Ablation device for treating target area of tissue in organ

Abstract

To provide an ablation device for treating a tissue in an organ.SOLUTION: An ablation catheter includes a catheter slender shaft including a slender shaft distal portion. The catheter slender shaft includes a flexible body passing through a blood vessel of a body. The ablation catheter further includes a shaft ablation assembly arranged in the slender shaft distal portion. The shaft ablation assembly includes a plurality of electrodes fixed to the slender shaft distal portion. All of the plurality of electrodes receive power supply by a single power source via an electric signal S, and transmit both a non-thermal energy for treating a tissue and thermal energy for ablation of the tissue.SELECTED DRAWING: Figure 63

Description

[Technical Field]

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

[0002] More specifically, the present invention relates to a combination system and method for non-thermally treating target tissue and thermally ablating tissue. The tissue may be any pathology, such as a patient with atrial fibrillation (i.e., AF), where the action potential of cardiac cells is abnormal, typically phases 0 through 3. The tissue may also be tissue where blocking of a refractory wavefront is deemed necessary to interrupt or prevent irregular arrhythmias in the patient.

[0003] The present invention generally relates to an ablation system and method for performing targeted tissue ablation in a patient. In particular, the present invention provides a catheter that delivers radio frequency (RF) and / or irreversible electroporation (IRE), which occurs when a powerful pulsed electric field (PEF) permeabilizes cell membranes, disrupting cellular homeostasis and causing cell death. The irreversible electroporation (IRE) energy creates safe and precise lesions in targeted tissue that can induce cardiac arrhythmias. [Background technology]

[0004] The applications of PEF in cardiology are vast, including atrial fibrillation, ventricular fibrillation, septal ablation, and targeting of vasculature. PEF has attractive properties, including the ability to be tissue-specific and non-thermal. The present invention provides a novel catheter design for delivering IRE / PEF to cardiac tissue.

[0005] Pulsed electric fields (PEF) refer to the application of intermittent, high-intensity electric fields for short periods (microseconds or nanoseconds), resulting in electroporation of cells and tissues. Electroporation is a process in which an applied electric field (i.e., PEF) leads to the formation of pores in cell membranes. Pore formation results in permeability that can be reversible or irreversible, depending on the parameters of the applied PEF. In reversible electroporation, cells remain viable, providing the basis for electrochemotherapy and gene electrotransfer. See references. 1)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, 2)Heller R,Heller LC.Gene Electrotransfer Clinical Trials.Adv Genet.2015;89:235-62,3)Neumann E, Schaefer-Ridder M, Wang Y, Hofschneider P. Gene transfer into mouse lyoma cells by electroporation in high electric fields.EMBO J.1982;1:841-5.

[0006] Electroporation is a phenomenon in which a high-voltage electric field (PEF) (generated by a high-voltage current) is applied to cells, resulting in the formation of pores in the cell membrane and subsequent increased cell permeability. The electric field is most commonly generated by a high-voltage direct current delivered between two or more electrodes. When the electric field is applied, a charge is established across the lipid bilayer, and once a critical threshold is reached (dependent on the transmembrane voltage), electroporation occurs. In contrast, irreversible electroporation (IRE) renders cells and tissues nonviable due to activation of the programmed cell death cascade. IRE is an established treatment for solid tumors. However, given the limitations of current heat-based approaches, PEF may also be useful in cardiology, particularly cardiac ablation. PEF can create lesions without tissue heating, preserving critical surrounding structures by selectively targeting cells and tissues.

[0007] Tissue ablation is used in many medical procedures to treat patients. Ablation can be performed to remove or modify unwanted tissue, such as diseased cardiac cells. Ablation procedures can also include modifying tissue without removal, such as stopping electrical function in specific areas in the chain of electrical propagation through cardiac tissue in patients with arrhythmias. Ablation can be performed by passing energy, such as electrical energy, through one or more electrodes, causing tissue death where the electrodes contact. Ablation procedures can be performed on patients with certain cardiac arrhythmias, such as atrial fibrillation (AF), by ablating tissue within the heart.

[0008] Mammalian organ function typically occurs when electrical activity is spontaneously generated by the sinoatrial node, the cardiac pacemaker. This electrical impulse propagates throughout the right atrium and then through the Bachmann bundle to the left atrium, stimulating the atrial myocardium to contract. The conduction system consists of specialized cardiac myocytes. Cardiac myocytes have a negative membrane potential at rest. Suprathreshold stimulation triggers the opening of voltage-gated ion channels and the influx of cations into the cell. Positively charged ions entering the cell trigger the depolarizing action potential. Similar to skeletal muscle, depolarization triggers the opening of voltage-gated calcium channels and the release of Ca2+ from the transverse tubules. This calcium influx triggers calcium-induced calcium release from the sarcoplasmic reticulum, and the free Ca2+ triggers muscle contraction. After a delay, potassium channels reopen, and the resulting influx of K+ from the cell triggers repolarization to the resting state. This transmission of the electrical impulse propagates through the heart chambers. Disruption of this electrical conduction can lead to organ dysfunction. One particular area where electrical impulse transmission is important for proper organ function is in the heart, where it causes the atria to contract, leading to the pumping of blood into the ventricles in a pulse-synchronous manner.

[0009] Atrial fibrillation (AF) refers to a type of cardiac arrhythmia in which there is disorganized electrical conduction in the atria, causing rapid, uncoordinated atrial contractions, resulting in ineffective and unsynchronized pumping of blood into the ventricles. During AF, the atrioventricular node receives electrical impulses from multiple locations throughout the atria, not just the sinoatrial node. These abnormal signals overwhelm the atrioventricular node, generating an irregular and rapid heartbeat. As a result, blood may pool in the atria, increasing the likelihood of blood clot formation. Major risk factors for AF include age, coronary artery disease, rheumatic heart disease, hypertension, diabetes, and thyrotoxicosis. AF affects 7% of the population over the age of 65.

[0010] Treatment options for atrial fibrillation are limited. Lifestyle modifications only help individuals with lifestyle-related AF. Pharmacological therapy manages AF symptoms, often has more dangerous side effects than AF, and does not cure AF. Cardioversion attempts to restore normal sinus rhythm, but disease progression increases the rate of AF recurrence. Furthermore, if there is a blood clot in the atrium, cardioversion can cause the clot to leave the heart and travel to the brain (causing a stroke) or other parts of the body. What is needed are new ways to treat AF and other conditions involving disordered electrical conduction.

[0011] Various ablation techniques have been proposed to treat AF, including Cox maze ablation procedures, linear ablation of various regions of the atrium, and circumferential ablation of the pulmonary vein ostia. Cox maze and linear ablation procedures are lengthy and require several hours to complete. Current pulmonary vein ostia ablations have proven ineffective in the long term. All ablation procedures carry the risk of inadvertently damaging non-target tissue, such as the esophagus, while ablating tissue in the left atrium of the heart. Therefore, improved atrial ablation products and techniques are needed to create effective lesions in a safe manner.

[0012] The applications of non-thermal and thermal ablation in cardiology are vast and include the treatment of patients with atrial fibrillation, ventricular fibrillation, septal ablation, and vascular structural disease. Ablation has attractive features, including the ability to be tissue specific.

[0013] Medical cardiac ablation techniques are known in the art and include treatments such as radio frequency (RF), focused ultrasound such as high intensity ultrasound beams, microwaves, lasers, thermoelectric heating, traditional heating methods using electrodes using direct current (DC) or alternating current (AC), as well as the application of heated fluids and cryotherapy (such as cryotherapy, also known as cryotherapy or cryoablation).

[0014] Solutions are known from the following documents: US8641704B2, US8475449B2, US2010152725A1, US2010152725A1, US8948865B2, US2008281314A1, US8540710B2, US2019038171A1, US8221411B2, US2016051324A1, US2015327994A1, WO2017192804A1, US2020229866A1, WO2019023280A1.

[0015] In many of these procedures, an energy delivery device, such as a probe, with or without a needle, is inserted into the target tissue to cause destruction of the target region of cardiac tissue through the application of energy, such as thermal energy, non-thermal energy, and energy associated with cryoablation procedures. Insertion of the energy delivery device into a cardiac chamber or other organ is typically accomplished through an elongated track created from a point inferior to the heart. The elongated track or access tube is defined as the space created by insertion of the device, extending from the point of skin puncture to the target tissue. When the energy delivery device is removed, it is pulled back along the elongated track or access tube previously created to allow for insertion of the energy delivery device.

[0016] Before the delivery device is withdrawn, tissue immediately adjacent to the energy delivery device is ablated. This creates a localized zone around the ablation element, maximizing the probability of death at the desired tissue location. It is known in the art that electrically induced thermal ablation, such as RF, can be used to effectively ablate a tissue site in a continuous, localized manner when an energy delivery device is placed on the tissue surface. RF can cause coagulation necrosis of the surrounding margin of normal tissue, while the hyperthermic state causes cellular injury, such as coagulation of cytoplasmic enzymes and damage to histone complexes, ultimately leading to cell death. While these tissue treatments and systems can effectively ablate large volumes of target tissue, each technology has limitations. One commonly cited challenge using these procedures during cardiac ablation involves heat sinking, where heat generated at the ablation element is removed / dissipated by cooler blood flow over the element, whereas the process can include blood flow in one aspect. This heat dissipation effect can alter both the shape and maximum volume of tissue ablated. After treating the target tissue region with the energy delivery device, when the energy delivery device is removed from the target tissue region, the energy delivery device can be placed in a new, unablative site requiring treatment.

[0017] More recently, irreversible electroporation (IRE) has been used as an alternative to the above-mentioned procedures for ablation of cardiac or organ tissue. However, while IRE can be a non-thermal method for causing cell death, it is not ideal for coagulation, particularly as it does not cause electrically induced thermal coagulation, highlighting the importance of using alternative sources, such as RF or long DC pulses, for heating the tissue site. Instead, IRE involves the application of electrical pulses to target tissue in the microsecond to millisecond range, which can result in non-thermally generated defects in cell membranes of nanoscale size. These defects can lead to disruption of cell membrane homeostasis, thereby causing irreversible cell membrane permeabilization that induces cell necrosis without increasing the temperature of the tissue ablation zone. During IRE ablation, connective tissue and scaffolding structures are left intact, leaving surrounding organs, structures, vasculature, and connective tissue intact. In non-thermal IRE (hereafter also referred to as non-thermal IRE), cell death is mediated by a non-thermal mechanism, thus negating the heat sink issue associated with many ablation techniques. Thus, the benefit of IRE, which allows for focused treatment without thermal effects with tissue sparing, can be effectively used in combination with thermal therapies such as RF, which has proven effective in preventing bleeding at the ablation site, and which (in this exemplary embodiment) also allows the user to utilize a determined RF level, resulting in possible ablation and possible coagulation, which is important because IRE does not effectively coagulate when dealing with large tissue areas. In this way, the newly discovered benefits of IRE can be effectively utilized with known techniques of non-thermal injury, with the added benefit of choosing between RF and no RF.

[0018] While IRE has clear advantages, there are also benefits to utilizing thermal ablation during therapeutic procedures. Prior to the disclosure of the present invention, no invention had been proposed that could solve the problem of non-thermally ablating a target region of cardiac or organ tissue while maintaining the integrity of the surrounding tissue and effectively switch to a device for effectively thermally ablating tissue along an ablation track. Certain proposed embodiments utilize an energy delivery device powered by a single energy source capable of applying various forms of energy, and then, to maximize treatment outcomes, the same energy delivery device, powered by different forms of energy from the same energy source, is used to ablate a tissue track during a medical procedure for the treatment of arrhythmia. As shown, IRE offers advantages for non-thermal cell death, while the thermal mechanism offers advantages for not only preventing seeding but also effectively resulting in coagulation. There is a need for systems and methods that can provide this combination of non-thermal / thermal tumor ablation and can switch between non-thermal IRE energy delivery and thermal energy delivery to increase the efficiency and effectiveness of tumor ablation and prevent tissue tracks.

[0019] Thus, there remains a strong need to simplify the treatment and ablation of tissue, particularly cardiac tissue, to speed up treatment and reduce intervention times. Summary of the Invention [Problem to be solved by the invention]

[0020] The present invention provides novel assemblies or devices and methods for delivering non-thermal and thermal energy to cardiac tissue. [Means for solving the problem]

[0021] It is an object of the present invention, in certain embodiments, to provide a combination treatment system having at least one energy delivery device, i.e., ablation catheter 1, and at least one power or energy or power source, i.e., a 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 either 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 in a thermal form to ablate tissue in a target region of tissue and along a track.

[0022] It is a further object of the present invention to provide a method for effectively ablating a target region of tissue using non-thermal IRE energy and thermal energy, comprising positioning at least one energy delivery device coupled to a single power source within the target region of tissue, applying IRE energy from the power source to the energy delivery device used to ablate the target region of tissue while preventing damage to surrounding structures, then switching from IRE energy to thermal energy using the same power source, and positioning the energy delivery device while ablating the tissue with thermal energy, such as RF energy, to enable focal tissue ablation and safe energy delivery used, among other things, during therapeutic procedures to coagulate tissue and prevent bleeding.

[0023] Described herein is a system and method 3 for selectively ablating tissue, the system 3 comprising an ablation catheter 1 and a single power source 4 .

[0024] According to an alternative embodiment, the method includes applying IRE to ablate and / or treat tissue, along with providing an alternative form of energy (such as thermal energy) to effectively ablate tissue from the same ablation device and the same energy source. The method includes providing at least one energy source, i.e., a single power source 4, having at least a non-thermal energy source 6 and a thermal energy source 7; providing at least one probe, i.e., an ablation catheter 1, configured to be selectively operably coupled to a desired one of the at least one energy sources; positioning at least a portion of the at least one probe within a desired region of the heart or organ via the probe; selectively coupling the at least one probe to the non-thermal energy source; selectively energizing the non-thermal energy source and applying non-thermal energy from the non-thermal energy source to at least a portion of the desired region to ablate at least a portion of the desired region; selectively coupling the at least one probe to a thermal energy source; retracting the at least one probe from the desired region; and selectively energizing the thermal energy source and applying thermal energy during at least a portion of the retraction of the at least one probe to ablate tissue substantially adjacent to the probe track.

[0025] According to an alternative embodiment, there is provided herein a system 3 for selectively ablating tissue, the system 3 comprising 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 8 for selectively coupling the probe to a desired one of the at least one energy source, means 11 for selectively energizing the non-thermal energy source of the at least one energy source to apply non-thermal energy to at least a portion of a desired region to ablate at least a portion of the desired region, and means 12 for selectively energizing the thermal energy source of the at least one energy source during retraction of the at least one probe to thermally ablate tissue substantially adjacent to the probe track.

[0026] According to an alternative embodiment, a unique multi-electrode and multi-function ablation catheter and ablation catheter system, i.e., ablation assembly or device 100, and method for mapping and ablating myocardial tissue within a patient's heart chamber are provided. Electrocardiogram signal sites (e.g., sites with abnormal signals) or combinations of sites discovered during this placement can be ablated. In an alternative embodiment, the ablation catheter and system can be used to treat non-cardiac patient tissue, such as, for example, tumor tissue, renal artery nerves, etc.

[0027] According to an alternative embodiment, a probe for performing a medical procedure on a patient, e.g., an ablation catheter 1, is provided. The ablation catheter 1 comprises an elongate shaft 13 with a proximal portion 14 including a proximal end 15 and a distal end 16, and a distal portion 17 with a proximal end 18 and a distal end 19. The elongate shaft 13 further comprises 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 proximal 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 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 41.

[0028] According to alternative embodiments, the distal portion 17 is configured to be circular and can be deflected in one or more directions with one or more deflection shapes and geometries 24. The deflection geometries 24 can be similar or symmetrical deflection geometries, or the deflection geometries can be dissimilar or asymmetrical deflection geometries. The shaft, i.e., the 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 installing or removing a shape-setting mandrel 26. The elongate shaft 13 can include a difference in shaft stiffness along its length. The elongate shaft 13 can include a shape-setting mandrel 26 within the shaft, i.e., the ablation catheter 1, configured to effect or enhance the deflection (steering and shape) of the distal portion 17, for example, to maintain deflection in a single plane. The shaft, i.e., the ablation catheter, may have variable material properties, such as an asymmetric joint 27 between two sections, an integral member 28 fixedly attached within the wall or to the shaft, a variable braid 29, or other variations used to create multiple deflections, such as deflections of asymmetric deflection geometries.

[0029] According to alternative embodiments, distal ablation assembly 21 may be fixedly attached to the distal end of distal section 19 or may be advanceable from distal shaft 17, such as via control port 30. Distal ablation assembly 21 may comprise 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. Distal ablation assembly 21 may include an ablation element shape-setting mandrel carrier assembly 33, or simply a shape-setting mandrel 26, which may be changeable from a compact geometry to an expanded geometry, such transition caused by, for example, advancement and / or retraction of a control shaft.

[0030] According to alternative embodiments, shaft ablation assembly 20 may include a single ablation element 31 or multiple ablation elements 32, or shaft electrodes 127, preferably 5-10 ablation elements fixedly attached to the shaft or shape-setting mandrel. The ablation elements may have a profile that is flush with the surface of the shaft, or more preferably, the outer diameter 35 of the shaft between the electrode elements, i.e., shaft outer diameter 35, is slightly smaller than the diameter of the ablation electrodes 36, i.e., shaft electrode outer diameter 36, so that the distal end of the catheter is more flexible.

[0031] 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 dissimilar 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 90° apart inside the ablation element. The ablation elements can include means for dissipating heat 38, such as increased surface area. According to alternative embodiments, one or more ablation elements are configured with a tubular geometry, with a wall thickness to outer diameter ratio approaching a 1:15 ratio. According to alternative embodiments, one or more ablation elements are configured to record or map tissue electrical activity, such as for electrocardiogram mapping. According to alternative embodiments, one or more ablation elements are configured to deliver pacing energy, such as energy delivered to pace a patient's heart.

[0032] According to alternative embodiments, the ablation catheters of the present invention may be used to treat one or more medical conditions by delivering ablation energy to tissue, including cardiac arrhythmias, cancer, and other medical conditions where removal or modification of tissue improves the health of the patient.

[0033] According to an alternative embodiment, a kit of ablation catheters is provided, namely, ablation catheter kit 300. A first ablation catheter 1 has a distal portion that can be deflected into at least two symmetrical geometries. A second ablation catheter 1' has a distal portion that can be deflected into at least two asymmetrical geometries.

[0034] According to an alternative embodiment, a method for treating proximal, persistent, or long-term persistent atrial fibrillation is provided. The ablation catheter 1 of the present invention can be placed in a patient's coronary sinus, for example, to map electrograms and / or ablate tissue, and subsequently placed in the left or right atrium for electrogram mapping and / or tissue ablation. 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 valve isthmus.

[0035] According to an alternative embodiment, a method of treating atrial flutter is provided. An ablation catheter of the present invention can be used to achieve bidirectional block, such as by placement at one or more locations in the right atrium of the heart 43.

[0036] According to an alternative embodiment, 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, between the coronary sinus and the inferior vena cava, between the superior vena cava and the coronary sinus, and combinations thereof. The catheter can be used to map and / or ablate the sinoatrial node, such as for mapping electrograms and / or treating sinoatrial nodal tachycardia.

[0037] According to an alternative embodiment, a method of treating ventricular tachycardia is provided, in which an ablation catheter of the present invention is placed in the left or right ventricle of the heart and can induce ventricular tachycardia by delivering pacing energy to ablate tissue to treat the patient.

[0038] According to an alternative embodiment, an ablation catheter having a first geometry larger than a second deflection geometry is provided via a shape-setting mandrel. The ablation catheter is placed in the smaller second geometry to ablate one or more of the following tissue locations: the left atrial septum; tissue adjacent to the left atrial septum; and tissue adjacent to the left atrial posterior wall. The ablation catheter is placed in the larger first geometry to ablate at least the area surrounding the pulmonary veins.

[0039] According to an alternative embodiment, an ablation catheter of the present invention is used to treat both the left and right atria of the heart. The catheter is configured to transition to a geometry having a first shape-setting mandrel and / or deflection geometry and a second shape-setting mandrel and / or deflection geometry, the first geometry being different from the second geometry. The catheter is used to ablate tissue in the right atrium using at least the first geometry and to ablate tissue in the left atrium using at least the second geometry.

[0040] According to an alternative embodiment, a catheter for performing a medical procedure on a patient is provided. The catheter, i.e., catheter assembly or device 100, comprises an elongate shaft with a proximal portion including a proximal end and a distal end, and a distal portion with a proximal end and a distal end. The catheter further comprises a shape-setting mandrel and / or deflection assembly configured to shape the distal portion in a first direction with a first geometry and in a second direction with a second geometry, the first and second geometries being different. The catheter further includes a functional element fixedly attached to the distal portion.

[0041] SUMMARY OF THE INVENTION It is therefore an object of the present invention to provide an ablation device or assembly having structural and functional features that, for example, meet the aforementioned needs and overcome the above-mentioned shortcomings associated with prior art devices. [Effects of the Invention]

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

[0043] Some advantageous embodiments are the subject matter of the dependent claims. [Brief explanation of the drawings]

[0044] Further features and advantages of the present invention will become apparent from the description given below of exemplary embodiments thereof, given as non-limiting examples, with reference to the attached drawings, in which:

[0045] [Figure 1] FIG. 1 is a perspective view of an ablation assembly according to one embodiment of the present invention showing an ablation catheter having an elongated shaft and a shape-setting mandrel disposed within the ablation catheter. [Figure 2] 2 is a detailed view of the ablation assembly of FIG. 1 showing a distal portion of the elongate shaft. [Figure 3] 2 is a detailed view of the ablation assembly of FIG. 1 showing the handle and a steering device connected to the handle and the elongated shaft. [Figure 4] 1 illustrates an ablation assembly according to the present invention in which the elongated shaft and steering device have been omitted to show the shape-setting mandrel partially inserted into the handle, the shape-setting mandrel having a bent pre-formed configuration. [Figure 5] FIG. 5 is a detailed view of the shape-setting mandrel of FIG. 4 showing the mandrel distal portion in a bent preformed configuration. [Figure 6]1 shows an ablation assembly according to the present invention in which the elongated shaft and steering device have been omitted to show the shape-setting mandrel partially inserted into the handle, the shape-setting mandrel having a preformed, helically bent configuration. [Figure 7] FIG. 7 is a detailed view of the shape-setting mandrel of FIG. 6 showing a distal portion of the mandrel in a helically bent preformed configuration. [Figure 8] 10A-10C illustrate different pre-formed configurations of the shape-setting mandrel and ablation assembly of the present invention. [Figure 9] Same as above. [Figure 10] Same as above. [Figure 11] Same as above. [Figure 12] Same as above. [Figure 13] Same as above. [Figure 14] 10A-10C illustrate a sequence for inserting a shape-setting mandrel into a loaded, straight configuration within the elongate shaft of the ablation catheter of FIG. 1, where the shape-setting mandrel slides into a steering device connectable to the handle of the ablation catheter. [Figure 15] Same as above. [Figure 16] FIG. 16 is a partial perspective view of an ablation assembly according to the present invention in which the steering device and elongate shaft of FIGS. 14 and 15 have been omitted to show a proximal portion of a mandrel disposed within a handle of an ablation catheter. [Figure 17] FIG. 10 is a perspective view of an ablation assembly according to another embodiment of the present invention showing an ablation catheter having an elongated shaft and a shape-setting mandrel having a circular preformed configuration disposed within the ablation catheter. [Figure 18] 2 is a detailed view of the ablation assembly of FIG. 1 showing a distal portion of the elongate shaft. [Figure 19]1 is a perspective schematic view of a distal shaft portion of an ablation catheter assembly according to the present invention, showing the locking mechanism between the shape-setting mandrel and the distal shaft portion. FIG. [Figure 20] 20 shows in detail the shape-setting mandrel of FIG. 19 having a ball-shaped tip. [Figure 21] 20 is a longitudinal cross-sectional view of the distal portion of the shaft of FIG. 19 showing elements of the locking mechanism in detail. [Figure 22] FIG. 20 is a cross-sectional view of the distal portion of the shaft of FIG. 19, with the shape-setting mandrel omitted. [Figure 23] 20 is a perspective view of the distal portion of the shaft of FIG. 19 with some external elements partially removed and the shape-setting mandrel omitted to show the inner lumen of the catheter. [Figure 24] FIG. 1 is a perspective schematic view of a portion of an ablation catheter showing an electrical connector disposed within the ablation catheter. [Figure 25] FIG. 10 is a perspective view of a distal portion of an ablation assembly according to a further embodiment of the present invention, showing an ablation catheter having an elongate shaft and a shape-setting mandrel having a circular preformed configuration, with the distal portion of the shape-setting mandrel disposed beyond the distal end of the elongate shaft. [Figure 26] FIG. 10 is a perspective view of a distal portion of an ablation assembly according to a further embodiment of the present invention, showing an ablation catheter having an elongate shaft and a shape-setting mandrel having a circular preformed configuration with the distal portion of the shape-setting mandrel disposed beyond the distal end of the elongate shaft, the distal portion of the elongate shaft being deflected in a deflection direction, the shape-setting mandrel comprising a plurality of mandrel electrodes disposed along its length, and the elongate shaft comprising a plurality of shaft electrodes. [Figure 27] FIG. 26 is a side view of the ablation assembly of FIG. 25. [Figure 28] 26 is a cross-sectional view of the ablation assembly of FIG. 25 with the distal portion of the shape-setting mandrel fully inserted into the elongate shaft. [Figure 29] FIG. 29 shows a detail of FIG. 28 showing the electrical connection between the mandrel electrode and the shaft electrode. [Figure 30a] Shown are shape-setting mandrels in a loaded straight configuration, a pre-formed circular configuration, and pre-formed circular and bent configurations, respectively. [Figure 30b] Same as above. [Figure 30c] Same as above. [Figure 31a] 1 shows a plurality of shape-setting mandrels having different pre-formed configurations. [Figure 31b] Same as above. [Figure 32a] Same as above. [Figure 32b] Same as above. [Figure 33a] 1 shows the shape-setting mandrel in preformed circular and bent configurations, as well as in a loaded straight configuration, and the shape-setting mandrel in preformed circular and bent configurations disposed within an ablation catheter. [Figure 33b] Same as above. [Figure 33c] Same as above. [Figure 34a] 1 illustrates two shape-setting mandrels coupled to respective heating elements configured to apply heat to the shape-setting mandrels to modify the shape of the shape-setting mandrels from a loaded configuration to a preformed configuration. [Figure 34b] Same as above. [Figure 35a] 1 illustrates different curves and 2D and 3D configurations of the distal portion of the ablation catheter with a shape-setting mandrel disposed within the distal portion of the ablation catheter. [Figure 35b] Same as above. [Figure 35c] Same as above. [Figure 35d] Same as above. [Figure 36]1 shows an ablation assembly according to the present invention disposed within the heart with the shape-setting mandrel fully inserted into the distal portion of the ablation catheter shaft. [Figure 37] 1 shows an x-ray of an ablation assembly according to the present invention in which the catheter distal section is shape-set in a preformed configuration with the shape-set catheter fully inserted within the catheter distal section. [Figure 38] 1 illustrates a plurality of shaft electrodes according to one embodiment fixedly disposed and spaced apart along a distal portion of a catheter shaft, the shaft electrodes being biased in a circular configuration on the catheter shaft. [Figure 39] 1 shows a shaft electrode disposed along a catheter shaft, the shaft electrode catheter being tubular and forming part of the catheter shaft. [Figure 40] 38 and 39 are shown in a bipolar configuration. [Figure 41] FIG. 1 is a side view of a distal portion of an ablation catheter according to the present invention, comprising multiple shaft electrodes and a tip electrode. [Figure 42a] 42A-42C show transverse and longitudinal cross-sectional views of the ablation catheter of FIG. 41, showing the electrical connections of the electrical wires for connecting one of the shaft electrodes to a single power source. [Figure 42b] Same as above. [Figure 43a] 42A-42C show transverse and longitudinal cross-sectional views of the ablation catheter of FIG. 41, showing the electrical connections of the electrical wires for connecting the tip electrodes to a single power source. [Figure 43b] Same as above. [Figure 44] FIG. 1 is a perspective view of a distal shaft portion of an ablation catheter according to the present invention comprising a plurality of shaft electrodes and a tip electrode, wherein the outer profile or diameter of the shaft electrodes and the outer profile of the tip electrode are larger than the outer profile or diameter of the distal shaft portion. [Figure 45]1 shows x-rays of an ablation assembly according to the present invention, with the catheter distal portion shown in two different shapes and deflections. [Figure 46] FIG. 1 shows a side view of an ablation catheter handle of an ablation assembly according to one embodiment. [Figure 47a] 1A-1C show schematic side views of three different configurations of an ablation catheter, where the ablation catheter has different stiffness along its length, where the ablation catheter is symmetrically deflectable or asymmetrically deflectable, and / or where multiple catheter shaft segments between two electrodes have a first stiffness, the remainder of the distal shaft segment has a second stiffness, and the proximal shaft segment has a third stiffness. [Figure 47b] Same as above. [Figure 47c] Same as above. [Figure 48] 10A-10C show side views of a distal shaft portion and a set of different tip electrodes, each of which can be coupled to the distal shaft portion. [Figure 49] 1A-1C show side views of different shaft distal portions of different ablation catheters. [Figure 50] 10A-10C show perspective views of different distal ablation assemblies that can be coupled to the shaft distal portion. [Figure 51] 1 shows an exploded side view of two parts: a tubular shaft electrode and a distal shaft portion. [Figure 52] 1 shows a schematic side view of an ablation catheter assembly according to one embodiment. [Figure 53] 1A-1C show cross-sectional side views of different ablation catheters and different shape-setting mandrels disposed within the ablation catheters, as well as a shape-setting mandrel having a rounded distal end. [Figure 54] 1 illustrates an example of the operation of an ablation device of the present invention to generate a monopolar electric field from each electrode using a ground electrode. [Figure 55]An example of the operation of an ablation device of the present invention is shown for generating both a monopolar field from each electrode using a ground electrode, and a bipolar field between two adjacent electrodes. [Figure 56] 1 shows a flow diagram of a method of ablation using the ablation assembly of the present invention. [Figure 57] 1A and 1B show a side view and a cross-sectional view, respectively, of a distal portion of a shaft of a catheter, showing a shaft ablation assembly with multiple electrodes, according to a first embodiment. [Figure 58] Same as above. [Figure 59] 10A and 10B show a side view and a cross-sectional view, respectively, of a distal portion of a shaft of a catheter, showing a shaft ablation assembly with multiple electrodes, according to a second embodiment. [Figure 60] Same as above. [Figure 61] 1 illustrates an embodiment of a bipolar electrode comprising a first electrode having an electrode body defining an externally accessible internal compartment of the first electrode, and a second point electrode housed in the internal compartment of the first electrode. [Figure 62a] 1 illustrates an ablation device comprising a single power source, a single control unit and power unit, an ablation catheter, and a shape-setting mandrel disposed within the ablation catheter, shown in three different electrical connection configurations between the ablation catheter and the single power source. [Figure 62b] Same as above. [Figure 62c] Same as above. [Figure 63] FIG. 1 shows a block diagram of a single power supply for an ablation device with a single control unit and power unit. [Figure 64a] 64 shows an example of an electrical signal generated by the single power supply of FIG. 63, including a pulse train. [Figure 64b] Same as above. [Figure 64c] Same as above. [Figure 65]1 illustrates an ablation kit comprising at least an ablation assembly and a set of shape-setting mandrels. [Figure 66] 1 illustrates an ablation catheter kit comprising a first ablation assembly and a second ablation assembly having different deflection configurations. [Figure 67] 1 shows an ablation catheter in schematic cross section along its length, showing steering and conductor wires. DETAILED DESCRIPTION OF THE INVENTION

[0046] The present invention can be more readily understood by reference to the following detailed description, examples, figures, and accompanying text. However, before the present devices, systems, and / or methods are disclosed and described, it should be understood that the present invention is not limited to the particular devices, systems, and / or methods disclosed, unless otherwise specified, and as such may, of course, vary. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0047] The following description of the invention is provided as an enabling teaching of the invention in its best, currently known embodiment. To this end, those skilled in the art will recognize and appreciate that many changes can be made to the various aspects of the invention described herein while still obtaining the beneficial results of the invention. It will also be 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. Thus, those working in the art will recognize that many modifications and variations to the present invention are possible and may even be desirable in particular circumstances and are a part of the present invention. Accordingly, the following description is provided as an illustration of the principles of the invention, not as a limitation thereof. As used throughout, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a "tube segment" can include two or more such tube segments unless the context dictates otherwise. As used herein, the term "plurality" refers to two or more.

[0048] Ranges can be expressed herein as from "about" one particular value and / or to "about" another particular value. When such a range is expressed, another embodiment includes from the one particular value and / or to the other particular value. Similarly, when values ​​are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. It will be further understood that each endpoint of the range is significant both in relation to the other endpoint, and independently of the other endpoint.

[0049] As used herein, the term "optional" or "optionally" means that the subsequently described event or circumstance may or may not occur, and the description includes cases where the event or circumstance occurs and cases where it does not occur.

[0050] The term "distal" is understood to mean away from the physician, toward the body part where the procedure is performed, and "proximal" means toward the physician, away from the body part.

[0051] According to a general embodiment, an ablation device 100 for treating a target region of tissue 41 within an organ 44 comprises an ablation catheter 1 and a single power source 4 .

[0052] The ablation catheter 1 comprises a catheter elongate shaft 13 comprising at least an elongate shaft distal portion 17 .

[0053] The catheter elongate shaft 13 comprises a flexible body 207 that is advanced through a body vessel 208 .

[0054] The ablation catheter 1 further comprises a shaft ablation assembly 20 disposed on the elongate shaft distal portion 17 .

[0055] The shaft ablation assembly 20 includes at least a plurality of electrodes 127 , 113 , or 114 fixedly disposed on the elongate shaft distal portion 17 .

[0056] All of the at least a plurality of electrodes 127, 113, or 114 are powered by the single power source 4 via an electrical signal S to deliver both non-thermal energy for treating tissue 41 and thermal energy for ablation of tissue 41.

[0057] The single power source 4 continuously varies the electrical signal S to power the at least multiple electrodes 127, 113, or 114 to deliver non-thermal energy to thermal energy, or vice versa, or to simultaneously deliver a combination of thermal and non-thermal energy, as required.

[0058] According to an alternative embodiment, the single power supply 4 comprises a single control unit 400 and a power unit 401 for generating the electrical signal S.

[0059] The power unit 401 is electrically connected to all of the at least a plurality of electrodes 127, 113, or 114.

[0060] According to an alternative embodiment, the power unit 401 is driven by a single control unit 400 to continuously vary the electrical energy level associated with the signal S supplied to the electrodes 127, 113, or 114 to deliver from non-thermal energy to thermal energy and vice versa, or to simultaneously deliver a combination of thermal and non-thermal energy.

[0061] According to an alternative embodiment, the power unit 401 comprises a power module 402. The power module 402 comprises:

[0062] a drive circuit block 403 controlled by the single control unit 400 to generate said electrical signal S, starting from a supply voltage signal Vcc provided by the single control unit 400;

[0063] a selection block 404 selectively controlled by the driver block 403 to continuously vary the electrical energy level associated with the signal S;

[0064] Filtering and electrical isolation blocks 405, 406.

[0065] According to an alternative embodiment, the single control unit 400 comprises a microprocessor 407 configured to control a variable high voltage power supply block 408 and a programmable logic controller block 409 .

[0066] The variable high voltage power supply block 408 is configured to provide the supply voltage signal Vcc to the power module 402 to generate the electrical signal S.

[0067] The programmable logic controller block 409 is configured to generate drive signals for controlling the drive circuit block 403 of the power module 402 .

[0068] According to an alternative embodiment, the single control unit 400 further comprises:

[0069] a video interface and push button block 410, 410', controlled by the microprocessor 407, for setting the parameters of the device 100 and displaying selected parameters;

[0070] a watchdog block 411 for controlling the proper functioning of the microprocessor 407;

[0071] An audio interface block 412 for providing audio information representative of the accuracy of the ablation process and / or any errors that have occurred.

[0072] According to an alternative embodiment, the power unit 401 comprises one or more power modules 402 that are identical to one another.

[0073] According to an alternative embodiment, at least one of the electrodes 127, 113 is a monopolar electrode 113, and the monopolar electrode 113 of the at least multiple electrodes is electrically connected to only one power module 402 of the power unit 401.

[0074] 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 of the at least plurality of electrodes is separately electrically connected to a respective power module 402 selectable from among the power modules of the power unit 401.

[0075] According to an alternative embodiment, the electrical signal S supplied to the plurality of 127, 113, or 114 electrodes comprises a pulse train 204.

[0076] According to an alternative embodiment, the single control unit 400 is configured to drive the power unit 401 to modify the pulse duration 203 of each pulse 201 of the pulse train 204 and to vary the electrical energy level associated with the signal S.

[0077] According to an alternative embodiment, the single control unit 400 is configured to drive the power unit 401 to modify the number of pulses 209 of the pulse train 204 and to vary the electrical energy level associated with the signal S.

[0078] According to an alternative embodiment, the single control unit 400 is configured to drive the power unit 401 to modify the time interval 205 between adjacent pulse trains 204 and to vary the electrical energy level associated with the signal S.

[0079] 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 unit 401 by a single wire 210 welded to the monopolar electrode 113.

[0080] 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 unit 401 by two wires 210 welded to the bipolar electrode 114.

[0081] According to an alternative embodiment, at least one electrode of the at least plurality of electrodes 127 comprises two conductive portions N electrically insulated from each other.

[0082] According to an alternative embodiment, at least one electrode of the at least plurality of electrodes 127 comprises four conductive portions N electrically insulated from one another.

[0083] 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.

[0084] According to an alternative embodiment, the electrical signal S supplied to the plurality of 127, 113 or 114 electrodes comprises at least a square wave signal.

[0085] According to an alternative embodiment, the electrical signal S supplied to the plurality of 127, 113 or 114 electrodes comprises a signal obtained by combining, summing or superimposing two or more square wave signals together.

[0086] According to alternative embodiments, the electrical signal S supplied to the plurality of 127, 113, or 114 electrodes comprises a DC signal or an AC signal, or a combination of a DC signal and an AC signal.

[0087] According to alternative embodiments, the single power source 4 is powered by a battery or connected to a standard wall outlet on an AC power grid capable of providing 110 volts or 240 volts.

[0088] According to an alternative embodiment, the at least two electrodes 127, 114 electrically connected to form the bipolar electrode 114 comprise:

[0089] a first electrode 114a connected to a first power module 402 of the power unit 401 by a first wire 210a, the first electrode 114a having an electrode body 424 that defines an interior compartment of the first electrode 114a accessible from outside the first electrode 114a;

[0090] A second point electrode 114b connected to a second power module 402 of the power unit 401 by a second wire 210b, the second point electrode 114b being housed in the internal compartment of the first electrode 114a.

[0091] According to an alternative embodiment, a single control unit 400 is configured to drive the power units 401 to generate, in each power module 402, a respective one of the plurality of electrical signals S supplied to the electrodes 127, 113 or 114;

[0092] The microprocessor 407 controls each power module 402 via the programmable logic controller block 409 to select two or more electrical signals S to be supplied to electrodes 127, 113, or 114, thereby modifying the on-state, off-state, and phase angle of each electrical signal S of the plurality of electrical signals so as to generate both a monopolar electric field from each electrode and a bipolar electric field between two adjacent electrodes using a ground electrode 425.

[0093] According to an alternative embodiment, the ablation catheter 1 comprises an elongate shaft 13 having a longitudinal main direction XX. The elongate shaft 13 includes at least a distal shaft portion 17. The distal shaft portion 17 includes a distal shaft end 19.

[0094] The ablation catheter 1 includes an inner lumen 118 disposed within the elongate shaft 13 .

[0095] The ablation catheter 1 includes a shaft ablation assembly 20 fixedly disposed on the shaft distal portion 17, the shaft ablation assembly 20 being configured to deliver both thermal energy for ablating the tissue 41 and non-thermal energy for treating the tissue 41.

[0096] The device 100 includes at least a shape-setting mandrel 26 disposed within the ablation catheter 1. The shape-setting mandrel 26 is insertable into and removable from the inner lumen 118.

[0097] The shape-setting mandrel 26 is free to move relative to the inner lumen 118, avoiding any constraint with the shaft distal portion 17 during insertion of the shape-setting mandrel.

[0098] The shape-setting mandrel 26 includes at least a pre-formed configuration, and the shape-setting mandrel 26 is reversibly transformable between at least a straight-loaded configuration and the pre-formed configuration.

[0099] When the shape-setting mandrel 26 is fully inserted into the shaft distal portion 17, the shape-setting mandrel 26 is configured to shape-set the shaft distal portion 17 into the preformed configuration.

[0100] According to an alternative embodiment, the shaft distal portion 17 is elastically deformable.

[0101] According to an alternative embodiment, when the shape-setting mandrel 26 is fully inserted into the distal shaft portion 17, the distal shaft portion 17 is configured to conform to the molded configuration.

[0102] According to an alternative embodiment, when the shape-setting mandrel 26 is fully inserted into the shaft distal portion 17, it is defined as the fully mandrel inserted position.

[0103] The shape-setting mandrel 26 slides within the inner lumen 118 toward the mandrel fully inserted position, with the shape-setting mandrel 26 configured to variably shape-set the shaft distal portion 17 passing from the loaded straight configuration to the pre-formed configuration.

[0104] According to an alternative embodiment, when the shape-setting mandrel 26 is fully inserted into the shaft distal portion 17, the shape-setting mandrel 26 deforms the shaft distal portion 17 at least in the shaft distal portion plane P.

[0105] According to an alternative embodiment, the ablation catheter 1 comprises a catheter bend portion 120 proximal to the shaft ablation assembly 20, the catheter bend portion 120 being configured to provide an elbow that steers the shaft distal portion plane P relative to the main longitudinal direction XX.

[0106] According to an alternative embodiment, at least when the shape-setting mandrel 26 is fully inserted into the shaft distal portion 17, said shaft distal portion 17 forms an acute angle ALFA with respect to the main longitudinal direction XX of the shaft.

[0107] According to an alternative embodiment, where the shape-setting mandrel 26 is configured to bend at the catheter bend section 120 when the shape-setting mandrel 26 is fully inserted into the shaft distal section 17 .

[0108] According to an alternative embodiment, the shape-setting mandrel 26 in the preformed configuration includes a mandrel bend portion 146 that is disposed at a corresponding location of the catheter bend portion 120 that executes the catheter bend portion 120 when the shape-setting mandrel 26 is fully inserted into the shaft distal portion 17.

[0109] According to an alternative embodiment, when the shape-setting mandrel 26 is fully inserted into the shaft distal portion 17, the shaft distal portion 17 assumes a circular configuration.

[0110] According to an alternative embodiment, the shape-setting mandrel 26 comprises a mandrel elastic 119 that can be deformed to at least the straight-loaded configuration and returned to the pre-formed configuration.

[0111] According to an alternative embodiment, the shape-setting mandrel 26 is made from at least a shape memory alloy.

[0112] According to an alternative embodiment, the assembly 100 includes a mandrel heating element 121 coupled to the shape-setting mandrel 26, the heating element 121 configured to apply heat to the shape-setting mandrel 26 such that the shape-setting mandrel 26 changes its shape configuration from the loaded linear configuration to the pre-formed configuration.

[0113] According to an alternative embodiment, the ablation assembly 100 includes a locking mechanism 122 configured to lock the shape-setting mandrel 26 to the shaft distal portion 17 when the shape-setting mandrel 26 is in the mandrel fully inserted position.

[0114] According to an alternative embodiment, the locking mechanism 122 comprises a retaining element 123 that reversibly locks the shape-setting mandrel 26 in the fully mandrel-inserted position.

[0115] According to an alternative embodiment, the retaining element 123 is configured to release the shape-setting mandrel 26 from the mandrel fully inserted position when a pulling force is applied to the shape-setting mandrel 26 .

[0116] According to alternative embodiments, the retaining element 123 is made from a metal, a metal alloy, rubber, or a polymer.

[0117] According to an alternative embodiment, the shape-setting mandrel 26 includes a ball-shaped tip 125 configured to engage the retaining element 123 when the shape-setting mandrel 26 is in the fully inserted position.

[0118] According to an alternative embodiment, the shape-setting mandrel 26 includes a mandrel distal portion 139 .

[0119] According to an alternative embodiment, the mandrel distal portion 139 comprises a mandrel seat 140 and the retaining element 123 is fixed to the shape-setting mandrel 26 and is partially received in the mandrel seat 140 .

[0120] According to an alternative embodiment, the inner lumen 118 proximal to the distal end 19 of the shaft distal portion presents a neck portion 141, and the retaining element 123 interferes with the neck portion 141 to lock the shape-setting mandrel 26 in the mandrel fully inserted position.

[0121] According to an alternative embodiment, the retaining element 123 is an O-ring and the mandrel seat 140 is toroidal.

[0122] According to alternative embodiments, shaft distal portion 17 is deflectable in one or more directions in one or more deflection shapes and geometries.

[0123] According to an alternative embodiment, the pre-formed configuration of the shape-setting mandrel 26 is configured to maintain deflection of the shaft distal portion 17 in a single plane.

[0124] According to alternative embodiments, the deflection direction is a symmetric deflection geometry or an asymmetric deflection geometry.

[0125] According to an alternative embodiment, the elongate shaft 13 has a variation in shaft stiffness along its length.

[0126] According to an alternative embodiment, the elongate shaft 13 includes a proximal shaft portion 14 .

[0127] According to an alternative embodiment, the proximal shaft portion 14 is stiffer than the distal shaft portion 17 .

[0128] According to an alternative embodiment, the elongate shaft 13 includes a shaft transition portion 126 disposed between the shaft proximal portion 14 and the shaft distal portion 17 .

[0129] According to an alternative embodiment, the shaft transition section 126 is stiffer than the shaft distal section 17 and less stiff than the shaft proximal section 14 .

[0130] According to an alternative embodiment, the elongated shaft 13 comprises shaft portions having different stiffnesses, and the elongated shaft 13 comprises at least one circumferentially asymmetric stiffness portion between two of the shaft portions having different stiffnesses.

[0131] According to alternative embodiments, the elongate shaft 13 is made of Pebax®, or the elongate shaft 13 is braided and made of stainless steel flat wire braid and / or Nylon® strand braid.

[0132] According to an alternative embodiment, the ablation catheter 1 includes at least one steering wire 25 configured to deflect the shaft distal portion 17 in one or more deflection directions, the at least one steering wire 25 being fixedly connected to the shaft distal portion 17.

[0133] According to an alternative embodiment, the at least one steering wire 25 includes a wire proximal extension 142 disposed externally relative to the shaft proximal portion 14 .

[0134] According to an alternative embodiment, the wire proximal extension 142 includes a wire gripping portion 143 configured to pull at least one steering wire 25 for steering the shaft distal portion 17 having the shape-setting mandrel 26 fully inserted within the shaft distal portion 17.

[0135] According to an alternative embodiment, the shaft distal portion 17 includes a shaft distal portion proximal end 18 .

[0136] According to an alternative embodiment, the ablation catheter 1 comprises at least two steering wires 25 .

[0137] According to an alternative embodiment, a first of the at least two steering wires 25 is fixedly connected proximal to the distal end 19 or the proximal end 18 of the distal shaft portion.

[0138] According to an alternative embodiment, a second steering wire of the at least two steering wires 25 is fixedly connected proximal to the distal shaft portion proximal end 18 or the distal shaft portion distal end 19 .

[0139] According to an alternative embodiment, a third of the at least two steering wires 25 is fixedly connected proximal to the distal end 19 or the proximal end 18 of the distal shaft portion.

[0140] According to an alternative embodiment, a fourth steering wire of the at least two steering wires 25 is fixedly connected proximal to the distal end 19 or the proximal end 18 of the distal shaft portion.

[0141] According to an alternative embodiment, the shape-setting mandrel 26 includes a mandrel proximal portion 138 that is disposed outside the inner lumen 118 such that the shape-setting mandrel 26 is actuatable by a user.

[0142] According to an alternative embodiment, the elongate shaft 13 includes a proximal shaft end 15 .

[0143] According to an alternative embodiment, the ablation catheter 1 includes a steering device 144 attached to the proximal shaft end 15 .

[0144] According to an alternative embodiment, the ablation catheter 1 comprises a handle 103 to which the steering device 144 is connected.

[0145] According to an alternative embodiment, the steering device 144 is drivable in rotation relative to the handle 103 such that rotation of the steering device 144 relative to the handle causes rotation of the elongated shaft 13 .

[0146] According to an alternative embodiment, the steering device 144 includes a through-hole 145 in communication with the inner lumen 118 .

[0147] According to an alternative embodiment, during insertion or removal of the shape-setting mandrel 26 into or from the ablation catheter 1, the shape-setting mandrel 26 passes through the through hole 145, and when the shape-setting mandrel 26 is fully inserted into the shaft distal portion 17, the mandrel proximal portion 138 is outside the steering device 144.

[0148] According to an alternative embodiment, when the shape-setting mandrel 26 is fully inserted into the shaft distal portion 17, the shape-setting mandrel 26 deforms the shaft distal portion 17 at least in the shaft distal portion plane P.

[0149] According to an alternative embodiment, the steering device 140 comprises at least two protrusions 147, the at least two protrusions and the shaft distal portion plane P being coplanar to assist the user in handling the catheter assembly 1.

[0150] According to an alternative embodiment, the ablation assembly 100 comprises, at least at the distal end 19 of the shaft distal portion, a disposable distal ablation assembly 21 .

[0151] According to an alternative embodiment, the distal ablation assembly 21 is configured to deliver both thermal energy to ablate the tissue 41 and non-thermal energy to treat the tissue 41 .

[0152] According to an alternative embodiment, the distal ablation assembly 21 includes at least an electrode tip 128 at at least the distal end 19 of the shaft distal portion that is disposable.

[0153] According to an alternative embodiment, the shaft electrodes 127 are spaced apart from one another along the shaft distal portion 17 .

[0154] According to an alternative embodiment, the shaft ablation assembly 20 is also configured to map tissue 41 .

[0155] According to an alternative embodiment, the electrode tip 128 is atraumatic and has an outer surface that is shaped so as to be resiliently biased in a rounded configuration.

[0156] According to alternative embodiments, the shaft electrode 127 and the electrode tip 128 comprise at least a monopolar electrode 113 and / or at least a bipolar electrode 114 .

[0157] According to an alternative embodiment, the distal ablation assembly 21 includes at least one thermocouple 37 .

[0158] According to an alternative embodiment, the shaft ablation assembly 20 includes at least one thermocouple 37 .

[0159] According to an alternative embodiment, the shaft electrodes 127 are 5 to 10 electrodes fixedly attached to the shaft distal portion 17 .

[0160] According to an alternative embodiment, the electrode tip 128 is fixedly disposed at least at the distal end 19 of the shaft distal portion.

[0161] According to an alternative embodiment, the electrode tip 128 is removable from the shaft distal portion distal end 19 and replaceable with a set of tip electrodes 39, the tip electrodes of which have different shapes and sizes.

[0162] According to alternative embodiments, the shaft electrodes 127 are spaced along the length of the shaft distal portion 17 in one of the following configurations: 1-5cm spacing, and / or 2-3cm apart, or When a voltage of 4000 volts is applied, the spacing is about 2 to 5 mm, preferably 4 mm, or When a voltage of 5000 volts is applied, the spacing is approximately 6 mm. and / or Here, each of the shaft electrodes 127 has an exposed length of 20 to 25 mm or 2 to 4 mm at maximum.

[0163] According to alternative embodiments, each shaft electrode of the plurality of shaft electrodes 127 comprises an electrode surface area of ​​about 0.05 cm 2 to about 5 cm 2 or about 1 cm 2 to about 2 cm 2 .

[0164] According to alternative embodiments, each shaft electrode of the plurality of shaft electrodes 127 is configured to deliver an electric field to the target tissue in at least one of the following field strength ranges: 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.

[0165] According to an alternative embodiment, the plurality of shaft electrodes 127 includes a distal shaft electrode 106 that is attached to the shaft distal portion 17 at a distance of 2 to 4 mm from the distal end 19 of the shaft distal portion.

[0166] According to an alternative embodiment, the shaft electrode 127 is cylindrical.

[0167] According to an alternative embodiment, the shaft electrode 127 has a profile that is flush with the surface of the shaft.

[0168] According to an alternative embodiment, the shaft electrodes 127 present a shaft electrode outer diameter 36, and the shaft portion between the shaft electrodes 127 presents an outer shaft diameter 35 that is slightly smaller than the shaft electrode outer diameter 36 so that the shaft distal end is more flexible.

[0169] According to an alternative embodiment, the shaft electrode 127 is resiliently biased in a circular configuration.

[0170] According to an alternative embodiment, the shaft electrode 127 presents a tubular geometry with a wall thickness to outer diameter ratio approaching 1:15.

[0171] According to an alternative embodiment, the plurality of shaft electrodes 127 includes at least a bipolar electrode 114 having a small electrode 130 and a large electrode 131 , the small electrode 130 being isolated from the large electrode 131 .

[0172] According to an alternative embodiment, the distal end 19 of the distal shaft section is open and the shape-setting mandrel 26 is slidable over the outside of the distal shaft section distal end 19 from a fully inserted mandrel position to a fully exposed mandrel position.

[0173] According to an alternative embodiment, the distal ablation assembly 21 is fixedly disposed on the mandrel distal portion 139 .

[0174] According to an alternative embodiment, the distal ablation assembly 21 includes a plurality of mandrel electrodes 132 that are axially spaced along the mandrel distal portion 139 .

[0175] According to alternative embodiments, the mandrel electrodes 132 include at least a monopolar electrode 113 and / or at least a bipolar electrode 114 .

[0176] According to an alternative embodiment, when the shape-setting mandrel 26 is in the fully mandrel inserted position, the shaft electrode 127 is in electrical communication with at least a portion of the plurality of mandrel electrodes 119 .

[0177] According to an alternative embodiment, when the shape-setting mandrel 26 is in the mandrel maximum exposed position, the shaft electrode 127 is electrically disconnected from any power source.

[0178] According to an alternative embodiment, the shape-setting mandrel 26 is slidable outside the distal end 19 of the shaft distal section from a fully mandrel-inserted position in which the mandrel 26 is in the loaded, straight configuration to a fully mandrel-exposed position in which the mandrel is in the pre-shaped configuration.

[0179] The present invention also refers to an ablation kit 200 .

[0180] The ablation kit 200 comprises:

[0181] at least an ablation device 100 according to any one of the preceding embodiments;

[0182] -Set of 134 shape setting mandrels.

[0183] The shape-setting mandrels of the set 134 have different pre-formed configurations.

[0184] The shape-setting mandrels of the set 134 are alternatively disposable and removable in the ablation catheter 1 .

[0185] According to an alternative embodiment, the set of shape-setting mandrels 134 includes at least a first shape-setting mandrel 135 and a second shape-setting mandrel 136 .

[0186] The first shape-setting mandrel 135 has a first pre-formed configuration and the second shape-setting mandrel 136 has a second pre-formed configuration.

[0187] The first pre-shaped configuration is different from the second pre-shaped configuration, resulting in different shapes of the shaft distal portion 17 being implemented depending on which shape-setting mandrel 135, 136 of the set of setting mandrels 134 is disposed in the ablation catheter 1.

[0188] According to an alternative embodiment, at least one shape-setting mandrel of the set of shape-setting mandrels 134 has a circular pre-formed configuration.

[0189] According to an alternative embodiment, at least one shape-setting mandrel of the set of shape-setting mandrels 134 has a helically pre-formed configuration.

[0190] According to an alternative embodiment, at least one shape-setting mandrel of the set of shape-setting mandrels 134 has a linear pre-formed configuration.

[0191] According to an alternative embodiment, at least one shape-setting mandrel of the set of shape-setting mandrels 134 has a circular pre-formed configuration with an elbow.

[0192] The present invention further refers to an ablation catheter kit 300 .

[0193] The ablation catheter kit 300 comprises at least a first ablation assembly 100 and a second ablation assembly 100' according to any of the previously described embodiments.

[0194] The shaft distal portion 17 of the ablation catheter 1 of the first ablation assembly 100 is deflectable into at least two symmetrical geometries.

[0195] The shaft distal portion 17' of the ablation catheter 1' of the second ablation assembly 100' is deflectable into at least two asymmetric geometries.

[0196] The present invention further refers to a method for controlling at least a plurality of electrodes 127, 113, or 114 in an ablation device 100. The ablation device comprises an ablation catheter 1 and a single power source 4 according to any of the previously described embodiments.

[0197] The method includes the following steps.

[0198] generating, by the single power supply 4, an electrical signal S comprising a pulse train 204 for powering all of the electrodes of the at least plurality 127, 113, or 114;

[0199] Modifying the pulse duration 203 of each pulse 201 in the pulse train 204; or

[0200] Modify the number of pulses 209 in the pulse train 204, or

[0201] modifying the time interval 205 between adjacent pulse trains 204;

[0202] Guiding the at least a plurality of electrodes 127, 113, or 114 to deliver non-thermal energy to thermal energy, or vice versa, or to simultaneously deliver a combination of thermal and non-thermal energy.

[0203] Thanks to the proposed solution it is possible to provide a method for configuring an ablation catheter, which method comprises the following steps:

[0204] - providing an ablation device 100 according to any of the above embodiments;

[0205] - inserting the shape-setting mandrel 26 into the inner lumen 118 of the ablation catheter 1 in the loaded, straight configuration;

[0206] - moving the shape-setting mandrel 26 within the inner lumen 118 towards the distal end 19 of the shaft distal portion until the shape-setting mandrel 26 is fully inserted into the shaft distal portion 17;

[0207] - Adapting the shape of the distal shaft portion 17 to the pre-formed configuration of the shape-setting mandrel 26 when the shape-setting mandrel 26 is fully inserted into the distal shaft portion 17 .

[0208] The present invention further refers to a method for multi-set molding an ablation catheter, comprising the steps of: - providing an ablation kit 200, as previously described; - inserting a first shape-setting mandrel 135 into the ablation catheter 1; - conforming the distal shaft portion 17 of the elongate shaft 13 of the ablation catheter 1 to the shape of a first pre-formed configuration of a first shape-setting mandrel 135; - removing the first shape-setting mandrel 135 from the elongate shaft 13 of the ablation catheter 1; - inserting a second shape-setting mandrel 136 into the ablation catheter 1;

[0209] - Conforming the shaft distal portion 17 to the shape of a second pre-formed configuration of a second shape-setting mandrel 136.

[0210] Thanks to the proposed solution it is possible to provide a method for the treatment of proximal, persistent or long-term persistent atrial fibrillation in a patient, comprising the following steps:

[0211] - providing an ablation device 100 according to any of the above embodiments;

[0212] placing an ablation catheter 1 within the patient's coronary sinus, for example to map electrograms and to provide both non-thermal energy for treating tissue and thermal energy for ablation of tissue 41; and thereafter

[0213] - placing the ablation catheter 1 in the left or right atrium to map electrograms and / or deliver both non-thermal energy to treat tissue 41 and thermal energy to ablate tissue 41;

[0214] Here, tissue locations include the fascia around the pulmonary veins, and / or the left atrial roof, and / or the mitral valve isthmus.

[0215] Thanks to the proposed solution it is possible to provide a method for the treatment of atrial flutter in a patient, which comprises the following steps:

[0216] - providing an ablation device 100 according to any of the above embodiments;

[0217] - A step of achieving bidirectional block by placing the ablation catheter 1 at one or more locations in the right atrium of the heart 43 to deliver both non-thermal energy to treat the tissue 41 and thermal energy to ablate the tissue 41.

[0218] Thanks to the proposed solution it is possible to provide a method for ablating tissue of the right atrium of the heart 43, comprising the following steps:

[0219] - providing an ablation device 100 according to any of the above embodiments;

[0220] - placing the ablation catheter 1 at one or more locations in the right atrium and / or left atrium of the heart 43; - Creating an ablation lesion between the superior vena cava and the inferior vena cava and / or the coronary sinus and the inferior vena cava and / or the superior vena cava and the coronary sinus by delivering both non-thermal energy to treat the tissue 41 and thermal energy to ablate the tissue 41.

[0221] Thanks to the proposed solution it is possible to provide a method for the treatment of a patient's sinus node tachycardia, which comprises the following steps:

[0222] - providing an ablation device 100 according to any of the above embodiments;

[0223] - placing the ablation catheter 1 at one or more locations in the right atrium and / or left atrium of the heart 43;

[0224] - Mapping an electrogram of the sinoatrial node and / or mapping and / or ablating the sinoatrial node by delivering both non-thermal energy to treat tissue and thermal energy to ablate tissue.

[0225] Thanks to the proposed solution it is possible to provide a method for the treatment of ventricular tachycardia in a patient, which comprises the following steps:

[0226] - providing an ablation device 100 according to any of the above embodiments;

[0227] - placing the ablation catheter 1 in the left or right ventricle of the heart 43;

[0228] - inducing ventricular tachycardia by delivering pacing energy; - Treating the patient by ablating tissue by delivering both non-thermal energy to treat the tissue 41 and thermal energy to ablate the tissue 41.

[0229] Thanks to the proposed solution it is possible to provide a method for ablation of atrial tissue, which comprises the following steps:

[0230] - providing an ablation device 100 according to any of the above embodiments,

[0231] the shaft distal portion 17 having a first deflection geometry when the shape-setting mandrel 26 is fully inserted into the elongate shaft 13, and the shaft distal portion 17 having a second deflection geometry when the shape-setting mandrel 26 is removed from the shaft distal portion 17, the first deflection geometry being a larger step than the second deflection geometry;

[0232] - placing the ablation catheter 1 against atrial tissue with the shaft distal portion 17 in a second deflection geometry and the shape-setting mandrel 26 outside the distal portion 17;

[0233] ablating one or more of the following tissue locations: the left atrial septum; tissue adjacent to the left atrial septum; and tissue adjacent to the left atrial posterior wall by delivering both non-thermal energy to treat the tissue and thermal energy to ablate the tissue;

[0234] - placing the ablation catheter 1 with the shaft distal portion 17 in a first deflection geometry by fully inserting the shape-setting mandrel 26 into the elongate shaft 13;

[0235] ablation of at least the periphery of the pulmonary vein by delivering both non-thermal energy to treat the tissue 41 and thermal energy to ablate the tissue 41;

[0236] The present invention further refers to the use of a kit according to any of the above embodiments and for treating both the left and right atria of the heart, wherein the ablation catheter 1 of the ablation device 100 is used to ablate tissue in the right atrium using at least a first shape-setting mandrel 135, and the same ablation catheter 1 is also used to ablate tissue in the left atrium using at least a second shape-setting mandrel 136.

[0237] Referring now in detail to the drawings, in which like reference numerals indicate like parts or elements throughout the several views, in various embodiments, and with reference to the included figures, presented herein are exemplary systems and methods for treating cardiac tissue using a combination of IRE and thermal ablation.

[0238] It is configured to be advanced percutaneously (through the septum via a transseptal sheath) into the left atrium and left ventricle of the heart.

[0239] It can be advanced through a sheath (eg, a deflectable or fixed therapeutic sheath) previously placed in the LA.

[0240] The elongate catheter body may be steerable (unidirectional or bidirectional)

[0241] For example, one tension wire

[0242] For example, two tension wires

[0243] For example, they are attached at 180° intervals near the distal tip.

[0244] For example, they are attached at 90° intervals near the distal tip.

[0245] For example, four tension wires

[0246] For example, they are attached at 90° intervals near the distal tip.

[0247] Can be asymmetric steerable curve

[0248] For example, a spring may limit the curve radius in one plane and not in the opposite plane.

[0249] composition

[0250] Preferably PeBax

[0251] Braiding (SS flat wire braiding, nylon strand braiding, combination)

[0252] Preferably, there is a transition from a stiffer proximal end to a less stiff distal end.

[0253] First control shaft (outer)

[0254] Distal end attached to the distal end of a single non-invasive electrode tip

[0255] Distal tip attached to the distal end of a two-part non-invasive electrode tip

[0256] Distal tip attached to the distal end of a quartered non-invasive electrode tip

[0257] a distal end suitably attached to an atraumatic tip electrode;

[0258] The shaft preferably has a lumen for saline flushing.

[0259] The shaft preferably has a lumen for isolating the signal wire.

[0260] The shaft preferably has side port holes spaced 90° apart around its diameter at various locations in the distal section.

[0261] Side-hole ports allow signal lines to pass from inside to outside

[0262] Proximal end attached to handle

[0263] Alternative configuration - the shaft may have one or more electrical (power / signal) wires (connected to the electrodes / thermocouples on a single wire segment)

[0264] Contains multiple electrodes along its length

[0265] Side port allows saline flush to reside within the control shaft lumen

[0266] Hole in the segment - under the electrode - wire passes through the hole

[0267] Cylindrical electrodes are placed 2-4 mm from the distal tip, spaced 2-3 mm apart.

[0268] Second lumen - multipurpose (fluid flush and shape setting mandrel)

[0269] It runs proximally to distally inside the first inner lumen.

[0270] Attached to the proximal end of the handle, with ports for either saline delivery and / or shape setting

[0271] Mandrel

[0272] Attached to a control shaft proximal to the distal electrode

[0273] The proximal end of the shaft, attached to a handle for control

[0274] Preferably, it is soft and flexible yet configured to withstand high pressure fluid flow.

[0275] non-invasive electrode tip

[0276] Rounded configuration and resiliently biased

[0277] Contains at least one thermocouple

[0278] For example, thermocouples are essential for electrodes.

[0279] Cylindrical shaft electrode

[0280] Resilient biased in a circular configuration

[0281] Hole in the segment - under the electrode - wire passes through the hole

[0282] Contains at least one thermocouple

[0283] For example, thermocouples are essential for electrodes.

[0284] electrode

[0285] composition

[0286] Platinum, platinum / iridium

[0287] >2mm length

[0288] <4mm length

[0289] Preferably includes a thermocouple

[0290] Copper Wire and Constantine Wire

[0291] Welded to the inner part of the electrode

[0292] Alternative Designs - Electrodes may have fins or other heat sinks

[0293] handle

[0294] On the proximal end of the catheter body

[0295] Lever (single) - connected to two pull wires to deflect the tip

[0296] First sliding knob for asymmetric steering engagement

[0297] Attach to the first control shaft

[0298] Attached to the second control shaft

[0299] Preferred - Includes energy activation control

[0300] Alternative - Single Control Shaft

[0301] The atraumatic electrode is attached to either the distal or proximal end of the tip.

[0302] According to an alternative embodiment, the present invention provides a catheter 1 or ablation assembly 100 for performing ablation of various targeted tissues 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 118 extending at least partially therebetween. The catheter is for performing intracardiac procedures and is preferably of the type typically used for introduction through the femoral vein in a patient's leg or through a blood vessel in the patient's neck. The catheter is preferably introduceable through a transport tube, such as a transseptal sheath, and preferably has a steerable tip that allows for positioning of the distal portion 17, such as when the distal end of the catheter is within a 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 within the outer surface of the shaft proximal to the distal end. The tip electrode 128 may be fixedly attached to the distal end of the shaft or may be mounted on an advanceable and / or expandable carrier assembly. The carrier assembly may be attached to a coaxially disposed control shaft and slidingly received within the shaft lumen. The carrier assembly is deployable, such as to engage one or more ablation elements against cardiac tissue, typically atrial wall tissue or other endocardial tissue, by activating one or more controls on the handle 103 of the catheter 1. The shaft may include deflection means, such as means operably connected to a control on the catheter handle or via a central lumen in which differently shaped mandrels 26 can be placed, to change the shape of the catheter distal section. The deflection means may deflect the distal portion of the shaft in one or more directions, such as deflection between two symmetrical geometries, two asymmetrical geometries, or a combination thereof.Asymmetry can be caused by differences in radius of curvature, differences in length of curvature, differences in planarity, other different 2D shapes, other different 3D shapes, and the like.

[0303] In particular, according to alternative embodiments, the present invention provides ablation catheters with multiple electrodes that deliver electrical energy, such as radiofrequency (RF) and / or irreversible electroporation (IRE), which occurs when intense pulsed electric fields (PEF) permeabilize cell membranes, disrupting cellular homeostasis and causing cell death. Monopolar, bipolar, or combined monopolar-bipolar RF energy and methods of using these devices to treat conditions such as paroxysmal atrial fibrillation, chronic atrial fibrillation, atrial flutter, supraventricular tachycardia, atrial tachycardia, ventricular tachycardia, and ventricular fibrillation.

[0304] Normal function of the heart depends on proper electrical impulse generation and transmission. In certain heart diseases (e.g., atrial fibrillation), proper electrical generation and transmission is blocked or otherwise abnormal. The ablation catheter and RF generator of the present invention can be employed to prevent improper impulse generation and transmission from causing undesirable conditions.

[0305] One current method for treating cardiac arrhythmias is through catheter ablation therapy. Physicians use catheters to access internal regions of the body. Catheters fitted with electrode arrays or other ablation devices are used to create ablation lesions that interrupt electrical pathways in cardiac tissue. In treating cardiac arrhythmias, specific areas of cardiac tissue with abnormal conduction pathways, such as atrial rotors, that emit or conduct irregular electrical impulses, are first localized. A user (e.g., a physician) directs a catheter through a vena cava or aorta to the internal region of the heart to be treated. An ablation element (or multiple ablation elements) is then placed near the target cardiac tissue to be ablated. The physician directs energy, provided by a source external to the patient, from one or more ablation elements to ablate adjacent tissue and form ablation lesions. In general, the goal of catheter ablation therapy is to interrupt electrical pathways in cardiac tissue to stop the emission and / or prevent the propagation of irregular electrical impulses, thereby treating the lesion. In the treatment of atrial fibrillation (AF), currently available methods and devices have shown limited success and / or employ devices that are very difficult to use or otherwise impractical.

[0306] The ablation system of the present invention enables the creation of lesions of appropriate size and shape to treat conditions involving unregulated electrical conduction (e.g., AF). The ablation system of the present invention is also practical in terms of ease of use, limiting risk to the patient (e.g., creating effective lesions while minimizing damage to non-target tissue), and significantly shortening procedure time. The present invention addresses this need by using 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 energy delivery to the tissue or other means. The electrodes of the present invention may include protruding fins or other heat-dissipating surfaces to improve cooling characteristics. The distal portion of the catheter shaft of the present invention may be deflected into two or more symmetrical or asymmetrical geometries, such as asymmetric geometries with different radii of curvature or other geometrical differences. The ablation catheter and RF generator of the present invention enable clinicians to treat patients with AF in procedures that are significantly 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 blocking the propagation of inappropriate electrical impulses in the heart to prevent reentrant arrhythmias, while minimizing damage to non-target tissues such as the patient's esophagus or phrenic nerve.

[0307] Referring to the figures, one embodiment of an energy delivery system, or ablation apparatus or assembly 100, for selectively ablating tissue is shown. In one aspect, the system can include at least one energy delivery device, i.e., ablation catheter 1, such as, but not limited to, a monopolar probe 101, and at least one energy delivery source, i.e., power source, i.e., single power source 4. In one aspect, at least a portion of the probe can be configured for insertion into a patient. In one aspect, the at least one energy source, i.e., 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 for coupling the probe to a desired one of the at least one energy sources 8, i.e., a probe connector. While in one aspect, a monopolar probe is described herein, those skilled in the art will recognize that the energy delivery device used in the systems described herein can be a different type of energy delivery device, such as, but not limited to, a bipolar probe 102. In one embodiment, the probe may 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.

[0308] This allows for the utilization of an optimal energy delivery device for a given medical procedure. In one embodiment, the monopolar probe 101 can include a handle 103, an electrode having a proximal end or electrode proximal tip 104 and a distal end or electrode distal tip 105, and at least one connector of the probe. In one embodiment, the electrode(s) can include at least one distal electrode 106 positioned at the distal end of the probe and a round electrode 107 located on the body of the probe, positioned within the heart chamber. In one embodiment, the tip can be rounded, conical in shape, and can slide along the wall of the heart, and the probe can be designed to allow the sliding to match the movement of the heart wall.

[0309] In one aspect, as described above, at least one monopolar probe can be used in the system. In another aspect, although not shown, as described above, at least two monopolar electrodes 113 can be used in the system. In one exemplary embodiment, when two or more electrodes are used in the system, it is contemplated that the probes can be used in various configurations and shapes, such as, but not limited to, a parallel or spiral configuration. In one aspect, when two electrodes are used, it is contemplated that there will be one distal electrode and each of the body electrodes will be selected based on the ablation length requirements. In another exemplary aspect, the electrodes can be positioned so that their distal tips can be offset in length relative to the body electrode. In one exemplary embodiment, when at least two electrodes are used in the system, the at least two electrodes can be attached to a catheter body inserted into a cardiac chamber and spaced approximately 2-5 mm apart, and can provide a voltage of up to 4000 volts. In yet another exemplary embodiment, the at least two electrodes can be spaced approximately 6 mm or more apart to select alternate electrodes on the catheter body, and can have a voltage of up to approximately 5000 volts. In one exemplary embodiment, at least two electrodes may be inserted into the target tissue while spaced apart such that they are spaced about 4 mm apart and can provide a voltage of up to about 4000 volts.

[0310] In one aspect, at least one electrode of the monopolar probe can be electrically coupled to and configured to be energized by an energy source. Additionally, although not shown, those skilled in the art will recognize that at least one ground pad 108 can be used in combination with at least one electrode to complete the electrical circuit 109. While a single electrode configuration is described herein, it is contemplated that various other needle 110 and / or electrode array arrangements may be used in any of the embodiments described herein. Array herein refers to an ordered arrangement of multiple probes 111. In one aspect, the array may be a plurality or series of monopolar and / or bipolar probes arranged in various shapes, configurations, or combinations to enable ablation of multiple shapes and sizes of target tissue regions. Various array patterns may reduce the need to reposition the electrode array during treatment by allowing for multiple selectively activatable electrode patterns 112. In one aspect, the electrodes may be of different sizes and shapes, such as, but not limited to, square, oval, rectangular, circular, or other shapes. In one aspect, the electrodes described herein may be made from various materials known in the art.

[0311] 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 while inserted into tissue, such as when at least two electrodes are spaced apart on the catheter body and distal tip by a distance of up to about 2-5 mm, which can be either a linear length or a circular length. In another exemplary aspect, the electrodes can have an exposed electrode length of up to about 2-4 mm, such as when at least two electrodes are spaced apart by a distance of about 2-5 mm. 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 to about 5 cm. In yet another exemplary embodiment, the electrode can have a surface area of ​​about 1 cm 2 to about 2 cm 2 .

[0312] In one aspect, the system can include means 11, 12 for selectively energizing a desired energy source to ablate at least a portion of tissue adjacent to the at least one probe. In one aspect, the non-thermal energy source 6 of the at least one energy source or single power source 4 can be selectively energized to apply non-thermal energy to at least a portion of the desired tissue region 45 and 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, such as, but not limited to, irreversible electroporation (IRE) energy, to the target tissue. 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 and ablate at least a portion of the desired tissue region. In one exemplary aspect, the at least one energy source can have at least one connector 8 configured for selective coupling to the at least one electrode / probe. In one embodiment, 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 via at least one of the positive and negative connectors.

[0313] In one exemplary embodiment, the power source, or energy source, may be an Arga Model 100 electrosurgical generator, capable of delivering up to 1000 watts of RF power. Those skilled in the art will recognize that various generator models may be used with the systems described herein. In one aspect, the generator may be powered by a battery 5. In one aspect, the generator may be plugged into a standard wall outlet capable of providing approximately 110 volts or approximately 240 volts. In one aspect, the power source may be manually adjustable depending on the voltage. In one exemplary embodiment, the generator may be capable of producing a minimum voltage of approximately 100 volts to approximately 4000 volts. In one aspect, at least one of the power outlets, generators, and battery sources described herein may be used to supply voltage to the target tissue during treatment. In yet another exemplary embodiment, the power source or generator may be used to deliver IRE energy to target tissue, including somewhat difficult-to-reach target tissue, to achieve IRE ablation of a target region of tissue. In one aspect, an exemplary embodiment of the IRE generator may include two to ten positive and negative connectors, although one skilled in the art will understand that other numbers of positive and negative connectors and different connector embodiments may be used and may be necessary for optimal ablation configurations. A system in which the bipolar probe 102 is used. In one aspect, the bipolar probe 102 may 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 may include at least one electrode positioned at the distal end within the catheter and positioned at the distal-most portion of the ablation element. In one aspect, the electrodes may further include a first electrode 115 positioned at the distal-most portion of the catheter, a second electrode 116 positioned proximal to the distal electrode, and at least one spacer 117 that may be positioned between and adjacent at least a portion of each of the first, second, and third, etc. electrodes.In one embodiment, at least a portion of the distal portion of the second electrode can abut at least a proximal portion of the spacer, and at least a distal portion of the spacer can abut at least a portion of the proximal portion of the first electrode. In one embodiment, similar to a monopolar probe, a bipolar probe can be coupled to a thermal energy source 8. During use of the system, the probe can be coupled to the energy source. More specifically, in one exemplary embodiment, at least one connector of the probe 8 can be connected to the energy source via at least one of a positive connector 9 and a negative connector 10, as also described above.

[0314] Depending on various parameters, such as the voltage (including application of DC or AC, or both, and also in volts per square centimeter), current, number of pulses 209, pulse duration 203, and the dwell between pulses applied to the tissue or the time gap between adjacent pulses 205, tissue can undergo reversible electroporation, irreversible electroporation, or thermal damage (commonly considered resistive heating). Non-thermal IRE ablation includes ablation where the primary method of cell destruction leading to death is achieved via electroporation (rather than factors such as heating effects or reactions). In certain embodiments, depending on the parameters mentioned (including the time the resulting temperature is achieved), cell death can be achieved via non-thermal IRE up to about >46°C. In certain embodiments, cell damage from thermal heating occurs above about >46°C. In various embodiments, parameters that result in non-thermal IRE may be altered to result in cell death via thermal heating. Parameters may also be changed from those that have a non-thermal IRE effect to alternative settings where the altered parameters also have a non-thermal IRE effect.

[0315] More specifically, in one aspect, the number of pulses 209 and the total number of pulse trains 204 in various embodiments can be varied based on the desired treatment outcome and the effectiveness of the treatment for a given tissue. While delivering non-thermal IRE energy to the target tissue, a voltage configured to smoothly ablate the tissue can be generated. In one aspect, certain embodiments can include pulses of about 1 microsecond to about 80,000 milliseconds, while other embodiments can include pulses of about 75 microseconds to about 20,000 milliseconds. In yet another embodiment, the ablation pulse applied to the target tissue 47 can be about 20 microseconds to 100 microseconds. In one aspect, the at least one energy source can be configured to emit at least one pulse of energy for about 100 microseconds to about 100 seconds, adjustable in 10 microsecond intervals. In certain embodiments, the electrodes described herein can deliver 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 may be from about 200 V / cm to about 2000 V / cm, and from about 300 V / cm to about 1000 V / cm. Other exemplary embodiments may include voltages from about 2000 V / cm to about 20,000 V / cm. In one exemplary aspect, the bipolar probe 100 can be used with voltages up to about 2700 volts.

[0316] In one aspect, the number of pulses 209 that can be used in IRE ablation can be varied. 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 sequentially, with a time interval between each group or train of pulses. In one exemplary embodiment, the time interval between groups of pulses can be from about 0.05 seconds to about 2 seconds. In one aspect, pulses can be delivered to the target tissue using energy delivery devices, such as, but not limited to, probes, electrodes, and other conductive materials. In one aspect, such energy delivery devices can be of various lengths suitable for use in procedures, such as, but not limited to, percutaneous, laparoscopic, and open surgical procedures. In one aspect, at least one energy source can be configured to emit at least one pulse of energy for about 5 microseconds to about 10 seconds. In one exemplary aspect, the voltages described herein can be applied to a target region of tissue using a bipolar electrode 114 in 5 microsecond-long pulses. In one embodiment, the voltage can be applied in pulses of about 1 microsecond duration in groups or trains of 10 pulses, with the interval between pulses being about 50 milliseconds and the time between pulse trains being about 0.5 seconds.

[0317] In one exemplary embodiment, at least two monopolar electrodes 113 can be used to ablate the target tissue, resulting in a zone of ablated tissue measuring approximately 20-25 mm x 5-10 mm. In one exemplary embodiment, two single electrodes can be configured to include other ablation areas, including, but not limited to, an ablation area of ​​approximately 30 mm x 25 mm. Those skilled in the art will appreciate that the size and shape of the ablation can be advantageously varied depending on the placement of the electrodes and the type of electrode. In one aspect, during treatment, an additional area surrounding the outer edge of the target area of ​​tissue is also ablated (ablation of unwanted or diseased tissue). This surrounding area of ​​tissue can be ablated to ensure patient safety and complete and adequate ablation of the target area of ​​tissue. In one aspect, the catheter electrode tip 128 of the catheter is designed not to puncture the patient's tissue during the method of use. Those skilled in the art will recognize that the target tissue region can be any tissue of any organ in which ablation can be used to ablate unwanted or diseased tissue, such as, but not limited to, cardiac tissue, gastrointestinal, skeletal, muscular, nervous, endocrine, circulatory, reproductive, integumentary, lymphatic, urinary tissue or organ, or other soft tissue or organ for which selective ablation is desired. Soft tissue can include, but is not limited to, tissue surrounding, supporting, or connecting other body structures and / or organs. For example, soft tissue includes muscle, tendons, ligaments, fascia, joint capsules, and other tissues. More specifically, target tissues include, among others, the cardiac area, prostate (including prostate cancer tissue), kidney (including renal cell cancer tissue), and breast, lung, pancreatic, uterine, and brain tissue.

[0318] In one embodiment, the energy source may be a thermal energy source. In one embodiment, a non-thermal energy source may be selectively energized for a desired period of time. More specifically, the period may be a predetermined period of time. In yet another embodiment, the period of time may be multiple predetermined periods of time. In one embodiment, the thermal energy source is selected from the group consisting of radiofrequency (RF), focused ultrasound, microwaves, lasers, thermoelectric heating, conventional heating methods using electrodes using DC or AC current, and the application of heated fluids and cryotherapy (such as cryotherapy). While RF energy is known in the art for effective use in tumor ablation, it is clear that any form of temperature-dependent continuous ablation may be used in a setting known in the art. In one embodiment, 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 embodiment, the thermal energy source 7 may be an alternating current thermal energy source. In yet another embodiment, the thermal energy source 7 is a direct current thermal energy source.

[0319] In one aspect, one (or more) electrodes can be initiated at the point of non-thermal ablation of the target region. In one aspect, thermal ablation can be initiated at the beginning of the electrode chain (longitudinally on the catheter), which in one embodiment is applied to prevent conduction of abrehent tissue. When the energy delivery device or electrode is withdrawn, thermal energy can be applied to the target tissue through the electrode. In one aspect, the electrode is selectively energized with thermal or non-thermal energy to ablate tissue adjacent to the electrode track and proximate the border of the ablated tissue.

[0320] In one aspect, IRE treatment of a target tissue followed by thermal ablation of at least one tissue area can be performed during procedures such as, but not limited to, cardiac, laparoscopic, and open surgical procedures. In one aspect, the ablation track can be ablated during electrode repositioning or dragging. In one aspect, after delivering IRE energy to the target tissue, an ablated region of tissue remains. In one aspect, the ablated region of tissue includes the target tissue region and a surrounding area of ​​tissue. In one exemplary embodiment, after treating the target tissue using IRE, treatment parameters can be reset to result in thermal track ablation. In one aspect, after IRE treatment of the target tissue, the energy delivery device or electrode is repositioned. In one aspect, ablating tissue in a different area / location upon termination of energy delivery (and possibly repositioning) of the energy delivery device can coagulate the tissue track and prevent bleeding. 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. Particularly during procedures that may involve ablation of the left side of the heart, it is important to prevent bleeding so that blood clots do not form.

[0321] In one embodiment, the generator or single power source 4 used during the thermal ablation procedure can be configured with various ablation settings and capabilities. In one exemplary embodiment, the Arga 1000 generator described above can be used as the RF energy source. In one embodiment, the RF energy source can be used to ablate tissue using 10-100 watts of power. In other exemplary embodiments, those skilled in the art will recognize that lesser or greater amounts of power can be used in various embodiments to provide ablation, as needed. In one exemplary embodiment utilizing a generator, the RF power source can provide AC power in addition to being used for ablation, while the IRE power source can be used to provide DC power.

[0322] In one aspect, when a thermal energy source is used, it can be used with a variety of techniques to effect tissue ablation. In one exemplary aspect, additional embodiments can include ablation performed using one or more of radio frequency (RF), focused ultrasound, microwaves, lasers, thermoelectric heating, traditional heating methods using electrodes using DC or AC current, heated fluids, and the application of cryotherapy, such as, but not limited to, those used in cryotherapy. In one aspect, the thermal energy can be delivered via pulses that, in certain embodiments, can range from about 35 microseconds to about 10 seconds. In other exemplary embodiments, the at least one energy source can be configured to emit or deliver at least one pulse of thermal energy in a range from about 35 microseconds to about 1 second. In yet another exemplary embodiment, the at least one energy source can emit or deliver at least one pulse of energy in a range from about 35 microseconds to about 1000 microseconds. In yet another exemplary embodiment, the at least one pulse can be delivered in a range from about 1 microsecond to about 100 microseconds.

[0323] In one exemplary embodiment, thermal energy can be applied to induce temperature fluctuations to achieve treatment. In one aspect, thermal energy provided to tissue can heat the target tissue to about 46°C to about 70°C, resulting in cell death. In one aspect, the temperature can be adjusted below or above this temperature range, depending on the exact rate at which heat generated via externally supplied fluid and / or blood is removed from the target tissue. In one embodiment, the temperature used is about 50°C to about 100°C, although those skilled in the art will recognize that temperatures above about 100°C can cause tissue vaporization. Ellis L, Curley S, Tanabe K. Radiofrequency Ablation for Cancer; Current Indications, Techniques, and Outcomes, NY: Springer, 2004. In one exemplary embodiment, thermal energy can be used to ablate about 2-3 mm of tissue. In one aspect, this tissue thickness can vary depending on various factors, including, but not limited to, the condition of the target tissue, the various parameters used, and treatment options.

[0324] In one embodiment, the mechanism by which a user sets parameters for producing an IRE effect is modified to produce a thermal outcome through resistive heating, i.e., thermal heating. In certain embodiments, the mechanism is reconfigured so that DC energy is applied to produce thermal ablation. In one exemplary embodiment, ablation can be performed using DC current. In one aspect, DC current can be used to heat the target tissue. In one aspect, at least one pulse of DC current can be delivered in one direction. In yet another aspect, at least one pulse of DC current can be delivered from the opposite direction of the electrical circuit. In one aspect, DC current can be applied to produce a tissue temperature of about 42°C to about 75°C. In one aspect, DC current can be applied to induce thermal damage at a temperature as low as about 42°C. In yet another aspect, DC current can be applied to the target tissue such that the temperature can be from about 42°C to about 75°C as the probe ablation rate increases. Davalos R, Mir L, Rubinsky B.Tissue Ablation with Irreversible Electroporation.Annals of Biomedical Engineering,Vol.33(2):223-231(2005).

[0325] Those skilled in the art will recognize that DC pulses of various lengths can be applied to produce effective track ablation. In yet other embodiments, AC pulses can be applied as the energy delivery device is gradually removed from the target tissue. In summary, a method for selectively ablating tissue includes providing at least one energy source, such as the generator described above. In one aspect, the at least one energy source, i.e., a single power source 4, can include at least a non-thermal energy source 6 and a thermal energy source 7, which are selectively manually operably coupled to a desired one of the at least one energy sources, providing at least one probe or at least one ablation catheter 1 configured to position at least a portion of at least one electrode within a desired region of the target tissue via the electrode. In one aspect, selectively coupling the electrode to the thermal energy source includes operably selecting between the non-thermal energy source 7 and the thermal energy source 8 by actuating a switch 40. Then, at least one probe is selectively coupled to a non-thermal energy source, 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 a thermal energy source, at least one probe is retracted from the desired region, and the thermal energy source is selectively energized to apply thermal energy during at least a portion of the retraction of the at least one probe to ablate tissue substantially adjacent to the probe track. In one aspect, prior to selectively coupling the at least one probe to the thermal energy source, the at least one probe is operably separated from the non-thermal energy source.

[0326] In one aspect, one pulse mediates thermal heating via resistive heating, but may be longer in duration than either. Thermal heating can also be achieved by changing the energy mode, such that more or shorter pulses, different pulse lengths, and varying dwells between pulses are applied to the tissue being ablated, with BIO feedback obtained from the system. It is also possible to modify either or both the voltage and pulses, increasing or decreasing either or both (including the option to change the time between pulses) to achieve the thermal effect of track ablation. In certain embodiments, a change from a pulse leading to an IRE effect, to using one or more pulses leading to a thermal effect, results in both an IRE and a thermal effect in tissue within the target region. In certain embodiments, the order in which pulses are applied to the target region and / or tissue and / or pulses and / or pulse switching is used to most effectively treat the patient. Pulses and pulses or pulse chains can also be used in combination with thermal heating methods such as radiofrequency, so that the non-thermal IRE effect, the resistive heating effect of DC current variations, and the thermal heating effect of AC current (such as RF) can be brought to bear on a target tissue or tissue track in any order for the benefit of the patient. For example, mitral isthmus tissue can be treated with IRE or RF (or other AC and other DC pulses that result in resistive heating), or one or more of these, in any order, to ablate the target tissue, control bleeding, or coagulate or ablate blood vessels or cells; then, when the probe is removed, IRE or RF (or other AC and other DC pulses that result in resistive heating) pulses can be used together or independently as needed, in any order, to control bleeding, coagulate or ablate tissue, blood vessels, tumor cells, or ablate or treat tissue surrounding that tissue.In certain embodiments, changes between treatments or methods may be effected using a mechanism or device or system for altering or changing one or more parameters described herein via an energy source, which may be coupled to one or more generators, and the parameters may be determined using a mechanism in the system or generator or energy source, which may include a control component that can be changed by the user directly from the probe or directly from the energy source.

[0327] References 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.

[0328] Heller R,Heller LC.Gene Electrotransfer Clinical Trials.Adv Genet.2015;89:235-62.

[0329] Neumann E, Schaefer-Ridder M, Wang Y, Hofschneider P. Gene transfer into mouse lyoma cells by electroporation in high electric fields.EMBO J.1982;1:841-5. [Explanation of symbols]

[0330] 1. Ablation catheter or energy delivery system or energy delivery device or probe or multi-electrode and multi-function ablation catheter 3. Systems for selective tissue ablation 4. Single power source or energy source or energy delivery source or generator 5. Battery-powered generator 6. Non-thermal energy sources 7. Thermal energy source or AC thermal energy source or DC thermal energy source 8. Means for selectively coupling the probe to one desired one of the at least one energy source, or mechanism for coupling the probe to one desired energy source, or probe connector 9 Positive connector 10 Negative connector 11. Means for selectively energizing non-thermal energy sources 12. Means for selectively energizing a thermal energy source 13 Thin shaft 14 proximal portion of elongated shaft 15 Proximal end of elongated shaft 16. Elongated shaft distal end 17. Elongated shaft distal portion 18 Proximal end of distal portion of elongated shaft 19. Distal end of distal portion of elongated shaft 20 Shaft ablation assembly or functional element fixedly attached to the distal portion 21 distal ablation assembly or distal ablation element or mandrel with tip or electrode 22 Shaft ablation element or electrode or single / multiple ablation elements 23 Tip Ablation Element 24 Distal deflection shape and geometry or deflection geometry 25 steering wires (configured to deflect the distal portion in one or more deflection directions) 26 Shape-setting mandrel or deflection assembly (to maintain deflection in a single plane) 27 Asymmetric joint (between two slender shaft sections) 28 Integrated components 29 Variable Braid or Steering Wire 30 Control port or opening at the tip of the elongated shaft 31 Single ablation element or ablation element (suitable for RF and irreversible electroporation) or electrode 32 Multiple ablation elements or electrodes 33 Shape-setting mandrel carrier assembly or shape-setting mandrel or deflection assembly or mandrel 34 Proximal portion of control shaft or mandrel 35 Shaft outer diameter 36 Ablation electrode / ablation element outer diameter 37 Thermocouple 38 Means of heat dissipation (e.g., increased surface area) 39 Electrode Tip Set 40 Switch for operably selecting between a non-thermal energy source and a thermal energy source 41 Organization 42 Ablated tissue 43 Heart 44 organs 45 Ablation area or desired area 100 Ablation device or assembly 101 Monopolar probe or ablation catheter with a monopolar strategy or ablation catheter with a monopolar arrangement of at least one electrode 102 Bipolar probe or ablation catheter with bipolar arrangement of electrodes 103 Handle 104 Proximal end of electrode 105 Electrode Distal End 106 Distal Electrode 107 Round Electrode 108 Grounding Pad 109 Electrical Circuits 110 needles 111 Electrode array or regular arrangement of multiple probes 112 Multiple selectively activatable electrode patterns. 113 Monopolar Electrode 114 Bipolar Electrode 115 First or most distal electrode 116 Second or Proximal Electrode 117 Spacer 118 Inner Lumen (Second Lumen - Multipurpose (Fluid Flush and Shape Setting Mandrel)) 119 Mandrel Elastic Body 120 Catheter bending part 121 Mandrel Heating Element 122 Mandrel lock mechanism 123 Holding Element 124 Lock seat 125 ball tip 126 Shaft transition section 127 Shaft electrode 128 Electrode tip / non-invasive tip 130 small electrode 131 Large electrode 132 Mandrel electrode 134 Set of Shape Fitting Mandrels 135 First shape setting mandrel 136 Second Shape Setting Mandrel 138 Mandrel proximal part 139 Mandrel Distal Portion 140 Mandrel seat 141 Inner lumen neck 142 Wire proximal extension 143 Wire gripping part 144 Steering Device 145 Steering device through hole 200 Ablation Catheter Kit and Mandrel Set 201 Pulse 202 Pulse Amplitude 203 Pulse Duration 204 Pulse Train 205 Time interval between adjacent pulse trains 206 Energizing Period 207 Flexible body of catheter elongated shaft = Flexible body 208 Blood vessels of the body 209 pulses 210 Wire 300 Ablation Catheter Kit 400 Single Control Unit 401 Power Unit 402 Power Module 403 Drive Circuit Block 404 Selection Block 405 Filtering Block 406 Electrical Insulation Block 407 Microprocessor 408 Variable High Voltage Power Block 409 Programmable Logic Controller Block 410 Video Interface Block 411 Watchdog Block 412 Audio Interface Block S Electrical signal Vcc supply voltage signal N Insulated conductive part of electrode IRE irreversible electroporation RF high frequency XX Main longitudinal direction of the elongated shaft P Plane of the distal part of the shaft ALFA acute angle 410' Push Button Block 114a first electrode 424 Electrode body 114b second point electrode 210a First wire 210b second wire 425 Ground electrode

Claims

1. An ablation device (100) for treating a target area of ​​tissue (41) within an organ (44), comprising an ablation catheter (1) and a single power source (4), The ablation catheter (1) a catheter elongate shaft (13) comprising at least a distal elongate shaft portion (17); a steering device (144) coupled to the catheter elongate shaft (13) for rotating the catheter elongate shaft (13) during insertion; Equipped with The ablation catheter (1) further comprises a handle (103), and the steering device (144) is connected to the handle (103); the catheter elongate shaft (13) comprises a flexible body (207) for passage through a body vessel (208); the ablation catheter (1) further comprises a shaft ablation assembly (20) disposed on the elongate shaft distal portion (17); the shaft ablation assembly (20) comprising at least a plurality of electrodes (127, 113, or 114) fixedly disposed on the elongate shaft distal portion (17); all of the at least a plurality of electrodes (127, 113, or 114) are powered by the single power source (4) via an electrical signal (S) to deliver both non-thermal energy for treating the tissue (41) and thermal energy for ablation of the tissue (41); An ablation device (100) wherein the single power source (4) powers the at least multiple electrodes (127, 113, or 114) to continuously vary the electrical signal (S) when required to deliver non-thermal energy to thermal energy, or vice versa, or to simultaneously deliver a combination of thermal and non-thermal energy.

2. said single power source (4) comprising a single control unit (400) and power unit (401) for generating said electrical signal (S); 2. The ablation device (100) of claim 1, wherein the power unit (401) is electrically connected to all electrodes of the at least a plurality of electrodes (127, 113, or 114).

3. 3. The ablation device (100) of claim 2, wherein the power unit (401) is driven by the single control unit (400) to continuously vary the electrical signal (S) supplied to the electrodes (127, 113, or 114) to deliver from non-thermal energy to thermal energy and vice versa, or to simultaneously deliver a combination of thermal energy and non-thermal energy.

4. The power unit (401) comprises a power module (402), and the power module (402) comprises: a driver circuit block (403) controlled by said single control unit (400) to generate said electrical signal (S), starting from a supply voltage signal (Vcc) provided by said single control unit (400); a selection block (404) selectively controlled by the drive circuit block (403) to continuously vary the electrical signal (S); The ablation device (100) of claim 2, comprising a filtering and electrical insulating block (405, 406).

5. The single control unit (400) a microprocessor (407) configured to control a variable high voltage power supply block (408) and a programmable logic controller block (409); the variable high voltage power supply block (408) is configured to provide the supply voltage signal (Vcc) to the power module (402) to generate the electrical signal (S); the programmable logic controller block (409) is configured to generate a drive signal for controlling the drive circuit block (403) of the power module (402); The single control unit (400) a video interface and push button block (410, 410') controlled by said microprocessor (407) to set the parameters of said device (100) and to display selected parameters; a watchdog block (411) for controlling the proper functioning of said microprocessor (407); Ablation device (100) according to claim 4, further comprising an audio interface block (412) for providing audio information representative of the accuracy of the ablation process and / or of any errors that have occurred.

6. The power unit (401) comprises one or more power modules (402) that are identical to one another; At least one of the electrodes (127, 113) is a monopolar electrode (113), and the monopolar electrode (113) of the at least plurality of electrodes is electrically connected to only one power module (402) of the power unit (401); 3. The ablation device (100) of claim 2, wherein at least two of the electrodes (127, 114) are electrically connected to form a bipolar electrode (114), and the bipolar electrodes (114) of the at least plurality of electrodes are separately electrically connected to respective power modules (402) selectable from the power modules of the power unit (401).

7. 4. The ablation device (100) of claim 3, wherein the electrical signal (S) supplied to the plurality of (127, 113, or 114) electrodes comprises a pulse train (204).

8. 8. The ablation device (100) of claim 7, wherein the single control unit (400) is configured to drive the power unit (401) to modify the pulse duration (203) of each pulse (201) of the pulse train (204) and vary the electrical signal (S).

9. 8. The ablation device (100) of claim 7, wherein the single control unit (400) is configured to drive the power unit (401) to modify the number of pulses (209) of the pulse train (204) and vary the electrical signal (S).

10. 8. The ablation device (100) of claim 7, wherein the single control unit (400) is configured to drive the power unit (401) to modify the time interval (205) between adjacent pulse trains (204) and to vary the electrical signal (S).

11. each monopolar electrode (113) of the at least plurality of electrodes is electrically connected to a corresponding power module (402) of the power unit (401) by a single wire (210) welded to the monopolar electrode (113); and / or 7. The ablation device (100) of claim 6, wherein each bipolar electrode (114) of the at least a plurality of electrodes is electrically connected to two selected power modules (402) of the power unit (401) by two wires (210) welded to the bipolar electrode (114).

12. At least one electrode of the at least a plurality of electrodes (127) comprises two conductive portions (N) electrically insulated from each other; and / or 10. The ablation device (100) of claim 1, wherein at least one electrode of the at least a plurality of electrodes (127) comprises four conductive portions (N) electrically isolated from one another.

13. 10. The ablation device (100) of claim 1, wherein the non-thermal energy is irreversible electroporation energy or IRE and the thermal energy is radio frequency energy or RF.

14. The ablation device (100) of claim 3, wherein the electrical signal (S) supplied to the plurality of electrodes (127, 113, or 114) comprises at least a square wave signal.

15. 4. The ablation device (100) of claim 3, wherein the electrical signal (S) supplied to the plurality of electrodes (127, 113, or 114) comprises a signal obtained by combining, summing, or superimposing two or more square wave signals with each other.

16. 4. The ablation device (100) of claim 3, wherein the electrical signal (S) supplied to the plurality of electrodes (127, 113, or 114) comprises a DC signal or an AC signal, or a combination of a DC signal and an AC signal.

17. 10. The ablation device (100) of claim 1, wherein the single power source (4) is powered by a battery or connected to a standard wall outlet on an AC power grid capable of providing 110 volts or 240 volts.

18. A method for operating a medical device configured to control at least a plurality of electrodes (127, 113 or 114) of an ablation device (100) comprising an ablation catheter (1) according to any one of claims 1 to 17 and a single power source (4), comprising: The method further comprises the step of: generating, by said single power source (4), an electrical signal (S) comprising a pulse train (204) for powering all of said at least a plurality of electrodes (127, 113, or 114); modifying the pulse duration (203) of each pulse (201) of said pulse train (204); or Modifying the number of pulses (209) in said pulse train (204), or Modifying the time interval (205) between adjacent pulse trains (204); and directing the at least a plurality of electrodes (127, 113, or 114) to deliver from non-thermal energy to thermal energy and vice versa, or to simultaneously deliver a combination of thermal and non-thermal energy.

19. The at least two electrodes (127, 114) are electrically connected to form a bipolar electrode (114), a first electrode (114a) connected to a first power module (402) of the power unit (401) by a first wire (210a), the first electrode (114a) having an electrode body (424) that defines an interior compartment of the first electrode (114a) accessible from outside the first electrode (114a); and 12. The ablation device (100) of claim 6 or 11, comprising a second point electrode (114b) connected to a second power module (402) of the power unit (401) by a second wire (210b), the second point electrode (114b) being housed in the internal compartment of the first electrode (114a).

20. the single control unit (400) is configured to drive the power units (401) to generate, in each power module (402), a respective one of the plurality of electrical signals (S) supplied to the electrodes (127, 113, or 114); 6. The ablation device of claim 5, wherein the microprocessor is configured to control each power module via the programmable logic controller block to select two or more electrical signals to be supplied to the electrodes, thereby modifying the on-state, off-state, and phase angle of each of the plurality of electrical signals so that both a monopolar electric field from each electrode and a bipolar electric field between two adjacent electrodes are generated using a ground electrode.

21. The ablation catheter (1) comprises an elongate shaft (13) having a longitudinal main direction (X-X), the elongate shaft (13) comprising at least a shaft distal portion (17), the shaft distal portion (17) comprising a shaft distal portion distal end (19); The ablation catheter (1) comprises an inner lumen (118) disposed within the elongate shaft (13); the ablation catheter (1) comprises a shaft ablation assembly (20) fixedly disposed on the shaft distal portion (17), the shaft ablation assembly (20) being configured to deliver both thermal energy for ablating the tissue (41) and non-thermal energy for treating the tissue (41); - at least a shape-setting mandrel (26) disposed within the ablation catheter (1), the shape-setting mandrel (26) being insertable into and removable from the inner lumen (118); the shape-setting mandrel (26) is free to move relative to the inner lumen (118) avoiding any constraint with the shaft distal portion (17) during insertion of the shape-setting mandrel; the shape-setting mandrel (26) includes at least a pre-formed configuration, the shape-setting mandrel (26) being reversibly transformable between at least a straight-loaded configuration and the pre-formed configuration; The ablation device (100) of any one of claims 1 to 17 or 19 or 20, wherein the shape-setting mandrel (26) is configured to shape-set the shaft distal portion (17) into the preformed configuration when the shape-setting mandrel (26) is fully inserted into the shaft distal portion (17).

22. the distal shaft portion (17) is elastically deformable; And / or the ablation device (100) of claim 21, wherein the shaft distal portion (17) is configured to conform to the molded configuration when the shape-setting mandrel (26) is fully inserted into the shaft distal portion (17).

23. When the shape-setting mandrel (26) is fully inserted into the shaft distal portion (17), it is defined as a mandrel fully inserted position; 23. The ablation device (100) of claim 21 or 22, wherein the shape-setting mandrel (26) slides within the inner lumen (118) toward the mandrel fully inserted position, but the shape-setting mandrel (26) is configured to variably shape-set the shaft distal portion (17) passing from the straight-loaded configuration to the pre-shaped configuration.

24. An ablation kit (200) comprising: - at least an ablation device (100) according to any one of the preceding claims 21 to 23, - a set of shape-setting mandrels (134), the shape-setting mandrels of the set (134) have different pre-formed configurations; An ablation kit (200), wherein the shape-setting mandrels of the set (134) are alternatively disposable and removable in the ablation catheter (1).

25. 1. A method for configuring and shaping an ablation catheter, comprising: - providing an ablation device (100) according to claim 23; - inserting the shape-setting mandrel (26) into the inner lumen (118) of the ablation catheter (1) in the straight-loaded configuration; - moving the shape-setting mandrel (26) within the inner lumen (118) towards the distal end (19) of the shaft distal section until the shape-setting mandrel (26) is fully inserted into the shaft distal section (17); - Adapting the shape of the distal shaft portion (17) to the pre-formed configuration of the shape-setting mandrel (26) when the shape-setting mandrel (26) is fully inserted into the distal shaft portion (17).

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