated and the effectiveness of pulsed field ablation depend on the strength of the electric field at the target location (e.g., the target location selected for ablation that provides a therapeutic benefit to the patient as described herein). The strength of the electric field is related to the distance from the electrode (e.g., the electrode 130 attached to the shaft 110 of the EDD 100 as shown in the figure), and the electric field strength decreases exponentially with increasing distance from the electrode. System 10 is configured to provide a sufficient level of electric field strength for all of the target tissue to be ablated (e.g., all of the intended width, length, and depth of the target tissue).

[0197] System 10 (e.g., algorithm 335 as described herein) uses the lesion size parameters (e.g., length, width, depth, and / or volume of the lesion), L P (L here) P This is the peak voltage of pulsed field ablation (PFA), which is pulse V. PEAK ), orientation angle α, and / or one or more electrophysical parameters EP PIt can be configured to determine the angle α, which is a function of . The angle α is the angle between the axis of the distal portion 102 of EDD100 and the plane of the tissue surface adjacent to the distal portion 102 of EDD100. In Figure 10A, the angle α is 90 degrees (i.e., the distal portion 102 of EDD100 is perpendicular to the adjacent tissue surface), and in Figure 10B, the angle α is 0 degrees (i.e., the distal portion 102 of EDD100 is parallel to and in contact with the adjacent tissue surface). Parameter EP P This may include one, two, or more of the following: contact force, pulse amplitude, pulse duration, number of pulses, number of electrodes sourcing and / or sinking the current, tissue temperature, and / or tissue impedance.

[0198] In some embodiments, the EDD 100 includes sensors or other components configured to determine the orientation angle α, such as those used in calculations to determine the lesion size as described above. For example, one or more sensors (e.g., sensing element 158) of the force-holding assembly 150 (e.g., as described herein) may be configured to provide a signal that can determine the angle α (e.g., by algorithm 335), for example, if the force-holding assembly 150 includes, for example, optical fibers, magnetic sensors, impedance measuring sensors, and / or other sensing elements configured to provide a signal related to the angle α. Alternatively or additionally, the angle α may be determined via signals provided by mapping and / or navigation sensors of the system 10. For example, if algorithm 335 performs impedance and / or magnetic-based localization to determine the angle α. Alternatively or additionally, the system 10 may include imaging devices, not shown. These are selected from the group consisting of, for example, intracardiac ultrasound imaging, X-ray, fluoroscopy, magnetic resonance imager, computed tomography imager, visible light camera, infrared camera, and combinations thereof. Algorithm 335 can utilize information provided by the imaging device to determine the angle α.

[0199] In some embodiments, an electrical pulse is applied between the tip electrode 130a and one or more adjacent electrodes 130 (e.g., electrodes 130b, 130c, and / or 130d are shown). Relating only to angle α, the electric field strength in the tissue is minimum when angle α is 90 degrees, as shown in Figure 10A, and increases as angle α decreases from 90 degrees, finally reaching a maximum when angle α is 0 degrees, as shown in Figure 10B. In other words, when one or more PFA pulses are delivered to the tissue by the EDD 100, the spatial extent of the resulting lesion (e.g., the depth of the resulting lesion) increases as the electrodes 130 associated with each PFA pulse (e.g., electrodes that source and / or sink the current) are brought closer to the tissue surface.

[0200] Referring here to Figures 11A and 11B, two user views of a graphical user interface displaying information about different orientation angles of the energy delivery device are shown, which are consistent with the concept of the present invention. System 10 may include a graphical user interface, GUI 3200 shown, via the user interface unit 320 of the EDC 300. GUI 3200 may be configured to provide information about an orientation angle α, such as that provided by the orientation angle display unit 3250 shown herein. GUI 3200 can display current (e.g., real-time) position information related to the EDD 100 (e.g., related to the distal portion 102 of the EDD 100). GUI 3200 may include a catheter display unit 3210 representing the position of the distal portion 102, and / or a tissue display unit 3220 representing the position of a tissue surface to be ablated (e.g., a tissue surface adjacent to the distal portion 102), which are each shown.

[0201] GUI3200 may further include an indicator graph 3230 that can provide the operator with electric field strength feedback. This electric field strength feedback may be, for example, a graphical representation of an estimate of the electric field strength in the tissue adjacent to electrode 130. The indicator graph 3230 may show the electric field strength of energy (e.g., the PFA pulse currently being delivered, or the electric field strength that will be present when the operator initiates energy delivery). The information provided by the indicator graph 3230, and other information provided by GUI3200, may be used by the operator (e.g., in an iterative or other adjustable manner) to create a lesion of a desired size (e.g., desired length, width, and / or depth dimensions). The indicator graph 3230 may include a first marker 3231 and a second marker 3232, which are illustrated respectively. The relative positions of markers 3231 and 3232 can correlate with the electric field strength within the tissue, such that as the electric field strength increases, marker 3231 moves closer to marker 3232 (for example, as shown by the transition from the orthogonal catheter orientation depicted on the catheter display unit 3210 in Figure 11A to the catheter orientation depicted on the catheter display unit 3210 in Figure 11B, where angle α is 5 degrees). It will be understood that system 10 can provide the operator with various other forms of visual feedback regarding the electric field strength and / or other ablation parameters of the current (e.g., real-time) or future (delivered based on the current state) pulsed electric field ablation energy delivery.

[0202] In some embodiments, the GUI 3200 may be configured to provide information about contact force, such as that provided by the illustrated contact force indicator 3260. The contact force indicator 3260 includes a force indicator 3261 that shows the current applied contact force (shown at the same level in each of Figures 11A and 11B). The contact force indicator 3260 may further include a threshold indicator 3262 that can indicate a required or recommended limit for the applied contact force (e.g., an amount less than the maximum available contact force). The contact force information provided can provide absolute measurements of force (e.g., measurements expressed in grams or other metrics indicating contact force) and / or relative measurements (e.g., a percentage of the maximum amount of contact force). In some embodiments, the GUI 3200 may further be configured to change the distance between a first marker 3231 and a second marker 3232 in response to a change in contact force, for example, the distance may decrease as the contact force increases (e.g., indicating an increase in the electric field within the structure). In some embodiments, the distance between two markers is based on both angle α and contact force, and the operator can change the electric field strength within the tissue by changing either or both of these. In some embodiments, GUI3200 controls the distance between two markers based on angle α, contact force, and / or one or more electrophysical parameters EP. P Modify based on all or some of the following.

[0203] Referring here to Figure 12, a perspective view of the distal portion of an energy delivery device including a plurality of ports for delivering irrigation fluid is shown, consistent with the concept of the present invention. The EDD100 in Figure 12 includes an electrode 130a shown on the distal portion 102. The distal portion 102 of the EDD100 may include one or more ports, ports 1305 (six shown), for delivering irrigation fluid 70. The irrigation fluid 70 is one or more similar or different irrigation fluids 70 provided, for example, by a fluid delivery module 370 of the EDC300 described herein. Two or more ports 1305 may be spatially distributed in a desired pattern, for example, in a pattern covering part or most of the distal portion 102 including the electrode 130. Two or more ports 1305 may be connected to separate lumens for delivering different irrigation fluids 70 (e.g., different fluids 70a, 70b, etc., such as different conductive fluids as described herein). Alternatively or additionally, two or more ports 1305 may be connected to a common lumen to deliver the same irrigation fluid 70.

[0204] Referring further to Figure 13, an anatomical lateral cross-sectional view of the distal portion of an energy delivery device that delivers an irrigation fluid in contact with a tissue surface is shown, consistent with the concept of the present invention. The distal portion 102 of the EDD100 is shown with an orientation angle α equal to 0 degrees, such that each of the electrodes 130a, 130b, 130c, and 130d is in contact with the tissue surface to be ablated. The irrigation fluid 70 is delivered through ports 1305 (eight are shown), and the delivered fluid 70 surrounds the electrodes 130a and 130b as shown (preventing, for example, blood, which is a relatively conductive substance, from surrounding those electrodes).

[0205] The EDD100 may be configured to deliver PFA pulses that form an electromagnetic field to ablate tissue (for example, to cause reversible or irreversible electroporation of tissue as described herein). One or more irrigation fluids 70 may be delivered through port 1305 to influence the pulsed electric field. For example, the delivered electric field will "bunch" when passing through a conductive medium, and when passing through a more resistant medium, the current will "spread" by passing through the path of least resistance (i.e., the path of highest conductivity). The system 10 may be configured to deliver one or more irrigation fluids 70 of known conductivity to the area around electrode 130 and to actively "steer" the delivered current and thus the generated electric field.

[0206] In some embodiments, the distal portion 102 of the EDD 100 comprises at least six ports 1305 (e.g., twelve ports 1305), where at least two ports 1305 (e.g., four ports 1305) face forward (e.g., distally from the distal end of the shaft 110), at least two ports 1305 (e.g., four ports 1305) are located at the distal end of the tip electrode 130a, and at least two ports 1305 (e.g., four ports 1305) are located at the proximal end of the tip electrode 130. The system 10 may include an irrigation fluid 70 having a conductivity different from (e.g., lower conductivity) than that of blood. Before applying pulsed electric field energy, the EDD 100 may be oriented such that one or more ports 1305 are blocked through contact with tissue (e.g., blocked by the tissue surface of the left atrium or other chambers of the heart). The delivery of the irrigation fluid 70 through the remaining port 1305 will have a steering effect on the desired electric field. For example, the delivery of the irrigation fluid 70 having a conductivity lower than that of blood will concentrate the current delivered by the electrode 130 into the contacting tissue, thereby increasing the electric field to the tissue (for example, because the fluid surrounding the electrode 130 delivering the current is surrounded by the irrigation fluid 70 with relatively low conductivity).

[0207] Before and / or during PFA pulse delivery, the orientation angle α can be monitored as described herein (e.g., via one or more sensors of system 10 and / or by another imaging device) so as to provide feedback information relating to the electric field to be delivered and / or being delivered. System 10 (e.g., algorithm 335, e.g., if algorithm 335 includes an AI algorithm) can detect the increase in electric field strength (e.g., steering of the electric field) due to the delivery of the low-conductivity irrigation fluid 70.

[0208] The embodiments described above should be understood to be for illustrative purposes only, and further embodiments are conceivable. Any feature described herein in relation to any one embodiment may be used alone or in combination with another described feature, or in combination with one or more features of another arbitrary embodiment, or with any combination of embodiments. Furthermore, equivalents and modifications not described above may be adopted without departing from the scope of the concept of the invention as defined in the appended claims.

Claims

1. A system for treating patient tissue, An energy delivery console for providing the energy of the first dose and the energy of the second dose, The energy delivery device includes a first delivery element configured to deliver the energy of the first dose to the target tissue, and a second delivery element configured to deliver the energy of the second dose to the target tissue, The energy of the first dose includes the delivery of energy that reversibly alters the target tissue, The energy of the second dose includes the delivery of energy that irreversibly alters the target tissue, A system in which the energy of the first dose is delivered to enhance the treatment provided by the energy of the second dose.

2. The system according to claim 1 or any other claim, wherein the target tissue includes cardiac tissue.

3. The system according to at least one of claims 1 to 2 or any other claim, wherein the target tissue includes nerve tissue.

4. The system according to at least one of claims 1 to 3 or any other claim, wherein the target tissue includes vascular wall tissue.

5. The system according to at least one of claims 1 to 4 or any other claim, wherein the target tissue includes organ tissue.

6. The system according to at least one of claims 1 to 5 or any other claim, wherein the target tissue includes tissue selected from the group consisting of cardiac tissue, nerve tissue, vascular wall tissue, organ tissue, brain tissue, lung tissue, kidney tissue, liver tissue, stomach tissue, muscle tissue, and combinations thereof.

7. The system according to at least one of claims 1 to 6 or any other claim, wherein the energy delivery device includes a catheter.

8. The system according to at least one of claims 1 to 7 or any other claim, wherein the energy delivery device includes a device selected from the group consisting of a catheter, a surgical tool, a laparoscopic tool, an endoscopic tool, and a combination thereof.

9. The system according to at least one of claims 1 to 8 or any other claim, wherein the first energy delivery element and the second energy delivery element include the same component.

10. The system according to at least one of claims 1 to 9 or any other claim, wherein the first energy delivery element and the second energy delivery element include different components.

11. The system according to at least one of claims 1 to 10 or any other claim, wherein the first energy delivery element comprises a plurality of energy delivery elements.

12. The system according to claim 11 or any other claim, wherein the second energy delivery element includes a single energy delivery element.

13. The system according to claim 11 or any other claim, wherein the second energy delivery element includes a plurality of energy delivery elements which are identical components to the first energy delivery element.

14. The system according to at least one of claims 1 to 13 or any other claim, wherein the second energy delivery element comprises a plurality of energy delivery elements.

15. The system according to claim 14 or any other claim, wherein the first energy delivery element comprises a single energy delivery element.

16. The system according to at least one of claims 1 to 15 or any other claim, wherein the energy delivery device includes a first energy delivery device and a second energy delivery device, and the plurality of energy delivery elements include a first device element of the first energy delivery device and a second device element of the second energy delivery device.

17. The system according to claim 16 or any other claim, wherein during the delivery of the second dose, the first device element is configured to be positioned on the endocardial surface of the patient's heart, and the second device element is configured to be positioned on the epicardial surface of the patient's heart.

18. The system according to at least one of claims 1 to 17 or any other claim, wherein the energy of the first dose includes the delivery of energy insufficient to ablate, necrotize, and / or otherwise permanently alter the target tissue, and the energy of the second dose includes the delivery of energy sufficient to ablate, necrotize, and / or otherwise permanently alter the target tissue.

19. The system according to at least one of claims 1 to 18 or any other claim, wherein the system is configured to deliver the energy of the first dose and / or the energy of the second dose to the surface of the endocardial tissue.

20. The system according to at least one of claims 1 to 19 or any other claim, wherein the system is configured to deliver the energy of the first dose and / or the energy of the second dose to the surface of the epicardial tissue.

21. The system according to at least one of claims 1 to 20 or any other claim, wherein the system is configured to deliver the energy of the second dose after the energy of the first dose has been delivered.

22. The system according to claim 21 or any other claim, wherein the energy of the second dose is configured to irreversibly electroperforate the target tissue.

23. The system according to at least one of claims 1 to 22 or any other claim, wherein the system is configured to deliver the energy of the second dose during at least a portion of the delivery of the energy of the first dose.

24. The system according to at least one of claims 1 to 23 or any other claim, wherein the energy of the first dose includes RF energy delivered at a level insufficient to ablate the tissue.

25. The system according to at least one of claims 1 to 24 or any other claim, wherein the energy of the first dose includes a form of energy selected from the group consisting of thermal energy, heat energy, cryogenic energy, electromagnetic energy, radio frequency (RF) energy, microwave energy, optical energy, laser light energy, sound energy, subsonic energy, ultrasonic energy, chemical energy, and combinations thereof.

26. The system according to at least one of claims 1 to 25 or any other claim, wherein the energy of the second dose includes a form of energy selected from the group consisting of thermal energy, heat energy, cryogenic energy, electromagnetic energy, radio frequency (RF) energy, microwave energy, optical energy, laser light energy, sound energy, subsonic energy, ultrasonic energy, chemical energy, and combinations thereof.

27. The system according to at least one of claims 1 to 26 or any other claim, wherein the energy of the first dose and the energy of the second dose include different forms of energy.

28. The system according to at least one of claims 1 to 27 or any other claim, wherein the energy of the second dose includes a pulse of energy for irreversible electroporation.

29. The system according to claim 28 or any other claim, wherein the second dose includes parameters selected from the group consisting of a dose delivered by an electrode having a length of at least 1.46 mm and / or 8 mm or less, a dose delivered by a pair of electrodes separated by a distance of at least 1 mm and / or 11 mm or less, a dose based on a supply voltage of at least 500 V and / or 5000 V or less, a dose including an electric field strength of at least 200 V / cm and / or 1000 V / cm or less, a dose including a pulse width of at least 0.1 μs and / or 200 μs or less, a dose including a series of pulses with a pulse repetition interval of at least 1 μs, and combinations thereof.

30. The system according to at least one of claims 1 to 29 or any other claim, wherein the energy of the first dose is delivered over a period of time.

31. The system according to claim 30 or any other claim, wherein the system is configured to monitor the patient's cardiac cycle, and the energy of the second dose is initiated when the cardiac cycle reaches a desired cardiac cycle point.

32. The system according to claim 30 or any other claim, wherein if the first dose is delivered and a timeout period is reached before the second dose is delivered, the system is configured to enter a warning mode.

33. The system according to at least one of claims 1 to 32 or any other claim, wherein the system is configured to monitor the patient's cardiac cycle during the delivery of the first dose and / or the delivery of the second dose.

34. The system according to claim 33 or any other claim, wherein the system is configured to monitor the patient's cardiac cycle both during the delivery of the first dose and during the delivery of the second dose.

35. The system according to claim 33 or any other claim, wherein the first dose is delivered until the patient's cardiac cycle reaches a desired cardiac cycle point or until a timeout is reached.

36. The system according to at least one of claims 1 to 35 or any other claim, wherein the system is configured to monitor the patient's heart before the delivery of the first dose of energy.

37. The system according to claim 36 or any other claim, wherein the system is configured to predict the time T1 of the next desired cardiac cycle point after receiving an energy delivery signal.

38. The system according to claim 37 or any other claim, wherein the energy of the first dose includes energy delivery parameters based on a target amount of energy to be delivered and the time to reach T1.

39. The system according to claim 38 or any other claim, wherein the system determines that the patient's cardiac cycle is equal to the desired cardiac cycle point at time T1, and the energy of the second dose is delivered.

40. The system according to claim 38 or any other claim, wherein if it is determined that the patient's cardiac cycle is different from the desired cardiac cycle point at time T1, the energy of the second dose is not delivered.

41. The system according to at least one of claims 1 to 40 or any other claim, wherein the energy of the first dose is configured to raise the temperature of the target tissue by at least 2°C.

42. The system is configured to deliver the energy of the third dose and the energy of the fourth dose to additional target tissue. The energy of the first dose includes the delivery of energy that reversibly alters the target tissue, The system according to at least one of claims 1 to 41 or any other claim, wherein the energy of the second dose includes the delivery of energy that irreversibly alters the target tissue.

43. The system according to claim 42 or any other claim, wherein the energy of the third dose is similar to the energy of the first dose, and the energy of the fourth dose is similar to the energy of the second dose.

44. The system according to at least one of claims 1 to 43 or any other claim, further comprising a monitoring device configured to provide physiological information of a patient, wherein the energy delivery console provides the energy of the first dose and / or the energy of the second dose based on the provided physiological information.

45. The system according to claim 44 or any other claim, wherein the physiological information includes cardiac cycle information.

46. The system according to claim 44 or any other claim, wherein the physiological information includes information on physiological parameters selected from the group consisting of cardiac cycle, heart rate, blood pressure, blood flow velocity, respiratory rate, brain activity, electrogram amplitude, tissue impedance, and combinations thereof.

47. A method for delivering energy to cardiac tissue, (1) Inserting a device having at least one electrical energy delivery element into the patient's ventricle, (2) The step of positioning the at least one electrical energy delivery element in close proximity to a target location including a target tissue to receive energy, (4) The step of delivering a dose of energy to the target tissue sufficient to irreversibly electroperforate the target tissue, A method further comprising the step of predicting a time T1 of a subsequent desired cardiac cycle point, wherein step (4) is performed at time T1.

48. Before step (4) above, (3) The method according to claim 47, comprising the step of delivering an additional dose of energy to raise the temperature of the target tissue.

49. The method according to claim 48, wherein the energy of the additional dose includes the delivery of RF energy.

50. The method according to claim 49, wherein the RF energy is delivered over a certain period of time.

51. The method according to claim 47, wherein if the patient's cardiac cycle is not equal to the desired cardiac cycle point, step (4) is not performed at time T1.

52. A method for delivering energy to cardiac tissue, The steps include inserting a device having at least one electrical energy delivery element into the patient's ventricle, The steps include: positioning the at least one electrical energy delivery element in close proximity to a target location including the target tissue to receive energy; The steps include heating the target tissue and A method comprising the steps of subsequently delivering a second energy to the target tissue, configured to irreversibly electroperforate the target tissue.

53. A system for treating patient tissue, An energy delivery console for providing electrical pulses configured to perform pulsed field ablation of target tissue, An energy delivery device including two or more electrodes, It features a graphical user interface, The electrical pulse is delivered between the two or more electrodes, and A system in which the graphical user interface is configured to provide information regarding the strength of the electric field generated by the electrical pulse.

54. A system for treating patient tissue, An energy delivery console for providing electrical pulses configured to perform pulsed field ablation of target tissue, An energy delivery device including two or more electrodes, The system comprises an irrigation fluid having a conductivity different from that of blood, The electrical pulse is delivered between the two or more electrodes, and A system configured to control the electric field generated by the electrical pulse via the delivery of the irrigation fluid.

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