Ablation assembly for treating target region of tissue in organ

Abstract

The present invention relates to an ablation assembly for treating a target region of tissue in an organ, comprising: an ablation catheter comprising an elongate shaft having a main longitudinal direction, the elongate shaft comprising at least a shaft distal portion, the shaft distal portion comprising a shaft distal portion distal end; the ablation catheter includes an internal lumen disposed within the elongate shaft; the ablation catheter includes a shaft ablation assembly fixedly disposed at a distal portion of the shaft, the shaft ablation assembly configured to deliver thermal energy for ablating tissue and non-thermal energy for treating tissue; at least a styling mandrel disposed within the ablation catheter, the styling mandrel being insertable into and removable from the internal cavity, where the styling mandrel is free to move relative to the internal cavity, where the styling mandrel includes at least a preformed configuration, and the styling mandrel is reversibly deformable between at least a straight loading configuration and a preformed configuration, where the styling mandrel is configured to be loaded into the ablation catheter. The styling mandrel is configured to styling the shaft distal portion to have a pre-formed configuration when the styling mandrel is fully inserted into the shaft distal portion.

Description

[0001] This application is a divisional application of the invention patent application of Egg Medical Technology Co., Ltd. with an application date of September 2, 2020, application number 202080074201.X, and invention name "Ablation component for treating a target area of ​​tissue in an organ". Technical Field

[0002] The present invention relates to an ablation device or assembly for treating a target region of tissue in an organ system and a method for treating a target region of tissue in an organ.

[0003] More particularly, the present invention relates to combined systems and methods for non-thermally treating target tissue and thermally ablating tissue. The tissue may be, for example, diseased tissue in a patient with atrial fibrillation (or AF), where the cardiac cell action potential is abnormal, typically phases 0-3. The tissue may also be tissue where blocking a refractory wavefront is deemed necessary to stop or prevent the patient's irregular heart rhythm.

[0004] The present invention generally relates to ablation systems and methods for ablating target tissue in a patient. In particular, the present invention provides catheters for delivering radiofrequency (RF) and / or irreversible electroporation (IRE), which occurs when intense pulsed electric fields (PEFs) cause permeabilization of cell membranes, leading to disruption of cellular homeostasis and cell death. IRE energy produces safe, precise lesions in target tissue, such as those that cause cardiac arrhythmias. Background Art

[0005] PEF has a wide range of applications in cardiology, including atrial fibrillation, ventricular fibrillation, septal ablation, and targeting vascular structures. PEF has attractive properties, including tissue specificity and athermal capabilities. The present invention provides a novel catheter design for delivering IRE / PEF to cardiac tissue.

[0006] Pulsed electric fields (PEF) involve the intermittent application of high-intensity electric fields for short periods of time (microseconds or nanoseconds), resulting in electroporation of cells and tissues. Electroporation is a process in which an applied electric field (i.e., PEF) causes pores to form in cell membranes. Pore formation leads to permeation, which can be reversible or irreversible, depending on the parameters of the applied PEF. In reversible electroporation, cells remain viable and are the basis for electrochemotherapy and gene electrotransfer. See references 1) Mali B, Jarm T, Snoj M, Sersa G, Miklavcic D; Antitumor effect of electrochemotherapy: a systematic review and meta-analysis; Ann Surg Oncol; 2013;39:4-16; 2) Heller R, Heller LC; Clinical trials of gene electrotransfer; Adv Genet; 2015;89:235-62; 3) Neumann E, Schaefer-Ridder M, Wang Y, Hofschneider P; Gene transfer into mouse lymphoma cells by high-field electroporation; EMBO J. 1982;1:841-5.

[0007] Electroporation is the phenomenon in which a PEF (generated by a high-voltage electric current) is applied to cells, resulting in the formation of pores in the cell membrane and subsequent increase in cellular permeability. The electric field is most commonly generated by a high-voltage direct current delivered between two or more electrodes. When the electric field is applied, an electric charge is created across the lipid bilayer and once a critical threshold (dependent on the transmembrane voltage) is reached, electroporation occurs. In contrast, with irreversible electroporation (IRE), cells and tissues cannot survive due to activation of the programmed cell death cascade. IRE is a well-established treatment for solid tumors. However, given the limitations of current heat-based methods, PEF may also be useful in cardiology, particularly for cardiac ablation. PEF can produce damage without tissue heating and is cell / tissue selective, enabling the preservation of critical surrounding structures.

[0008] Tissue ablation is used to treat patients in many medical procedures. Ablation can be performed to remove or denature unwanted tissue, such as diseased heart cells. Ablation procedures can also involve modifying tissue without removing it, such as stopping electrical function in a specific area of ​​the electrical propagation chain in the heart tissue of a patient with an arrhythmia. Ablation can be performed by passing energy (e.g., electrical energy) through one or more electrodes and causing tissue death at the electrode contact. By ablating cardiac tissue, ablation procedures can be performed on patients with any arrhythmia, such as atrial fibrillation (AF).

[0009] Mammalian organ function typically occurs when the SA node (pacemaker) spontaneously generates electrical activity. This electrical impulse propagates throughout the right atrium and reaches the left atrium via Bachmann's bundle, stimulating contraction of the atrial myocardium. The conduction system is composed of specialized cardiomyocytes. Cardiac myocardial cells have a negative membrane potential at rest. A stimulus above threshold causes the opening of voltage-gated ion channels and the influx of large amounts of cations into the cell. The influx of positively charged ions causes the depolarizing characteristic of the action potential. As in skeletal muscle, depolarization leads to the opening of voltage-gated calcium channels and the release of Ca2+ from the t-tubules. This calcium influx triggers calcium-induced calcium release from the sarcoplasmic reticulum, and the free Ca2+ leads to muscle contraction. After a delay, potassium channels reopen, and the resulting K+ outflow from the cell causes repolarization to the resting state. This electrical impulse propagates through the cardiac chambers. Disruption of this electrical transmission can lead to organ dysfunction. One specific area where electrical impulse transmission is critical for normal organ function is the heart, causing the atria to contract, which in turn causes blood to be pumped into the ventricles in sync with the pulse.

[0010] Atrial fibrillation (AF) is a heart rhythm disorder in which there is disrupted electrical conduction in the atria, causing them to contract rapidly and uncoordinatedly. This in turn leads to an inability to effectively pump blood into the ventricles and a lack of synchrony. During AF, the AV node receives electrical impulses from multiple locations throughout the atria, not just from the sinus node. These abnormal signals overwhelm the AV node, producing an irregular and rapid heartbeat. As a result, blood may pool in the atria, increasing the likelihood of blood clots forming. Major risk factors for AF include age, coronary artery disease, rheumatic heart disease, hypertension, diabetes, and thyrotoxicosis. AF affects 7% of the population over the age of 65.

[0011] Treatment options for atrial fibrillation are limited. Lifestyle changes can only help people with lifestyle-related AF. Medication can control AF symptoms, often with side effects that are more dangerous than AF itself, and does not cure AF. Electrical cardioversion attempts to restore normal sinus rhythm, but as the disease progresses, AF has a high rate of recurrence. In addition, if there is a blood clot in the atrium, cardioversion may cause the clot to escape the heart and travel to the brain (causing a stroke) or some other part of the body. What is needed are new approaches for treating AF and other medical conditions that involve disturbances in electrical conduction.

[0012] Various ablation techniques have been proposed to treat AF, including the Cox-Maze ablation procedure, linear ablation of various areas of the atria, and circumferential ablation of the pulmonary vein ostia. The Cox-Maze ablation procedure and linear ablation procedures are cumbersome and time-consuming, taking several hours to complete. Current ablations of the pulmonary vein ostia have been shown to be ineffective in the long term. All ablation procedures carry the risk of inadvertently damaging non-target tissue (such as the esophagus) while ablating tissue in the left atrium of the heart.

[0013] Therefore, there is a need for improved atrial ablation products and techniques that produce effective lesions in a safe manner.

[0014] The solution can be found in the following documents: US8641704B2, US8475449B2, US2010152725A1, US2010152725A1, US8948865B2, US2008281314A1, US8540710B2, US2019038171A1, US8221411B2, US2016051324A1, US2015327994A1, WO2017192804A1, US2020229866A1, WO2019023280A1.

[0015] In many of these procedures, an energy delivery device (such as a probe with or without a needle) is inserted into the target tissue to damage the target area of ​​cardiac tissue by applying energy (e.g., thermal energy, non-thermal energy, and energy associated with cryoablation procedures). Insertion of the energy delivery device into the cardiac chamber or other organ is accomplished through an elongated track, which is generally formed from a point below the heart. The elongated track or access tube is defined as the space created by the insertion of the device extending from the skin puncture point to the target tissue. When the energy delivery device is removed, it is pulled back along the elongated track or access tube that has been previously formed to allow for the insertion of the energy delivery device.

[0016] Before the delivery device is withdrawn, the tissue immediately adjacent to the energy delivery device is ablated. This creates a focal zone around the ablation element, maximizing the chance of ablation at the desired tissue location. It is known in the art that when an energy delivery device is placed on a tissue surface, electrically induced thermal ablation, such as RF, can be used to effectively and continuously ablate a tissue site locally. RF can induce coagulative necrosis surrounding a margin of normal tissue, where the high temperature conditions cause cellular damage, such as coagulation of cytosolic enzymes and disruption of histone complexes, ultimately leading to cell death. While these tissue treatment methods and systems can effectively ablate large volumes of target tissue, each technique has limitations. A frequently cited issue with using these procedures during cardiac ablation involves heat dissipation, which can involve blood flow. Heat generated by the ablation element is removed / dissipated by the cooler blood flow over the element. This heat dissipation can alter the shape and maximum volume of the ablated tissue. After treating the target tissue area with the energy delivery device, once the energy delivery device is removed from the target tissue area, it can be placed in a new, unablated area requiring treatment.

[0017] Recently, irreversible electroporation (IRE) has been used as an alternative to the above procedures to ablate cardiac or organ tissue. However, while IRE may be a non-thermal method to cause cell death, it is not ideal for coagulation, and in particular does not cause electrothermal coagulation, which highlights the importance of using alternative sources (such as RF or long DC pulses) when heating the tissue site. Instead, IRE involves applying electrical pulses to the target tissue in the microsecond to millisecond range, which can cause non-thermally generated nanoscale defects in the cell membrane. These defects can lead to a disruption of cell membrane homeostasis, resulting in irreversible cell membrane permeabilization, thereby inducing cell necrosis without increasing the temperature of the tissue ablation zone. During IRE ablation, connective tissue and scaffolding structures are preserved, thereby leaving the surrounding organs, structures, blood vessels and connective tissue intact. In the case of non-thermal IRE (also referred to as non-thermal IRE below), cell death is mediated by a non-thermal mechanism, and therefore the heat dissipation problem associated with many ablation techniques is eliminated. Thus, IRE has the advantage of allowing for focused treatment while sparing tissue and without thermal effects, and can be effectively combined with thermal treatments such as RF, which have been shown to be effective in preventing bleeding at the ablation site. This will also allow (in this example embodiment) the user to utilize a defined RF level, resulting in ablation in some cases and coagulation in others. This is important because IRE does not effectively coagulate when treating large tissue areas. In this way, the newly discovered advantages of IRE can be effectively utilized with known non-thermal injury techniques, with the added advantage of the option to use RF in conjunction with or without RF.

[0018] While IRE offers significant advantages, there are also advantages to using thermal ablation during treatment. Prior to the disclosure of the present invention, no invention has been proposed that addresses the problem of non-thermal ablation of a target area of ​​cardiac or organ tissue while maintaining the integrity of surrounding tissue and efficiently switching to a device for effectively thermally ablating tissue along the ablation track. In certain proposed embodiments, an energy delivery device powered by a single energy source can be used that is capable of applying energy in various forms, and the same energy delivery device can be subsequently used to ablate tissue tracks during a medical procedure for treating arrhythmias, with the same energy delivery device being powered by different forms of energy from the same energy source to maximize surgical outcomes. As noted, IRE offers advantages for non-thermal cell death, while thermal mechanisms offer advantages for not only preventing bleeding but also for effectively inducing coagulation. Systems and methods are needed that can provide this combined non-thermal / thermal tumor ablation and allow switching between non-thermal IRE energy delivery and thermal energy delivery to improve tumor ablation efficiency and efficacy and prevent tissue tracks.

[0019] Nevertheless, there is therefore a strongly felt need to simplify tissue, especially cardiac tissue, to speed up treatment and reduce intervention times. Summary of the Invention

[0020] Workaround

[0021] The present invention provides a novel assembly or device and method for delivering non-thermal and thermal energy to cardiac tissue.

[0022] A unique multi-electrode and multifunctional ablation catheter and ablation catheter system, or ablation assembly or device 100, and a method for mapping and ablating myocardial tissue within a patient's cardiac chamber are provided. Any electrogram signal site (e.g., a site with an abnormal signal) or a combination of sites identified by this placement can be ablated. In alternative embodiments, the ablation catheter and system can be used to treat non-cardiac tissue, such as tumor tissue, renal artery nerves, and the like.

[0023] According to an alternative embodiment, a probe, such as an ablation catheter 1 for performing a medical procedure on a patient, is provided. The ablation catheter 1 includes an elongated shaft 13 having a proximal portion 14 and a distal portion 17, wherein the proximal portion 14 includes a proximal end 15 and a distal end 16, and the distal portion 17 has a proximal end 18 and a distal end 19. The elongated shaft 13 also includes a shaft ablation assembly 20 and a distal ablation assembly 21 configured to deliver energy, such as RF and / or irreversible electroporation energy, to tissue 41. The shaft ablation assembly 20 is proximate the distal end of the distal portion 19 and includes at least one shaft ablation element 22 or shaft electrode 127, fixedly or removably attached to the shaft 13 and configured to deliver ablation energy to the tissue. The distal ablation assembly 21 is located at the distal end of the distal portion 19 and includes at least one tip ablation element 23 or electrode tip 128, configured to deliver ablation energy to the tissue.

[0024] According to an alternative embodiment, the distal portion 17 is configured in a circular configuration and can be deflected in one or more directions with one or more deflection shapes and geometries 24. The deflection geometries 24 can be similar or symmetrical deflection geometries, or the deflection geometries can be different or asymmetrical deflection geometries. The shaft or ablation catheter 1 can include one or more steering wires 25 configured to deflect the distal portion 17 in one or more deflection directions. Catheter deflection can also occur by placing or removing a shaping mandrel 26. The elongated shaft 13 can include a stiffness difference of the shaft along its length. The elongated shaft 13 can include a shaping mandrel 26 within the shaft or ablation catheter 1, the shaping mandrel 26 being configured to perform or enhance the deflection (steering and shape) of the distal portion 17, for example to maintain deflection in a single plane. The shaft or ablation catheter may include variable material properties, such as an asymmetric joint 27 between two portions, an integral component 28 intramurally or fixedly attached to the shaft, a variable braid 29, or other variations for producing multiple deflections, such as deflections with asymmetric deflection geometry.

[0025] According to alternative embodiments, the distal ablation assembly 21 can be fixedly attached to the distal end of the distal portion 19, or can be advanced from the distal shaft 17, such as through the control port 30. The distal ablation assembly 21 can include a single ablation element 31, such as an electrode, or a tip ablation element 23 or an electrode tip 128, or a plurality of ablation elements 32, or a mandrel electrode 132. The distal ablation assembly 21 can include a shaped mandrel carrier assembly 33 for the ablation element, or simply a shaped mandrel 26, and the shaped mandrel carrier assembly 33 can transition from a compact geometry to an expanded geometry, this transition being caused by advancement and / or retraction of the control shaft.

[0026] According to alternative embodiments, the shaft ablation assembly 20 can include a single ablation element 31 or multiple ablation elements 32 or shaft electrodes 127, preferably five to ten ablation elements fixedly attached to the shaft or shaped mandrel. The ablation element can have a profile that is flush with the surface of the shaft, or more preferably, the shaft between the electrode element outer diameter 35 or the shaft outer diameter 35 is slightly smaller than the diameter of the ablation electrode 36 or the shaft electrode outer diameter 36, making the distal end of the catheter more flexible.

[0027] According to alternative embodiments, the ablation elements 31, 32, 127, 128, 132 of the present invention can deliver one or more forms of energy, preferably RF and / or irreversible electroporation energy. The ablation elements can have similar or different configurations and can be configured in various sizes and geometries. The ablation element can include one or more thermocouples 37, such as two thermocouples mounted at 90° to each other on the inner side of the ablation element. The ablation element can include a heat dissipation member 38, such as to increase the surface area. According to alternative embodiments, one or more ablation elements are configured in a tubular geometry and have a wall thickness to outer diameter ratio of approximately 1:15. According to alternative embodiments, one or more ablation elements are configured to record or map electrical activity in tissue, such as to map a cardiac electrogram. According to alternative embodiments, one or more ablation elements are configured to deliver pacing energy, such as energy delivered to a patient's heart for pacing.

[0028] According to alternative embodiments, the ablation catheters of the present invention can be used to treat one or more medical conditions by delivering ablative energy to tissue. Conditions include cardiac arrhythmias, cancer, and other conditions where the removal or degeneration of tissue can improve a patient's health.

[0029] According to an alternative embodiment, a set of ablation catheters or an ablation catheter kit 300 is provided. A first ablation catheter 1 has a distal portion deflectable in at least two symmetrical geometries. A second ablation catheter 1 ' has a distal portion deflectable in at least two asymmetrical geometries.

[0030] According to an alternative embodiment, a method for treating proximal, persistent, or long-standing persistent atrial fibrillation is provided. The ablation catheter 1 of the present invention can be placed in the patient's coronary sinus, for example, to generate an electrogram and / or ablate tissue, and then placed in the left or right atrium to generate an electrogram and / or ablate tissue. The ablation catheter can be placed to ablate one or more tissue locations, including but not limited to: the fascia surrounding the pulmonary veins; the left atrial roof; and the mitral isthmus.

[0031] According to an alternative embodiment, a method of treating atrial flutter is provided. The ablation catheter of the present invention can be used to achieve bidirectional blockade, for example, by placement at one or more locations in the right atrium of the heart 43 .

[0032] According to an alternative embodiment, a method of ablating tissue in the right atrium of a heart is provided. The ablation catheter of the present invention can be used to create a lesion between the superior vena cava and the inferior vena cava; between the coronary sinus and the inferior vena cava; between the superior vena cava and the coronary sinus; and combinations thereof. The catheter can be used to generate an electrogram and / or to map and / or ablate the sinus node, for example, to treat sinus node tachycardia.

[0033] According to an alternative embodiment, a method for treating ventricular tachycardia is provided. The ablation catheter of the present invention can be placed in the left or right ventricle of the heart to treat the patient by delivering pacing energy and ablating tissue to induce ventricular tachycardia.

[0034] According to an alternative embodiment, an ablation catheter having a first geometry that is larger than a second deflected geometry is provided via a shaped mandrel. The ablation catheter is placed in the smaller second geometry to ablate one or more of the following tissue locations: the left atrial septum; tissue adjacent to the left atrial septum; and tissue adjacent to the posterior wall of the left atrium. The ablation catheter is placed in the larger first geometry to ablate at least the circumference surrounding the pulmonary veins.

[0035] According to an alternative embodiment, the ablation catheter of the present invention is used to treat the left atrium and the right atrium of the heart. The catheter is configured to transition to a geometry having a first shaped mandrel and / or deflection geometry and a second shaped mandrel and / or deflection geometry, wherein the first geometry is different from the second geometry. The catheter is used to ablate tissue in the right atrium using at least the first geometry and also to ablate tissue in the left atrium using at least the second geometry.

[0036] According to an alternative embodiment, a catheter for performing a medical procedure on a patient is provided. The catheter or catheter assembly or device 100 includes an elongated shaft having a proximal portion and a distal portion, wherein the proximal portion includes a proximal end and a distal end, and the distal portion has a proximal end and a distal end. The catheter also includes a shaping mandrel and / or a deflection assembly configured to shape the distal portion in a first geometric shape along a first direction and in a second geometric shape along a second direction, wherein the first geometric shape is different from the second geometric shape. The catheter also includes a functional element fixedly mounted to the distal portion.

[0037] According to an alternative embodiment, a combination therapy system has at least one energy delivery device or ablation catheter 1 and at least one power source or power source or single power source 4 capable of providing IRE energy and thermal energy to the energy delivery device. The at least one energy delivery device can be a monopolar or bipolar device. The system can continuously modify the energy or power source from energy utilized in a non-thermal form to energy utilized in a thermal form to ablate the target area of ​​tissue as well as tissue along the trajectory.

[0038] According to an alternative embodiment, a method is provided for effectively ablating a target region of tissue using both non-thermal IRE energy and thermal energy. The method includes positioning at least one energy delivery device coupled to a single power source within the target region of tissue, applying IRE energy from the power source to the energy delivery device for ablating the target region of tissue while preventing damage to surrounding structures, then switching from IRE energy to thermal energy using the same power source, and positioning the energy delivery device while ablating the tissue with thermal energy, such as RF energy, to allow for focal tissue ablation and safe energy delivery for use in a therapeutic procedure, while, among other things, coagulating the tissue and preventing bleeding.

[0039] According to alternative embodiments, described herein are systems and methods for selectively ablating tissue 3 , the system 3 comprising an ablation catheter 1 and a single power source 4 .

[0040] According to an alternative embodiment, a method involves providing application of IRE to ablate and / or treat tissue and treatment of tissue with an alternative energy form (e.g., thermal energy) to effectively ablate tissue from the same ablation device and the same energy source. The method can include providing at least one energy source or single power source 4, the at least one energy source or single power source 4 having at least a non-thermal energy source 6 and a thermal energy source 7, providing at least one probe or ablation catheter 1, the at least one probe or ablation catheter 1 being configured to be selectively operably coupled to a desired energy source of the at least one energy source, positioning at least a portion of the at least one probe within a desired region of the heart or organ via the probe, selectively coupling the at least one probe to the non-thermal energy source, selectively energizing the non-thermal energy source to apply non-thermal energy from the non-thermal energy source to at least a portion of the desired region to ablate at least a portion of the desired region, selectively coupling the at least one probe to the thermal energy source, withdrawing the at least one probe from the desired region, and selectively energizing the thermal energy source during withdrawal of at least a portion of the at least one probe to apply thermal energy to ablate tissue substantially adjacent to the probe trajectory.

[0041] According to an alternative embodiment, a system for selectively ablating tissue 3 is provided herein, the system having at least one energy source or a single power source 4, the at least one energy source or the single power source 4 having a non-thermal energy source 6 and a thermal energy source 7, at least one probe, or an ablation catheter 1, a component for selectively coupling the probe 8 to a desired energy source of the at least one energy source, a component for selectively energizing the non-thermal energy source 11 of the at least one energy source to apply non-thermal energy to at least a portion of the desired area to ablate at least a portion of the desired area, and a component for selectively energizing the thermal energy source 12 of the at least one energy source during withdrawal of the at least one probe to thermally ablate tissue substantially adjacent to the probe trajectory.

[0042] It is therefore an object of the present invention to provide an ablation assembly having structural and functional characteristics such as to meet the above needs and overcome the above-mentioned deficiencies of prior art devices.

[0043] These and other objects are achieved by a device according to claim 1 .

[0044] Advantageous embodiments are the subject matter of the dependent claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Further features and advantages of the invention will become apparent from the following description of exemplary embodiments given by way of non-limiting example with reference to the accompanying drawings, in which:

[0046] - Figure 1 is a perspective view of an ablation assembly according to an embodiment of the present invention, showing an ablation catheter having an elongated shaft and a shaped mandrel disposed within the ablation catheter;

[0047] - Figure 2 yes Figure 1 Detail of the ablation assembly showing the distal portion of the elongated shaft;

[0048] - Figure 3 yes Figure 1 Detail of the ablation assembly showing the handle and the steering device connected to the handle and the elongated shaft;

[0049] - Figure 4 An ablation assembly according to the present invention is shown with the elongated shaft and steering device omitted to show the shaping mandrel partially inserted into the handle, wherein the shaping mandrel has a curved pre-formed configuration;

[0050] - Figure 5 yes Figure 4 Detail of a forming mandrel showing a distal portion of the mandrel in a bent pre-formed configuration;

[0051] - Figure 6 An ablation assembly according to the present invention is shown with the elongated shaft and steering device omitted to show a shaping mandrel partially inserted into a handle, wherein the shaping mandrel has a helically curved preformed configuration;

[0052] - Figure 7 yes Figure 6 Detail of a forming mandrel showing the distal portion of the mandrel in a helically bent preformed configuration;

[0053] - Figures 8 to 13 Different preformed configurations of the shaping mandrel and ablation assembly of the present invention are shown;

[0054] - Figures 14 to 15 Shown in Figure 1insertion sequence of a shaping mandrel in a straight loaded configuration within an elongated shaft of an ablation catheter, wherein the shaping mandrel slides into a steering device connectable to a handle of the ablation catheter;

[0055] - Figure 16 is a partial perspective view of an ablation assembly according to the present invention, wherein Figure 14 and Figure 15 The steering device and the elongated shaft are shown to illustrate the proximal portion of the mandrel disposed within the handle of the ablation catheter;

[0056] - Figure 17 is a perspective view of an ablation assembly according to another embodiment of the present invention, showing an ablation catheter having an elongated shaft and a shaped mandrel having a circular preformed configuration disposed within the ablation catheter;

[0057] - Figure 18 yes Figure 1 Detail of the ablation assembly showing the distal portion of the elongated shaft;

[0058] - Figure 19 is a perspective schematic view of a distal portion of a shaft of an ablation catheter according to an assembly of the present invention, showing a locking mechanism between the shaping mandrel and the distal portion of the shaft;

[0059] - Figure 20 Shown in detail Figure 19 A shaped mandrel with a spherical tip;

[0060] - Figure 21 yes Figure 19 a cross-sectional view of a distal portion of the shaft taken in a longitudinal direction, showing in detail the elements of the locking mechanism;

[0061] - Figure 22 yes Figure 19 a cross-sectional view of a distal portion of the shaft with the shaping mandrel omitted;

[0062] - Figure 23 yes Figure 19 a perspective view of a distal portion of the shaft of FIG. 1 with some exterior components partially removed and the shaping mandrel omitted to illustrate the lumen of the catheter;

[0063] - Figure 24 is a perspective schematic diagram of a portion of an ablation catheter, showing an electrical connector disposed within the ablation catheter;

[0064] - Figure 25 is a perspective view of a distal portion of an ablation assembly according to yet another embodiment of the present invention, showing an ablation catheter having an elongated shaft and a shaping mandrel having a circular preformed configuration, the distal portion of the shaping mandrel being disposed beyond the distal end of the elongated shaft;

[0065] - Figure 26 is a perspective view of a distal portion of an ablation assembly according to yet another embodiment of the present invention, showing an ablation catheter having an elongated shaft and a shaped mandrel having a circular preformed configuration, the distal portion of the shaped mandrel extending beyond the distal end of the elongated shaft, and wherein the distal portion of the elongated shaft deflects in a deflection direction, wherein the shaped mandrel includes a plurality of mandrel electrodes disposed along its length, and the elongated shaft includes a plurality of shaft electrodes;

[0066] - Figure 27 yes Figure 25 A side view of the ablation assembly;

[0067] - Figure 28 yes Figure 25 a cross-sectional view of the ablation assembly of FIG. 1 , wherein the distal portion of the shaping mandrel is fully inserted into the elongated shaft;

[0068] - Figure 29 Shown Figure 28 Detail showing the electrical connections between the mandrel electrode and the shaft electrode;

[0069] - Figures 30a to 30c shows the shaping mandrel in a straight loaded configuration, a pre-formed circular configuration, and a pre-formed circular and bent configuration, respectively;

[0070] - Figure 31a to Figure 31b and Figure 32a to Figure 32b A plurality of shaping mandrels having different pre-forming configurations are shown;

[0071] - Figures 33a to 33c Shown are a shaping mandrel in preformed rounded and curved configurations and a loaded straight configuration, respectively, and a shaping mandrel disposed within an ablation catheter in the preformed rounded and curved configurations;

[0072] - Figure 34a to Figure 34b shows two shaping mandrels coupled to respective heating elements, wherein the heating elements are configured to apply heat to the shaping mandrels to modify the shape of the shaping mandrels from a loaded configuration to a pre-formed configuration;

[0073] - Figures 35a to 35d shows different curves and 2-D and 3-D configurations of a distal portion of an ablation catheter with a shaped mandrel disposed within the distal portion of the ablation catheter;

[0074] - Figure 36 An ablation assembly according to the present invention is shown positioned within a heart, wherein a shaping mandrel is fully inserted into a distal portion of an ablation catheter shaft;

[0075] - Figure 37 shows a radiographic image of an ablation assembly according to the present invention, wherein the distal portion of the catheter is shaped into a preformed configuration of the shaped catheter fully inserted into the distal portion of the catheter;

[0076] - Figure 38 illustrates a plurality of shaft electrodes fixedly disposed and spaced apart along a distal portion of a catheter shaft, wherein the shaft electrodes are biased in a circular configuration on the catheter shaft, according to an embodiment;

[0077] - Figure 39 A shaft electrode is shown disposed along a catheter shaft, wherein the shaft electrode catheter is tubular and forms a portion of the catheter shaft;

[0078] - Figure 40 Shown Figure 38 and Figure 39 Axial electrodes in a bipolar configuration;

[0079] - Figure 41 is a side view of a distal portion of an ablation catheter including a plurality of shaft electrodes and a tip electrode according to the present invention;

[0080] - Figure 42a to Figure 42b Shown Figure 41 ablation catheter of FIG. 1 , showing electrical connections for connecting one of the shaft electrodes to a single power source;

[0081] - Figure 43a to Figure 43b Shown Figure 41 A cross-sectional view and a longitudinal cross-sectional view of an ablation catheter of FIG. 1 showing electrical connections for connecting the tip electrode to a single power source;

[0082] - Figure 44 is a perspective view of a distal portion of a shaft of an ablation catheter according to the present invention comprising a plurality of shaft electrodes and a tip electrode, wherein an outer profile or diameter of the shaft electrodes and an outer profile of the tip electrodes are larger than an outer profile or diameter of the distal portion of the shaft;

[0083] - Figure 45 shows a radiographic image of an ablation assembly according to the present invention, wherein the distal portion of the catheter is shown in two different shapes and deflections;

[0084] - Figure 46 shows a side view of an ablation catheter handle of an ablation assembly according to an embodiment;

[0085] - Figures 47a to 47c shows schematic side views of three different configurations of an ablation catheter, wherein the ablation catheter has different stiffnesses along its length, wherein the ablation catheter is symmetrically deflectable, or asymmetrically deflectable, and / or wherein a plurality of catheter shaft portions between two electrodes have a first stiffness, the remainder of a distal portion of the shaft has a second stiffness and a proximal portion of the shaft has a third stiffness;

[0086] - Figure 48shows a side view of a distal portion of a shaft and a set of different tip electrodes, each of which can be coupled to the distal portion of the shaft;

[0087] - Figure 49 side views of distal portions of different shafts of different ablation catheters are shown;

[0088] - Figure 50 shows perspective views of different distal ablation assemblies that may be coupled to a distal portion of a shaft;

[0089] - Figure 51 An exploded side view of two portions of a tubular shaft electrode and a distal portion of the shaft is shown;

[0090] - Figure 52 shows a side schematic view of an ablation catheter assembly according to an embodiment;

[0091] - Figure 53 shows cross-sectional side views of different ablation catheters and different shaped mandrels disposed within the ablation catheters, and a shaped mandrel having a rounded distal end;

[0092] - Figure 54 An example of the operation of the ablation device of the present invention is shown to generate a monopolar electric field between each electrode and a ground electrode;

[0093] - Figure 55 An example of the operation of the ablation device of the present invention is shown to generate a monopolar electric field between each electrode and the ground electrode and a bipolar electric field between two adjacent electrodes;

[0094] - Figure 56 A flux diagram illustrating a method of ablation using the ablation assembly of the present invention;

[0095] - Figure 57 and Figure 58 showing a side view and a cross-sectional view, respectively, of a distal portion of a shaft of a catheter, illustrating a shaft ablation assembly including a plurality of electrodes according to a first embodiment;

[0096] - Figure 59 and Figure 60 showing a side view and a cross-sectional view, respectively, of a distal portion of a shaft of a catheter, illustrating a shaft ablation assembly including a plurality of electrodes according to a second embodiment;

[0097] - Figure 61 An embodiment of a bipolar electrode is shown, comprising a first electrode having an electrode body defining an internal compartment of the first electrode accessible from the outside and a second point-shaped electrode housed in the internal compartment of the first electrode;

[0098] - Figure 62a 、 Figure 62b 、 Figure 62c An ablation device is shown, comprising a single power source, a single control unit and power source unit, an ablation catheter, and a shaped mandrel disposed in the ablation catheter, wherein three different electrical connection configurations between the ablation catheter and the single power source are shown;

[0099] - Figure 63 A block diagram of a single power supply for an ablation device is shown, comprising a single control unit and a power supply unit;

[0100] - Figure 64a 、 Figure 64b 、 Figure 64c Shown by Figure 63 An example of an electrical signal comprising a pulse train generated by a single power supply;

[0101] - Figure 65 An ablation kit is shown, comprising at least an ablation assembly and a set of shaping mandrels;

[0102] - Figure 66 An ablation catheter kit is shown, comprising a first ablation assembly and a second ablation assembly having different deflection configurations;

[0103] - Figure 67 A schematic cross-sectional view of an ablation catheter along its length is shown, showing the steering guide wire and the electrical guide wire. DETAILED DESCRIPTION

[0104] The present invention may be more readily understood by reference to the following detailed description, examples, figures, and the preceding and following descriptions thereof. However, before disclosing and describing the present apparatus, systems, and / or methods, it should be understood that the present invention is not limited to the particular apparatus, systems, and / or methods disclosed, unless otherwise indicated, as such may, of course, vary. It should also be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.

[0105] The following description of the present invention is provided as an effective teaching of the present invention in its best currently known embodiment. To this end, those skilled in the relevant art will recognize and understand that many changes can be made to the various aspects of the invention described herein while still obtaining the beneficial results of the present invention. It is obvious that some of the expected benefits of the present invention can be obtained by selecting some features of the present invention without utilizing other features. Therefore, those skilled in the art will recognize that many modifications and adaptations to the present invention are possible, and in some cases may even be desirable and part of the present invention. Therefore, the following description is provided to illustrate the principles of the present invention rather than to limit it. As used throughout, the singular forms "a / an" and "said" include plural forms unless the context clearly indicates otherwise. Thus, for example, a reference to a "pipe segment" may include two or more such pipe segments unless the context indicates otherwise. As used herein, the term "plurality" refers to two or more.

[0106] Ranges may be expressed herein as from "about" one particular value, and / or to "about" another particular value. When such a range is expressed, another aspect includes from the one particular value and / or to the other particular value. Similarly, when values ​​are expressed as approximations, by use of the antecedent "about," it should be understood that the particular value forms another aspect. It will be further understood that the endpoints of each range are meaningful both in relation to the other endpoint and independently of the other endpoint.

[0107] As used herein, the terms "optional" or "optionally" mean that the subsequently described event or circumstance may but need not occur, and that the description includes instances where the event or circumstance occurs and instances where it does not.

[0108] The term "distal" is understood to mean away from the practitioner and toward the body part where the procedure is being performed, while "proximal" means toward the practitioner and away from the body part.

[0109] According to a general embodiment, an ablation assembly 100 for treating a target region of tissue 41 in an organ 44 includes an ablation catheter 1 and at least a shaping mandrel 26 disposed within the ablation catheter 1 .

[0110] The ablation catheter 1 comprises a catheter elongated shaft 13 having a longitudinal main direction XX and comprising at least an elongated shaft distal portion 17 .

[0111] The shaft distal portion 17 includes a shaft distal portion distal end 19 .

[0112] The ablation catheter 1 includes an inner lumen 118 disposed within the elongated shaft 13 .

[0113] According to one embodiment, the catheter elongated shaft 13 includes a flexible body 207 for navigation through a body vessel 208 .

[0114] The ablation catheter 1 further includes a shaft ablation assembly 20 fixedly disposed at the distal portion 17 of the elongated shaft.

[0115] The shaft ablation assembly 20 is configured to deliver thermal energy for ablating the tissue 41 and non-thermal energy for treating the tissue 41 .

[0116] The at least sizing mandrel 26 is insertable into and removable from the inner cavity 118 .

[0117] At least the shaping mandrel 26 is free to move relative to the lumen 118, avoiding any constraint on the shaft distal portion 17 during insertion of the shaping mandrel.

[0118] The at least shaping mandrel 26 comprises at least a pre-formed configuration, and the at least shaping mandrel 26 is reversibly deformable between at least a straight-loaded configuration and the pre-formed configuration.

[0119] When at least the shaping mandrel 26 is fully inserted into the shaft distal portion 17 , the shaping mandrel 26 is configured to shape the shaft distal portion 17 into the pre-formed configuration.

[0120] According to an alternative embodiment, the shaft distal portion 17 is elastically deformable.

[0121] According to an alternative embodiment, when the shaping mandrel 26 is fully inserted into the shaft distal portion 17 , the shaft distal portion 17 is configured to conform to the pre-formed configuration.

[0122] According to an alternative embodiment, the fully inserted mandrel position is defined when the sizing mandrel 26 is fully inserted into the shaft distal portion 17 .

[0123] According to an alternative embodiment, the shaping mandrel 26 is configured to variably shape the shaft distal portion 17 from the straight loaded configuration to the pre-formed configuration as the shaping mandrel 26 slides within the lumen 118 toward the fully inserted mandrel position.

[0124] According to an alternative embodiment, when the shaping mandrel 26 is fully inserted into the shaft distal portion 17 , said shaping mandrel 26 deforms said shaft distal portion 17 at least in the shaft distal portion plane P.

[0125] According to an alternative embodiment, the ablation catheter 1 comprises a catheter curvature 120 proximate the shaft ablation assembly 20 , wherein the catheter curvature 120 is configured to implement a bend relative to the longitudinal main direction XX towards the shaft distal portion plane P.

[0126] According to an alternative embodiment, at least when the shaping mandrel 26 is fully inserted into the shaft distal portion 17 , said shaft distal portion 17 forms an acute angle ALFA with respect to the main longitudinal direction XX of the shaft.

[0127] According to an alternative embodiment, wherein the shaping mandrel 26 is configured to bend at the catheter bending portion 120 when the shaping mandrel 26 is fully inserted into the shaft distal portion 17 .

[0128] According to an alternative embodiment, the shaping mandrel 26 in the pre-formed configuration includes a mandrel bend 146, and when the shaping mandrel 26 is fully inserted into the shaft distal portion 17, the mandrel bend 146 is configured to perform the catheter bend 120 corresponding to the catheter bend 120.

[0129] According to an alternative embodiment, when the sizing mandrel 26 is fully inserted into the shaft distal portion 17 , the shaft distal portion 17 adopts a circular configuration.

[0130] According to an alternative embodiment, the shaping mandrel 26 comprises a mandrel elastic body 119 that is deformable to at least the straight loaded configuration and back to the pre-formed configuration.

[0131] According to an alternative embodiment, the shaping mandrel 26 is made at least of a shape memory alloy.

[0132] According to an alternative embodiment, the assembly 100 includes a mandrel heating element 121 coupled to the shaping mandrel 26, wherein the heating element 121 is configured to apply heat to the shaping mandrel 26 to cause the shaping mandrel 26 to change from the straight-loaded configuration to the pre-forming configuration.

[0133] According to an alternative embodiment, the ablation assembly 100 includes a locking mechanism 122 configured to lock the setting mandrel 26 to the shaft distal portion 17 when the setting mandrel 26 is in the fully inserted mandrel position.

[0134] According to an alternative embodiment, the locking mechanism 122 comprises a retaining element 123 that reversibly locks the sizing mandrel 26 in the mandrel fully inserted position.

[0135] According to an alternative embodiment, the retaining element 123 is configured to release the sizing mandrel 26 from the mandrel fully inserted position when a pulling force is applied to the sizing mandrel 26 .

[0136] According to alternative embodiments, said retaining element 123 is made of metal, a metal alloy, rubber or a polymer.

[0137] According to an alternative embodiment, the sizing mandrel 26 includes a spherical tip 125 configured to engage the retaining element 123 when the sizing mandrel 26 is in the fully inserted position.

[0138] According to an alternative embodiment, the shaping mandrel 26 includes a mandrel distal portion 139 .

[0139] According to an alternative embodiment, the mandrel distal portion 139 includes a mandrel seat 140 , wherein the retaining element 123 is secured to the sizing mandrel 26 and is partially housed in the mandrel seat 140 .

[0140] According to an alternative embodiment, the lumen 118 proximate the distal end 19 of the shaft distal portion has a neck portion 141 , wherein the retaining element 123 interferes with the neck portion 141 to lock the sizing mandrel 26 in the mandrel fully inserted position.

[0141] According to an alternative embodiment, the retaining element 123 is an O-ring, wherein the spindle seat 140 is annular.

[0142] According to alternative embodiments, the shaft distal portion 17 is deflectable in one or more directions and in one or more deflectable shapes and geometries.

[0143] According to an alternative embodiment, the sizing mandrel 26 in the pre-formed configuration is configured to maintain the deflection of the shaft distal portion 17 in a single plane.

[0144] According to alternative embodiments, the deflection direction is a symmetrical deflection geometry or an asymmetrical deflection geometry.

[0145] According to an alternative embodiment, the elongated shaft 13 has a difference in shaft hardness along its length.

[0146] According to an alternative embodiment, the elongated shaft 13 includes a proximal shaft portion 14 .

[0147] According to an alternative embodiment, the proximal shaft portion 14 is more rigid than the distal shaft portion 17 .

[0148] According to an alternative embodiment, the elongated shaft 13 includes a shaft transition portion 126 disposed between the proximal shaft portion 14 and the distal shaft portion 17 .

[0149] According to an alternative embodiment, the shaft transition portion 126 is more rigid than the shaft distal portion 17 and less rigid than the shaft proximal portion 14 .

[0150] According to an alternative embodiment, the elongated shaft 13 comprises shaft portions having different hardnesses, wherein the elongated shaft 13 comprises at least one circumferentially asymmetric hardness portion between two of the shaft portions having different hardnesses.

[0151] According to an alternative embodiment, the elongated shaft 13 is made of Made of, or the elongated shaft 13 is made of stainless steel flat wire braid and / or Braided with twisted strands.

[0152] According to an alternative embodiment, the ablation catheter 1 comprises at least one steering wire 25 configured to deflect the shaft distal portion 17 in one or more deflection directions, wherein the at least one steering wire 25 is fixedly connected to the shaft distal portion 17 .

[0153] According to an alternative embodiment, the at least one steering guide wire 25 includes a guide wire proximal extension 142 disposed externally relative to the shaft proximal portion 14 .

[0154] According to an alternative embodiment, the proximal guide wire extension 142 includes a guide wire clamping portion 143 configured to pull at least one steering guide wire 25 for steering the shaft distal portion 17 with the sizing mandrel 26 fully inserted into the shaft distal portion 17 .

[0155] According to an alternative embodiment, the shaft distal portion 17 comprises a shaft distal portion proximal end 18 .

[0156] According to an alternative embodiment, the ablation catheter 1 comprises at least two steering wires 25 .

[0157] According to an alternative embodiment, a first steering wire of the at least two steering wires 25 is fixedly connected to the distal end 19 of the distal portion of the shaft or near the proximal end 18 of the distal portion of the shaft.

[0158] According to an alternative embodiment, a second steering wire of the at least two steering wires 25 is fixedly connected to the shaft distal portion proximal end 18 or near the shaft distal portion distal end 19 .

[0159] According to an alternative embodiment, a third steering wire of the at least two steering wires 25 is fixedly connected to the distal end 19 of the distal shaft portion or near the proximal end 18 of the distal shaft portion.

[0160] According to an alternative embodiment, a fourth steering wire of the at least two steering wires 25 is fixedly connected to the distal end 19 of the distal shaft portion or near the proximal end 18 of the distal shaft portion.

[0161] According to an alternative embodiment, the sizing mandrel 26 includes a proximal mandrel portion 138 , wherein the proximal mandrel portion 138 is disposed outside of the lumen 118 such that the sizing mandrel 26 is user-drivable.

[0162] According to an alternative embodiment, the elongated shaft 13 comprises a proximal shaft end 15 .

[0163] According to an alternative embodiment, the ablation catheter 1 comprises a steering device 144 attached to the proximal end 15 of the shaft.

[0164] According to an alternative embodiment, the ablation catheter 1 comprises a handle 103 , wherein the steering device 144 is connected to the handle 103 .

[0165] According to an alternative embodiment, the steering device 144 is rotatably driven relative to the handle 103 such that rotation of the steering device 144 relative to the handle causes rotation of the elongated shaft 13 .

[0166] According to an alternative embodiment, the diverting device 144 comprises a through hole 145 communicating with the inner cavity 118 .

[0167] According to an alternative embodiment, the shaping mandrel 26 passes through the through hole 145 during insertion or removal of the shaping mandrel 26 into the ablation catheter 1 or from the ablation catheter 1, and when the shaping mandrel 26 is fully inserted into the distal part 17 of the shaft, the proximal part 138 of the mandrel is outside the steering device 144.

[0168] According to an alternative embodiment, when the shaping mandrel 26 is fully inserted into the shaft distal portion 17 , said shaping mandrel 26 deforms said shaft distal portion 17 at least in the shaft distal portion plane P.

[0169] According to an alternative embodiment, the steering device 140 includes at least two protrusions 147 , wherein the at least two protrusions are coplanar with the shaft distal portion plane P to assist the user in steering the catheter assembly 1 .

[0170] According to an alternative embodiment, the ablation assembly 100 includes a distal ablation assembly 21 that is positionable at least at the distal end 19 of the distal portion of the shaft.

[0171] According to an alternative embodiment, the distal ablation assembly 21 is configured to deliver thermal energy for ablating the tissue 41 and non-thermal energy for treating the tissue 41 .

[0172] According to an alternative embodiment, the distal ablation assembly 21 includes at least an electrode tip 128 , which may be disposed at least at the distal end 19 of the distal shaft portion.

[0173] According to an alternative embodiment, the shaft electrodes 127 are arranged to be spaced apart from one another along the shaft distal portion 17 .

[0174] According to an alternative embodiment, the shaft ablation assembly 20 is also configured to map tissue 41 .

[0175] According to an alternative embodiment, the electrode tip 128 has an outer surface shaped to be atraumatic and resiliently biased into a rounded configuration.

[0176] According to alternative embodiments, the shaft electrode 127 and the electrode tip 128 include at least a monopolar electrode 113 and / or at least a bipolar electrode 114 .

[0177] According to an alternative embodiment, the distal ablation assembly 21 includes at least one thermocouple 37 .

[0178] According to an alternative embodiment, the shaft ablation assembly 20 includes at least one thermocouple 37 .

[0179] According to an alternative embodiment, the shaft electrodes 127 are five to ten electrodes fixedly attached to the shaft distal portion 17 .

[0180] According to an alternative embodiment, the electrode tip 128 is fixedly disposed at least at the distal end 19 of the shaft distal portion.

[0181] According to an alternative embodiment, the electrode tip 128 is removable from the distal end 19 of the shaft distal portion and interchangeable with a set of electrode tips 39 having tip electrodes of different shapes and sizes.

[0182] According to an alternative embodiment, the shaft electrodes 127 are spaced apart along the length of the shaft distal portion 17 in one of the following configurations:

[0183] 1-5 cm apart, and / or

[0184] 2-3cm apart, or

[0185] When a tensile force of 4000V is applied, the spacing is about 2-5mm, preferably 4mm; or

[0186] When a tensile force of 5000V is applied, the separation is about 6mm;

[0187] and / or

[0188] Each of the plurality of axial electrodes 127 includes an exposed length of up to 20-25 mm or 2-4 mm.

[0189] According to an alternative embodiment, each of the plurality of shaft electrodes 127 comprises approximately 0.05 cm 2To approximately 5cm 2 or about 1cm 2 To approximately 2cm 2 of electrode surface area.

[0190] According to an alternative embodiment, each of the plurality of shaft electrodes 127 is configured to deliver an electric field having at least one of the following electric field strength ranges to the target tissue: approximately 100 V / cm to approximately 7,000 V / cm; and / or approximately 200 V / cm to approximately 2000 V / cm; and / or approximately 300 V / cm to approximately 1000 V / cm; and / or approximately 2,000 V / cm to approximately 20,000 V / cm.

[0191] According to an alternative embodiment, the plurality of shaft electrodes 127 includes a distal shaft electrode 106 mounted on the shaft distal portion 17 2-4 mm from the shaft distal portion distal end 19 .

[0192] According to an alternative embodiment, the shaft electrode 127 is cylindrical.

[0193] According to an alternative embodiment, the shaft electrode 127 has a profile that is flush with the shaft surface.

[0194] According to an alternative embodiment, the shaft electrodes 127 present a shaft electrode outer diameter 36 and the shaft portion between the shaft electrodes 127 presents a shaft outer diameter 35 that is slightly smaller than the shaft electrode outer diameter 36, making the shaft distal end more flexible.

[0195] According to an alternative embodiment, the shaft electrode 127 is resiliently biased into a circular configuration.

[0196] According to an alternative embodiment, the shaft electrode 127 exhibits a tubular geometry with a wall thickness to outer diameter ratio approaching 1:15.

[0197] According to an alternative embodiment, the plurality of shaft electrodes 127 includes at least a bipolar electrode 114 including a small electrode 130 and a large electrode 131 , wherein the small electrode 130 is isolated from the large electrode 131 .

[0198] According to an alternative embodiment, at least one of the shaft electrodes 127 comprises at least two electrically conductive portions N electrically insulated from each other, wherein each electrically conductive portion N radially covers less than 180° around the shaft distal portion 17 .

[0199] According to an alternative embodiment, at least one of the shaft electrodes 127 comprises at least four electrically conductive portions N electrically insulated from one another, wherein each electrically conductive portion N radially covers less than 90° around the shaft distal portion 17 .

[0200] According to an alternative embodiment, the shaft distal portion distal end 19 is open and the sizing mandrel 26 is slidable outside the shaft distal portion distal end 19 from the mandrel fully inserted position to the mandrel maximum exposed position.

[0201] According to an alternative embodiment, the distal ablation assembly 21 is fixedly disposed at the mandrel distal portion 139 .

[0202] According to an alternative embodiment, the distal ablation assembly 21 includes a plurality of mandrel electrodes 132 , wherein the mandrel electrodes 132 are axially spaced apart along the mandrel distal portion 139 .

[0203] According to alternative embodiments, the mandrel electrode 132 includes at least a monopolar electrode 113 and / or at least a bipolar electrode 114 .

[0204] According to an alternative embodiment, the shaft electrode 127 is electrically connected to at least a portion of the plurality of mandrel electrodes 119 when the sizing mandrel 26 is in the fully inserted mandrel position.

[0205] According to an alternative embodiment, when the sizing mandrel 26 is in the mandrel maximum exposure position, the shaft electrode 127 is electrically disconnected from any power source.

[0206] According to an alternative embodiment, the non-thermal energy is irreversible electroporation energy or IRE and the thermal energy is radiofrequency energy or RF.

[0207] According to an alternative embodiment, the shaping mandrel 26 can be slid from a mandrel fully inserted position to a mandrel maximum exposed position outside the distal end 19 of the distal portion of the shaft. In the mandrel fully inserted position, the mandrel 26 is in the straight loading configuration, and in the mandrel maximum exposed position, the mandrel is in the pre-shaped configuration.

[0208] According to an alternative embodiment, the ablation assembly 100 comprises a single power source 4 .

[0209] The shaft ablation assembly 20 includes at least a plurality of electrodes 127, 113, or 114 fixedly disposed at the elongated shaft distal portion 17. All of the at least a plurality of electrodes 127, 113, or 114 are powered by the single power source 4 via an electrical signal S to deliver non-thermal energy for treating tissue 41 and thermal energy for ablating tissue 41.

[0210] The single power supply 4 continuously changes the electrical signal S when requested to power the at least plurality of electrodes 127, 113 or 114 to switch from delivering non-thermal energy to thermal energy, vice versa, or a combination of thermal and non-thermal energy simultaneously.

[0211] According to an alternative embodiment, said single power supply 4 comprises a single control unit 400 and a power supply unit 401 for generating said electrical signal S.

[0212] According to an alternative embodiment, the power supply unit 401 is electrically connected to all electrodes of the at least plurality of electrodes 127 , 113 or 114 .

[0213] According to an alternative embodiment, the power supply unit 401 is driven by a single control unit 400 to continuously change the electrical energy level associated with the signal S to be provided to the electrode 127, 113 or 114 to switch from delivering non-thermal energy to thermal energy, vice versa, or a combination of thermal and non-thermal energy simultaneously.

[0214] According to an alternative embodiment, the power supply unit 401 comprises a power supply module 402. The power supply module 402 comprises:

[0215] a driving circuit block 403 , controlled by the single control unit 400 , configured to generate the electrical signal S starting from the power supply voltage signal Vcc provided by the single control unit 400 ;

[0216] a selection block 404 selectively controlled by the driver circuit block 403 to continuously change the power level associated with the signal S;

[0217] Filtering and electrical insulation blocks 405 , 406 .

[0218] According to an alternative embodiment, the single control unit 400 includes a microprocessor 407 and a programmable logic controller block 409 configured to control a variable high voltage power supply block 408 .

[0219] The variable high-voltage power supply block 408 is configured to provide the power supply voltage signal Vcc to the power supply module 402 to generate the electrical signal S.

[0220] The programmable logic controller block 409 is configured to generate a driving signal to control the driving circuit block 403 of the power module 402 .

[0221] According to an alternative embodiment, the single control unit 400 further comprises:

[0222] a video interface and button block 410, 410', controlled by the microprocessor 407 to set parameters of the device 100 and to display selected parameters;

[0223] A watchdog block 411 is used to control the normal operation of the microprocessor 407;

[0224] The audio interface block 412 is configured to provide audio information indicating the correctness of the ablation process and / or any errors that occur.

[0225] According to an alternative embodiment, the power supply unit 401 comprises one or more power supply modules 402 that are identical to each other.

[0226] According to an alternative embodiment, at least one of the electrodes 127 , 113 is a monopolar electrode 113 , and the monopolar electrode 113 of the at least plurality of electrodes is electrically connected to only one power module 402 of the power supply unit 401 .

[0227] According to an alternative embodiment, at least two of the electrodes 127, 114 are electrically connected to form a bipolar electrode 114, and the bipolar electrodes 114 of the at least plurality of electrodes are respectively electrically connected to a corresponding power supply module 402 that can be selected from the power supply modules of the power supply unit 401. According to an alternative embodiment, the electrical signal S to be provided to the plurality of electrodes 127, 113, or 114 comprises a pulse train 204. According to an alternative embodiment, the single control unit 400 is configured to drive the power supply unit 401 to modify the pulse duration 203 of each pulse 201 in the pulse train 204 to change the electrical energy level associated with the signal S.

[0228] According to an alternative embodiment, the single control unit 400 is configured to drive the power supply unit 401 to modify the number of pulses 209 in the pulse train 204 in order to change the electrical energy level associated with the signal S.

[0229] According to an alternative embodiment, the single control unit 400 is configured to drive the power supply unit 401 to modify the time interval 205 between adjacent pulse trains 204 to change the electrical energy level associated with the signal S. According to an alternative embodiment, each monopolar electrode 113 of the at least plurality of electrodes is electrically connected to a corresponding power supply module 402 of the power supply unit 401 via a single wire 210 welded to the monopolar electrode 113 .

[0230] According to an alternative embodiment, each bipolar electrode 114 of the at least plurality of electrodes is electrically connected to two selected power modules 402 of the power supply unit 401 via two wires 210 welded to the bipolar electrode 114 .

[0231] According to an alternative embodiment, the electrical signal S to be provided to the plurality of electrodes 127, 113 or 114 comprises at least a square wave signal.

[0232] According to an alternative embodiment, the electrical signal S to be supplied to the plurality of electrodes 127, 113 or 114 comprises a signal obtained by combining or adding or superimposing two or more square wave signals to each other.

[0233] According to alternative embodiments, the electrical signal S to be provided to the plurality of electrodes 127, 113 or 114 comprises a DC signal, or an AC signal, or a combination of a DC signal and an AC signal.

[0234] According to an alternative embodiment, the single power source 4 is powered by batteries or connected to a standard wall socket capable of generating an alternating current (AC) grid of 110 volts or 240 volts.

[0235] According to an alternative embodiment, the at least two electrodes 127, 114 electrically connected to form the bipolar electrode 114 comprise:

[0236] a first electrode 114 a connected to the first power module 402 of the power supply unit 401 via a first lead 210 a , the first electrode 114 a having an electrode body 424 defining an internal compartment of the first electrode 114 a , the internal compartment being accessible from outside the first electrode 114 a ;

[0237] The second point-shaped electrode 114 b is connected to the second power module 402 of the power supply unit 401 through a second wire 210 b , and the second point-shaped electrode 114 b is accommodated in the inner compartment of the first electrode 114 a .

[0238] According to an alternative embodiment, a single control unit 400 is configured to drive the power supply unit 401 to generate a corresponding electrical signal S in each power supply module 402 to provide a plurality of electrical signals S to the electrode 127, 113 or 114,

[0239] The microprocessor 407 is configured to control each power supply module 402 through the programmable logic controller block 409 to modify the ON state, OFF state and phase angle of each electrical signal S of the multiple electrical signals, thereby generating a unipolar electric field between each electrode and the ground electrode 425 and a bipolar electric field between two adjacent electrodes by selecting two or more electrical signals S provided to the electrodes 127, 113 or 114.

[0240] The present invention also relates to a method for controlling at least a plurality of electrodes 127, 113 or 114 in an ablation assembly or device 100 comprising an ablation catheter 1 according to the aforementioned embodiments and a single power source 4. The method comprises:

[0241] generating, by the single power supply 4, an electrical signal S comprising a pulse train 204 for powering all of the at least plurality of electrodes 127, 113 or 114;

[0242] Modify the pulse duration 203 of each pulse 201 in the pulse train 204, or

[0243] Modify the number of pulses 209 in the pulse train 204, or

[0244] Modify the time interval 205 between adjacent pulse trains 204,

[0245] The at least a plurality of electrodes 127, 113 or 114 are induced to switch from delivering non-thermal energy to thermal energy, vice versa, or a combination of thermal and non-thermal energy simultaneously.

[0246] According to an alternative embodiment, each monopolar electrode 113 of the at least plurality of electrodes is electrically connected to a corresponding power module 402 of the power supply unit 401 via a single wire 210 welded to the monopolar electrode 113 .

[0247] According to an alternative embodiment, each bipolar electrode 114 of the at least plurality of electrodes is electrically connected to two selected power modules 402 of the power supply unit 401 via two wires 210 welded to the bipolar electrode 114 .

[0248] The present invention also relates to an ablation kit 200 .

[0249] The ablation kit 200 includes:

[0250] - at least the ablation device 100 according to any of the preceding embodiments;

[0251] - A set of shaping mandrels 134 .

[0252] The set of shaping mandrels 134 have different pre-forming configurations.

[0253] Alternatively, the set of shaping mandrels 134 are instead disposable and removable in the ablation catheter 1 .

[0254] According to an alternative embodiment, the set of shaping mandrels 134 comprises at least a first shaping mandrel 135 and a second shaping mandrel 136 .

[0255] The first forming mandrel 135 has a first pre-forming configuration and the second forming mandrel 136 has a second pre-forming configuration.

[0256] The first pre-shaped configuration is different from the second pre-shaped configuration, such that a different shape of the shaft distal portion 17 is performed depending on which shaping mandrel 135 , 136 of the set of setting mandrels 134 is provided in the ablation catheter 1 .

[0257] According to an alternative embodiment, at least one shaping mandrel of the set of shaping mandrels 134 has a circular pre-formed configuration.

[0258] According to an alternative embodiment, at least one shaping mandrel of the set of shaping mandrels 134 has a helical pre-formed configuration.

[0259] According to an alternative embodiment, at least one shaping mandrel of the set of shaping mandrels 134 has a straight pre-formed configuration.

[0260] According to an alternative embodiment, at least one shaping mandrel of the set of shaping mandrels 134 has a circular preformed configuration provided with an elbow.

[0261] The present invention also relates to an ablation catheter kit 300 .

[0262] The ablation catheter kit 300 includes at least a first ablation assembly 100 and a second ablation assembly 100 ′ according to any of the preceding embodiments.

[0263] The distal shaft portion 17 of the ablation catheter 1 of the first ablation assembly 100 can be deflected in at least two symmetrical geometric shapes.

[0264] The distal shaft portion 17 ′ of the ablation catheter 1 ′ of the second ablation assembly 100 ′ is deflectable in at least two asymmetric geometries.

[0265] The present invention also relates to a method for shaping an ablation catheter, comprising the following steps:

[0266] - providing an ablation assembly 100 according to any of the preceding embodiments,

[0267] - inserting the shaping mandrel 26 in the straight loading configuration into the inner lumen 118 of the ablation catheter 1,

[0268] - moving the shaping mandrel 26 within the lumen 118 towards the distal end 19 of the shaft distal portion until the shaping mandrel 26 is fully inserted into the shaft distal portion 17, and

[0269] When the shaping mandrel 26 is fully inserted into the shaft distal portion 17 , the shape of the shaft distal portion 17 is brought into conformity with the preformed configuration of the shaping mandrel 26 .

[0270] The present invention also relates to a multiple shaping method for an ablation catheter, comprising the following steps:

[0271] - providing an ablation kit 200 as previously described,

[0272] - inserting the first shaping mandrel 135 into the ablation catheter 1,

[0273] - conforming the distal shaft portion 17 of the elongated shaft 13 of the ablation catheter 1 to the shape of the first preformed configuration of the first shaping mandrel 135,

[0274] - removing the first shaping mandrel 135 from the elongated shaft 13 of the ablation catheter 1,

[0275] - inserting the second shaping mandrel 136 into the ablation catheter 1, and

[0276] - Conforming the shaft distal portion 17 to the shape of the second pre-formed configuration of the second shaping mandrel 136 .

[0277] The present invention also relates to a method for controlling at least a plurality of electrodes 127, 113 or 114 in an ablation device 100. The ablation device comprises an ablation catheter 1 according to any of the preceding embodiments and a single power source 4.

[0278] The method comprises the following steps:

[0279] generating, by the single power supply 4, an electrical signal S comprising a pulse train 204 for powering all of the at least plurality of electrodes 127, 113 or 114;

[0280] Modify the pulse duration 203 of each pulse 201 in the pulse train 204, or

[0281] Modify the number of pulses 209 in the pulse train 204, or

[0282] Modify the time interval 205 between adjacent pulse trains 204,

[0283] The at least a plurality of electrodes 127, 113 or 114 are induced to switch from delivering non-thermal energy to thermal energy, vice versa, or a combination of thermal and non-thermal energy simultaneously.

[0284] Thanks to the proposed solution, it is possible to provide a method for profiling an ablation catheter comprising the following steps:

[0285] - providing an ablation device 100 according to any one of the above embodiments,

[0286] - inserting the shaping mandrel 26 in the straight loading configuration into the inner lumen 118 of the ablation catheter 1,

[0287] - moving the shaping mandrel 26 within the lumen 118 towards the distal end 19 of the shaft distal portion until the shaping mandrel 26 is fully inserted into the shaft distal portion 17, and

[0288] When the shaping mandrel 26 is fully inserted into the shaft distal portion 17 , the shape of the shaft distal portion 17 is brought into conformity with the preformed configuration of the shaping mandrel 26 .

[0289] Thanks to the proposed solution, it is possible to provide a method for treating proximal, persistent or long-standing persistent atrial fibrillation in a patient, comprising the following steps:

[0290] - providing an ablation assembly 100 according to any of the above embodiments,

[0291] - placing the ablation catheter 1 in the patient's coronary sinus in order to map the electrogram and / or ablate tissue, and then;

[0292] - placing the ablation catheter 1 in the left or right atrium to take an electrogram and / or deliver energy for treating tissue 41 using at least the shaft ablation assembly 20, wherein the shaft distal portion 17 is formed into a pre-shaped configuration imposed by the shaping mandrel 26 fully inserted into the shaft distal portion 17,

[0293] - placing an ablation catheter in the left or right atrium to deliver energy for treating tissue using at least the shaft ablation assembly 20, wherein the shaft distal portion 17 is shaped into a pre-shaped configuration imposed by a shaping mandrel 26 fully inserted into the shaft distal portion 17,

[0294] Tissue locations include the fascia surrounding the pulmonary veins, and / or the left atrial roof, and / or the mitral valve isthmus.

[0295] Thanks to the proposed solution, it is possible to provide a method for treating atrial flutter in a patient, comprising the following steps:

[0296] - providing an ablation assembly 100 according to any of the above embodiments,

[0297] -Placing the ablation catheter 1 in one or more locations in the right atrium of the heart to achieve bidirectional blocking of energy for treating tissue 41 using at least the shaft ablation assembly 20, wherein the shaft distal portion 17 is formed into a pre-formed configuration imposed by a shaping mandrel 26 fully inserted into the shaft distal portion 17.

[0298] Thanks to the proposed solution, it is possible to provide a method for ablating tissue in the right atrium of the heart, comprising the following steps:

[0299] - providing an ablation assembly 100 according to any of the above embodiments,

[0300] - placing the ablation catheter 1 in one or more locations in the right and / or left atrium of the heart 43;

[0301] -By delivering energy for treating tissue using at least a shaft ablation assembly 20, wherein the shaft distal portion 17 is formed into a pre-shaped configuration imposed by a shaping mandrel 26 fully inserted into the shaft distal portion 17, creating a lesion between the superior vena cava and the inferior vena cava and / or the coronary sinus and the inferior vena cava and / or the superior vena cava and the coronary sinus.

[0302] Thanks to the proposed solution, it is possible to provide a method for treating sinus node tachycardia in a patient, comprising the following steps:

[0303] - providing an ablation assembly 100 according to any of the above embodiments,

[0304] - placing the ablation catheter 1 in one or more locations in the right and / or left atrium of the heart 43;

[0305] -By delivering energy for treating tissue using at least a shaft ablation assembly 20, wherein the shaft distal portion 17 is formed into a pre-shaped configuration imposed by a shaping mandrel 26 fully inserted into the shaft distal portion 17, electrogramming the sinoatrial node and / or mapping the sinoatrial node and / or ablating the sinoatrial node.

[0306] Thanks to the proposed solution, it is possible to provide a method for treating ventricular tachycardia in a patient, comprising the following steps:

[0307] - providing an ablation assembly 100 according to any of the above embodiments,

[0308] - placing the ablation catheter 1 in the left or right ventricle of the heart 43;

[0309] - Induction of ventricular tachycardia by delivery of pacing energy, and

[0310] ablating tissue to treat a patient by delivering energy for treating tissue using at least the shaft ablation assembly 20 , wherein the shaft distal portion 17 is shaped into a pre-shaped configuration imposed by a shaping mandrel 26 fully inserted into the shaft distal portion 17 .

[0311] Thanks to the proposed solution, it is possible to provide a method for ablating atrial tissue comprising the following steps:

[0312] - providing an ablation assembly 100 according to any of the above embodiments,

[0313] wherein when the shaping mandrel 26 is fully inserted into the elongated shaft 13, the shaft distal portion 17 comprises a first deflection geometry, and when the shaping mandrel 26 is removed from the shaft distal portion, the shaft distal portion 17 comprises a second deflection geometry 17, wherein the first deflection geometry is greater than the second deflection geometry;

[0314] - exposing the ablation catheter 1 to the atrial tissue with the shaft distal portion 17 in the second deflected geometry, wherein the shaping mandrel 26 is located outside the distal portion 17;

[0315] - ablation of one or more of the following tissue locations: the left atrial septum; tissue adjacent to the left atrial septum; and tissue adjacent to the posterior wall of the left atrium;

[0316] - placing the ablation catheter 1 with the shaft distal portion 17 in the first deflected geometry by fully inserting the shaping mandrel 26 into the elongated shaft 13,

[0317] - Ablate at least the circumference around the pulmonary veins.

[0318] The present invention also relates to the use of a kit according to any of the above-mentioned embodiments and to treating the left atrium and the right atrium of the heart, wherein the ablation catheter 1 of the ablation assembly 100 is used to ablate tissue in the right atrium using at least a first shaping core shaft 135, and the same ablation catheter 1 is also used to ablate tissue in the left atrium using at least a second shaping core shaft 136.

[0319] Reference will now be made in detail to the present embodiments of the invention, examples of which are illustrated in the accompanying drawings.

[0320] Configured for percutaneous access to the left atrium and left ventricle of the heart (through the septum via a transseptal sheath).

[0321] It can be advanced through a sheath previously placed in the LA (eg, a deflectable or fixed curing sheath).

[0322] The elongated catheter body 13, 207 may be steerable (one-way or two-way)

[0323] For example, a pull wire 25

[0324] For example, two pulling wires 25

[0325] For example, attached near the distal tip at _180° intervals

[0326] For example, attached near the distal tip at _90° intervals

[0327] For example, four pull wires 25

[0328] For example, attached near the distal tip at _90° intervals

[0329] Can be asymmetric steerable curves

[0330] For example, a spring can constrain the radius of a curve to a plane other than the opposite plane.

[0331] structure

[0332] PeBax

[0333] Braid, (SS flat wire braid, nylon strand braid, combination)

[0334] Preferably with a transition 126 from a more rigid proximal end to a less rigid distal end

[0335] First control axis (external)

[0336] Distal end attached to the distal end of a single atraumatic electrode tip

[0337] Distal end attached to the distal end of the split atraumatic electrode tip

[0338] Distal end attached to the distal end of the quartered atraumatic electrode tip

[0339] The distal end is preferably attached to an atraumatic tip electrode

[0340] The shaft preferably has a lumen for saline flushing

[0341] The shaft preferably has an inner cavity for insulation from the signal wires

[0342] The shaft preferably has side hole ports spaced 90° apart around the diameter at various locations on the distal portion.

[0343] Side hole port allows signal line to pass from inside to outside

[0344] Proximal end attached to handle

[0345] Alternative Design - The shaft can have 1 or more electrical (power / signal) wires 210 (connected to electrodes / thermocouples on a single wire segment)

[0346] Includes multiple electrodes along its length

[0347] Side port allows for saline flushing Holes present in the inner section of the control shaft lumen 118 - Below the electrode - Wire feed-through Cylindrical electrodes are mounted 2-4 mm from the distal tip and spaced 2-3 mm apart Second lumen 118 - Multipurpose (fluid flushing and styling mandrel)

[0348] Traveling within the first lumen from the proximal end to the distal end.

[0349] Attaches to the proximal end of the handle with ports for saline delivery and / or shaping mandrel

[0350] Attached to the control shaft near the distal electrode

[0351] The proximal end of the shaft is attached to the control on the handle

[0352] Preferably constructed to withstand high pressure fluid flow while being soft and flexible

[0353] No damage to the electrode tip

[0354] Elastically biased into rounded corner configuration

[0355] Includes at least one thermocouple

[0356] For example, thermocouples integrated with electrodes

[0357] Cylindrical shaft electrode

[0358] elastically biased in a circular configuration

[0359] Holes in segments - below electrodes - wire feed through holes

[0360] Includes at least one thermocouple

[0361] For example, thermocouples integrated with electrodes

[0362] electrode

[0363] structure

[0364] Platinum, Platinum / Iridium

[0365] Length>2mm

[0366] Length <4mm

[0367] Preferably includes a thermocouple

[0368] Copper wire and Constantine conductor

[0369] Welded to the inner part of the electrode

[0370] Alternative designs - electrodes can have fins, other heat sinks

[0371] handle

[0372] At the proximal end of the catheter body

[0373] Control rod (single) - connected to two pull wires for tip deflection

[0374] First sliding knob for asymmetric steering engagement

[0375] Attached to the first control axis

[0376] Attached to the second control axis

[0377] Preferably includes energy activation control

[0378] Instead have a single control axis

[0379] Attaches to the distal or proximal end of an atraumatic electrode tip.

[0380] According to an alternative embodiment, the present invention provides a catheter 1 or ablation assembly 100 for performing various target tissue ablations in a subject. According to an alternative embodiment, the catheter includes an elongated shaft 13 having a proximal end 15 and a distal end 16, and an inner cavity or internal chamber 118 preferably extending at least partially therebetween. The catheter is preferably of the type used to perform intracardiac procedures and is typically introduced from the femoral vein in the patient's leg or from a blood vessel in the patient's neck. The catheter is preferably introduceable through a transport tube (e.g., a transseptal sheath) and also preferably has a steerable tip that allows positioning of the distal portion 17, for example, when the distal end of the catheter is within a cardiac chamber. The catheter includes an ablation element 23 or tip ablation element 23 (tip electrode 128) located at the distal end of the shaft, and an ablation element 22 or shaft ablation element 22 (tube electrode or shaft electrode 127) located on or in the outer surface of the shaft near the distal end. The tip electrode 128 can be fixedly attached to the distal end of the shaft, or can be mounted on a propulsible and / or expandable carrier assembly. The carrier assembly can be attached to a control shaft that is coaxially disposed within the lumen of the shaft and slidably received therein. The carrier assembly can be deployed by activating one or more controls on the handle 103 of the catheter 1, for example, to cause one or more ablation elements to abut against cardiac tissue, typically atrial wall tissue or other endocardial tissue. The shaft can include a deflection member, such as a control operably connected to the handle of the catheter or a member through a central lumen in which a differently shaped mandrel 26 can be positioned to change the shape of the distal portion of the catheter. The deflection member can deflect the distal portion of the shaft in one or more directions, such as deflection having two symmetrical geometries, two asymmetrical geometries, or a combination thereof. The asymmetry can be caused by different radii of curvature, different lengths of curvature, different degrees of flatness, other different 2-D shapes, other different 3-D shapes, etc.

[0381] In particular, according to alternative embodiments, the present invention provides ablation catheters having multiple electrodes that provide electrical energy, such as radiofrequency (RF) and / or irreversible electroporation (IRE) that occurs when a strong pulsed electric field (PEF) causes cell membrane permeabilization, thereby leading to disruption of cellular homeostasis and cell death. Radiofrequency (RF) energy, in a single polar (monopolar), bipolar, or monopolar-bipolar combination manner, and methods for using these devices to treat conditions such as paroxysmal atrial fibrillation, chronic atrial fibrillation, atrial flutter, supraventricular tachycardia, atrial tachycardia, ventricular tachycardia, ventricular fibrillation, and the like.

[0382] The normal function of the heart depends on proper electrical pulse generation and transmission. In certain heart diseases (e.g., atrial fibrillation), proper generation and transmission are disrupted or otherwise abnormal. To prevent adverse conditions caused by improper pulse generation and transmission, the ablation catheter and RF generator of the present invention can be used.

[0383] One method currently used to treat arrhythmias is catheter ablation therapy. A physician uses a catheter to access an internal area of ​​the body. A catheter with an attached electrode array or other ablation device is used to create damage that destroys the electrical pathways in the heart tissue. In the treatment of arrhythmias, a specific area of ​​heart tissue (e.g., an atrial rotor) with an abnormal conduction pathway is initially located, which emits or conducts unstable electrical pulses. The user (e.g., a physician) guides the catheter through a major vein or artery into the internal area of ​​the heart to be treated. Next, an ablation element (or multiple ablation elements) is placed near the target heart tissue to be ablated. The physician guides energy provided by a source external to the patient from one or more ablation elements to ablate adjacent tissue and form damage. In general, the goal of catheter ablation therapy is to destroy the electrical pathways in the heart tissue to stop the emission and / or prevent the propagation of unstable electrical pulses, thereby curing the lesions of the disease. For the treatment of atrial fibrillation (AF), currently available methods and devices have only shown limited success and / or employ devices that are extremely difficult to use or impractical.

[0384] The ablation system of the present invention allows for the generation of lesions of appropriate size and shape to treat conditions involving disordered electrical conduction (e.g., AF). The ablation system of the present invention is also practical in terms of ease of use and limiting risks to the patient (e.g., while minimizing damage to non-target tissue while generating effective lesions) and significantly reducing procedure time. The present invention addresses this need by, for example, arranging one or more tip ablation elements and one or more shaft ablation elements that are configured to generate linear lesions in tissue (e.g., the endocardial surface of a cardiac chamber) by delivering energy to the tissue or otherwise. The electrodes of the present invention may include protruding fins or other heat dissipation surfaces to improve cooling performance. The distal portion of the catheter shaft of the present invention may be deflected in two or more symmetrical or asymmetrical geometries, such as asymmetric geometries having different radii of curvature or other geometric differences. The ablation catheter and RF generator of the present invention allow clinicians to treat patients with AF with procedures that are much shorter in duration than current AF ablation procedures. The lesions generated by the ablation catheter and RF generator of the present invention are suitable for suppressing the propagation of inappropriate electrical impulses in the heart to prevent reentrant arrhythmias while minimizing damage to non-target tissue, such as the patient's esophagus or phrenic nerve.

[0385] Referring to the accompanying drawings, one embodiment of an energy delivery system or ablation device or assembly 100 for selectively ablating tissue is illustrated. In one aspect, the system can include at least one energy delivery device or ablation catheter 1, such as, but not limited to, a monopolar probe 101, and at least one energy delivery source or power source or single power source 4. In one aspect, at least a portion of the probe can be configured for insertion into a patient. In one aspect, the at least one energy source or single power source 4 can also include at least a non-thermal energy source 6 and a thermal energy source 7. In one aspect, the system can include a mechanism or probe connector for coupling the probe to a desired energy source of the at least one energy source 8. In one aspect, although a monopolar probe is described herein, one of ordinary skill in the art will recognize that the energy delivery device used with the system described herein can be a different type of energy delivery device, such as, but not limited to, a bipolar probe 102. In one aspect, the probe can be selected from the group consisting of: a monopolar electrode 113, a bipolar electrode 114, and an electrode array 111, such as a shaft electrode 127, a mandrel electrode 132, and a tip electrode 128.

[0386] This can allow a given medical procedure to utilize the best energy delivery device. In one aspect, the monopolar probe 101 can include a handle 103, an electrode having a proximal end or electrode proximal end 104 and a distal end or electrode distal end 105, and at least one connector for the probe. In one aspect, the electrode can include at least one distal electrode 106 positioned at the distal end of the probe and a rounded electrode 107 positioned on the body of the probe, the body of the probe being positioned in the heart chamber. In one aspect, the tip can be a rounded conical shape and capable of sliding along the heart wall, and the probe is designed to allow sliding to match the movement of the heart wall.

[0387] In one aspect, at least one monopolar probe as described above can be used with the system. In another aspect, although not illustrated, at least two monopolar electrodes 113 as described above can be used with the system. In one exemplary embodiment, it is contemplated that if more than one electrode is used in the system, the probes can be used in various configurations and shapes, such as, but not limited to, parallel or spiral configurations. In one aspect, if two electrodes are used, it is contemplated that the distal electrode will be one, and each main electrode will be selected based on the desired ablation length. In another exemplary aspect, the electrodes can be positioned so that the distal tips are staggered in length compared to the main electrode. In one exemplary embodiment, if at least two electrodes are used in the system, the at least two electrodes can be spaced approximately 2-5 mm apart when mounted on a catheter body inserted into the ventricle and can provide a voltage of up to 4000V. In another exemplary embodiment, the at least two electrodes can be spaced approximately 6 mm or more apart to select alternate electrodes on the catheter body and can have a voltage of up to approximately 5000V. In one exemplary embodiment, the at least two electrodes can be spaced apart so that they are approximately 4 mm apart when inserted into the target tissue and can provide a voltage of up to approximately 4000V.

[0388] In one aspect, at least one electrode of the monopolar probe can be configured to be electrically coupled to and powered by an energy source. In addition, although not shown, one of ordinary skill in the art will recognize that at least one ground pad 108 can be used in conjunction with at least one electrode to complete the circuit 109. Although a single electrode configuration is described herein, it is contemplated that various other needle 110 and / or electrode array formations can be used in any of the embodiments described herein. An array here refers to an ordered arrangement 111 of multiple probes. In one aspect, this array can be a plurality or a series of monopolar and / or bipolar probes arranged in various shapes, configurations, or combinations to allow ablation of target areas of various shapes and sizes in tissue. By allowing multiple selectively activatable electrode patterns 112, the various array patterns can reduce the need to reposition the electrode array during treatment. In one aspect, the electrodes can have different sizes and shapes, such as, but not limited to, square, oval, rectangular, circular, or other shapes. In one aspect, the electrodes described herein can be made of various materials known in the art.

[0389] In one aspect, the electrodes described herein can be exposed up to various lengths. In one aspect, the electrodes can have an exposed length of up to about 20-25 mm when inserted into tissue, which can be a linear length or a circular length when at least two electrodes are spaced up to approximately 2-5 mm apart on the catheter body and distal tip. In another exemplary aspect, the electrodes can have an exposed electrode length of up to approximately 2-4 mm, for example when at least two electrodes are spaced approximately 2-5 mm apart. In yet another aspect, the electrodes can be spaced apart from each other by various distances. In one aspect, the electrodes can be spaced apart by a distance of about 0.5 cm to about 1 cm. In another exemplary embodiment, the electrodes can be spaced apart by a distance of about 1 cm to about 5 cm. In yet another embodiment, the electrodes can be spaced apart by a distance of between about 2 cm and about 3 cm. In one exemplary aspect, the electrode surface area can vary. In one exemplary embodiment, the electrode surface area can be from about 0.05 cm to about 1 cm. 2 Change to about 5cm 2 In yet another exemplary embodiment, the electrodes may have a width of approximately 1 cm 2 About 2cm 2 The surface area between.

[0390] In one aspect, the system can include components 11, 12 for selectively energizing a desired energy source to ablate at least a portion of tissue adjacent to at least one probe. In one aspect, the non-thermal energy source 6 of at least one energy source or a single power source 4 can be selectively energized to apply non-thermal energy to at least a portion of the desired tissue region to ablate at least a portion of the desired tissue region 45. Thus, in one aspect, the energy source can be configured to deliver non-thermal energy to the target tissue, such as, but not limited to, irreversible electroporation (IRE) energy. In an exemplary embodiment, the thermal energy source can be an RF energy source. In one aspect, although not shown, during use of the system, at least one electrode / probe can be selectively coupled to the non-thermal energy source, and the non-thermal energy source can be selectively energized to apply non-thermal energy from the non-thermal energy source to at least a portion of the desired tissue region to ablate at least a portion of the desired tissue region. In one exemplary aspect, at least one energy source can have at least one connector 8 configured for selective coupling to at least one electrode / probe. In one aspect, the energy source can have a positive connector 9 and a negative connector 10. More specifically, at least one connector of the electrode / probe may be connected to the energy source via at least one of a positive connector and a negative connector.

[0391] In one exemplary embodiment, the power source or energy source can be an Argá Model 100 electrosurgical generator capable of delivering up to 1000W of RF power. Those skilled in the art will recognize that a variety of generator models can be used with the systems described herein. In one aspect, the generator can be powered by a battery 5. In one aspect, the generator can be connected to a standard wall outlet capable of producing approximately 110V or approximately 240V. In one aspect, the power source can be manually adjusted depending on the voltage. In one exemplary embodiment, the generator can produce a minimum voltage of approximately 100V to approximately 4000V. In one aspect, at least one of the power outlet, generator, and battery source described herein can be used to provide voltage to the target tissue during treatment. In another exemplary embodiment, to achieve IRE ablation of a target region of tissue, the power source or generator can be used to deliver IRE energy to the target tissue, including target tissue that may be somewhat difficult to reach. In one aspect, exemplary embodiments of the IRE generator can include anywhere from two to ten positive and negative connectors, although those skilled in the art will appreciate that other numbers of positive and negative connectors, as well as different embodiments of the connectors, can be used and may be necessary for optimal ablation configuration. A system using a bipolar probe 102. In one aspect, the bipolar probe 102 can include a handle 103, electrodes having a proximal end 104 and a distal end 105, and at least one probe connector 9. In one aspect, the electrodes can include at least one electrode positioned at the distal end of the catheter and at the distal-most portion of the ablation element. In one aspect, the electrodes can also include a first electrode 115 positioned at the distal-most portion of the catheter, a second electrode 116 positioned proximal to the distal electrode, and at least one septum 117 positioned between and adjacent to at least a portion of each of the first and second electrodes, a third electrode, and so on. In one aspect, at least a portion of the distal portion of the second electrode can abut at least a proximal portion of the septum, and at least the distal portion of the septum can abut at least a portion of the proximal portion of the first electrode. In one aspect, similar to a monopolar probe, the bipolar probe can be coupled to a thermal energy source 8. During use of the system, the probe can be coupled to the energy source. More specifically, in one exemplary aspect, at least one connector of the probe 8 can be connected to the energy source via at least one of a positive connector 9 and a negative connector 10, as also described above.

[0392] Depending on various parameters, such as voltage (including application of DC or AC or both and voltage per square centimeter), current, number of pulses 209, pulse duration 203, and pauses between pulses applied to the tissue, or time interval 205 between adjacent pulses, the tissue can undergo reversible electroporation, irreversible electroporation, or thermal injury (generally considered resistive heating). Non-thermal IRE ablation involves ablation in which the primary method of cell destruction leading to death is mediated by electroporation (rather than factors such as heating effects or reactions to heating). In certain embodiments, depending on the parameters mentioned (including the time over which the resulting temperature occurs), cell death can be mediated by non-thermal IRE up to approximately >46°C. In certain embodiments, cell damage due to thermal heating occurs above approximately >46°C. In various embodiments, the parameters that lead to non-thermal IRE can be changed to cause cell death through thermal heating. Parameters can also be changed from parameters that have a non-thermal IRE effect to other settings, where the changed parameters also have a non-thermal IRE effect.

[0393] More specifically, in one aspect, the total number of pulses 209 and the pulse train 204 in various embodiments can vary based on the desired treatment outcome and the effectiveness of the treatment for a given tissue. During the delivery of non-thermal IRE energy to the target tissue, a voltage can be generated that is configured to successfully ablate the tissue. In one aspect, certain embodiments can involve pulses between about 1 μs and about 80,000 ms, while other embodiments can involve pulses between about 75 μs and about 20,000 ms. In yet another embodiment, the ablation pulses applied to the target tissue 47 can be between about 20 μs and 100 μs. In one aspect, at least one energy source can be configured to release at least one energy pulse lasting between about 100 μs and about 100 s and can be adjusted in intervals of 10 μs. In certain embodiments, the electrodes described herein can provide a voltage of about 100 volts / cm (V / cm) to about 7,000 V / cm to the target tissue. In other exemplary embodiments, the voltage can be from about 200 V / cm to about 2000 V / cm and from about 300 V / cm to about 1000 V / cm. Other exemplary embodiments can involve voltages from about 2,000 V / cm to about 20,000 V / cm. In one exemplary aspect, the bipolar probe 100 can be used at voltages up to about 2700 V.

[0394] In one aspect, the number of pulses 209 that can be used in IRE ablation can vary. In certain exemplary embodiments, the number of pulses 209 can be from about 1 pulse to about 25 pulses. In other exemplary embodiments, groups of about 1 pulse to about 25 pulses can be applied continuously with a time interval between each pulse group or pulse train. In one exemplary embodiment, the time interval between pulse groups can be about 0.05 seconds to about 2 seconds. In one aspect, the pulses can be delivered to the target tissue using an energy delivery device, such as, but not limited to, a probe, electrode, and other conductive material. In one aspect, such an energy delivery device can have different lengths suitable for procedures such as, but not limited to, percutaneous, laparoscopic, and open surgical procedures. In one aspect, at least one energy source can be configured to release at least one energy pulse lasting between about 5 μs and about 10 seconds. In one exemplary aspect, the voltages described herein can be applied to the target area of ​​tissue using a bipolar electrode 114 in pulses of 5 μs in length. In one aspect, the voltage can be applied in pulses of about 1 μs in groups or trains of 10 pulses, with a spacing between pulses of about 50 ms and a time between pulse trains of about 0.5 s.

[0395] In one exemplary aspect, at least two monopolar electrodes 113 can be used to ablate target tissue, thereby producing an ablated tissue zone of approximately 20-25 mm by 5-10 mm. In an exemplary embodiment, two single electrodes can be configured to involve other ablation zones, including but not limited to an ablation zone of approximately 30 mm by 25 mm. One of ordinary skill in the art will appreciate that the ablation size and shape can advantageously vary with the placement of the electrodes and the various electrode types. In one aspect, during treatment, an additional area surrounding the outer edge of the target area of ​​tissue is also ablated (ablation of unwanted or diseased tissue). This surrounding area of ​​tissue can be ablated to ensure patient safety and complete and sufficient ablation of the target area of ​​tissue. In one aspect, during the method of use, the catheter electrode tip 128 of the catheter is designed not to puncture the patient's tissue. Those of ordinary skill in the art will recognize that the target area of ​​tissue can be any tissue from any organ, wherein ablation can be used to ablate unwanted or diseased tissue, such as, but not limited to, cardiac tissue, digestive tract, bone, muscle tissue, nerves, endocrine, circulatory, reproductive, skin, lymphatic, urinary tissue or organs, or other soft tissues or organs in which selective ablation is desired. Soft tissue can include, but is not limited to, any tissue that surrounds, supports, or connects other body structures and / or organs. For example, soft tissue can include muscles, tendons, ligaments, fascia, joint capsules, and other tissues. More specifically, target tissue can include, but is not limited to, areas of the heart, prostate (including cancerous prostate tissue), kidney (including renal cells, cancerous tissue), and breast, lung, pancreas, uterus, and brain tissue.

[0396] On the one hand, the energy source can be a thermal energy source. On the one hand, a non-thermal energy source can be selectively energized for a desired time period. More specifically, the time period can be a predetermined time period. On the other hand, the time period can be multiple predetermined time periods. On the one hand, the thermal energy source is selected from the group consisting of: radio frequency (RF), focused ultrasound, microwaves, lasers, thermoelectric heating, traditional heating methods using DC or AC current through electrodes, and the application of heated fluids and cold therapies (such as cryosurgery). RF energy is known in the art to be effective for tumor ablation, but it is clear that any form of temperature-mediated continuous ablation can be used under settings known in the art. On the one hand, after the energy delivery device is inserted into the target organ 44, the tissue 43 is ablated and the energy delivery device is withdrawn. On the one hand, the thermal energy source 7 can be an AC thermal energy source. On the other hand, the thermal energy source 7 is a DC thermal energy source.

[0397] On the one hand, the electrode can start at a non-thermal ablation point in the target area. On the one hand, thermal ablation can start at the beginning of the electrode chain (lengthwise on the catheter), and in one embodiment, thermal ablation is applied to prevent conduction of surrounding tissue. When the energy delivery device or electrode is withdrawn, thermal energy can be applied to the target tissue through the electrode. On the one hand, the electrode is selectively energized to ablate tissue adjacent to the electrode track and close to the boundary of the ablated tissue by thermal energy or non-thermal energy.

[0398] In one aspect, IRE treatment of target tissue can be performed during a procedure such as, but not limited to, cardiac surgery, laparoscopic surgery, and open surgery, followed by thermal ablation of at least one tissue region. In one aspect, the ablation track can be ablated during repositioning or retraction of the electrode. In one aspect, the ablated region of tissue remains after IRE energy is delivered to the target tissue. In one aspect, the ablated region of tissue includes the target tissue region and surrounding regions of tissue. In one exemplary embodiment, after IRE treatment of the target tissue, treatment parameters can be reset to achieve thermal track ablation. In one aspect, after IRE treatment of the target tissue, the energy delivery device or electrode is repositioned. In one aspect, upon termination of energy delivery (and, in some cases, repositioning) by the energy delivery device, tissue is ablated at a different region / location, the tissue track is coagulated, and bleeding can be prevented. In one aspect, thermal energy, such as, but not limited to, RF energy, can be applied to the ablation track during the ablation cycle. In another aspect, a track ablation zone is created to stop bleeding. Preventing bleeding is important to prevent clot formation, particularly during procedures that may involve ablation of the left side of the heart.

[0399] In one aspect, a generator or single power source 4 used in a thermal ablation procedure can be configured with various ablation settings and capabilities. In one exemplary aspect, the Arga 1000 generator described above can be used as the RF energy source. In one aspect, the RF energy source can be used to ablate tissue using 10-100W of power. In other exemplary aspects, one of ordinary skill in the art will recognize that in various embodiments, lesser or greater amounts of power can be used as needed to provide ablation. In one exemplary embodiment utilizing a generator, the RF power source can provide AC power in addition to ablation, while the IRE power source can be used to provide DC power.

[0400] On the one hand, if a thermal energy source is used, it can be used together with a variety of technologies to achieve tissue ablation. In an exemplary aspect, additional embodiments may involve using one or more of the following to perform ablation: radio frequency (RF), focused ultrasound, microwaves, lasers, thermoelectric heating, traditional heating methods with electrodes using DC or AC current, and the application of heated fluids and cold therapies (such as, but not limited to, the therapy used in cryosurgery). On the one hand, in certain embodiments, thermal energy can be delivered in pulses that can be in the range of about 35 μs to about 10s. In other exemplary embodiments, at least one energy source can be configured to release or deliver at least one thermal energy pulse in the range of about 35 μs to about 1s. In another exemplary embodiment, at least one energy source can release or deliver at least one energy pulse, lasting between about 35 μs to about 1000 μs. In another exemplary embodiment, at least one pulse can be delivered in the range of about 1 μs to about 100 μs.

[0401] In one exemplary embodiment, thermal energy can be applied to produce temperature fluctuations for treatment. In one aspect, the thermal energy provided to the tissue can heat the target tissue to between approximately 46°C and approximately 70°C, thereby causing cell death. In one aspect, the temperature can be adjusted so that it is less than or greater than this temperature range, depending on the precise rate at which heat generated by the externally supplied fluid and / or blood is removed from the target tissue. In one embodiment, the temperature used is between approximately 50°C and approximately 100°C, although one of ordinary skill will recognize that temperatures above approximately 100°C can result in tissue vaporization. Ellis L, Curley S, Tanabe K; Radiofrequency Ablation for Cancer; Current Indications, Techniques, and Results, New York: Springer, 2004. In one exemplary embodiment, thermal energy can be used to ablate approximately 2-3 mm of tissue. In one aspect, this tissue thickness can vary depending on various factors, such as, but not limited to, the condition of the target tissue, the various parameters used, and the treatment options.

[0402] In one embodiment, the user sets the parameters for generating the IRE effect to produce a thermal result by thermal heating as resistive heating. In certain embodiments, the mechanisms are reset so that DC energy is applied to cause thermal ablation. In one exemplary embodiment, ablation can be performed using a DC current. In one aspect, the DC current can be used to heat the target tissue. In one aspect, at least one pulse of the DC current can be delivered in one direction. In another aspect, at least one pulse of the DC current can be delivered from the opposite direction of the circuit. In one aspect, the DC current can be applied such that the temperature of the tissue can be between about 42°C and about 75°C. In one aspect, the DC current can be applied such that thermal damage is induced at a temperature as low as about 42°C. In another aspect, as the probe withdrawal rate increases, the DC current can be applied to the target tissue such that the temperature can be increased from about 42°C to about 75°C. Davalos R / Mir L / Rubinsky B; Irreversible Electroporation Tissue Ablation; Annals of Biomedical Engineering; Vol. 33(2): 223-231 (2005).

[0403] One of ordinary skill in the art will recognize that DC pulses of various lengths can be applied to achieve effective trajectory ablation. In yet other embodiments, AC pulses can be applied as the energy delivery device is removed from the target tissue in stages. In summary, a method for selectively ablating tissue includes providing at least one energy source, such as a generator as described above. In one aspect, at least one energy source or single power source 4 can include at least a non-thermal energy source 6 and a thermal energy source 7, providing at least one probe or at least one ablation catheter 1, the at least one probe or at least one ablation catheter 1 being configured to be selectively manually operably coupled to a desired energy source of the at least one energy source, positioning at least a portion of the at least one electrode within a desired area of ​​the target tissue via an electrode. In one aspect, the selective coupling of the electrode to the thermal energy source includes actuating a switch 40 to operatively select between the non-thermal energy source 7 and the thermal energy source 8. The at least one probe is then selectively coupled to a non-thermal energy source, and the non-thermal energy source is selectively energized to apply non-thermal energy from the non-thermal energy source to at least a portion of the desired area to ablate at least a portion of the desired area, the at least one probe is selectively coupled to a thermal energy source, the at least one probe is withdrawn from the desired area, and the thermal energy source is selectively energized during at least a portion of the withdrawal of the at least one probe to apply thermal energy to ablate tissue substantially adjacent to the probe trajectory. In one aspect, the at least one probe is operably decoupled from the non-thermal energy source prior to selectively coupling the at least one probe to the thermal energy source.

[0404] In one aspect, the duration of a pulse can be longer than any of the other pulses, but the pulses mediate thermal heating via resistive heating. Furthermore, thermal heating can be achieved by varying the energy profile, such that the number of pulses is greater or lesser, the pulse lengths are varied, and the pause time between pulses is varied to accommodate the tissue being ablated and the bio-inductive feedback received from the system. It is also contemplated that one or both of the voltage and pulses can be varied to increase or decrease one or both (including the option to vary the time between pulses) to produce a thermal effect for trajectory ablation. In certain embodiments, variations in the pulses that result in an IRE effect and variations in the pulse or pulses that result in a thermal effect are used to produce both an IRE and a thermal effect on tissue within the target area where both effects are present. Furthermore, in certain embodiments, the order in which the pulses are applied and the switching of one or more pulses within the target area, within the tissue, or both, is most effective in treating the patient. Furthermore, one or more pulses or pulse trains can be used in conjunction with thermal heating methods (e.g., radiofrequency) such that non-thermal IRE effects, resistive heating effects caused by altered DC current, and thermal heating effects of AC current (e.g., RF) are applied in any order within the target tissue or tissue trajectory for the benefit of the patient. For example, mitral valve isthmus tissue can be treated with IRE or RF (or other AC and other DC pulses that cause resistive heating) or more than one of these in any order to ablate one or more target tissues and control bleeding or coagulation or ablation of blood vessels or cells, and then after the probe is removed, IRE or RF (or other AC and other DC pulses that cause resistive heating) pulses can be used together or separately in any order to control bleeding, coagulation or ablation of tissue, blood vessels, tumor cells, or to ablate or treat tissue surrounding the tissue, as needed. In some embodiments, changes between treatments or therapeutic methods can be achieved using a mechanism or device or system for changing or varying one or more parameters described herein via an energy source; the source can have one or more coupled generators, and the parameters can be determined using a system or mechanism of generators or energy sources, and the mechanism can have control components that allow the user to make changes directly from the probe or directly from the energy source.

[0405] References

[0406] Mali B, Jarm T, Snoj M, Sersa G, Miklavcic D. Antitumor effectiveness of electrochemotherapy: A systematic review and meta-analysis. Eur J SurgOncol. 2013; 39:4-16.

[0407] Heller R,Heller LC.Gene Electrotransfer Clinical Trials.AdvGenet.2015;89:235-62.

[0408] Component Symbol List

[0409] 1 Ablation catheter, or energy delivery system, or energy delivery device, or probe, or multi-electrode and multifunctional ablation catheter

[0410] 3 Systems for Selectively Ablating Tissue

[0411] 4 Single power source, or energy source, or energy source delivery source, or generator

[0412] 5 Battery-powered generator

[0413] 6 Non-thermal energy sources

[0414] 7. Thermal energy source, or AC thermal energy source, or DC thermal energy source

[0415] 8. A member for selectively coupling the probe to a desired one of at least one energy source, or a mechanism for coupling the probe to a desired energy source, or a probe connector

[0416] 9 Positive connector

[0417] 10 Negative connector

[0418] 11. Means for selectively energizing a non-thermal energy source

[0419] 12. Components for selectively energizing a thermal energy source

[0420] 13 Slender shaft

[0421] 14 Proximal portion of the slender shaft

[0422] 15 Proximal end of slender shaft

[0423] 16 Distal end of slender shaft

[0424] 17 Distal portion of the slender shaft

[0425] 18 Proximal end of the distal portion of the slender shaft

[0426] 19 Distal end of the distal portion of the slender shaft

[0427] 20-axis ablation assembly, or functional element fixedly mounted to the distal portion

[0428] 21 Distal ablation assembly, or tip ablation element, or tip, or mandrel with electrodes

[0429] 22-axis ablation element, or electrode, or single / multiple ablation elements

[0430] 23 Tip ablation element

[0431] 24 Deflection shape and geometry of the distal portion, or deflection geometry

[0432] 25 Steering guidewire (configured to deflect the distal portion in one or more deflection directions)

[0433] 26. A fixed mandrel, or deflection assembly (to maintain deflection in a single plane)

[0434] 27 Asymmetric joint (between two slender shaft sections)

[0435] 28 Overall components

[0436] 29 Variable braid, or steering wire

[0437] 30 Control port, or hole on the tip of the elongated shaft

[0438] 31 Single ablation element, or ablation element (for radiofrequency and irreversible electroporation), or electrode

[0439] 32 multiple ablation elements, or electrodes

[0440] 33. Shaping mandrel support assembly, or shaping mandrel, or deflection assembly, or mandrel

[0441] 34 Control shaft, or proximal portion of the mandrel

[0442] 35 shaft outer diameter

[0443] 36 Ablation electrode / ablation element outer diameter

[0444] 37 Thermocouple

[0445] 38 Heat dissipation components (e.g., increased surface area)

[0446] 39 A set of electrode tips

[0447] 40 Switch to operationally select between non-thermal energy source and thermal energy source

[0448] 41 Organization

[0449] 42 Ablation tissue

[0450] 43 Heart

[0451] 44 organs

[0452] 45 Ablation area or desired area

[0453] 100 Ablation components or devices

[0454] 101 Monopolar probe, or ablation catheter with a monopolar solution, or ablation catheter with a monopolar arrangement of at least one electrode

[0455] 102 Bipolar probe, or ablation catheter with bipolar arrangement of electrodes

[0456] 103 handle

[0457] 104 Electrode proximal end

[0458] 105 distal electrode

[0459] 106 distal electrodes

[0460] 107 rounded electrode

[0461] 108 grounding pad

[0462] 109 Circuit

[0463] 110 pins

[0464] 111 Electrode array, or an orderly arrangement of multiple probes

[0465] 112 A plurality of selectively activatable electrode patterns.

[0466] 113 Monopolar Electrode

[0467] 114 Bipolar Electrode

[0468] 115 First electrode or most distal portion electrode

[0469] 116 Second electrode or proximal electrode

[0470] 117 gasket

[0471] 118 Internal chambers (Second internal chamber - multi-purpose (fluid flushing and shaping mandrel))

[0472] 119 Spindle elastic body

[0473] 120 Catheter bend

[0474] 121 Mandrel Heating Element

[0475] 122 Spindle locking mechanism

[0476] 123 Holding element

[0477] 124 lock seat

[0478] 125 Ball Tip

[0479] 126 Shaft transition section

[0480] 127 axis electrode

[0481] 128 Electrode tip / non-damaging tip

[0482] 130 small electrode

[0483] 131 Large Electrode

[0484] 132 Mandrel Electrode

[0485] 134 A set of shaping mandrels

[0486] 135 First shaping mandrel

[0487] 136 Second shaping mandrel

[0488] 138 Proximal part of the mandrel

[0489] 139 distal portion of the mandrel

[0490] 140 spindle seat

[0491] 141 Inner cavity neck part

[0492] 142 Proximal extension of the wire

[0493] 143 Wire clamping part

[0494] 144 Steering device

[0495] 145 Steering device through hole

[0496] 200 Ablation Catheter Kit and Mandrel Set

[0497] 201 Pulse

[0498] 202 Pulse Amplitude

[0499] 203 Pulse duration

[0500] 204 pulse train

[0501] 205 Time interval between adjacent pulse trains

[0502] 206 Power-on time

[0503] 207 Catheter slender shaft flexible body = flexible body

[0504] 208 Body Blood Vessels

[0505] 209 Number of pulses

[0506] 210 wire

[0507] 300 Ablation Catheter Kit

[0508] 400 single control unit

[0509] 401 Power Supply Unit

[0510] 402 Power Module

[0511] 403 drive circuit block

[0512] 404 Select Block

[0513] 405 filter block

[0514] 406 Electrical Insulation Block

[0515] 407 Microprocessor

[0516] 408 variable high voltage power supply block

[0517] 409 Programmable Logic Controller Block

[0518] 410 Video Interface Block

[0519] 411 Watchdog Block

[0520] 412 Audio Interface Block

[0521] S electrical signal

[0522] VCC power supply voltage signal

[0523] Isolated conductive part of the N electrode

[0524] IRE irreversible electroporation

[0525] RF

[0526] XX Longitudinal main direction of slender axis

[0527] P-axis distal part plane

[0528] ALFA Sharp Angle

[0529] 410' button block

[0530] 114a first electrode

[0531] 424 electrode body

[0532] 114b Second dot electrode

[0533] 210a First conductor

[0534] 210b Second wire

[0535] 425 ground electrode

Claims

1. An ablation assembly (100) for treating a target area of ​​tissue (41) in an organ (44), comprising: - an ablation catheter (1) comprising an elongated shaft (13) having a longitudinal main direction (XX), said elongated shaft (13) comprising at least a shaft distal portion (17), said shaft distal portion (17) comprising a shaft distal portion distal end (19); The ablation catheter (1) includes an internal lumen (118) disposed within the elongated shaft (13); The ablation catheter (1) includes a shaft ablation assembly (20) fixedly disposed at the shaft distal portion (17), the shaft ablation assembly (20) being configured to deliver thermal energy for ablating the tissue (41) and non-thermal energy for treating the tissue (41); - at least a shaping mandrel (26), arranged in the ablation catheter (1), the shaping mandrel (26) being insertable into and removable from the inner cavity (118), wherein the shaping mandrel (26) is freely movable relative to the internal cavity (118) thereby avoiding any binding with the distal shaft portion (17) during insertion of the shaping mandrel, wherein the shaping mandrel (26) comprises at least a pre-formed configuration, and the shaping mandrel (26) is reversibly deformable between at least a straight-loaded configuration and the pre-formed configuration, Wherein, when the shaping mandrel (26) is fully inserted into the shaft distal portion (17), the shaping mandrel (26) is configured to shape the shaft distal portion (17) to have the pre-formed configuration.

2. An ablation assembly (100) for treating a target area of ​​tissue (41) in an organ (44), comprising: - an ablation catheter (1) comprising an elongated shaft (13) having a longitudinal main direction (XX), said elongated shaft (13) comprising at least a shaft distal portion (17), said shaft distal portion (17) comprising a shaft distal portion distal end (19); The ablation catheter (1) includes an internal lumen (118) disposed within the elongated shaft (13); The ablation catheter (1) includes a shaft ablation assembly (20) fixedly disposed at the shaft distal portion (17), the shaft ablation assembly (20) being configured to deliver thermal energy for ablating the tissue (41) and non-thermal energy for treating the tissue (41); - the assembly (100) comprises a distal ablation assembly (21) displaceable at least at a distal end (19) of the distal portion of the shaft, the distal ablation assembly (21) being configured to deliver thermal energy for ablating the tissue (41) and non-thermal energy (41) for treating the tissue, - at least a shaping mandrel (26), arranged in the ablation catheter (1), the shaping mandrel (26) being insertable into and removable from the inner cavity (118), wherein the shaping mandrel (26) is freely movable relative to the internal cavity (118) thereby avoiding any binding with the distal shaft portion (17) during insertion of the shaping mandrel, wherein the shaping mandrel (26) comprises at least a mandrel distal portion (139), wherein the distal ablation assembly is fixedly disposed at the mandrel distal portion (139), wherein the shaping mandrel (26) comprises at least a pre-shaped configuration, and the shaping mandrel (26) is reversibly deformable between at least a straight loading configuration and the pre-shaped configuration, wherein the shaping mandrel (26) is slidable outside the distal end (19) of the distal portion of the shaft from a fully inserted mandrel position to a maximum exposed mandrel position, wherein in the fully inserted position of the mandrel, the mandrel (26) is in the loaded straight configuration, wherein in the maximum exposed position of the mandrel, the mandrel is in the pre-forming configuration.

3. An ablation kit (200), comprising: - at least an ablation assembly (100) according to any one of the preceding claims; - a set of shaping mandrels (134); wherein the set of shaping mandrels (134) have different pre-forming configurations, The set of shaping mandrels (134) in the ablation catheter (1) is alternatively disposable and removable.

4. An ablation catheter kit (300), comprising: - at least a first ablation assembly (100) and a second ablation assembly (100') according to any of the preceding claims 1 to 31, wherein the distal portion (17) of the ablation catheter (1) of the first ablation assembly (100) is deflectable in at least two symmetrical geometric shapes, and The distal portion (17') of the ablation catheter (1') of the second ablation assembly (100) is deflectable in at least two asymmetric geometric shapes.

5. A method for shaping an ablation catheter, comprising the following steps: - providing an ablation assembly (100) according to any one of claims 1 to 30, - inserting the shaping mandrel (26) in the loaded straight configuration into the inner lumen (118) of the ablation catheter (1), - moving the shaping mandrel (26) within the internal cavity (118) towards the distal end (19) of the distal shaft portion until the shaping mandrel (26) is fully inserted into the distal shaft portion (17), and - When the shaping mandrel (26) is fully inserted into the shaft distal portion (17), the shape of the shaft distal portion (17) is made to conform to the preformed configuration of the shaping mandrel (26).

6. A method for multiple shaping of an ablation catheter, comprising the following steps: - providing an ablation kit (200) according to claim 33, - inserting the first shaping mandrel (135) into the ablation catheter (1), - conforming the distal shaft portion (17) of the elongated shaft (13) of the ablation catheter (1) to the shape of the first preformed configuration of the first shaping mandrel (135), - removing the first shaping mandrel (135) from the elongated shaft (13) of the ablation catheter (1), - inserting the second shaping mandrel (136) into the ablation catheter (1), and - conforming said shaft distal portion (17) to the shape of said second pre-formed configuration of said second shaping mandrel (136).

7. A method for treating proximal, persistent or long-standing persistent atrial fibrillation in a patient, comprising the steps of: - providing an ablation assembly (100) according to any one of claims 1 to 31, - placing the ablation catheter (1) in the coronary sinus of the patient to deliver energy for treating tissue using at least a shaft ablation assembly (20), wherein the shaft distal portion (17) is shaped into a preformed configuration imposed by the shaping mandrel (26) fully inserted into the shaft distal portion (17), followed by - placing the ablation catheter in the left atrium or the right atrium to deliver energy for treating tissue using at least the shaft ablation assembly (20), wherein the shaft distal portion (17) is shaped into a pre-shaped configuration imposed by the shaping mandrel (26) fully inserted into the shaft distal portion (17), The tissue locations include the fascia surrounding the pulmonary veins, and / or the left atrial roof, and / or the mitral valve isthmus.

8. A method for treating atrial flutter in a patient, comprising the steps of: - providing an ablation assembly (100) according to any one of claims 1 to 31, -Placing the ablation catheter (1) in one or more locations in the right atrium of the heart to achieve bidirectional blocking of energy delivery for treating tissue using at least the shaft ablation assembly (20), wherein the shaft distal portion (17) is formed into a pre-formed configuration imposed by the shaping mandrel (26) fully inserted into the shaft distal portion (17).

9. A method of ablating tissue in the right atrium of a heart, comprising the steps of: - providing an ablation assembly (100) according to any one of claims 1 to 31; - placing the ablation catheter (1) in one or more locations of the right (and / or left) atrium of the heart (43); - creating a lesion between the superior and inferior vena cava and / or coronary sinus and the inferior vena cava and / or the superior vena cava and coronary sinus by delivering energy for treating tissue using at least a shaft ablation assembly (20), wherein the shaft distal portion (17) is shaped into a pre-shaped configuration imposed by the shaping mandrel (26) fully inserted into the shaft distal portion (17).

10. A method for treating sinus node tachycardia in a patient, comprising the steps of: - providing an ablation assembly (100) according to any one of claims 1 to 30; - placing the ablation catheter (1) in one or more locations of the right (and / or left) atrium of the heart (43); - ablating the sinoatrial node by delivering energy for treating tissue using at least a shaft ablation assembly (20), wherein the shaft distal portion (17) is shaped into a pre-shaped configuration imposed by the shaping mandrel (26) fully inserted into the shaft distal portion (17).

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