Ablation assembly for treating a target region of tissue in an organ

Abstract

The present invention relates to an ablation assembly (100) for treating a target region of tissue (41) in an organ (44), comprising: an ablation catheter (1) including an elongate shaft (13) having a longitudinal main direction (X-X), the elongate shaft (13) including at least a distal portion (17) of the shaft, the distal portion (17) of the shaft including a distal end (19) of the distal portion of the shaft; the ablation catheter (1) including an internal lumen (118) disposed within the elongate shaft (13); the ablation catheter (1) including a shaft ablation assembly (20) fixedly disposed at the distal portion (17) of the shaft, 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) disposed within the ablation catheter (1), the shaping mandrel (26) being insertable into and removable from the internal lumen (118), wherein the shaping mandrel (26) is freely movable relative to the internal lumen (118) so as to avoid any constraint with the distal portion (17) of the shaft during insertion of the shaping mandrel, wherein the shaping mandrel (26) includes at least a preformed configuration, and the shaping mandrel (26) is reversibly deformable between at least a straight loading configuration and the preformed configuration, wherein when the shaping mandrel (26) is fully inserted into the distal portion (17) of the shaft, the shaping mandrel (26) is configured to shape the distal portion (17) of the shaft to have the preformed configuration.

Description

Technical Field

[0001] The present invention relates to an ablation device or component for a target region of tissue in an organ system and a method for treating a target region of tissue in an organ.

[0002] More particularly, the present invention relates to a combined system and method for non-thermal treatment of target tissue and thermal ablation of 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 in which it is considered necessary to block refractory wavefronts to stop or prevent irregular arrhythmias in the patient.

[0003] The present invention generally relates to an ablation system and method for performing target tissue ablation in a patient. In particular, the present invention provides a catheter for delivering radiofrequency (RF) and / or irreversible electroporation (IRE), where the radiofrequency (RF) and / or irreversible electroporation (IRE) occurs when a strong pulsed electric field (PEF) causes cell membrane permeabilization, resulting in disruption of cellular homeostasis and cell death. The irreversible electroporation (IRE) energy creates a safe and precise lesion in the target tissue, such as a lesion that causes arrhythmias. Background Art

[0004] The use of PEF in cardiology is very extensive, including atrial fibrillation, ventricular fibrillation, septal ablation, and targeting vascular structures. PEF has attractive properties, including tissue specificity and non-thermal capabilities. The present invention provides a novel catheter design for delivering IRE / PEF to cardiac tissue.

[0005] Pulsed electric field (PEF) refers to the application of intermittent high-intensity electric fields over a short period (microseconds or nanoseconds), which results in electroporation of cells and tissues. Electroporation is the process by which the applied electric field (i.e., PEF) causes the formation of pores in the cell membrane. The formation of pores leads to permeabilization, which can be reversible or irreversible depending on the parameters of the applied PEF. In reversible electroporation, the 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 effects of electrochemotherapy: systematic review and meta-analysis"; Annals of Surgical Oncology; 2013; 39:4-16; 2) Heller R, Heller LC; "Clinical trials of gene electrotransfer"; Advanced Gene; 2015; 89:235-62; 3) Neumann E, Schaefer-Ridder M, Wang Y, Hofschneider P; "Gene transfer into mouse lymphoma cells by electroporation in high electric fields"; EMBO J. 1982; 1:841-5.

[0006] Electroporation is the phenomenon in which PEF (generated by a high-voltage current) is applied to cells, causing the formation of pores in the cell membrane and subsequent increased cell permeability. The electric field is most commonly generated by high-voltage direct current delivered between two or more electrodes. When the electric field is applied, charges are created across the lipid bilayer, and once a critical threshold (depending on the transmembrane voltage) is reached, electroporation occurs. In contrast, through irreversible electroporation (IRE), cells and tissues cannot survive due to the activation of the programmed cell death cascade. IRE is a well-established method for treating solid tumors. However, given the limitations of current heat-based methods, PEF may also be useful in cardiology, particularly for cardiac ablation. PEF can create lesions without tissue heating and has cell / tissue selectivity, enabling the preservation of critical surrounding structures.

[0007] 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 may also involve modifying tissue without removal, such as stopping electrical function in specific regions of the electrical conduction chain of cardiac tissue in patients with arrhythmias. Ablation can be performed by passing energy (such as 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).

[0008] The functions of mammalian organs usually occur when the SA node (the heart pacemaker) spontaneously generates electrical activity. This electrical impulse spreads throughout the right atrium and reaches the left atrium through Bachmann's bundle, stimulating the atrial myocardium to contract. The conduction system consists of specialized myocardial cells. Cardiac myocardial cells have a negative membrane potential at rest. A stimulus above the threshold causes the opening of voltage-gated ion channels and the influx of a large number of cations into the cell. The positively charged ions entering the cell cause the depolarization characteristic of the action potential. Similar to skeletal muscle, depolarization causes the opening of voltage-gated calcium channels and the release of Ca2+ from the t-tubules. This influx of calcium leads to calcium-induced calcium release from the sarcoplasmic reticulum, and the free Ca2+ causes muscle contraction. After a delay, potassium channels reopen, and the resulting K+ efflux from the cell causes repolarization to the resting state. This electrical impulse transmission propagates through the heart chambers. Interference with this electrical transmission can lead to organ dysfunction. A specific area where electrical impulse transmission is crucial for the normal function of the organ is the heart, resulting in atrial contraction, which in turn causes blood to be pumped into the ventricles in a manner synchronous with the impulse.

[0009] Atrial fibrillation (AF) is an arrhythmia in which there is disordered electrical conduction in the atria, leading to rapid and uncoordinated atrial contractions, which in turn result in the inability to effectively pump blood into the ventricles and a lack of synchrony. During AF, the atrioventricular node receives electrical impulses from multiple locations throughout the atria, not just from the sinoatrial node. These abnormal signals overwhelm the atrioventricular node, producing an irregular and rapid heartbeat. As a result, blood may pool in the atria, increasing the likelihood of thrombus formation. The main risk factors for AF include age, coronary artery disease, rheumatic heart disease, hypertension, diabetes, and thyrotoxicosis. AF affects 7% of the population over 65 years old.

[0010] The treatment options for atrial fibrillation are limited. Lifestyle changes can only help those with lifestyle-related AF. Drug therapy can control the symptoms of AF, usually with side effects that are more dangerous than AF and cannot cure AF. Electrical cardioversion attempts to restore normal sinus rhythm, but due to disease progression, the recurrence rate of AF is very high. In addition, if there is a blood clot in the atrium, cardioversion may cause the blood clot to leave the heart and enter the brain (causing a stroke) or some other part of the body. What is needed is a new method for treating AF and other medical conditions involving electrical conduction disorders.

[0011] Various ablation techniques have been proposed to treat AF, including the Cox-Maze ablation procedure, linear ablation of various regions 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 pulmonary vein ostia ablation has been proven ineffective in the long term. All ablation procedures carry the risk of inadvertently damaging non-target tissues (such as the esophagus) when ablating the left atrial tissue of the heart.

[0012] Therefore, improved atrial ablation products and techniques for creating effective lesions in a safe manner are needed.

[0013] Solutions can be found in the following documents: US8641704B2, US8475449B2, US2010152725A1, US2010152725A1, US8948865B2, US2008281314A1, US8540710B2, US2019038171A1, US8221411B2, US2016051324A1, US2015327994A1, WO2017192804A1, US2020229866A1, WO2019023280A1.

[0014] 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 ablate a target area of cardiac tissue by applying energy (such as thermal energy, non-thermal energy, and energy associated with cryoablation procedures). Inserting the energy delivery device into the heart cavity or other organ is accomplished through an elongate tract, which is typically formed by a point below the heart. The elongate tract or access tube is defined as the space created by inserting a device that extends from a skin puncture point to the target tissue. When the energy delivery device is removed, it is pulled back along the elongate tract or access tube that was previously formed to allow insertion of the energy delivery device.

[0015] Before the delivery device is withdrawn, the tissue adjacent to the energy delivery device is ablated. This can create a lesion zone around the ablation element, thereby maximizing the chance of death at the desired tissue location. It is known in the art that when an energy delivery device is placed on the tissue surface, electrically induced thermal ablation such as RF can be used to effectively and continuously locally ablate tissue sites. RF can cause coagulative necrosis at the margins surrounding normal tissue, where high temperature conditions lead to cell damage, such as the coagulation of cytosolic enzymes and damage to histone complexes, ultimately resulting in cell death. Although these tissue treatment methods and systems can effectively ablate large amounts of target tissue, each technique has limitations. A frequently mentioned problem with using these procedures during cardiac ablation involves heat dissipation, which on the one hand can include blood flow, and the heat generated on the ablation element will be removed / dissipated by the cooler blood flow on the element. This heat dissipation effect can change the shape and maximum volume of the tissue being ablated. After treating the target tissue area with the energy delivery device, once the energy delivery device is removed from the target tissue area, the energy delivery device can be placed in a new, unablated site that needs treatment.

[0016] Recently, irreversible electroporation (IRE) has been used as an alternative to the above procedures for ablating cardiac or organ tissue. However, although IRE may be a non-thermal method of causing cell death, it is not ideal for coagulation, particularly not causing electrothermal coagulation, which indicates the importance of using an alternative source (such as RF or long DC pulses) when heating tissue sites. Instead, IRE involves applying electrical pulses to the target tissue in the microsecond to millisecond range, which may result in non-thermally generated nanoscale defects in the cell membrane. These defects lead to disruption of the cell membrane homeostasis, resulting in irreversible cell membrane permeabilization and thus inducing cell necrosis without increasing the temperature of the tissue ablation zone. During IRE ablation, connective tissue and scaffold structures are preserved, thus keeping the surrounding organs, structures, blood vessels, and connective tissue intact. In the case of using non-thermal IRE (also referred to hereinafter as non-thermal IRE), cell death is mediated by non-thermal mechanisms, and thus the heat dissipation problems associated with many ablation techniques are eliminated. Therefore, the advantage of IRE is that it allows for focused treatment while preserving tissue and without thermal effects, and can be effectively combined with heat treatments such as RF that have been shown to be effective in preventing bleeding at the ablation site; this will also allow (in this exemplary embodiment) the user to utilize a determined RF level, which may result in ablation in some cases and coagulation in some cases; 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 damage techniques, with the additional advantage of the option to combine RF or not combine RF.

[0017] Despite the obvious advantages of IRE, there are also advantages to using thermal ablation during treatment. Prior to the disclosure of the present invention, no invention has been proposed that can address the problem of non-thermal ablation of a target region of cardiac or organ tissue while maintaining the integrity of the surrounding tissue and effectively switching to a device for effectively thermally ablating tissue along the ablation track. In some proposed embodiments, an energy delivery device powered by a single energy source can be used, the energy delivery device being capable of applying energy in various forms and subsequently using the same energy delivery device to ablate a tissue track during a medical procedure for treating arrhythmia, the same energy delivery device being powered by different forms of energy from the same energy source to maximize the surgical outcome. As noted, IRE provides advantages for non-thermal cell death, while thermal mechanisms provide advantages not only for preventing bleeding but also for effectively causing coagulation. There is a need for systems and methods that can provide this combination of 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.

[0018] Nonetheless, there is still a strong felt need to simplify the organization, especially the cardiac tissue, to speed up treatment and shorten the intervention time.

[0019] Solution

[0020] The present invention provides a novel assembly or device and method for delivering non-thermal energy and thermal energy to cardiac tissue.

[0021] There is provided a unique multi-electrode and multi-functional ablation catheter and ablation catheter system, or ablation assembly or device 100, and a method of mapping and ablating myocardial tissue within a patient's heart chamber. Any electrogram signal site (e.g., a site with abnormal signals) or a combination of multiple sites found by this placement can be ablated. In alternative embodiments, the ablation catheter and system can be used to treat non-cardiac patient tissues, such as tumor tissues, renal artery nerves, etc.

[0022] According to an alternative embodiment, there is provided a probe, such as an ablation catheter 1 for performing a medical procedure on a patient. The ablation catheter 1 includes an elongate shaft 13 having a proximal portion 14 and a distal portion 17, the proximal portion 14 including a proximal end 15 and a distal end 16, and the distal portion 17 having a proximal end 18 and a distal end 19. The elongate shaft 13 further 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 adjacent to 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.

[0023] According to an alternative embodiment, the distal portion 17 is configured in a circular configuration and can be deflected in one or more directions in one or more deflection shapes and geometries 24. The deflection geometries 24 can be similar or symmetric deflection geometries, or the deflection geometries can be different or asymmetric 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 elongate shaft 13 can include a difference in shaft stiffness along its length. The elongate shaft 13 can include a shaping mandrel 26 or ablation catheter 1 within the shaft, the shaping mandrel 26 being configured to perform or enhance the deflection (steering and shaping) of the distal portion 17, such as to maintain deflection in a single plane. The shaft or ablation catheter can include variable material properties, such as an asymmetric joint 27 between two sections, an integral component 28 within the wall or fixedly attached to the shaft, a variable braid 29, or other variations for producing multiple deflections, such as a deflection with an asymmetric deflection geometry.

[0024] According to an alternative embodiment, 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, for example through a 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 electrode tip 128, or multiple ablation elements 32, or a mandrel electrode 132. The distal ablation assembly 21 can include a shaping mandrel carrier assembly 33 for the ablation elements, or simply a shaping mandrel 26, and the shaping mandrel carrier assembly 33 can change from a compact geometry to an expanded geometry, this transition being caused by the advancement and / or retraction of the control shaft.

[0025] According to an alternative embodiment, the shaft ablation assembly 20 can include a single ablation element 31 or multiple ablation elements 32 or a shaft electrode 127, preferably five to ten ablation elements fixedly attached to the shaft or shaping mandrel. The ablation elements can have a profile flush with the surface of the shaft, or more preferably, the shaft between the outer diameter 35 of the electrode element or the outer diameter 35 of the shaft is slightly smaller than the diameter of the ablation electrode 36 or the outer diameter of the shaft electrode 36, such that the distal end of the catheter is more flexible.

[0026] 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 elements 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 elements can include a heat dissipation member 38, such as an increased surface area. According to alternative embodiments, one or more ablation elements are configured in a tubular geometry, and the ratio of the wall thickness to the outer diameter is close to 1:15. According to alternative embodiments, one or more ablation elements are configured to record or map the electrical activity in tissue, such as mapping an electrocardiogram. According to alternative embodiments, one or more ablation elements are configured to deliver pacing energy, such as energy for pacing a patient's heart.

[0027] According to alternative embodiments, the ablation catheter of the present invention can be used to treat one or more medical conditions by delivering ablation energy to tissue. The conditions include arrhythmias, cancer, and other conditions that can improve a patient's health by removing or denaturing tissue.

[0028] According to alternative embodiments, a set of ablation catheters or an ablation catheter kit 300 is provided. The first ablation catheter 1 has a distal portion that can be deflected in at least two symmetric geometries. The second ablation catheter 1' has a distal portion that can be deflected in at least two asymmetric geometries.

[0029] According to alternative embodiments, 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 a patient's coronary sinus, such as to map an electrocardiogram and / or ablate tissue, and then placed in the left atrium or right atrium to map an electrocardiogram and / or ablate tissue. The ablation catheter can be placed to ablate one or more tissue locations, including but not limited to: the fascia around the pulmonary veins; the left atrial roof and the mitral isthmus.

[0030] According to alternative embodiments, a method for treating atrial flutter is provided. The ablation catheter of the present invention can be used to achieve bidirectional block, such as by placing it in one or more locations in the right atrium of the heart 43.

[0031] According to alternative embodiments, a method for ablating tissue in the right atrium of the heart is provided. The ablation catheter of the present invention can be used to create lesions between: the superior vena cava and the inferior vena cava; the coronary sinus and the inferior vena cava; the superior vena cava and the coronary sinus; and combinations thereof. The catheter can be used to map an electrocardiogram and / or map and / or ablate the sinoatrial node, such as for treating sinoatrial node tachycardia.

[0032] 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 ventricle or the right ventricle of the heart to treat a patient by delivering pacing energy and ablating tissue to induce ventricular tachycardia.

[0033] According to an alternative embodiment, an ablation catheter having a first geometry greater than a second deflection geometry is provided by a shaping mandrel. The ablation catheter is placed in a smaller second shape geometry to ablate one or more of the following tissue locations: the left atrial septum; tissue near the left atrial septum; and tissue near the posterior wall of the left atrium. The ablation catheter is placed in the larger first geometry to ablate at least the circumference around the pulmonary vein.

[0034] 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 shaping mandrel and / or deflection geometry and a second shaping 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.

[0035] 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 elongate shaft having a proximal portion and a distal portion, the proximal portion including a proximal end and a distal end, and the distal portion having a proximal end and a distal end. The catheter further includes a shaping mandrel and / or a deflection assembly configured to shape the distal portion in a first geometry along a first direction and in a second geometry along a second direction, wherein the first geometry is different from the second geometry. The catheter further includes a functional element fixedly mounted to the distal portion.

[0036] According to an alternative embodiment, a combined treatment system has at least one energy delivery device or ablation catheter 1, and at least one power source or energy 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 a target area of tissue and tissue along a trajectory.

[0037] According to an alternative embodiment, a method is provided that involves using non-thermal IRE energy and thermal energy to effectively ablate a target region of tissue. The method includes positioning at least one energy delivery device coupled to a single power source within the target region of the tissue, applying IRE energy from the power source to the energy delivery device for ablating the target region of the 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 ablation of diseased tissue and safe energy delivery during a treatment procedure, and in addition, coagulating the tissue and preventing bleeding simultaneously.

[0038] According to an alternative embodiment, described herein is a system and method for selectively ablating tissue 3, the system 3 including an ablation catheter 1 and a single power source 4.

[0039] According to an alternative embodiment, the method involves providing application of IRE to ablate and / or treat tissue and treating the tissue with an alternative energy form (such as thermal energy) to effectively ablate the tissue from the same ablation device and the same energy source. The method can include providing at least one energy source or a 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 through 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 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 track.

[0040] According to an alternative embodiment, provided herein is a system for selectively ablating tissue 3, the system having at least one energy source or a single power source 4, the at least one energy source or single power source 4 having a non-thermal energy source 6 and a thermal energy source 7, at least one probe, or ablation catheter 1, means for selectively coupling the probe 8 to a desired energy source of the at least one energy source, means 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 region to ablate at least a portion of the desired region, and means for selectively energizing the thermal energy source 12 of the at least one energy source during withdrawal of at least one probe to thermally ablate tissue substantially adjacent to the probe track.

[0041] Accordingly, it is an object of the present invention to provide an ablation assembly having structural and functional features, such as meeting the above needs and overcoming the deficiencies of the above prior art devices.

[0042] These and other objects are achieved by the device according to claim 1.

[0043] Some advantageous embodiments are the subject of the dependent claims.

[0044] Drawings

[0045] Further features and advantages of the present 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 elongate shaft and a shaped mandrel disposed within the ablation catheter;

[0047] - Figure 2 is Figure 1 details of the ablation assembly of

[0048] - Figure 3 is Figure 1 details of the ablation assembly of

[0049] - Figure 4 shows an ablation assembly according to the present invention, with the elongate shaft and steering device omitted to show the shaped mandrel partially inserted into the handle, wherein the shaped mandrel has a curved preformed configuration;

[0050] - Figure 5 is Figure 4 details of the shaped mandrel of

[0051] - Figure 6 shows an ablation assembly according to the present invention, with the elongate shaft and steering device omitted to show the shaped mandrel partially inserted into the handle, wherein the shaped mandrel has a helically curved preformed configuration;

[0052] - Figure 7 is Figure 6 details of the shaped mandrel of

[0053] - Figures 8 to 13 shows different preformed configurations of the shaped mandrel and ablation assembly of the present invention;

[0054] - Figures 14 to 15 shows in Figure 1The insertion sequence of a shaped mandrel in a straight loading configuration within the elongate axis of an ablation catheter, wherein the shaped mandrel slides into a steering device connectable to the handle of the ablation catheter;

[0055] - Figure 16 is a partial perspective view of an ablation assembly according to the present invention, wherein the Figure 14 and Figure 15 steering device and elongate shaft are omitted to show 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 elongate shaft and a shaped mandrel having a circular preformed configuration disposed within the ablation catheter;

[0057] - Figure 18 is Figure 1 details of the ablation assembly, showing the distal portion of the shaft of the elongate shaft;

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

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

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

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

[0062] - Figure 23 is Figure 19 a perspective view of the distal portion of the shaft, with some external elements partially removed and the shaped mandrel omitted to show the lumen of the catheter;

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

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

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

[0066] - Figure 27 is Figure 25 a side view of the ablation assembly;

[0067] - Figure 28 is Figure 25 a cross-sectional view of the ablation assembly, wherein the distal portion of the shaped mandrel is fully inserted into the elongate shaft;

[0068] - Figure 29 shows Figure 28 details of

[0069] - Figures 30a to 30c the shaped mandrel in a straight loaded configuration, a preformed circular configuration, and a preformed circular and bent configuration, respectively;

[0070] - Figures 31a to 31b and Figures 32a to 32b show a plurality of shaped mandrels having different preformed configurations;

[0071] - Figures 33a to 33c show the shaped mandrel in a preformed circular and bent configuration and a loaded straight configuration, respectively, and the shaped mandrel in a preformed circular and bent configuration disposed within the ablation catheter;

[0072] - Figures 34a to 34b show two shaped mandrels coupled to respective heating elements, wherein the heating elements are configured to apply heat to the shaped mandrels to modify the shape of the shaped mandrels from the loaded configuration to the preformed configuration;

[0073] - Figures 35a to 35d show different curves and 2-D and 3-D configurations of the distal portion of the ablation catheter, wherein the shaped mandrel is disposed within the distal portion of the ablation catheter;

[0074] - Figure 36 show an ablation assembly disposed within the heart according to the present invention, wherein the shaped mandrel is fully inserted into the distal portion of the ablation catheter shaft;

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

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

[0077] - Figure 39 Shows a shaft electrode disposed along a catheter axis, wherein the shaft electrode catheter is tubular and forms a part of the catheter axis;

[0078] - Figure 40 Shows Figure 38 and Figure 39 the shaft electrodes in a bipolar configuration;

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

[0080] - Figures 42a to 42b Shows Figure 41 a cross-sectional view and a longitudinal-sectional view of the ablation catheter, showing the electrical connection of a wire for connecting one of the shaft electrodes to a single power source;

[0081] - Figures 43a to 43b Shows Figure 41 a cross-sectional view and a longitudinal-sectional view of the ablation catheter, showing the electrical connection of a wire 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 including a plurality of shaft electrodes and a tip electrode, wherein the outer contour or diameter of the shaft electrodes and the outer contour of the tip electrode are greater than the outer contour or diameter of the distal portion of the shaft;

[0083] - Figure 45 Shows a radiograph 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 a handle of an ablation catheter 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 multiple catheter shaft portions between two electrodes have a first stiffness, the remaining portion of the distal portion of the shaft has a second stiffness and the proximal portion of the shaft has a third stiffness;

[0086] - Figure 48A side view of the distal portion of the shaft and a set of different tip electrodes is shown, where each tip electrode can be coupled to the distal portion of the shaft;

[0087] - Figure 49 A side view of different distal portions of different ablation catheters is shown;

[0088] - Figure 50 A perspective view of different distal ablation assemblies that can be coupled to the distal portion of the shaft is shown;

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

[0090] - Figure 52 A schematic side view of an ablation catheter assembly according to an embodiment is shown;

[0091] - Figure 53 A cross-sectional side view of different ablation catheters and different shaped mandrels disposed within the ablation catheter, and a shaped mandrel having a rounded distal end is shown;

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

[0093] - Figure 55 An operating example 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 of a method of ablation using the ablation assembly of the present invention is shown;

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

[0096] - Figure 59 and Figure 60 A side view and a cross-sectional view of the distal portion of the catheter are respectively shown, showing 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, including a first electrode and a second dot electrode, the first electrode having an electrode body defining an internal compartment of the first electrode accessible from the outside and the second dot electrode received in the internal compartment of the first electrode;

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

[0099] - Figure 63 A block diagram of the single power source of the ablation device is shown, including a single control unit and a power supply unit;

[0100] - Figure 64a 、 Figure 64b 、 Figure 64c An example of an electrical signal including a pulse train generated by the Figure 63 single power source is shown;

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

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

[0103] - Figure 67 A schematic cross-sectional view of the ablation catheter along its length is shown, where steering wires and electrical wires are shown.

[0104] Description of some preferred embodiments

[0105] The present invention can be more easily understood by referring to the following detailed description, examples, drawings, and the descriptions before and after them. However, before disclosing and describing the device, system, and / or method, it should be understood that the present invention is not limited to the specific device, system, and / or method disclosed, and such situations can of course vary unless otherwise stated. It should also be understood that the terms used herein are for the purpose of describing specific aspects only and are not intended to be limiting.

[0106] The following description of the invention is provided as an enabling teaching of the invention in its presently known best 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 achieving the beneficial results of the invention. It is apparent that some of the desired benefits of the invention can be obtained by selecting some of the features of the invention without utilizing other features. Accordingly, those skilled in the art will recognize that many modifications and adaptations of the invention are possible and, in some cases, even desirable and are part of the invention. Accordingly, the following description is provided to illustrate the principles of the invention and not to limit it. As used throughout, the singular forms "a / an" and "the" include plural forms unless the context clearly dictates otherwise. Thus, for example, a reference to "a tube segment" can include two or more such tube segments unless the context otherwise indicates. As used herein, the term "plurality" means two or more.

[0107] Ranges may be expressed herein as from "about" one particular value, and / or to "about" another particular value. When such a range is expressed, on the one hand it includes from one particular value and / or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about" it is understood that the particular value forms on the other hand. It will be further understood that the endpoints of each of the ranges are meaningful both in relation to and independent of the other endpoint.

[0108] As used herein, the term "optional" or "optionally" means that the subsequent described event or circumstance may but need not occur, and the description includes instances where the event or circumstance occurs and instances where it does not occur.

[0109] The term "distal" is understood to mean away from the practitioner and towards the body part where the procedure is being performed, while "proximal" means towards the practitioner and away from the body part.

[0110] 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 shaped mandrel 26 disposed within the ablation catheter 1.

[0111] The ablation catheter 1 includes a catheter elongate shaft 13 having a longitudinal major direction X-X and including at least an elongate shaft distal portion 17.

[0112] The shaft distal portion 17 includes a shaft distal portion distal end 19.

[0113] The ablation catheter 1 includes an internal lumen 118 disposed within the elongate shaft 13.

[0114] According to one embodiment, the catheter elongate shaft 13 includes a flexible body 207 for navigating through body vessels 208.

[0115] The ablation catheter 1 further includes a shaft ablation assembly 20 fixedly disposed at the distal portion 17 of the elongate shaft.

[0116] 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.

[0117] The at least one shaping mandrel 26 is insertable into the internal lumen 118 and removable from the internal lumen 118.

[0118] The at least one shaping mandrel 26 is movable freely relative to the internal lumen 118, avoiding any constraint on the distal portion 17 of the shaft during insertion of the shaping mandrel.

[0119] The at least one shaping mandrel 26 includes at least a preformed configuration, and the at least one shaping mandrel 26 is reversibly deformable between at least a straight loaded configuration and the preformed configuration.

[0120] When the at least one shaping mandrel 26 is fully inserted into the distal portion 17 of the shaft, the shaping mandrel 26 is configured to shape the distal portion 17 of the shaft to have the preformed configuration.

[0121] According to an alternative embodiment, the distal portion 17 of the shaft is elastically deformable.

[0122] According to an alternative embodiment, when the shaping mandrel 26 is fully inserted into the distal portion 17 of the shaft, the distal portion 17 of the shaft is configured to conform to the preformed configuration.

[0123] According to an alternative embodiment, when the shaping mandrel 26 is fully inserted into the distal portion 17 of the shaft, a mandrel fully inserted position is defined.

[0124] According to an alternative embodiment, when the shaping mandrel 26 slides within the internal lumen 118 towards the mandrel fully inserted position, the shaping mandrel 26 is configured to variably shape the distal portion 17 of the shaft from the straight loaded configuration to the preformed configuration.

[0125] According to an alternative embodiment, when the shaping mandrel 26 is fully inserted into the distal portion 17 of the shaft, the shaping mandrel 26 deforms the distal portion 17 of the shaft at least in the plane P of the distal portion of the shaft.

[0126] According to an alternative embodiment, the ablation catheter 1 includes a catheter bending portion 120 adjacent to the shaft ablation assembly 20, wherein the catheter bending portion 120 is configured to effect an elbow for turning the plane P of the distal portion of the shaft relative to the longitudinal main direction X-X.

[0127] According to an alternative embodiment, at least when the shaping mandrel 26 is fully inserted into the distal portion 17 of the shaft, the distal portion 17 of the shaft forms an acute angle ALFA with respect to the longitudinal main direction X-X of the shaft.

[0128] According to an alternative embodiment, when the shaping mandrel 26 is fully inserted into the distal portion 17 of the shaft, the shaping mandrel 26 is configured to bend at the catheter bending portion 120.

[0129] According to an alternative embodiment, the shaping mandrel 26 in the preformed configuration includes a mandrel bending portion 146, and when the shaping mandrel 26 is fully inserted into the distal portion 17 of the shaft, the mandrel bending portion 146 is arranged to perform the catheter bending portion 120 corresponding to the catheter bending portion 120.

[0130] According to an alternative embodiment, when the shaping mandrel 26 is fully inserted into the distal portion 17 of the shaft, the distal portion 17 of the shaft adopts a circular configuration.

[0131] According to an alternative embodiment, the shaping mandrel 26 includes a mandrel elastic body 119, and the mandrel elastic body 119 can be deformed into at least the straight loading configuration and return to the preformed configuration.

[0132] According to an alternative embodiment, the shaping mandrel 26 is made at least of a shape memory alloy.

[0133] 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, so that the shaping mandrel 26 changes from the straight loading configuration to the preformed configuration.

[0134] According to an alternative embodiment, the ablation assembly 100 includes a locking mechanism 122, and the locking mechanism 122 is configured to lock the shaping mandrel 26 to the distal portion 17 of the shaft when the shaping mandrel 26 is in the fully inserted position of the mandrel.

[0135] According to an alternative embodiment, the locking mechanism 122 includes a retaining element 123, and the retaining element 123 reversibly locks the shaping mandrel 26 in the fully inserted position of the mandrel.

[0136] According to an alternative embodiment, the retaining element 123 is configured to release the shaping mandrel 26 from the fully inserted position of the mandrel when a pulling force is applied to the shaping mandrel 26.

[0137] According to an alternative embodiment, the retaining element 123 is made of metal, metal alloy, rubber or polymer.

[0138] 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.

[0139] According to an alternative embodiment, the sizing mandrel 26 includes a distal portion 139 of the mandrel.

[0140] According to an alternative embodiment, the distal portion 139 of the mandrel includes a mandrel seat 140, wherein the retaining element 123 is fixed to the sizing mandrel 26 and is partially received in the mandrel seat 140.

[0141] According to an alternative embodiment, the inner cavity 118 adjacent to the distal end 19 of the distal portion of the shaft has a neck portion 141, wherein the retaining element 123 interferes with the neck portion 141 to lock the sizing mandrel 26 in the fully inserted position of the mandrel.

[0142] According to an alternative embodiment, the retaining element 123 is an O-ring, wherein the mandrel seat 140 is annular.

[0143] According to an alternative embodiment, the distal portion 17 of the shaft is capable of deflecting in one or more directions with one or more deflected shapes and geometries.

[0144] According to an alternative embodiment, the sizing mandrel 26 in a preformed configuration is configured to hold the deflection of the distal portion 17 of the shaft in a single plane.

[0145] According to an alternative embodiment, the deflection direction is a symmetric deflection geometry or an asymmetric deflection geometry.

[0146] According to an alternative embodiment, the elongate shaft 13 has a difference in shaft hardness along its length.

[0147] According to an alternative embodiment, the elongate shaft 13 includes a proximal portion 14 of the shaft.

[0148] According to an alternative embodiment, the proximal portion 14 of the shaft is more rigid than the distal portion 17 of the shaft.

[0149] According to an alternative embodiment, the elongate shaft 13 includes a transition portion 126 of the shaft disposed between the proximal portion 14 of the shaft and the distal portion 17 of the shaft.

[0150] According to an alternative embodiment, the transition portion 126 of the shaft is more rigid than the distal portion 17 of the shaft and less rigid than the proximal portion 14 of the shaft.

[0151] According to an alternative embodiment, the elongate shaft 13 comprises shaft portions having different hardnesses, wherein the elongate shaft 13 comprises at least one circumferentially asymmetric hardness portion between two of the shaft portions having different hardnesses.

[0152] According to an alternative embodiment, the elongate shaft 13 is made of or the elongate shaft 13 is braided from stainless steel flat wires and / or stranded braids.

[0153] According to an alternative embodiment, the ablation catheter 1 comprises at least one steering wire 25 configured to deflect a distal shaft portion 17 in one or more deflection directions, wherein the at least one steering wire 25 is fixedly connected to the distal shaft portion 17.

[0154] According to an alternative embodiment, the at least one steering wire 25 comprises a proximal wire extension 142 disposed externally relative to the proximal shaft portion 14.

[0155] According to an alternative embodiment, the proximal wire extension 142 comprises a wire clamping portion 143 configured to pull the at least one steering wire 25 for steering the distal shaft portion 17 in the case where the shaping mandrel 26 is fully inserted into the distal shaft portion 17.

[0156] According to an alternative embodiment, the distal shaft portion 17 comprises a proximal end 18 of the distal shaft portion.

[0157] According to an alternative embodiment, the ablation catheter 1 comprises at least two steering wires 25.

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

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

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

[0161] According to an alternative embodiment, a fourth steering wire of the at least two steering wires 25 is fixedly connected near the distal end 19 or the proximal end 18 of the distal shaft portion.

[0162] According to an alternative embodiment, the shaping mandrel 26 includes a mandrel proximal portion 138, wherein the mandrel proximal portion 138 is disposed outside the internal cavity 118 such that the shaping mandrel 26 is drivable by a user.

[0163] According to an alternative embodiment, the elongate shaft 13 includes a shaft proximal end 15.

[0164] According to an alternative embodiment, the ablation catheter 1 includes a steering device 144 attached to the shaft proximal end 15.

[0165] According to an alternative embodiment, the ablation catheter 1 includes a handle 103, wherein the steering device 144 is connected to the handle 103.

[0166] According to an alternative embodiment, the steering device 144 is rotatably drivable relative to the handle 103 such that rotation of the steering device 144 relative to the handle causes rotation of the elongate shaft 13.

[0167] According to an alternative embodiment, the steering device 144 includes a through hole 145 in communication with the internal cavity 118.

[0168] According to an alternative embodiment, during insertion of the shaping mandrel 26 into or removal of the shaping mandrel 26 from the ablation catheter 1, the shaping mandrel 26 passes through the through hole 145, and wherein when the shaping mandrel 26 is fully inserted into the shaft distal portion 17, the mandrel proximal portion 138 is outside the steering device 144.

[0169] According to an alternative embodiment, when the shaping mandrel 26 is fully inserted into the shaft distal portion 17, the shaping mandrel 26 deforms the shaft distal portion 17 at least in the shaft distal portion plane P.

[0170] 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 a user in manipulating the catheter assembly 1.

[0171] According to an alternative embodiment, the ablation assembly 100 includes a distal ablation assembly 21 that is at least disposed at the distal end 19 of the shaft distal portion.

[0172] 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.

[0173] According to an alternative embodiment, the distal ablation assembly 21 includes at least an electrode tip 128 that is at least disposed at the distal end 19 of the shaft distal portion.

[0174] According to an alternative embodiment, the shaft electrodes 127 are arranged to be spaced apart from each other along the distal portion 17 of the shaft.

[0175] According to an alternative embodiment, the shaft ablation assembly 20 is further configured to map tissue 41.

[0176] According to an alternative embodiment, the electrode tip 128 has an outer surface shaped to be atraumatic and elastically biased to a circular configuration.

[0177] According to an alternative embodiment, the shaft electrodes 127 and the electrode tip 128 include at least monopolar electrodes 113 and / or at least bipolar electrodes 114.

[0178] According to an alternative embodiment, the distal ablation assembly 21 includes at least one thermocouple 37.

[0179] According to an alternative embodiment, the shaft ablation assembly 20 includes at least one thermocouple 37.

[0180] According to an alternative embodiment, the shaft electrodes 127 are five to ten electrodes fixedly attached to the distal portion 17 of the shaft.

[0181] According to an alternative embodiment, the electrode tip 128 is at least fixedly disposed at the distal end 19 of the distal portion of the shaft.

[0182] According to an alternative embodiment, the electrode tip 128 is removable from the distal end 19 of the distal portion of the shaft and is interchangeable with a set of electrode tips 39, wherein the tip electrodes of the set of tip electrodes 39 have different shapes and sizes.

[0183] According to an alternative embodiment, the shaft electrodes 127 are spaced apart along the length of the distal portion 17 of the shaft in one of the following configurations:

[0184] Spaced 1 - 5 cm apart, and / or

[0185] Spaced 2 - 3 cm apart, or

[0186] When a pulling force of 4000 V is applied, spaced approximately 2 - 5 mm apart, preferably spaced 4 mm apart; or

[0187] When a pulling force of 5000 V is applied, spaced approximately 6 mm apart;

[0188] and / or

[0189] wherein each of the plurality of shaft electrodes 127 includes an exposed length of up to 20 - 25 mm or 2 - 4 mm.

[0190] According to an alternative embodiment, each of the plurality of shaft electrodes 127 includes approximately 0.05 cm 2to about 5 cm 2 or about 1 cm 2 to about 2 cm 2 of the electrode surface area.

[0191] 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 ranges of electric field strengths to the target tissue: from about 100 V / cm to about 7,000 V / cm; and / or from about 200 V / cm to about 2,000 V / cm; and / or from about 300 V / cm to about 1,000 V / cm; and / or from about 2,000 V / cm to about 20,000 V / cm.

[0192] According to an alternative embodiment, the plurality of shaft electrodes 127 includes a distal shaft electrode 106, and the distal shaft electrode 106 is mounted on the distal portion 17 of the shaft and is spaced 2-4 mm from the distal end 19 of the shaft distal portion.

[0193] According to an alternative embodiment, the shaft electrode 127 is cylindrical.

[0194] According to an alternative embodiment, the shaft electrode 127 has a profile flush with the shaft surface.

[0195] According to an alternative embodiment, the shaft electrode 127 presents 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, such that the shaft distal end is more flexible.

[0196] According to an alternative embodiment, the shaft electrode 127 is elastically biased into a circular configuration.

[0197] According to an alternative embodiment, the shaft electrode 127 presents a tubular geometry with a wall thickness to outer diameter ratio close to 1:15.

[0198] According to an alternative embodiment, the plurality of shaft electrodes 127 includes at least a bipolar electrode 114, and the bipolar electrode 114 includes a small electrode 130 and a large electrode 131, wherein the small electrode 130 is isolated from the large electrode 131.

[0199] According to an alternative embodiment, at least one of the shaft electrodes 127 includes at least two conductive portions N that are electrically insulated from each other, and each conductive portion N radially covers less than 180° around the shaft distal portion 17.

[0200] According to an alternative embodiment, at least one of the shaft electrodes 127 includes at least four conductive portions N that are electrically insulated from each other, and each conductive portion N radially covers less than 90° around the shaft distal portion 17.

[0201] According to an alternative embodiment, the distal end 19 of the distal portion of the shaft is open, and the shaped mandrel 26 can slide from the fully inserted position of the mandrel outside the distal end 19 of the distal portion of the shaft to the maximum exposed position of the mandrel.

[0202] According to an alternative embodiment, the distal ablation assembly 21 is fixedly disposed at the distal portion 139 of the mandrel.

[0203] 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 along the distal portion 139 of the mandrel.

[0204] According to an alternative embodiment, the mandrel electrodes 132 include at least monopolar electrodes 113 and / or at least bipolar electrodes 114.

[0205] According to an alternative embodiment, when the shaped mandrel 26 is in the fully inserted position of the mandrel, the shaft electrode 127 is electrically connected to at least a portion of the plurality of mandrel electrodes 119.

[0206] According to an alternative embodiment, when the shaped mandrel 26 is in the maximum exposed position of the mandrel, the shaft electrode 127 is electrically disconnected from any power source.

[0207] According to an alternative embodiment, the non-thermal energy is irreversible electroporation energy or IRE, and the thermal energy is radio frequency energy or RF.

[0208] According to an alternative embodiment, the shaped mandrel 26 can slide from the fully inserted position of the mandrel outside the distal end 19 of the distal portion of the shaft to the maximum exposed position of the mandrel. In the fully inserted position of the mandrel, the mandrel 26 is in the straight loading configuration, and in the maximum exposed position of the mandrel, the mandrel is in the preformed configuration.

[0209] According to an alternative embodiment, the ablation assembly 100 includes a single power source 4.

[0210] The shaft ablation assembly 20 includes at least a plurality of electrodes 127, 113 or 114 fixedly disposed at the distal portion 17 of the elongated shaft. All of the at least plurality of electrodes 127, 113 or 114 are powered by the single power source 4 through an electrical signal S to deliver non-thermal energy for treating tissue 41 and thermal energy for ablating tissue 41.

[0211] The single power source 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, and vice versa, or to deliver a combination of thermal energy and non-thermal energy simultaneously.

[0212] According to an alternative embodiment, the single power supply 4 includes a single control unit 400 and a power supply unit 401 for generating the electrical signal S.

[0213] According to an alternative embodiment, the power supply unit 401 is electrically connected to all of the at least plurality of electrodes 127, 113 or 114.

[0214] According to an alternative embodiment, the power supply unit 401 is driven by the single control unit 400 to continuously change the electrical energy level associated with the signal S to be provided to the electrodes 127, 113 or 114, to go from delivering non-thermal energy to thermal energy and vice versa, or to deliver a combination of thermal energy and non-thermal energy simultaneously.

[0215] According to an alternative embodiment, the power supply unit 401 includes a power supply module 402. The power supply module 402 includes:

[0216] A drive circuit block 403, controlled by the single control unit 400, for generating the electrical signal S starting from the power supply voltage signal Vcc provided by the single control unit 400;

[0217] A selection block 404, selectively controlled by the drive circuit block 403 to continuously change the electrical energy level associated with the signal S;

[0218] Filtering and electrical insulation blocks 405, 406.

[0219] 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.

[0220] 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.

[0221] The programmable logic controller block 409 is configured to generate drive signals to control the drive circuit block 403 of the power supply module 402.

[0222] According to an alternative embodiment, the single control unit 400 further includes:

[0223] Video interface and button blocks 410, 410', controlled by the microprocessor 407 to set the parameters of the device 100 and display the selected parameters;

[0224] A watchdog block 411 for controlling the normal operation of the microprocessor 407;

[0225] An audio interface block 412 for providing audio information indicating the correctness of the ablation process and / or an error that has occurred.

[0226] According to an alternative embodiment, the power supply unit 401 includes one or more power modules 402 that are identical to each other.

[0227] According to an alternative embodiment, at least one of the electrodes 127, 113 is a monopolar electrode 113, and the monopolar electrode 113 among the at least plurality of electrodes is only electrically connected to one power module 402 of the power supply unit 401.

[0228] 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 electrode 114 among the at least plurality of electrodes is electrically connected to corresponding power modules 402 that can be selected from the power modules of the power supply unit 401, respectively. According to an alternative embodiment, the electrical signal S to be provided to the plurality of electrodes 127, 113 or 114 includes 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.

[0229] 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 to change the electrical energy level associated with the signal S.

[0230] 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 among the at least plurality of electrodes is electrically connected to the corresponding power module 402 of the power supply unit 401 through a single wire 210 welded to the monopolar electrode 113.

[0231] According to an alternative embodiment, each bipolar electrode 114 among the at least plurality of electrodes is electrically connected to two selected power modules 402 of the power supply unit 401 through two wires 210 welded to the bipolar electrode 114.

[0232] According to an alternative embodiment, the electrical signal S to be provided to the plurality of electrodes 127, 113 or 114 includes at least a square wave signal.

[0233] According to an alternative embodiment, the electrical signal S to be provided to the plurality of electrodes 127, 113 or 114 includes a signal obtained by combining, adding or superimposing two or more square wave signals on each other.

[0234] According to an alternative embodiment, the electrical signal S to be provided to the plurality of electrodes 127, 113, or 114 includes a DC signal, or an AC signal, or a combination of a DC signal and an AC signal.

[0235] According to an alternative embodiment, the single power supply 4 is powered by a battery or connected to a standard wall socket capable of generating an alternating current (AC) power grid of 110 volts or 240 volts.

[0236] According to an alternative embodiment, the at least two electrodes 127, 114 that are electrically connected to form the bipolar electrode 114 include:

[0237] A first electrode 114a, connected to a first power module 402 of the power supply unit 401 through a first wire 210a, the first electrode 114a having an electrode body 424 that defines an internal compartment of the first electrode 114a, and the internal compartment is accessible from outside the first electrode 114a;

[0238] A second dot electrode 114b, connected to a second power module 402 of the power supply unit 401 through a second wire 210b, and the second dot electrode 114b is accommodated in the internal compartment of the first electrode 114a.

[0239] 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 module 402 among the plurality of electrical signals S for providing to the electrodes 127, 113, or 114.

[0240] The microprocessor 407 is configured to control each power 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 plurality of electrical signals, so as to generate a monopolar 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.

[0241] 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, and the ablation assembly or device 100 includes an ablation catheter 1 and a single power supply 4 according to the foregoing embodiments. The method includes:

[0242] Generating an electrical signal S including a pulse train 204 through the single power supply 4 for powering all of the at least plurality of electrodes 127, 113, or 114;

[0243] Modifying the pulse duration 203 of each pulse 201 in the pulse train 204, or

[0244] Modifying the number of pulses 209 in the pulse train 204, or

[0245] Modify the time interval 205 between adjacent pulse trains 204,

[0246] induce the at least plurality of electrodes 127, 113 or 114 to change from delivering non-thermal energy to thermal energy, or vice versa, or to deliver a combination of thermal energy and non-thermal energy simultaneously.

[0247] 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 by a single wire 210 welded to the monopolar electrode 113.

[0248] 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 by two wires 210 welded to the bipolar electrode 114.

[0249] The present invention also relates to an ablation kit 200.

[0250] The ablation kit 200 includes:

[0251] - at least the ablation device 100 according to any one of the foregoing embodiments;

[0252] - a set of sizing mandrels 134.

[0253] The set of sizing mandrels 134 has different preformed configurations.

[0254] Alternatively, the set of sizing mandrels 134 is disposable and removable in the ablation catheter 1.

[0255] According to an alternative embodiment, the set of sizing mandrels 134 includes at least a first sizing mandrel 135 and a second sizing mandrel 136.

[0256] The first sizing mandrel 135 has a first preformed configuration and the second sizing mandrel 136 has a second preformed configuration.

[0257] The first preformed configuration is different from the second preformed configuration, such that different shapes of the distal portion 17 of the shaft are performed according to which sizing mandrel 135, 136 of the set of sizing mandrels 134 is disposed in the ablation catheter 1.

[0258] According to an alternative embodiment, at least one sizing mandrel of the set of sizing mandrels 134 has a circular preformed configuration.

[0259] According to an alternative embodiment, at least one sizing mandrel of the set of sizing mandrels 134 has a helical preformed configuration.

[0260] According to an alternative embodiment, at least one of the set of sizing mandrels 134 has a straight preformed configuration.

[0261] According to an alternative embodiment, at least one of the set of sizing mandrels 134 has a circular preformed configuration with a bend.

[0262] The present invention also relates to an ablation catheter kit 300.

[0263] The ablation catheter kit 300 includes at least a first ablation assembly 100 and a second ablation assembly 100' according to any of the foregoing embodiments.

[0264] The distal portion 17 of the shaft of the ablation catheter 1 of the first ablation assembly 100 can be deflected in at least two symmetric geometries.

[0265] The distal portion 17' of the shaft of the ablation catheter 1' of the second ablation assembly 100' can be deflected in at least two asymmetric geometries.

[0266] The present invention also relates to a method of sizing an ablation catheter, comprising the steps of:

[0267] - providing an ablation assembly 100 according to any of the foregoing embodiments,

[0268] - inserting a sizing mandrel 26 in the straight loading configuration into the internal lumen 118 of the ablation catheter 1,

[0269] - moving the sizing mandrel 26 distally in the internal lumen 118 towards the distal end 19 of the distal portion until the sizing mandrel 26 is fully inserted into the distal portion 17 of the shaft, and

[0270] - when the sizing mandrel 26 is fully inserted into the distal portion 17 of the shaft, conforming the shape of the distal portion 17 of the shaft to the preformed configuration of the sizing mandrel 26.

[0271] The present invention also relates to a method of multi-sizing an ablation catheter, comprising the steps of:

[0272] - providing an ablation kit 200 as described above,

[0273] - inserting a first sizing mandrel 135 into the ablation catheter 1,

[0274] - conforming the distal portion 17 of the elongated shaft 13 of the ablation catheter 1 to the shape of the first preformed configuration of the first sizing mandrel 135,

[0275] - removing the first sizing mandrel 135 from the elongated shaft 13 of the ablation catheter 1,

[0276] - inserting a second sizing mandrel 136 into the ablation catheter 1, and

[0277] - conform the shape of the distal portion 17 of the shaft to the shape of the second preformed configuration of the second sizing mandrel 136.

[0278] 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 includes an ablation catheter 1 and a single power source 4 according to any one of the foregoing embodiments.

[0279] The method includes the following steps:

[0280] Generate an electrical signal S including a pulse train 204 through the single power source 4 for powering all of the at least a plurality of electrodes 127, 113 or 114;

[0281] Modify the pulse duration 203 of each pulse 201 in the pulse train 204, or

[0282] Modify the number of pulses 209 in the pulse train 204, or

[0283] Modify the time interval 205 between adjacent pulse trains 204,

[0284] Induce the at least a plurality of electrodes 127, 113 or 114 to switch from delivering non-thermal energy to thermal energy, and vice versa, or deliver a combination of thermal energy and non-thermal energy simultaneously.

[0285] Due to the proposed solution, it is possible to provide a method for sizing an ablation catheter, including the following steps:

[0286] - Provide an ablation device 100 according to any one of the foregoing embodiments,

[0287] - Insert a sizing mandrel 26 in the straight loading configuration into the internal lumen 118 of the ablation catheter 1,

[0288] - Move the sizing mandrel 26 in the internal lumen 118 towards the distal end 19 of the distal portion of the shaft until the sizing mandrel 26 is fully inserted into the distal portion 17 of the shaft, and

[0289] - When the sizing mandrel 26 is fully inserted into the distal portion 17 of the shaft, conform the shape of the distal portion 17 of the shaft to the preformed configuration of the sizing mandrel 26.

[0290] Due to the proposed solution, it is possible to provide a method for treating proximal, persistent or long-term persistent atrial fibrillation in a patient, including the following steps:

[0291] - Provide an ablation assembly 100 according to any one of the foregoing embodiments,

[0292] - Place the ablation catheter 1 in the coronary sinus of the patient to map electrograms and / or ablate tissue, and then;

[0293] - Place the ablation catheter 1 in the left atrium or right atrium to map electrograms and / or deliver energy for treating tissue 41 using at least the shaft ablation assembly 20, wherein the distal portion 17 of the shaft is shaped into a preformed configuration imposed by a sizing mandrel 26 fully inserted into the distal portion 17 of the shaft.

[0294] - Place the ablation catheter in the left atrium or right atrium to deliver energy for treating tissue using at least the shaft ablation assembly 20, wherein the distal portion 17 of the shaft is shaped into a preformed configuration imposed by a sizing mandrel 26 fully inserted into the distal portion 17 of the shaft.

[0295] wherein the tissue location includes the fascia around the pulmonary veins, and / or the left atrial roof, and / or the mitral isthmus.

[0296] Due to the proposed solution, it is possible to provide a method for treating atrial flutter in a patient, comprising the steps of:

[0297] - Provide an ablation assembly 100 according to any one of the above embodiments.

[0298] - Place the ablation catheter 1 in one or more positions in the right atrium of the heart to effect bidirectional block by delivering energy for treating tissue 41 using at least the shaft ablation assembly 20, wherein the distal portion 17 of the shaft is shaped into a preformed configuration imposed by a sizing mandrel 26 fully inserted into the distal portion 17 of the shaft.

[0299] Due to the proposed solution, it is possible to provide a method for ablating tissue in the right atrium of the heart, comprising the steps of:

[0300] - Provide an ablation assembly 100 according to any one of the above embodiments.

[0301] - Place the ablation catheter 1 in one or more positions in the right atrium and / or left atrium of the heart 43;

[0302] - Create lesions 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 by delivering energy for treating tissue using at least the shaft ablation assembly 20, wherein the distal portion 17 of the shaft is shaped into a preformed configuration imposed by a sizing mandrel 26 fully inserted into the distal portion 17 of the shaft.

[0303] Due to the proposed solution, it is possible to provide a method for treating sinus node tachycardia in a patient, comprising the steps of:

[0304] - Provide the ablation assembly 100 according to any one of the above embodiments,

[0305] - Place the ablation catheter 1 in one or more positions in the right atrium and / or left atrium of the heart 43;

[0306] - Treat tissue by delivering energy for at least using the shaft ablation assembly 20, wherein the distal portion 17 of the shaft is shaped into a preformed configuration applied by a sizing mandrel 26 fully inserted into the distal portion 17 of the shaft, map the electrogram of the sinoatrial node and / or map the sinoatrial node and / or ablate the sinoatrial node.

[0307] Due to the proposed solution, it is possible to provide a method for treating ventricular tachycardia in a patient, comprising the steps of:

[0308] - Provide the ablation assembly 100 according to any one of the above embodiments,

[0309] - Place the ablation catheter 1 in the left ventricle or right ventricle of the heart 43;

[0310] - Induce ventricular tachycardia by delivering pacing energy, and

[0311] - Treat tissue by delivering energy for at least using the shaft ablation assembly 20, wherein the distal portion 17 of the shaft is shaped into a preformed configuration applied by a sizing mandrel 26 fully inserted into the distal portion 17 of the shaft, ablate the tissue to treat the patient.

[0312] Due to the proposed solution, it is possible to provide a method for ablating atrial tissue, comprising the steps of:

[0313] - Provide the ablation assembly 100 according to any one of the above embodiments,

[0314] wherein, when the sizing mandrel 26 is fully inserted into the elongate shaft 13, the distal portion 17 of the shaft includes a first deflection geometry, and when the sizing mandrel 26 is removed from the distal portion 17 of the shaft, the distal portion 17 of the shaft includes a second deflection geometry 17, wherein the first deflection geometry is greater than the second deflection geometry;

[0315] - Expose the ablation catheter 1 to atrial tissue such that the distal portion 17 of the shaft is in the second deflection geometry, wherein the sizing mandrel 26 is located outside the distal portion 17;

[0316] - Ablate one or more of the following tissue locations: the left atrial septum; tissue near the left atrial septum; and tissue near the posterior wall of the left atrium;

[0317] - Place the ablation catheter 1 having the distal portion 17 of the shaft in the first deflection geometry by fully inserting the sizing mandrel 26 into the elongate shaft 13,

[0318] - Ablate at least the circumference around the pulmonary vein.

[0319] The present invention also relates to the use of a kit according to any one of the above embodiments and to treating the left and right atria 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 shaped mandrel 135, and the same ablation catheter 1 is also used to ablate tissue in the left atrium using at least a second shaped mandrel 136.

[0320] Reference will now be made in detail to the current embodiments of the present invention, examples of which are illustrated in the accompanying drawings.

[0321] Configured for percutaneous access to the left atrium and left ventricle of the heart (through a transseptal sheath).

[0322] Can be advanced through a sheath previously placed in the LA (e.g., a deflectable or fixed stiffening sheath).

[0323] The elongate catheter bodies 13, 207 can be steerable (unidirectional or bidirectional)

[0324] For example, one pull wire 25

[0325] For example, two pull wires 25

[0326] For example, attached near the distal tip at _180° intervals

[0327] For example, attached near the distal tip at _90° intervals

[0328] For example, four pull wires 25

[0329] For example, attached near the distal tip at _90° intervals

[0330] Can be an asymmetric steerable curve

[0331] For example, a spring to limit the radius of curvature in one plane rather than the opposite plane

[0332] Configuration

[0333] Preferably PeBax

[0334] Woven fabric, (SS flat wire woven fabric, nylon strand woven fabric, combination)

[0335] Preferably having a transition 126 from a more rigid proximal end to a less rigid distal end

[0336] First control shaft (outer)

[0337] The distal end is attached to the distal end of a single atraumatic electrode tip

[0338] The distal end is attached to the distal end of a split non-invasive electrode tip

[0339] The distal end is attached to the distal end of a quadrisected non-invasive electrode tip

[0340] The distal end is preferably attached to a non-invasive tip electrode

[0341] The shaft preferably has a lumen for saline flushing

[0342] The shaft preferably has a lumen for insulating the signal wire

[0343] The shaft preferably has side hole ports spaced 90° around the diameter at different positions on the distal portion

[0344] The side hole ports allow the signal wire to pass from the inside to the outside

[0345] The proximal end is attached to the handle

[0346] Alternative design - the shaft can have one or more electrical (power / signal) wires 210 (connected to electrodes / thermocouples on a single wire segment)

[0347] Including multiple electrodes along its length

[0348] The side hole ports allow saline flushing to be present in the control shaft lumen

[0349] Holes in the segment - under the electrode - wire feed through holes

[0350] Cylindrical electrodes are mounted 2 - 4 mm from the distal tip and spaced 2 - 3 mm apart

[0351] Second lumen – multi-purpose (fluid flushing and sizing mandrel)

[0352] Travels from the proximal end to the distal end within the first lumen

[0353] Attached to the proximal end of the handle, with ports for saline delivery and / or sizing

[0354] Mandrel

[0355] Attached to the control shaft near the distal electrode

[0356] The proximal end of the shaft is attached to controls on the handle preferably configured to withstand high-pressure fluid flow while the soft and flexible non-invasive electrode tip

[0357] Elastically biased to a rounded corner configuration

[0358] Including at least one thermocouple

[0359] For example, a thermocouple integrated with the electrode

[0360] Cylindrical shaft electrode

[0361] Elastically biased in a circular configuration

[0362] Hole in the segment - under the electrode - wire feed through hole

[0363] Including at least one thermocouple

[0364] For example, a thermocouple integrated with the electrode

[0365] Electrode

[0366] Configuration

[0367] Platinum, platinum / iridium

[0368] Length > 2 mm

[0369] Length < 4 mm

[0370] Preferably includes a thermocouple

[0371] Copper wire and Constantine wire

[0372] Welded to the inner part of the electrode

[0373] Alternative design - the electrode can have fins, other heat sinks

[0374] Handle

[0375] At the proximal end of the catheter body

[0376] Control rod (single) - connected to two pull wires for tip deflection for the first sliding knob for asymmetric steering engagement

[0377] Attached to the first control shaft

[0378] Attached to the second control shaft

[0379] Preferably includes energy activation control

[0380] Alternatively has a single control shaft

[0381] Attached to the distal or proximal end of the atraumatic electrode tip.

[0382] According to an alternative embodiment, the present invention provides a catheter 1 or an ablation assembly 100 for performing various target tissue ablations in a subject. According to an alternative embodiment, the catheter includes an elongate shaft 13 having a proximal end 15 and a distal end 16, and preferably an inner lumen or internal cavity 118 extending at least partially therebetween. The catheter is preferably of the type used for performing 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 introducible through a delivery tube (such as a transseptal sheath) and also preferably has a steerable tip that allows positioning of the distal portion 17, such as when the distal end of the catheter is within the heart 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 may be fixedly attached to the distal end of the shaft or may be mounted on a propellable and / or expandable carrier assembly. The carrier assembly may be attached to a control shaft that is coaxially disposed within the lumen of the shaft and slidably received therein. The carrier assembly may be deployed by activating one or more controls on the handle 103 of the catheter 1, such as bringing one or more ablation elements into contact with heart tissue, typically atrial wall tissue or other endocardial tissue. The shaft may include a deflection member, such as a member operably connected to a control on the catheter handle or a central lumen through which different shaped mandrels 26 may be placed to change the shape of the distal portion of the catheter. The deflection member may deflect the distal portion of the shaft in one or more directions, such as deflection having two symmetric geometries, two asymmetric geometries, or a combination of these. Asymmetry may be caused by different radii of curvature, different curvature lengths, different flatness, other different 2-D shapes, other different 3-D shapes, etc.

[0383] In particular, according to an alternative embodiment, the present invention provides an ablation catheter having a plurality of electrodes that provide electrical energy, such as radiofrequency (RF) and / or irreversible electroporation (IRE) that occurs when a high-intensity pulsed electric field (PEF) causes cell membrane permeabilization, resulting in disruption of cellular homeostasis and cell death. Radiofrequency (RF) energy, in monopolar (single pole), bipolar, or monopolar-bipolar combination modes, 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, etc.

[0384] The normal function of the heart depends on proper electrical impulse generation and transmission. In certain heart diseases (e.g., atrial fibrillation), proper generation and transmission are disrupted or otherwise abnormal. To prevent inappropriate impulse generation and transmission from causing adverse conditions, the ablation catheter and RF generator of the present invention may be employed.

[0385] One method of treating cardiac arrhythmias currently is catheter ablation therapy. A physician uses a catheter to access an internal region of the body. The catheter with an attached electrode array or other ablation device is used to create lesions that disrupt the electrical pathways in the heart tissue. In the treatment of cardiac arrhythmias, initially a specific region of the heart tissue with abnormal conduction pathways (such as atrial rotors) is located, which emits or conducts unstable electrical impulses. A user (e.g., a physician) guides the catheter through a major vein or artery into the internal region of the heart to be treated. Next, an ablation element (or ablation elements) is placed near the target heart tissue to be ablated. The physician guides the energy provided by a source external to the patient from one or more ablation elements to ablate the adjacent tissue and form a lesion. Generally, the goal of catheter ablation treatment is to disrupt the electrical pathways in the heart tissue to stop the emission and / or prevent the propagation of unstable electrical impulses, thereby curing the disease focus. For the treatment of atrial fibrillation AF, currently available methods and devices only show limited success and / or employ devices that are extremely difficult to use or impractical.

[0386] 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 the risk to the patient (e.g., minimizing damage to non-target tissue while creating an effective lesion) and significantly shortening the procedure time. The present invention addresses this need through, for example, an arrangement of one or more tip ablation elements and one or more shaft ablation elements configured to create linear lesions in tissue (such as the endocardial surface of a heart chamber) by delivering energy to the tissue or other means. The electrodes of the present invention may include protruding fins or other heat-dissipating surfaces to improve cooling performance. The distal portion of the catheter shaft of the present invention can be deflected in two or more symmetric or asymmetric geometries, such as asymmetric geometries with different radii of curvature or other geometric differences. The ablation catheter and RF generator of the present invention allow a clinician to treat patients with AF in a procedure that is much shorter in duration than current AF ablation procedures. The lesions created by the ablation catheter and RF generator of the present invention are suitable for inhibiting 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.

[0387] Referring to the accompanying drawings, an 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 a single power source 4. In one aspect, at least a portion of the probe can be configured to be inserted into a patient. In one aspect, at least one energy source or a single power source 4 can further 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 at least one energy source 8. In one aspect, although a monopolar probe is described herein, those of ordinary skill in the art will recognize that the energy delivery device used with the system described herein can be different types of energy delivery devices, 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.

[0388] This can allow a given medical procedure to utilize the optimal energy delivery device. In one aspect, the monopolar probe 101 can include a handle 103, an electrode having a proximal end or electrode proximal 104 and a distal end or electrode distal 105, and at least one connector of 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 corner electrode 107 positioned on the body of the probe, the body of the probe being positioned in a 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 the sliding to match the heart wall movement.

[0389] In one aspect, at least one of the monopolar probes described above can be used with the system. In another aspect, although not stated, at least two of the monopolar electrodes 113 described above can be used with the system. In an 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 a parallel configuration or a helical configuration. In one aspect, if two electrodes are used, it is contemplated that the distal electrode will be one, and each body electrode will be selected based on the ablation length requirements. In another exemplary aspect, the electrodes can be positioned such that the distal tip can be staggered in length compared to the body electrodes. In an exemplary embodiment, if at least two electrodes are used in the system, the at least two electrodes can be spaced approximately 2 - 5 mm when mounted on a catheter body inserted into the ventricle and can provide a voltage of up to 4000 V. In yet another exemplary embodiment, the at least two electrodes can be spaced approximately 6 mm or greater to select alternative electrodes on the catheter body and can have a voltage of up to approximately 5000 V. In an exemplary embodiment, the at least two electrodes can be spaced apart from each other such that they are approximately 4 mm apart when inserted into the target tissue and can provide a voltage of up to approximately 4000 V.

[0390] 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. Additionally, 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 needles 110 and / or electrode arrays can be used in any of the embodiments described herein. An array herein 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 for ablation of target regions of various shapes and sizes in tissue. By allowing multiple selectively activatable electrode patterns 112, 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.

[0391] 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, and this length can be a linear length or a circular length when at least two electrodes are spaced up to approximately 2 - 5 mm 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 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 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 vary from about 0.05 cm 2 to about 5 cm 2 . In yet another exemplary embodiment, the electrodes can have a surface area between about 1 cm 2 and about 2 cm 2 .

[0392] 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, at least one energy source or the non-thermal energy source 6 of a single power supply 4 can be selectively energized to apply non-thermal energy to at least a portion of a 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 one 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 selectively 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 can be connected to the energy source through at least one of the positive connector and the negative connector.

[0393] In an exemplary embodiment, the power source or energy source can be an Argá Model 100 electrosurgical generator capable of delivering up to 1000 W of RF power. Those of ordinary skill 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 110 V or approximately 240 V. In one aspect, the power source can be manually adjusted according to voltage. In an exemplary embodiment, the generator is capable of producing a minimum voltage of approximately 100 V to approximately 4000 V. In one aspect, at least one of the power outlets, generators, and battery sources described herein can be used to provide voltage to the target tissue during treatment. In yet another exemplary embodiment, to effect 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, an exemplary embodiment of an IRE generator can include any number from 2 to 10 positive and negative connectors, although those of ordinary skill in the art will understand that other numbers of positive connectors and negative connectors, as well as different embodiments of the connectors, can be used and may be necessary for an optimal ablation configuration. Systems 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 most distal portion of the ablation element. In one aspect, the electrodes can further include a first electrode 115 positioned at the most distal portion of the catheter, a second electrode 116 positioned proximal to the distal electrode, and at least one separator 117 that can be positioned between and adjacent to at least a portion of each of the first and second electrodes, as well as a third electrode and the like. In one aspect, at least a portion of the distal portion of the second electrode can abut at least the proximal portion of the separator, and at least the distal portion of the separator 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 an exemplary aspect, at least one connector of the probe 8 can be connected to the energy source through at least one of a positive connector 9 and a negative connector 10, as also described above.

[0394] Depending on various parameters such as voltage (including the application of DC or AC or both and the voltage per square centimeter), current, the number of pulses 209, the pulse duration 203, and the pause between pulses applied to the tissue, or the time interval 205 between adjacent pulses, the tissue can undergo reversible electroporation, irreversible electroporation, or thermal damage (commonly 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 responses to heating). In certain embodiments, depending on the parameters mentioned (including the time at 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 leading to non-thermal IRE can be altered to cause cell death by thermal heating. The parameters can also be changed from parameters having a non-thermal IRE effect to other settings, where the changed parameters also have a non-thermal IRE effect.

[0395] More specifically, in one aspect, in various embodiments the total number of pulses 209 and the pulse train 204 can vary based on the desired treatment outcome and the effectiveness of 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 for a duration between about 100 μs and about 100 s, and can be adjusted at intervals of 10 μs. In certain embodiments, the electrodes described herein can provide a voltage of about 100 volts per centimeter (V / cm) to about 7,000 V / cm to the target tissue. In other exemplary embodiments, the voltage can be about 200 V / cm to about 2,000 V / cm and about 300 V / cm to about 1,000 V / cm. Other exemplary embodiments can involve a voltage of about 2,000 V / cm to about 20,000 V / cm. In one exemplary aspect, the bipolar probe 100 can be used at a voltage of up to about 2,700 V.

[0396] 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 after a time interval between each pulse group or train. In one exemplary embodiment, the time interval between pulse groups can be from about 0.05 s to about 2 s. 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, an electrode, and other conductive materials. In one aspect, such an energy delivery device can have different lengths and be suitable for procedures such as, but not limited to, percutaneous, laparoscopic, and open surgeries. In one aspect, at least one energy source can be configured to release at least one energy pulse for a duration between about 5 μs and about 10 s. In one exemplary aspect, a bipolar electrode 114 can be used to apply the voltage described herein to the target area of the tissue in pulses that are 5 μs long. In one aspect, the voltage can be applied in pulses of about 1 μs in a pulse group or train of 10 pulses, where the interval between pulses is about 50 ms and the time between pulse trains is about 0.5 s.

[0397] In one exemplary aspect, at least two monopolar electrodes 113 can be used to ablate the target tissue, thereby creating an ablated tissue zone of approximately 20 - 25 mm × 5 - 10 mm. In one exemplary embodiment, the two individual electrodes can be configured to involve other ablation zones, including but not limited to an ablation zone of approximately 30 mm × 25 mm. One of ordinary skill in the art will understand that the ablation size and shape can vary advantageously with the electrode placement and the various electrode types. In one aspect, during treatment, an additional zone around the outer edge of the target area of the tissue is also ablated (ablation of unwanted or diseased tissue). This surrounding zone of the tissue can be ablated to ensure patient safety as well as complete and adequate ablation of the target area of the tissue. In one aspect, during the use method, the catheter electrode tip 128 of the catheter is designed not to pierce the patient's tissue. One of ordinary skill in the art will recognize that the target area of the tissue can be any tissue from any organ where ablation can be used to ablate unwanted or diseased tissue, such as, but not limited to, heart tissue, the digestive tract, bone, muscle tissue, nerves, endocrine, circulatory, reproductive, skin, lymphatic, urinary tissue or organs, or other soft tissues or organs where selective ablation is desired. Soft tissues can include, but are not limited to, any tissue that surrounds, supports, or connects other body structures and / or organs. For example, soft tissues can include muscle, tendon, ligament, fascia, joint capsule, and other tissues. More specifically, the target tissue can include, but is not limited to, areas of the heart, prostate (including cancerous prostate tissue), kidneys (including renal cell, cancer tissue), and breast, lung, pancreas, uterus, and brain tissue, etc.

[0398] In one aspect, the energy source can be a thermal energy source. In one aspect, the non-thermal energy source can be selectively energized for a desired period of time. More specifically, the period of time can be a predetermined period of time. In yet another aspect, the period of time can be multiple predetermined periods of time. In one aspect, the thermal energy source is selected from the group consisting of: radio frequency (RF), focused ultrasound, microwave, laser, thermoelectric heating, conventional heating methods through electrodes using DC or AC current, and the application of heated fluid and cryotherapy (such as cryosurgery). RF energy is known in the art to be effective for tumor ablation, but clearly any form of temperature-mediated continuous ablation can be used in settings known in the art. In one aspect, after the energy delivery device is inserted into the target organ 44, the tissue 43 is ablated and the energy delivery device is withdrawn. In one aspect, the thermal energy source 7 can be an alternating current thermal energy source. In yet another aspect, the thermal energy source 7 is a direct current thermal energy source.

[0399] In one aspect, the electrode can start at the non-thermal ablation point of the target region. In one aspect, thermal ablation can start at the beginning of the electrode chain (in the longitudinal direction on the catheter). In one embodiment, thermal ablation is applied to prevent conduction of the surrounding tissue. When the energy delivery device or the electrode is withdrawn, thermal energy can be applied to the target tissue through the electrode. In one aspect, the electrode is selectively energized to ablate the tissue adjacent to the electrode track and close to the boundary of the tissue to be ablated by thermal or non-thermal energy.

[0400] In one aspect, IRE treatment can be performed on the target tissue during a surgery such as but not limited to cardiac surgery, laparoscopic surgery, and open surgery, and then thermal ablation can be performed on at least one tissue area. In one aspect, the ablation track can be ablated during repositioning or dragging of the electrode. In one aspect, after delivering IRE energy to the target tissue, the ablated area of the tissue remains. In one aspect, the ablated area of the tissue includes the target tissue area and the surrounding area of the tissue. In an exemplary embodiment, after treating the target tissue with IRE, the 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 the electrode is repositioned. In one aspect, when the energy delivery of the energy delivery device terminates (and in some cases is repositioned), the tissue is ablated in different regions / locations, 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 so as not to form clots, especially during a procedure that may involve ablation on the left side of the heart.

[0401] In one aspect, the generator or single power source 4 used during thermal ablation can be configured to have various ablation settings and capabilities. In an exemplary aspect, the aforementioned Arga 1000 generator can be used as an RF energy source. In one aspect, the RF energy source can be used to ablate tissue using a power of 10 - 100W. In other exemplary aspects, those of ordinary skill in the art will recognize that smaller or larger amounts of power can be used as needed in various embodiments to provide ablation. In an exemplary embodiment utilizing the generator, the RF power source can provide an AC power source in addition to being used for ablation, while the IRE power source can be used to provide a DC power source.

[0402] In one aspect, if a thermal energy source is used, it can be used in conjunction with a variety of techniques to achieve tissue ablation. In an exemplary aspect, additional embodiments can involve using one or more of the following to perform ablation: radiofrequency (RF), focused ultrasound, microwave, laser, thermoelectric heating, conventional heating methods with electrodes using DC or AC current, and the application of heated fluids and cryotherapy (such as but not limited to the therapies used in cryosurgery). In one aspect, in certain embodiments, the thermal energy can be delivered in pulses that can range from approximately 35 μs to approximately 10 s. 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 from approximately 35 μs to approximately 1 s. In yet another exemplary embodiment, at least one energy source can release or deliver at least one energy pulse that lasts between approximately 35 μs and approximately 1000 μs. In yet another exemplary embodiment, at least one pulse can be delivered in the range from approximately 1 μs to approximately 100 μs.

[0403] In an exemplary embodiment, thermal energy can be applied to cause 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, resulting in cell death. In one aspect, the temperature can be adjusted such that it can be less than or greater than this temperature range, depending on the exact rate of removing heat generated by the externally supplied fluid and / or blood from the target tissue. In one embodiment, the temperature used is between approximately 50°C and approximately 100°C, although those of ordinary skill will recognize that temperatures above approximately 100°C will cause tissue vaporization. Ellis L, Curley S, Tanabe K; Radiofrequency Ablation for Cancer; Current Indications, Techniques, and Results, New York: Springer, 2004. In an exemplary embodiment, thermal energy can be used to ablate tissue that is approximately 2 - 3 mm. 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.

[0404] In one embodiment, the mechanism for the user to set parameters for generating IRE effects is changed to generate thermal results by thermal heating as resistive heating. In certain embodiments, these mechanisms are reset so that DC energy is applied to cause thermal ablation. In an 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 yet another aspect, at least one pulse of the DC current can be delivered from the opposite direction of the circuit. In one aspect, a 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, a 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, a DC current can be applied to the target tissue such that the temperature can range 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).

[0405] One of ordinary skill in the art will recognize that DC pulses of various lengths can be applied to achieve effective track ablation. In still other embodiments, AC pulses can be applied when the energy delivery device is withdrawn from the target tissue in stages. In summary, methods for selectively ablating tissue include providing at least one energy source, such as the generator described above. In one aspect, the at least one energy source or a 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 at least one electrode within a desired region of the target tissue through the electrode. In one aspect, the selective coupling of the electrode to the thermal energy source includes actuating a switch 40 to operably select between the non-thermal energy source 7 and the thermal energy source 8. Then the at least one probe is selectively coupled to the 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 region to ablate at least a portion of the desired region, the at least one probe is selectively coupled to the thermal energy source, the at least one probe is withdrawn from the desired region, and the thermal energy source is selectively energized during the withdrawal of at least a portion of the at least one probe to apply thermal energy to ablate the tissue substantially adjacent to the probe track. In one aspect, the at least one probe is operably decoupled from the non-thermal energy source before the at least one probe is selectively coupled to the thermal energy source.

[0406] In one aspect, the duration of one pulse can be longer than any of the pulses, but these pulses mediate thermal heating through resistive heating. Additionally, thermal heating can be achieved by changing the energy pattern such that the number of pulses is greater or shorter, the lengths of the pulses are different, and the pause times between the pulses are also changed to accommodate the tissue being ablated and the BIO feedback obtained from the system. It is also conceivable to change one or both of the voltage and the pulses to increase or decrease one or both of them (including the option to selectively change the time between the pulses) to produce a thermal effect for track ablation. In certain embodiments, the alteration of the pulses that result in the IRE effect and the alteration of one or more pulses that result in the thermal effect are used to produce both the IRE and thermal effects on the tissue within the target region. Further, in certain embodiments, the order of application of the pulses and the switching of one or more pulses in the target region or in the tissue or in both are most effective in treating the patient. Additionally, one or more pulses or pulse trains can be used in combination with a thermal heating method such as radiofrequency such that, for the benefit of the patient, the non-thermal IRE effect, the resistive heating effect caused by the DC current alteration, and the thermal heating effect of the AC current (such as RF) occur in any order in the target tissue or tissue track. For example, the mitral isthmus tissue can be treated with IRE or RF (or other ACs that cause resistive heating as well as other DC pulses) or more than one of them in any order to ablate one or more target tissues and control bleeding or coagulation or ablate blood vessels or cells, and then, after removing the probe, the IRE or RF (or other ACs that cause resistive heating as well as other DC pulses) pulses can be used together or individually in any order as needed to control bleeding, coagulation or ablate tissues, blood vessels, tumor cells, or ablate or treat the tissues surrounding the tissue. In certain embodiments, the change between treatments or treatment methods can be achieved using an agency or device or system for changing or altering one or more parameters described herein through an energy source; the source can have one or more coupled generators, and the system or generator or the agency of the energy source can be used to determine the parameters, and the agency can have a control component that allows the user to make changes directly from the probe or directly from the energy source.

[0407] References

[0408] Mali B, Jarm T, Snoj M, Sersa G, Miklavcic D. Antitumor effectiveness of electrochemotherapy: A systematic review and meta-analysis. Eur J Surg Oncol. 2013;39:4 - 16.

[0409] Heller R, Heller LC. Gene Electrotransfer Clinical Trials. Adv Genet. 2015;89:235 - 62.

[0410] List of Component Symbols

[0411] 1 Ablation catheter, or energy delivery system, or energy delivery device, or probe or multi - electrode and multi - functional ablation catheter

[0412] 3 System for selectively ablating tissue

[0413] 4 Single power supply, or energy source, or energy source delivery source, or generator

[0414] 5 Battery - powered generator

[0415] 6 Non - thermal energy source

[0416] 7 Thermal energy source, or alternating current thermal energy source, or direct current thermal energy source

[0417] 8 Component for selectively coupling a probe to a desired energy source of at least one energy source, or mechanism for coupling a probe to a desired energy source, or probe connector

[0418] 9 Positive electrode connector

[0419] 10 Negative electrode connector

[0420] 11 Component for selectively energizing a non - thermal energy source

[0421] 12 Component for selectively energizing a thermal energy source

[0422] 13 Elongated shaft

[0423] 14 Proximal portion of the elongated shaft

[0424] 15 Proximal end of the elongated shaft

[0425] 16 Distal end of the elongated shaft

[0426] 17 Distal portion of the elongated shaft

[0427] 18 Proximal end of the distal portion of the elongated shaft

[0428] 19 Distal end of the distal portion of the elongated shaft

[0429] 20 Shaft ablation assembly, or functional element fixedly mounted to the distal portion

[0430] 21 Distal ablation assembly, or tip ablation element, or tip, or electrode - bearing mandrel

[0431] 22 - shaft ablation element, or electrode, or single / multiple ablation elements

[0432] 23 - tip ablation element

[0433] 24 - deflection shape and geometry of the distal portion, or deflection geometry

[0434] 25 - steering wire (configured to deflect the distal portion in one or more deflection directions)

[0435] 26 - shaping mandrel, or deflection assembly (to maintain deflection in a single plane)

[0436] 27 - asymmetric joint (between two elongated shaft portions)

[0437] 28 - integral component

[0438] 29 - variable braiding, or steering wire

[0439] 30 - control port, or hole in the tip of the elongated shaft

[0440] 31 - single ablation element, or ablation element (suitable for radiofrequency and irreversible electroporation), or electrode

[0441] 32 - multiple ablation elements, or electrodes

[0442] 33 - shaping mandrel support assembly, or shaping mandrel, or deflection assembly, or mandrel

[0443] 34 - control shaft, or proximal portion of the mandrel

[0444] 35 - shaft outer diameter

[0445] 36 - ablation electrode / ablation element outer diameter

[0446] 37 - thermocouple

[0447] 38 - heat dissipation member (e.g., increased surface area)

[0448] 39 - a set of electrode tips

[0449] 40 - switch to operatively select between a non - thermal energy source and a thermal energy source

[0450] 41 - tissue

[0451] 42 - ablated tissue

[0452] 43 - heart

[0453] 44 - organ

[0454] 45 - ablation area or desired area

[0455] 100 Ablation assembly or device

[0456] 101 Monopolar probe, or ablation catheter with a monopolar solution, or ablation catheter with a monopolar arrangement of at least one electrode

[0457] 102 Bipolar probe, or ablation catheter with electrodes arranged in a bipolar configuration

[0458] 103 Handle

[0459] 104 Electrode proximal end

[0460] 105 Electrode distal end

[0461] 106 Distal electrode

[0462] 107 Rounded corner electrode

[0463] 108 Grounding pad

[0464] 109 Circuit

[0465] 110 Needle

[0466] 111 Electrode array, or an ordered arrangement of multiple probes

[0467] 112 Multiple selectively activatable electrode patterns.

[0468] 113 Monopolar electrode

[0469] 114 Bipolar electrode

[0470] 115 First electrode or the most distal partial electrode

[0471] 116 Second electrode or proximal electrode

[0472] 117 Spacer

[0473] 118 Internal lumen (Second lumen - multipurpose (fluid flush and shaping mandrel))

[0474] 119 Mandrel elastic body

[0475] 120 Catheter bending section

[0476] 121 Mandrel heating element

[0477] 122 Mandrel locking mechanism

[0478] 123 Retaining element

[0479] 124 Lock seat

[0480] 125 Ball tip

[0481] 126 Axial transition part

[0482] 127 Axial electrode

[0483] 128 Electrode tip / Atraumatic tip

[0484] 130 Small electrode

[0485] 131 Large electrode

[0486] 132 Mandrel electrode

[0487] 134 Set of sizing mandrels

[0488] 135 First sizing mandrel

[0489] 136 Second sizing mandrel

[0490] 138 Proximal part of mandrel

[0491] 139 Distal part of mandrel

[0492] 140 Mandrel seat

[0493] 141 Inner lumen neck part

[0494] 142 Proximal extension of wire

[0495] 143 Wire clamping part

[0496] 144 Steering device

[0497] 145 Steering device through-hole

[0498] 200 Ablation catheter kit and set of mandrels

[0499] 201 Pulse

[0500] 202 Pulse amplitude

[0501] 203 Pulse duration

[0502] 204 Pulse train

[0503] 205 Time interval between adjacent pulse trains

[0504] 206 Energization time

[0505] 207 Catheter elongate shaft flexible body = flexible body

[0506] 208 Body blood vessel

[0507] 209 Number of pulses

[0508] 210 Wire

[0509] 300 Ablation Catheter Kit

[0510] 400 Single Control Unit

[0511] 401 Power Supply Unit

[0512] 402 Power Module

[0513] 403 Drive Circuit Block

[0514] 404 Selection Block

[0515] 405 Filter Block

[0516] 406 Electrical Insulation Block

[0517] 407 Microprocessor

[0518] 408 Variable High-Voltage Power Supply Block

[0519] 409 Programmable Logic Controller Block

[0520] 410 Video Interface Block

[0521] 411 Watchdog Block

[0522] 412 Audio Interface Block

[0523] S Electrical Signal

[0524] VCC Power Supply Voltage Signal

[0525] Isolated Conductive Portion of Electrode N

[0526] IRE Irreversible Electroporation

[0527] RF Radio Frequency

[0528] X-X Longitudinal Main Direction of Elongated Shaft

[0529] Plane of Distal Portion of Axis P

[0530] ALFA Acute Angle

[0531] 410' Button Block

[0532] 114a First Electrode

[0533] 424 Electrode Body

[0534] 114b Second Dot Electrode

[0535] 210a First Lead

[0536] 210b Second Lead

[0537] 425 Ground Electrode

Claims

1. An ablation assembly (100) for treating a target region of tissue (41) in an organ (44), comprising: - An ablation catheter (1) including an elongate shaft (13) having a longitudinal main direction (X-X), the elongate shaft (13) including at least a distal shaft portion (17), the distal shaft portion (17) including a distal end (19) of the distal shaft portion; The ablation catheter (1) includes an internal lumen (118) disposed within the elongate shaft (13); The ablation catheter (1) includes a shaft ablation assembly (20) fixedly disposed at the distal shaft 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) disposed within the ablation catheter (1), the shaping mandrel (26) being insertable into and removable from the internal lumen (118), wherein the shaping mandrel (26) is movable freely relative to the internal lumen (118) so as to avoid any constraint with the distal shaft portion (17) during insertion of the shaping mandrel, wherein the shaping mandrel (26) includes at least a preformed configuration, and the shaping mandrel (26) is reversibly deformable between at least a straight loading configuration and the preformed configuration, wherein when the shaping mandrel (26) is fully inserted into the distal shaft portion (17), the shaping mandrel (26) is configured to shape the distal shaft portion (17) to have the preformed configuration, wherein the shaping mandrel (26) includes a proximal mandrel portion (138), wherein the proximal mandrel portion (138) is disposed outside the internal lumen (118) such that the shaping mandrel (26) is drivable by a user; wherein the elongate shaft (13) includes a proximal shaft (15), wherein the ablation catheter (1) includes a steering device (144) attached to the proximal shaft (15), wherein the ablation catheter (1) includes a handle (103), wherein the steering device (144) is connected to the handle (103) and is rotatable relative to the handle (103) such that rotation of the steering device (144) relative to the handle causes rotation of the elongate shaft (13).

2. The ablation assembly (100) according to the preceding claim 1, wherein the steering device (144) includes a through-hole (145) in communication with the internal lumen (118), wherein the shaping mandrel (26) passes through the through-hole (145) during insertion of the shaping mandrel (26) into or removal from the ablation catheter (1), and wherein when the shaping mandrel (26) is fully inserted into the distal shaft portion (17), the proximal mandrel portion (138) is located outside the steering device (144), and / or wherein, when the shaping mandrel (26) is fully inserted into the distal shaft portion (17), the shaping mandrel (26) deforms the distal shaft portion (17) at least in a distal shaft portion plane (P). The steering device (144) includes at least two protrusions (147), and the at least two protrusions (147) are coplanar with the plane (P) of the distal portion of the shaft to assist a user in manipulating the ablation catheter (1).

3. The ablation assembly (100) according to the preceding claim 1, wherein the ablation catheter (1) includes at least one steering wire (25), the at least one steering wire (25) being configured to deflect the distal portion of the shaft (17) in one or more deflection directions, wherein the at least one steering wire (25) is fixedly connected to the distal portion of the shaft (17), wherein the at least one steering wire (25) includes a proximal extension of the wire (142) disposed externally relative to the proximal portion of the shaft (14), and wherein the proximal extension of the wire (142) includes a wire clamping portion (143), the wire clamping portion (143) being configured to pull the at least one steering wire (25) for steering the distal portion of the shaft (17) when the sizing mandrel (26) is fully inserted into the distal portion of the shaft (17).

4. The ablation assembly (100) according to the preceding claim 3, wherein the distal portion of the shaft (17) includes a proximal end of the distal portion of the shaft (18), wherein the ablation catheter (1) includes at least two steering wires (25).

5. The ablation assembly (100) according to the preceding claim 4, wherein a first steering wire of the at least two steering wires (25) is fixedly connected near the distal end (19) of the distal portion of the shaft; and / or wherein a second steering wire of the at least two steering wires (25) is fixedly connected near the proximal end (18) of the distal portion of the shaft; and / or wherein a third steering wire of the at least two steering wires (25) is fixedly connected near the distal end (19) of the distal portion of the shaft; and / or wherein a fourth steering wire of the at least two steering wires (25) is fixedly connected near the distal end (19) of the distal portion of the shaft.

6. The ablation assembly (100) according to the preceding claim 1, wherein when the sizing mandrel (26) is fully inserted into the distal portion of the shaft (17), a mandrel fully inserted position is defined, wherein the ablation assembly (100) includes a locking mechanism (122), the locking mechanism (122) being configured to lock the sizing mandrel (26) to the distal portion of the shaft (17) when the sizing mandrel (26) is in the mandrel fully inserted position.

7. The ablation assembly (100) according to claim 6, wherein the locking mechanism (122) includes a retaining element (123) that reversibly locks the sizing mandrel (26) in the mandrel fully inserted position, and wherein 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); and / or wherein the retaining element (123) is made of metal or polymer; and / or wherein the sizing mandrel (26) includes a spherical tip (125) configured to engage the retention element (123) when the sizing mandrel (26) is in the fully inserted position.

8. The ablation assembly (100) according to claim 7, wherein the metal is a metal alloy and the polymer is a rubber.

9. The ablation assembly (100) according to claim 8, wherein the sizing mandrel (26) includes a distal mandrel portion (139), wherein the distal mandrel portion (139) includes a mandrel seat (140), wherein the retention element (123) is fixed to the sizing mandrel (26) and is partially received in the mandrel seat (140), wherein the inner cavity (118) near the distal end (19) of the distal portion of the shaft has a neck portion (141), wherein the retention element (123) interferes with the neck portion (141) to lock the sizing mandrel (26) in the fully inserted mandrel position.

10. The ablation assembly (100) according to claim 9, wherein the retention element (123) is an O-ring and the mandrel seat (140) is annular.

11. The ablation assembly (100) according to any one of the preceding claims 1-10, including a distal ablation assembly (21) that can be disposed at least at the 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 for treating the tissue (41), wherein the distal ablation assembly (21) includes at least an electrode tip (128) that can be disposed at least at the distal end (19) of the distal portion of the shaft, wherein shaft electrodes (127) are arranged spaced apart from each other along the distal portion of the shaft (17), and / or wherein, the shaft ablation assembly (20) is further configured to map the tissue (41).

12. The ablation assembly (100) according to claim 11, wherein at least one of the shaft electrodes (127) includes at least two conductive portions (N) that are electrically insulated from each other, wherein each conductive portion (N) radially covers less than 180° around the distal portion of the shaft (17), and / or wherein at least one of the shaft electrodes (127) includes at least four conductive portions (N) that are electrically insulated from each other, wherein each conductive portion (N) radially covers less than 90° around the distal portion of the shaft (17).

13. The ablation assembly (100) according to claim 11, wherein when the sizing mandrel (26) is fully inserted into the distal portion of the shaft (17), a fully inserted mandrel position is defined, wherein the distal end (19) of the distal portion of the shaft is open, and the sizing mandrel (26) can slide from the fully inserted mandrel position to a maximum exposure mandrel position outside the distal end (19) of the distal portion of the shaft, wherein the sizing mandrel (26) includes a distal mandrel portion (139), wherein the distal ablation assembly (21) is fixedly disposed at the distal mandrel portion (139), Wherein the distal ablation assembly (21) includes a plurality of mandrel electrodes (132), and the mandrel electrodes (132) are axially spaced along the distal portion (139) of the mandrel.

14. The ablation assembly (100) according to claim 13, wherein when the shaped mandrel (26) is in the fully inserted position of the mandrel, the shaft electrode (127) is electrically connected to at least a portion of the plurality of mandrel electrodes (132); and / or wherein when the shaped mandrel (26) is in the maximum exposed position of the mandrel, the shaft electrode (127) is electrically disconnected from any power source.

15. An ablation assembly (100) for treating a target region of tissue (41) in an organ (44), comprising: - an ablation catheter (1) including an elongate shaft (13) having a longitudinal main direction (X-X), the elongate shaft (13) including at least a distal shaft portion (17), the distal shaft portion (17) including a distal end (19) of the distal shaft portion; The ablation catheter (1) includes an internal lumen (118) disposed within the elongate shaft (13); The ablation catheter (1) includes a shaft ablation assembly (20) fixedly disposed at the distal shaft 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 ablation catheter (1) includes a distal ablation assembly (21) that can be disposed at least at the distal end (19) of the distal shaft portion, the distal ablation assembly (21) being configured to deliver thermal energy for ablating the tissue (41) and non-thermal energy for treating the tissue; - at least a shaped mandrel (26) disposed within the ablation catheter (1), the shaped mandrel (26) being insertable into and removable from the internal lumen (118); wherein the shaped mandrel (26) is movable freely relative to the internal lumen (118) so as to avoid any constraint with the distal shaft portion (17) during insertion of the shaped mandrel; wherein the shaped mandrel (26) includes at least a distal mandrel portion (139), and the distal ablation assembly is fixedly disposed at the distal mandrel portion (139); wherein the shaped mandrel (26) includes at least a preformed configuration, and the shaped mandrel (26) is reversibly deformable between at least a straight loading configuration and the preformed configuration; wherein the shaped mandrel (26) is slidable from a fully inserted position of the mandrel to a maximum exposed position of the mandrel outside the distal end (19) of the distal shaft portion; wherein in the fully inserted position of the mandrel, the shaped mandrel (26) is in the straight loading configuration; wherein in the maximum exposed position of the mandrel, the shaped mandrel (26) is in the preformed configuration; wherein the shaped mandrel (26) includes a proximal mandrel portion (138), and the proximal mandrel portion (138) is disposed outside the internal lumen (118) such that the shaped mandrel (26) can be driven by a user; Wherein, the elongate shaft (13) includes a proximal shaft end (15), wherein the ablation catheter (1) includes a steering device (144) attached to the proximal shaft end (15), wherein the ablation catheter (1) includes a handle (103), and wherein the steering device (144) is connected to the handle (103) and is rotatable relative to the handle (103) such that rotation of the steering device (144) relative to the handle causes rotation of the elongate shaft (13).

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