Patent Description:
More particularly, the present invention relates to a combination system for non-thermally treating target tissue and thermally ablating tissue. Said tissue would be that which is either diseased such as in atrial fibrillation (or AF) patient where the cardiac cell action potential is not normal, typically phase phases <NUM>-<NUM>. Said tissue could also be tissue where it is deemed necessary to block a refractory wave-front to stop or prevent irregular arrhythmias in patients.

The present invention relates generally to ablation systems for performing targeted tissue ablation in a patient. In particular, the present invention provides catheters which deliver radiofrequency (RF) and/or Irreversible electroporation (IRE) which occurs when a strong, pulsed electrical field (PEF) causes permeabilization of the cell membrane, leading to cellular homeostasis disruption and cell death. Irreversible Electroporation (IRE) energies that create safe, precision lesions in targeted tissue such as that cause heart arrhythmias.

Applications of PEF in cardiology are vast and include atrial fibrillation, ventricular fibrillation, septal ablation, and targeting vascular structures. PEF has appealing characteristics including ability to be tissue specific and non-thermal. This invention provides for a novel catheter design to delivery IRE / PEF to cardiac tissue.

Pulsed electric fields (PEF) refer to application of intermittent, high-intensity electric fields for short periods of time (micro- or nanoseconds), which results in cellular and tissue electroporation. Electroporation is a process whereby an applied electric field (i.e. PEF) results in formation of pores in cell membranes. Pore formation leads to permeabilization, which can be reversible or irreversible, depending upon parameters of the applied PEF. In reversible electroporation, cells remain viable. , and underlies the basis of electrochemotherapy and gene electrotransfer. See references <NUM>) <NPL>; <NUM>) <NUM>)<NPL>; <NUM>) <NPL>.

Electroporation is a phenomenon whereby PEF (created by high voltage currents) are applied to a cell resulting in pore formation in the cell membrane with a subsequent increase in cell permeability. The electric field is most commonly produced by high voltage direct current delivered between two or more electrodes. When electric fields are applied, charge is established across the lipid bilayer and, once a critical threshold is reached (dependent on transmembrane voltage), electroporation occurs. In contrast, with irreversible electroporation (IRE), cells and tissue are non-viable because of programmed cell death cascade activation. IRE is a well-established treatment for solid tumors. However, PEFs may also be useful in cardiology, particularly for cardiac ablation, given limitations of current thermal based approaches. PEF can create lesions without tissue heating, and be cell/tissue selective which enables preservation of critical surrounding structures.

Tissue ablation is used in numerous medical procedures to treat a patient. Ablation can be performed to remove or denature undesired tissue such as diseased cardiac cells. Ablation procedures may also involve the modification of the tissue without removal, such as to stop electrical function in a particular area in the chain of electrical propagation through the heart tissue in patients with an arrhythmia condition. The ablation can be performed by passing energy, such as electrical energy, through one or more electrodes and causing tissue death where the electrodes are in contact. Ablation procedures can be performed on patients with any cardiac arrythmia such as atrial fibrillation (AF) by ablating tissue in the heart.

Mammalian organ function typically occurs when electrical activity is spontaneously generated by the SA node, the cardiac pacemaker. This electrical impulse is propagated throughout the right atrium, and through Bachmann's bundle to the left atrium, stimulating the myocardium of the atria to contract. The conduction system consists of specialized heart muscle cells. Cardiac myocardial cell has a negative membrane potential when at rest. Stimulation above a threshold value induces the opening of voltage-gated ion channels and a flood of cations into the cell. The positively charged ions entering the cell cause the depolarization characteristic of an action potential. Like skeletal muscle, depolarization causes the opening of voltage-gated calcium channels and release of Ca2+ from the t-tubules. This influx of calcium causes calcium-induced calcium release from the sarcoplasmic reticulum, and free Ca2+ causes muscle contraction. After a delay, potassium channels reopen, and the resulting flow of K+ out of the cell causes repolarization to the resting state. This transmission of electrical impulses propagates through the heart chamber. A disturbance of such electrical transmission may lead to organ malfunction. One particular area where electrical impulse transmission is critical for proper organ function is in the heart, resulting in atrial contractions which leads to the pumping of blood into the ventricles in a manner synchronous with the pulse.

Atrial fibrillation (AF) refers to a type of cardiac arrhythmia where there is disorganized electrical conduction in the atria causing rapid uncoordinated atrial contractions that result in ineffective pumping of blood into the ventricle as well as a lack of synchrony. During AF, the atrioventricular node receives electrical impulses from numerous locations throughout the atria instead of only from the sinus node. These aberrant signals overwhelm the atrioventricular node, producing an irregular and rapid heartbeat. As a result, blood may pool in the atria, increasing the likelihood of blood clot formation. The major risk factors for AF include age, coronary artery disease, rheumatic heart disease, hypertension, diabetes, and thyrotoxicosis. AF affects <NUM>% of the population over age <NUM>.

Atrial fibrillation treatment options are limited. Lifestyle changes only assist individuals with lifestyle related AF. Medication therapy manages AF symptoms, often presents side effects more dangerous than AF, and fails to cure AF. Electrical cardioversion attempts to restore a normal sinus rhythm, but has a high AF recurrence rate due to disease progression. In addition, if there is a blood clot in the atria, cardioversion may cause the clot to leave the heart and travel to the brain (causing a stroke) or to some other part of the body. What are needed are new methods for treating AF and other medical conditions involving disorganized electrical conduction.

Various ablation techniques have been proposed to treat AF, including the Cox-Maze ablation procedure, linear ablation of various regions of the atrium, and circumferential ablation of pulmonary vein ostia. The Cox-Maze ablation procedure and linear ablation procedures are tedious and time-consuming, taking several hours to accomplish. Current pulmonary vein ostial ablation is proving to be ineffective long-term. All ablation procedures involve the risk of inadvertently damaging untargeted tissue, such as the esophagus while ablating tissue in the left atrium of the heart.

There is therefore a need for improved atrial ablation products and techniques that create efficacious lesions in a safe manner.

Solutions are known in the following documents: <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>.

In many of these procedures an energy delivery device, such as a probe with or without a needle, is inserted into a target tissue to cause destruction of a target region of the cardiac tissue through the application of energy, such as thermal energy, non-thermal energy, and energy associated with cryo ablation procedures. The insertion of the energy delivery device into the heart chamber or other organs is accomplished by an elongated track which is typically created from points inferior to the heart. An elongated track or access tube is defined as the space created by the insertion of a 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 that had been previously created to allow insertion of the energy delivery device.

Prior to delivery device being withdrawn, the tissue immediately adjacent to the energy delivery device is ablated. This can produce a focalized zone around the ablation elements, maximizing the chance of death in the desired tissue location. It is known in the art that electrically induced thermal ablation such as RF can be used to effectively and continuously locally ablate a tissue site as an energy delivery device is placed on the tissue surface. RF can lead to coagulation necrosis in a margin surrounding normal tissue where hyperthermic conditions lead to cellular injury such as coagulation of cytosolic enzymes and damage to histone complexes, leading to ultimate cell death. Although these tissue treatment methods and systems can effectively ablate volumes of target tissue, there are limitations to each technique. One often cited problem using these procedures during cardiac ablation involves heat sink, a process whereby one aspect can include blood flow whereas the heat generated on the ablation element will be removed/dissipated by the cooler blood flows over the element. This heat dissipation effect can change both the shape and maximum volume of the tissue being ablated. After treatment of a target tissue region with an energy delivery device, upon removal of the energy delivery device from the targeted tissue region, the energy delivery device can be placed in a new, un-ablated site needing treatment.

More recently, irreversible electroporation (IRE) has been used as an alternative to the above-mentioned procedures to ablate cardiac or organ tissue. However, though IRE can be a non-thermal method causing cell death, it is not ideal for coagulation, and specifically does not cause electrically induced thermal coagulation, demonstrating the importance of using an alternative source such as RF or long DC pulses in heating a tissue site. Instead, IRE involves the application of electrical pulses to targeted tissue in the range of microseconds to milliseconds that can lead to non-thermally produced defects in the cell membrane that are nanoscale in size. These defects can lead to a disruption of homeostasis of the cell membrane, thereby causing irreversible cell membrane permeabilization which induces cell necrosis, without raising the temperature of the tissue ablation zone. During IRE ablation, connective tissue and scaffolding structures are spared, thus allowing the surrounding organs, structures, blood vessels, and connective tissue to remain intact. With nonthermal IRE (hereinafter also called non-thermal IRE), cell death is mediated through a nonthermal mechanism, so the heat sink problem associated with many ablation techniques is nullified. Therefore the advantages of IRE to allow focused treatment with tissue sparing and without thermal effects can be used effectively in conjunction with thermal treatment such as RF that has been proven effective to prevent ablation site bleeding; this will also allow (in this example embodiment) the user to utilize determined RF levels leading to in some cases ablation and in some cases coagulation; this is important since IRE will not effectively coagulate when dealing with large tissue regions. In this way the newly discovered advantages of IRE can be utilized effectively with known techniques of nonthermal damage with the added advantage of either selecting to use RF or no RF in conjunction.

Although IRE has distinct advantages, there are also advantages of utilizing thermal ablation during treatment procedures. Prior to the disclosure of this invention, an invention had not been proposed that could solve the problems of nonthermally ablating a target region of cardiac or organ tissue, while maintaining integrity of the surrounding tissue, and effectively switching to a device for effectively thermally ablating tissue along the ablation track. In certain proposed embodiments, an energy delivery device can be utilized that is powered by a single energy source that is capable of application of energy in various forms, and subsequently ablating a tissue track during a medical procedure for the treatment of arrhythmias using the same energy delivery device that can be powered by a different form of energy from the same energy source, to maximize procedure outcomes. As indicated, IRE provides advantages for nonthermal cell death and thermal mechanisms provide advantages for not only preventing seeding, but also for effectively bringing about coagulation. A need exists for a system and method that can provide this combined non-thermal/thermal tumor ablation and that allows for switching between non-thermal IRE energy delivery and thermal energy delivery to increase tumor ablation efficiency and efficacy and the prevention of tissue track.

Nevertheless, it is therefore still strongly felt the need to simplifying the tissue, especially the heart tissue, speeding up treatment and reducing intervention times.

<CIT> discloses, in a shapable catheter and method for positioning a shapable catheter within a body cavity, a core wire is provided which includes a pre-shaped region bent into a predetermined shape. A catheter is provided which includes a lumen proportioned to slidably receive the core wire. The catheter includes a rigid proximal section and a flexible distal section. <CIT> discloses a system for selectively ablating tissue that has at least one energy source that has a non-thermal energy source and a thermal energy source, at least one probe, means for selectively coupling the probe to the one desired energy source of the at least one energy source, means 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 the desired region to ablate at least a portion of the desired region, and means for selectively energizing the thermal energy source of the at least one energy source during the withdrawal of the at least one probe to thermally blate tissue substantially adjacent to a probe track.

This invention provides for a novel assembly or equipment to deliver non-thermal and thermal energies to cardiac tissue.

A unique multi-electrode and multi-functional ablation catheter and ablation catheter systems, or ablation assembly or equipment <NUM>, are provided which map and ablate myocardial tissue within the heart chambers of a patient. Any electrocardiogram signal site (e.g. a site with aberrant signals) or combination of multiple sites that are discovered with this placement may be ablated. In alternative embodiments, the ablation catheters and systems may be used to treat non-cardiac patient tissue, such as tumor tissue, renal artery nerves, etc..

According to alternative embodiments,an probe, e.g. an ablation catheter <NUM> for performing a medical procedure on a patient is provided. The ablation catheter <NUM> comprises an elongate shaft <NUM> with a proximal portion <NUM> including a proximal end <NUM> and a distal end <NUM>, and a distal portion <NUM> with a proximal end <NUM> and a distal end <NUM>. The elongate shaft <NUM> further comprises a shaft ablation assembly <NUM> and a distal ablation assembly <NUM> configured to deliver energy, such as RF and/or Irreversible Electroporation energy, to tissue <NUM>. The shaft ablation assembly <NUM> is proximal to the distal end of the distal portion <NUM>, and includes at least one shaft ablation element <NUM>, or shaft electrode <NUM>, fixedly or removable attached to the shaft <NUM> and configured to deliver ablation energy to tissue. The distal ablation assembly <NUM> is at the distal end of the distal portion <NUM> and includes at least one tip ablation element <NUM>, or electrode tip <NUM>, configured to deliver ablation energy to tissue.

According to alternative embodiments,the distal portion <NUM> is configured to be in a circular configuration and can deflected in one or more directions, in one or more deflection shapes and geometries <NUM>. The deflection geometries <NUM> may be similar or symmetric deflection geometries, or the deflection geometries may be dissimilar or asymmetric deflection geometries. The shaft, or ablation catheter <NUM>, may include one or more steering wires <NUM> configured to deflect the distal portion <NUM> in the one or more deflection directions. The catheter deflection can also occur by placing or removing a shape setting mandrel <NUM>. The elongate shaft <NUM> may include difference is the stiffness of the shaft along its length. The elongate shaft <NUM> may include a shape setting mandrel <NUM> within the shaft, or ablation catheter <NUM>, the shape setting mandrel <NUM> configured to perform or enhance the deflection (steering and shape) of the distal portion <NUM>, such as to maintain deflections in a single plane. The shaft, or ablation catheter, may include variable material properties such as a asymmetric joint <NUM> between two portions, an integral member <NUM> within a wall or fixedly attached to the shaft, a variable braid <NUM> or other variation used to create multiple deflections, such as deflections with asymmetric deflection geometries.

According to alternative embodiments,the distal ablation assembly <NUM> may be fixedly attached to the distal end of the distal portion <NUM>, or it may be advanceable from the distal shaft <NUM>, such as via a control port <NUM>. The distal ablation assembly <NUM> may comprise a single ablation element <NUM>, such as an electrode, or tip ablation element <NUM> or electrode tip <NUM>, or multiple ablation elements <NUM>, or mandrel electrodes <NUM>. The distal ablation assembly <NUM> may include a shape setting mandrel carrier assembly <NUM> of ablation elements, or simply shape setting mandrel <NUM>, and the shape setting mandrel carrier assembly <NUM> may be changeable from a compact geometry to an expanded geometry, such transition caused by advancement and/or retraction of a control shaft.

According to alternative embodiments,the shaft ablation assembly <NUM> may include a single ablation element <NUM> or multiple ablation elements <NUM>, or shaft electrodes <NUM>, preferably five to ten 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 shaft between the electrode elements outer diameter <NUM>, or shaft outer diameter <NUM>, is slightly smaller than the diameter of the ablation electrodes <NUM>, or shaft electrodes outer diameter <NUM>, such that the distal end of the catheter is more flexible.

According to alternative embodiments, the ablation elements <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of the present invention can deliver one or more forms of energy, preferably RF and/or Irreversible Electroporation energy. The ablation elements may have similar or dissimilar construction, and may be constructed in various sizes and geometries. The ablation elements may include one or more thermocouples <NUM>, such as two thermocouples mounted <NUM>° from each other on the inside of an ablation element. The ablation elements may include means of dissipating heat <NUM>, such as increased surface area. According to alternative embodiments, one or more ablation elements is configured in a tubular geometry, and the wall thickness to outer diameter approximates a <NUM>:<NUM> ratio. According to alternative embodiments, one or more ablation elements is configured to record, or map electrical activity in tissue such as mapping of cardiac electrograms. According to alternative embodiments, one or more ablation elements is configured to deliver pacing energy, such as to energy delivered to pace the heart of a patient.

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. Conditions include an arrhythmia of the heart, cancer, and other conditions in which removing or denaturing tissue improves the patient's health.

According to alternative embodiments, a kit of ablation catheters, or ablation catheter kit <NUM>, is provided. A first ablation catheter <NUM> has a distal portion which can be deflected in at least two symmetric geometries. A second ablation catheter <NUM>' has a distal portion which can be deflected in at least two asymmetric geometries.

According to alternative non-claimed embodiments,a method of treating proximal, persistent or long-standing persistent atrial fibrillation is provided. An ablation catheter of the present invention <NUM> may be placed in the coronary sinus of the patient, such as to map electrograms and/or ablate tissue, and subsequently placed in the left or right atrium to map electrograms and/or ablate tissue. The ablation catheter may be placed to ablate one or more tissue locations including but not limited to: fasicals around a pulmonary vein; the left atrial roof, and the mitral isthmus.

According to alternative non-claimed embodiments,a method of treating atrial flutter is provided. An ablation catheter of the present invention may be used to achieve bi-directional block, such as by placement in one or more locations in the right atrium of the heart <NUM>.

According to alternative non-claimed embodiments, a method of ablating tissue in the right atrium of the heart is provided. An ablation catheter of the present invention may be used to: create lesions between the superior vena cava and the inferior vena cava; the coronary sinus and the inferior vena cava; the superior vena cava and the coronary sinus; and combinations of these. The catheter can be used to map electrograms and/or map and/or ablate the sinus node, such as to treat sinus node tachycardia.

According to alternative non-claimed embodiments, a method of treating ventricular tachycardia is provided. An ablation catheter of the present invention may be placed in the left or right ventricles of the heart, induce ventricular tachycardia by delivering pacing energy, and ablating tissue to treat the patient.

According to alternative embodiments, an ablation catheter with a first geometry larger than a second deflection geometry is provided via the shape setting mandrel. The ablation catheter is placed in the smaller second shape geometry to ablate one or more of the following tissue locations: left atrial septum; tissue adjacent the left atrial septum; and tissue adjacent the left atrial posterior wall. The ablation catheter is placed in the larger first geometry to ablate at least the circumference around the pulmonary veins.

According to alternative embodiments, an ablation catheter of the present invention is used to treat both the left and right atria of a heart. The catheter is configured to transition to a geometry with a first shape setting mandrel and/or deflection geometry and a second shape setting mandrel and/or deflection geometry, where the first geometry is different than the second geometry. The catheter is used to ablate tissue in the right atrium using at least the first geometry and also ablate tissue in the left atrium using at least the second geometry.

According to alternative embodiments,a catheter for performing a medical procedure on a patient is provided. The catheter, or catheter assembly or equipment <NUM>, 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 in a first geometry and a second direction in a second geometry, wherein the first and second geometries are different. The catheter further includes a functional element fixedly mounted to the distal portion.

According to alternative embodiments,a combination treatment system that has at least one energy delivery device, or ablation catheter <NUM>, and at least one power or energy or power source, or single power source <NUM>, that is capable of providing IRE energy and thermal energy to the energy delivery device is provided. 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 nonthermal form to energy in a thermal form to ablate target regions of tissue as well as tissue along a track.

According to alternative non-claimed embodiments, a method that involves using non-thermal IRE energy and thermal energy to effectively ablate target regions of tissue is provided. The method involves positioning at least one energy delivery device that is coupled to a single power source within a target region of a tissue, applying IRE energy from the power source to the energy delivery device which is used to ablate a 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 said tissue with thermal energy such as RF energy, to allow for focal tissue ablation and the safe energy delivery used during the treatment procedure, while among other things, coagulating tissue and preventing bleeding.

According to alternative embodiments, what is described herein is a system for selectively ablating tissue <NUM>, the system <NUM> comprising an ablation catheter <NUM> and a single power source <NUM>.

According to alternative non-claimed embodiments, the method involves providing application of IRE to ablate and or treat tissue and treatment of tissue with an alternative energy form (such as thermal energy) to effectively ablate tissue from the same ablation device and the same energy source. The method can involve providing at least one energy source, or single power source <NUM>, which has at least a non-thermal energy source <NUM> and a thermal energy source <NUM>, providing at least one probe, or ablation catheter <NUM>, that is configured to be selectively operatively coupled to a desired energy source of the at least one energy source, positioning via a probe at least a portion of the at least one probe within a desired region of a heart or organ, selectively coupling the at least one probe to the non-thermal energy source, selectively energizing the non-thermal energy source to apply non-thermal energy from the non-thermal energy source to at least a portion of the desired region to ablate at least a portion of the desired region, selectively coupling the at least one probe to the thermal energy source, withdrawing the at least probe from the desired region, and selectively energizing the thermal energy source to apply thermal energy during at least a portion of withdrawal of the at least one probe to ablate tissue substantially adjacent to the probe track.

According to alternative embodiments, a system for selectively ablating tissue <NUM> is provided herein that has at least one energy source, or single power source <NUM>, that has a non-thermal energy source <NUM> and a thermal energy source <NUM>, at least one probe, or ablation catheter <NUM>, a means for selectively coupling <NUM> the probe to one desired energy source of the at least one energy source means for selectively energizing the non-thermal energy source <NUM> of the at least one energy source to apply non-thermal energy to at least a portion of the desired region to ablate at least a portion of the desired region, and means for selectively energizing the thermal energy source <NUM> of the at least one energy source during the withdrawal of the at least one probe to thermally ablate tissue substantially adjacent to a probe track.

Therefore, it is the object of the present invention to provide an ablation assembly having structural and functional features such as to meet the aforementioned needs and overcome the drawbacks mentioned above with reference to the devices of the prior art.

These and other objects are achieved by a device according to claim <NUM>.

Some advantageous embodiments are the subject of the dependent claims.

Further features and advantages of the invention will become apparent from the description provided below of exemplary embodiment thereof, given by way of non-limiting example, with reference to the accompanying drawings, in which:.

The present invention can be understood more readily by reference to the following detailed description, examples, drawing, and their previous and following description. However, before the present devices and systems are disclosed and described, it is to be understood that this invention is not limited to the specific devices and systems disclosed unless otherwise specified, as such can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.

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 relevant 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 present invention. It will also be apparent that some of the desired benefits of the present invention can be obtained by selecting some of the features of the present invention without utilizing other features. Accordingly, those who work in the art will recognize that many modifications and adaptations to the present invention are possible and can even be desirable in certain circumstances and are a part of the present invention. Thus, the following description is provided as illustrative of the principles of the present invention and not in 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 indicates otherwise. The term "plurality," as used herein refers to two or more.

As used herein, the terms "optional" or "optionally" mean that the subsequently described event or circumstance can or cannot occur, and that the description includes instances where the event or circumstance occurs and instances where it does not.

The term "distal" is understood to mean away from a medical practitioner and towards the body site at which the procedure is performed, and "proximal" means towards the medical practitioner and away from the body site.

In accordance with a general embodiment, an ablation assembly <NUM> to treat target regions of tissue <NUM> in organs <NUM>, comprises an ablation catheter <NUM> and at least a shape setting mandrel <NUM> disposed within the ablation catheter <NUM>.

Said ablation catheter <NUM> comprises a catheter elongate shaft <NUM> having a longitudinal main direction X-X and comprising at least an elongate shaft distal portion <NUM>.

Said shaft distal portion <NUM> comprises a shaft distal portion distal end <NUM>.

Said ablation catheter <NUM> comprises an inner lumen <NUM> arranged within the elongate shaft <NUM>.

According to an embodiment, said catheter elongated shaft <NUM> comprises a flexible body <NUM> to navigate through body vessels <NUM>.

Said ablation catheter <NUM> further comprises a shaft ablation assembly <NUM> fixedly disposed at said elongate shaft distal portion <NUM>.

Said shaft ablation assembly <NUM> is configured to deliver both thermal energy for ablating said tissue <NUM> and non-thermal energy for treating said tissue <NUM>.

Said least a shape setting mandrel <NUM> is insertable within the inner lumen <NUM> and removable from the inner lumen <NUM>.

Said at least shape setting mandrel <NUM> is free to move in respect of the inner lumen <NUM> avoiding any constraint with said shaft distal portion <NUM> during the shape setting mandrel insertion.

Said at least a shape setting mandrel <NUM> comprises at least a pre-shaped configuration and the at least a shape setting mandrel <NUM> is reversibly deformable between at least a straight loaded configuration and said pre-shaped configuration.

When the at least a shape setting mandrel <NUM> is fully inserted in the shaft distal portion <NUM>, the shape setting mandrel <NUM> is configured to shape set said shaft distal portion <NUM> with said pre-shaped configuration.

In accordance with an alternative embodiment, said shaft distal portion <NUM> is elastically deformable.

In accordance with an alternative embodiment, when the shape setting mandrel <NUM> is fully inserted in the shaft distal portion <NUM>, said shaft distal portion <NUM> is configured to conform to said pre-shaped configuration.

In accordance with an alternative embodiment, when the shape setting mandrel <NUM> is fully inserted in the shaft distal portion <NUM> it is defined a mandrel fully inserted position.

In accordance with an alternative embodiment, while the shape setting mandrel <NUM> slides within the inner lumen <NUM> towards said mandrel fully inserted position, the shape setting mandrel <NUM> is configured to variably shape set the shaft distal portion <NUM> passing from said loaded straight configuration to said pre-shaped configuration.

In accordance with an alternative embodiment, when the shape setting mandrel <NUM> is fully inserted in the shaft distal portion <NUM>, said shape setting mandrel <NUM> deform said shaft distal portion <NUM> at least in a shaft distal portion plane P.

In accordance with an alternative embodiment, said ablation catheter <NUM> comprises a catheter bend portion <NUM> proximal to the shaft ablation assembly <NUM>, wherein said catheter bend portion <NUM> is configured to realize an elbow that steer said shaft distal portion plane P with respect to said longitudinal main direction X-X.

In accordance with an alternative embodiment, at least when the shape setting mandrel <NUM> is fully inserted in the shaft distal portion <NUM> said shaft distal portion <NUM> forms an acute angle ALFA with respect to the shaft longitudinal main direction X-X.

In accordance with an alternative embodiment, wherein when the shape setting mandrel <NUM> is fully inserted in the shaft distal portion <NUM>, the shape setting mandrel <NUM> is configured to bend at said catheter bend portion <NUM>.

In accordance with an alternative embodiment, said shape setting mandrel <NUM> in said pre-shaped configuration comprises a mandrel bend portion <NUM>, and when said shape setting mandrel <NUM> is fully inserted in said shaft distal portion <NUM>, said mandrel bend portion <NUM> is disposed in correspondence of said catheter bend portion <NUM> performing said catheter bend portion <NUM>.

In accordance with an alternative embodiment, when the shape setting mandrel <NUM> is fully inserted in the shaft distal portion <NUM>, the shaft distal portion <NUM> takes a circular configuration.

In accordance with an alternative embodiment, the shape setting mandrel <NUM> comprises a mandrel elastic body <NUM> capable to deform into at least said straight loaded configuration and to return to said pre-shaped configuration.

In accordance with an alternative embodiment, the shape setting mandrel <NUM> is made of at least a shape memory alloy.

In accordance with an alternative embodiment, said assembly <NUM> comprises a mandrel heating element <NUM> coupled to said shape setting mandrel <NUM>, wherein said heating element <NUM> is configured to apply heat to said shape setting mandrel <NUM> so that shape setting mandrel <NUM> changes shape configuration from said loaded straight configuration to said pre-shaped configuration.

In accordance with an alternative embodiment, said ablation assembly <NUM> comprises a locking mechanism <NUM> configured to lock said shape setting mandrel <NUM> to said shaft distal portion <NUM> when said shape setting mandrel <NUM> is in said mandrel fully inserted position.

In accordance with an alternative embodiment, said locking mechanism <NUM> comprises a retention element <NUM> that reversibly locks said shape setting mandrel <NUM> in said mandrel fully inserted position.

In accordance with an alternative embodiment, said retention element <NUM> is configured to release said shape setting mandrel <NUM> from said mandrel fully inserted position when a pull force is applied to said shape setting mandrel <NUM>.

In accordance with an alternative embodiment, said retention element <NUM> is made of metal, metal alloy, rubber or polymer.

In accordance with an alternative embodiment, said shape setting mandrel <NUM> comprises a ball-tip <NUM> configured to engage said retention element <NUM> when said shape setting mandrel <NUM> is in said fully inserted position.

In accordance with an alternative embodiment, said shape setting mandrel <NUM> comprises a mandrel distal portion <NUM>.

In accordance with an alternative embodiment, said mandrel distal portion <NUM> comprises a mandrel seat <NUM>, wherein said retention element <NUM> is fixed to said shape setting mandrel <NUM> and partially housed in said mandrel seat <NUM>.

In accordance with an alternative embodiment, said inner lumen <NUM> proximal to said shaft distal portion distal end <NUM> presents a neck portion <NUM>, wherein said retention element <NUM> interferes with said neck portion <NUM> to lock said shape setting mandrel <NUM> in said mandrel fully inserted position.

In accordance with an alternative embodiment, said retention element <NUM> is an O-ring, wherein said mandrel seat <NUM> is toroidal.

In accordance with an alternative embodiment, the shaft distal portion <NUM> is deflectable in one or more directions, in one or more deflections shapes and geometries.

In accordance with an alternative embodiment, the shape setting mandrel <NUM> in the pre-shaped configuration is configured to maintain the deflections of the shaft distal portion <NUM> in a single plane.

In accordance with an alternative embodiment, the deflection directions are symmetric deflection geometries or asymmetric deflection geometries.

In accordance with an alternative embodiment, the elongate shaft <NUM> has difference in the stiffness of the shaft along its length.

In accordance with an alternative embodiment, the elongate shaft <NUM> comprises a shaft proximal portion <NUM>.

In accordance with an alternative embodiment, said shaft proximal portion <NUM> is more rigid than said shaft distal portion <NUM>.

In accordance with an alternative embodiment, the elongate shaft <NUM> comprises a shaft transition portion <NUM> disposed between said shaft proximal portion <NUM> and said shaft distal portion <NUM>.

In accordance with an alternative embodiment, said shaft transition portion <NUM> is more rigid than said shaft distal portion <NUM> and less rigid then said shaft proximal portion <NUM>.

In accordance with an alternative embodiment, said elongate shaft <NUM> comprises shaft portions having different stiffness, wherein said elongate shaft <NUM> comprises at least one circumferentially dissymmetric stiffness portions between two of said shaft portions having different stiffness.

In accordance with an alternative embodiment, said elongate shaft <NUM> is made of Pebax®, or said elongate shaft <NUM> is braided and made of stainless steel flat wire brake and/or Nylon® strand braid.

In accordance with an alternative embodiment, said ablation catheter <NUM> comprises at least one steering wire <NUM> configured to deflect the shaft distal portion <NUM> in one or more deflection directions, wherein said at least one steering wire <NUM> is fixedly connected to said shaft distal portion <NUM>.

In accordance with an alternative embodiment, said at least one steering wire <NUM> comprises a wire proximal extension <NUM> that is arranged outside with respect to a shaft proximal portion <NUM>.

In accordance with an alternative embodiment, said wire proximal extension <NUM> comprises a wire gripping portion <NUM> configured to pull at least one the steering wire <NUM> for steering the shaft distal portion <NUM> with shape setting mandrel <NUM> fully inserted into the shaft distal portion <NUM>.

In accordance with an alternative embodiment, said shaft distal portion <NUM> comprises a shaft distal portion proximal end <NUM>.

In accordance with an alternative embodiment, said ablation catheter <NUM> comprises at least two steering wires <NUM>.

In accordance with an alternative embodiment, a first steering wire of said at least two steering wires <NUM> is fixedly connected proximal to the shaft distal portion distal end <NUM> or the shaft distal portion proximal end <NUM>.

In accordance with an alternative embodiment, a second steering wire of said at least two steering wires <NUM> is fixedly connected proximal to the shaft distal portion proximal end <NUM> or to the shaft distal portion distal end <NUM>.

In accordance with an alternative embodiment, a third steering wire of said at least two steering wires <NUM> is fixedly connected proximal to the shaft distal portion distal end <NUM> or to the shaft distal portion proximal end <NUM>.

In accordance with an alternative embodiment, a fourth steering wire of said at least two steering wires <NUM> is fixedly connected proximal to the shaft distal portion distal end <NUM> or to the shaft distal portion proximal end <NUM>.

In accordance with an alternative embodiment, said shape setting mandrel <NUM> comprises a mandrel proximal portion <NUM>, wherein said mandrel proximal portion <NUM> is disposed outside said inner lumen <NUM> so that said shape setting mandrel <NUM> is drivable by a user.

In accordance with an alternative embodiment, said elongate shaft <NUM> comprises a shaft proximal end <NUM>.

In accordance with an alternative embodiment, said ablation catheter <NUM> comprises a steering device <NUM> attached to said shaft proximal end <NUM>.

In accordance with an alternative embodiment, said ablation catheter <NUM> comprises an handle <NUM>, wherein said steering device <NUM> is connected to said handle <NUM>.

In accordance with an alternative embodiment, said steering device <NUM> is drivable in rotation with respect to said handle <NUM> so that a rotation of said steering device <NUM> with respect to said handle causes a rotation of said elongate shaft <NUM>.

In accordance with an alternative embodiment, said steering device <NUM> comprises a through hole <NUM> in communication with said inner lumen <NUM>.

In accordance with an alternative embodiment, during insertion or removal of the shape setting mandrel <NUM> within or from said ablation catheter <NUM> said shape setting mandrel <NUM> passes through said through hole <NUM>, and wherein when the shape setting mandrel <NUM> is fully inserted in the shaft distal portion <NUM>, said mandrel proximal portion <NUM> is outside said steering device <NUM>.

In accordance with an alternative embodiment, when the shape setting mandrel <NUM> is fully inserted in the shaft distal portion <NUM>, said shape setting mandrel <NUM> deforms said shaft distal portion <NUM> at least in a shaft distal portion plane P.

In accordance with an alternative embodiment, said steering device <NUM> comprises at least two protrusion <NUM>, wherein said at least two protrusions and said shaft distal portion plane P are coplanar to help a user to handle the catheter assembly <NUM>.

In accordance with an alternative embodiment, said ablation assembly <NUM> comprises a distal ablation assembly <NUM> disposable at least at said shaft distal portion distal end <NUM>.

In accordance with an alternative embodiment, said distal ablation assembly <NUM> is configured to deliver both thermal energy for ablating said tissue <NUM> and non-thermal energy for treating said tissue <NUM>.

In accordance with an alternative embodiment, said distal ablation assembly <NUM> comprises at least an electrode tip <NUM> disposable at least at said shaft distal portion distal end <NUM>.

In accordance with an alternative embodiment, said shaft electrodes <NUM> are arranged along the shaft distal portion <NUM> spaced apart from each other.

In accordance with an alternative embodiment, said shaft ablation assembly <NUM> is configured also to map a tissue <NUM>.

In accordance with an alternative embodiment, said electrode tip <NUM> has an external surface shaped to be atraumatic and resiliently biased in rounded configuration.

In accordance with an alternative embodiment, said shaft electrodes <NUM> and said electrode tip <NUM> comprise at least a monopolar electrode <NUM> and/or at least a bipolar electrode <NUM>.

In accordance with an alternative embodiment, said distal ablation assembly <NUM> comprises at least one thermocouple <NUM>.

In accordance with an alternative embodiment, said shaft ablation assembly <NUM> comprises at least one thermocouple <NUM>.

In accordance with an alternative embodiment, the shaft electrodes <NUM> are five to ten electrodes fixedly attached to the shaft distal portion <NUM>.

In accordance with an alternative embodiment, said electrode tip <NUM> is fixedly disposed at least at said shaft distal portion distal end <NUM>.

In accordance with an alternative embodiment, said electrode tip <NUM> is removable from said shaft distal portion distal end <NUM> and interchangeable with a set of tip electrodes <NUM>, wherein the tip electrodes of said set of tip electrodes <NUM> have different shapes and dimensions.

In accordance with an alternative embodiment, the shaft electrodes <NUM> are arranged spaced apart along a length of the shaft distal portion <NUM> in one of the following configurations:.

In accordance with an alternative embodiment, each shaft electrode of said plurality of shaft electrodes <NUM> comprises an electrode surface area from about <NUM>. 05cm2 to about 5cm2 or from about 1cm2 to about 2cm2.

In accordance with an alternative embodiment, each shaft electrode of said plurality of shaft electrodes <NUM> is configured to deliver an electric field to the target tissue with at least one of the following electric field intensity ranges: about <NUM> V/cm to about <NUM>,<NUM> V/cm; and/or about <NUM> V/cm to about <NUM> V/cm; and/or about <NUM> V/cm to about <NUM> V/cm; and/or about <NUM>,<NUM> V/cm to about <NUM>,<NUM> V/cm.

In accordance with an alternative embodiment, said plurality of shaft electrodes <NUM> comprise a distal shaft electrode <NUM>, said distal shaft electrode <NUM> being mounted on the shaft distal portion <NUM> at a distance of <NUM>-<NUM> from the shaft distal portion distal end <NUM>.

In accordance with an alternative embodiment, the shaft electrodes <NUM> are cylindrical.

In accordance with an alternative embodiment, the shaft electrodes <NUM> have a profile that is flush with the surface of the shaft.

In accordance with an alternative embodiment, the shaft electrodes <NUM> present a shaft electrodes outer diameter <NUM>, and the shaft portions between the shaft electrodes <NUM> present an outer shaft diameter <NUM> that is slightly smaller than the shaft electrodes outer diameter <NUM> such that the shaft distal end is more flexible.

In accordance with an alternative embodiment, the shaft electrodes <NUM> are resiliently biased in circular configuration.

In accordance with an alternative embodiment, the shaft electrodes <NUM> present a tubular geometry having a wall thickness to outer diameter that approximates a <NUM>:<NUM> ratio.

In accordance with an alternative embodiment, said plurality of shaft electrodes <NUM> comprise at least a bipolar electrode <NUM>, said bipolar electrode <NUM> comprising a small electrode <NUM> and a large electrode <NUM>, wherein the small electrode <NUM> is isolated from the large electrode <NUM>.

In accordance with an alternative embodiment, at least one of said shaft electrodes <NUM> comprises at least two conductive portions N electrically isolated from each other, wherein each conductive portion N covers radially less than <NUM>° around the shaft distal portion <NUM>.

In accordance with an alternative embodiment, at least one of said shaft electrodes <NUM> comprises at least four conductive portions N electrically isolated from each other, wherein each conductive portion N covers radially less than <NUM>° around the shaft distal portion <NUM>.

In accordance with an alternative embodiment, the shaft distal portion distal end <NUM> is open and the shape setting mandrel <NUM> is slidable outside said shaft distal portion distal end <NUM> from said mandrel fully inserted position to a mandrel maximum exposed position.

In accordance with an alternative embodiment, said distal ablation assembly <NUM> is fixedly disposed at said mandrel distal portion <NUM>.

In accordance with an alternative embodiment, said distal ablation assembly <NUM> comprises a plurality of mandrel electrodes <NUM>, wherein said mandrel electrodes <NUM> are axially spaced along said mandrel distal portion <NUM>.

In accordance with an alternative embodiment, said mandrel electrodes <NUM> comprise at least a monopolar electrode <NUM> and/or at least a bipolar electrode <NUM>.

In accordance with an alternative embodiment, when said shape setting mandrel <NUM> is in said mandrel fully inserted position, the shaft electrodes <NUM> are electrically connected with at least a part of the plurality of mandrel electrodes <NUM>.

In accordance with an alternative embodiment, when said shape setting mandrel <NUM> is in said mandrel maximum exposed position the shaft electrodes <NUM> are electrically disconnected from any electrical source.

In accordance with an alternative embodiment, the non-thermal energy is irreversible electroporation energy or, IRE, the thermal energy is radiofrequency energy or RF.

In accordance with an alternative embodiment, the shape setting mandrel <NUM> is slidable outside the shaft distal portion distal end <NUM> from a mandrel fully inserted position to a mandrel maximum exposed position. In said mandrel fully inserted position, the mandrel <NUM> is in said loaded straight configuration, and in said mandrel maximum exposed position, the mandrel is in said pre-shaped configuration.

In accordance with an alternative embodiment, said ablation assembly <NUM> comprises a single power source <NUM>.

Said shaft ablation assembly <NUM> comprising at least a plurality of electrodes <NUM>, <NUM> or <NUM> fixedly disposed at said elongated shaft distal portion <NUM>. All electrodes of said at least a plurality <NUM>, <NUM> or <NUM> being electrically powered by said single power source <NUM> through an electric signal S to deliver both non-thermal energy for treating the tissue <NUM> and thermal energy for ablating the tissue <NUM>.

Said single power source <NUM>, when requested, changes continuously said electric signal S in order to power the said least a plurality of electrodes <NUM>, <NUM> or <NUM> to deliver from a non-thermal energy to a thermal energy, and vice versa, or to deliver at the same time a combination of thermal energy and non-thermal energy.

In accordance with an alternative embodiment, said single power source <NUM> comprises a single control unit <NUM> and a power unit <NUM> for generating said electric signal S.

In accordance with an alternative embodiment, said power unit <NUM> being electrically connected to all electrodes of said at least a plurality of electrodes <NUM>, <NUM> or <NUM>.

In accordance with an alternative embodiment, said power unit <NUM> is driven by the single control unit <NUM> to change continuously the electric energy level associated to the signal S to be supplied to the electrodes <NUM>, <NUM> or <NUM> to deliver from a non-thermal energy to a thermal energy, and vice versa, or to deliver a combination of thermal energy and non-thermal energy at the same time.

In accordance with an alternative embodiment, said power unit <NUM> comprises a power module <NUM>. Said power module <NUM> comprises:.

In accordance with an alternative embodiment, said single control unit <NUM> comprises a Microprocessor <NUM> configured to control a variable High Voltage Power Supply block <NUM> and a Programmable Logic Controller block <NUM>.

Said variable High Voltage Power Supply block <NUM> being configured to provide said supply voltage signal Vcc to the power module <NUM> for generating said electric signal S.

Said Programmable Logic Controller block <NUM> being configured to generate drive signals to control the drive circuit block <NUM> of the power module <NUM>.

In accordance with an alternative embodiment, said single control unit <NUM> further comprises:.

In accordance with an alternative embodiment, said power unit <NUM> comprises one or more power modules <NUM> equal to each other.

In accordance with an alternative embodiment, at least one of said electrodes <NUM>, <NUM> is a monopolar electrode <NUM>, and said monopolar electrode <NUM> of said at least a plurality of electrodes is electrically connected to only one power module <NUM> of said power unit <NUM>.

In accordance with an alternative embodiment, at least two of said electrodes <NUM>, <NUM> are electrically connected to form a bipolar electrodes <NUM>, and said bipolar electrodes <NUM> of said at least a plurality of electrodes are electrically connected separately to respective power module <NUM> selectable among the power modules of said power unit <NUM>. ln accordance with an alternative embodiment, said electric signal S to be supplied to the electrodes of said plurality <NUM>, <NUM> or <NUM> comprises pulse trains <NUM>. ln accordance with an alternative embodiment, said single control unit <NUM> is configured to drive the power unit <NUM> to modify the pulse duration <NUM> of each pulse <NUM> in the pulse trains <NUM> to change the electric energy level associated with the signal S.

In accordance with an alternative embodiment, said single control unit <NUM> is configured to drive the power unit <NUM> to modify the number of pulses <NUM> in the pulse train <NUM> to change the electric energy level associated with the signal S.

In accordance with an alternative embodiment, said single control unit <NUM> is configured to drive the power unit <NUM> to modify the gap of time <NUM> between adjacent pulse trains <NUM> to change the electric energy level associated with the signal S. In accordance with an alternative embodiment, each monopolar electrode <NUM> of said least a plurality of electrodes is electrically connected to the corresponding power module <NUM> of said power unit <NUM> by a single wire <NUM> welded to the monopolar electrode <NUM>.

In accordance with an alternative embodiment, each bipolar electrode <NUM> of said least a plurality of electrodes is electrically connected to the two selected power modules <NUM> of said power unit <NUM> by two wires <NUM> welded to the bipolar electrode <NUM>.

In accordance with an alternative embodiment, said electric signal S to be supplied to the electrodes of said plurality <NUM>, <NUM> or <NUM> comprises at least a square wave signal.

In accordance with an alternative embodiment, said electric signal S to be supplied to the electrodes of said plurality <NUM>, <NUM> or <NUM> comprises a signal obtained by combining or summing or superimposing two or more square wave signals each other.

In accordance with an alternative embodiment, said electric signal S to be supplied to the electrodes of said plurality <NUM>, <NUM> or <NUM> comprises a DC signal or an AC signal or a combination of a DC signal and an AC signal.

In accordance with an alternative embodiment, said single power source <NUM> is powered by a battery or is connected to a standard wall outlet of an AC electrical power grid capable of producing <NUM> volts or <NUM> volts.

In accordance with an alternative embodiment, said least two electrodes <NUM>, <NUM> electrically connected to form a bipolar electrodes <NUM> comprise:.

In accordance with an alternative embodiment, the single control unit <NUM> is configured to drive said power unit <NUM> to generate in each power module <NUM> a respective electric signal S of a plurality of electric signals S to be supplied to the electrodes <NUM>, <NUM> or <NUM>,. said Microprocessor <NUM> being configured to control, through said Programmable Logic Controller block <NUM>, each power module <NUM> to modify the ON status, the OFF status and the phase angle of each electric signal S of said plurality of electric signals so that, by selecting two or more electric signals S supplied to the electrodes <NUM>, <NUM> or <NUM>, both a monopolar electric filed from each electrode with a ground electrode <NUM> and a bipolar electric field between two contiguous electrodes is generated.

The present disclosure refers also to a non-claimed method for controlling at least a plurality of electrodes <NUM>, <NUM> or <NUM> in an ablation assembly or equipment <NUM> comprising an ablation catheter <NUM> and a single power source <NUM> according to the embodiments previously described. The method comprising:.

In accordance with an alternative embodiment, each monopolar electrode <NUM> of said least a plurality of electrodes is electrically connected to the corresponding power module <NUM> of said power unit <NUM> by a single wire <NUM> welded to the monopolar electrode <NUM>.

The present invention refers also to an ablation kit <NUM>.

The shape setting mandrels of said set <NUM> have different pre-shaped configurations.

The shape setting mandrels of said set <NUM> are alternatively disposable and removable in said ablation catheter <NUM>.

According to an alternative embodiment, said set of shape setting mandrels <NUM> comprises at least a first shape setting mandrel <NUM> and a second shape setting mandrel <NUM>.

The first shape setting mandrel <NUM> has a first pre-shaped configuration and the second shape setting mandrel <NUM> has a second pre-shaped configuration.

Said first pre-shaped configuration is different than said second pre-shaped configuration so that different shapes of shaft distal portion <NUM> are performed depending on which shape setting mandrel <NUM>, <NUM> of said set of setting mandrels <NUM> is disposed into the ablation catheter <NUM>.

In accordance with an alternative embodiment, at least one shape setting mandrel of said set of shape setting mandrels <NUM>, has a circular pre-formed configuration.

In accordance with an alternative embodiment, at least one shape setting mandrel of said set of shape setting mandrels <NUM>, has a spiral pre-formed configuration.

In accordance with an alternative embodiment, at least one shape setting mandrel of said set of shape setting mandrels <NUM> has a straight pre-formed configuration.

In accordance with an alternative embodiment, at least one shape setting mandrel of said set of shape setting mandrels <NUM> has a circular pre-formed configuration provided with an elbow.

The present invention furthermore refers to ablation catheter Kit <NUM>.

The ablation catheter kit <NUM> comprises at least a first ablation assembly <NUM> and a second ablation assembly <NUM>' according to any of the preceding described embodiments.

The shaft distal portion <NUM> of the ablation catheter <NUM> of the first ablation assembly <NUM> is deflectable in at least two symmetric geometries.

The shaft distal portion <NUM>' of the ablation catheter <NUM>' of the second ablation assembly <NUM>' is deflectable in in at least two asymmetric geometries.

The present disclosure furthermore refers to a non-claimed method for set shaping an ablation catheter, comprising the following steps:.

The present disclosure furthermore refers to a non-claimed method for multiple set shaping an ablation catheter, comprising the following steps:.

The present disclosure furthermore refers to a non-claimed method for controlling at least a plurality of electrodes <NUM>, <NUM> or <NUM> in an ablation equipment <NUM>. Said ablation equipment comprises an ablation catheter <NUM> and a single power source <NUM> according to anyone of the embodiments described before.

Thanks to the solutions proposed, it is possible to provide a non-claimed method for set shaping an ablation catheter, comprising the following steps:.

Thanks to the solutions proposed, it is possible to provide a non-claimed method for the treatment of proximal persistent or long-standing persistent atrial fibrillation in a patient comprising the following steps:.

wherein the tissue locations include fasicals around a pulmonary vein, and/or the left atrial roof, and/or the mitral isthmus.

Thanks to the solutions proposed, it is possible to provide a non-claimed method for the treatment of atrial flutter in a patient comprising the following steps:.

Thanks to the solutions proposed, it is possible to provide a non-claimed method of ablating tissue in the right atrium of the heart comprising the following steps:.

Thanks to the solutions proposed, it is possible to provide a non-claimed method for the treatment of sinus node tachycardia in a patient comprising the following steps:.

Thanks to the solutions proposed, it is possible to provide a non-claimed method for the treatment of ventricular tachycardia in a patient comprising the following steps:.

Thanks to the solutions proposed, it is possible to provide a non-claimed method to ablate atrial tissues comprising the following steps:.

The present disclosure furthermore refers to a non-claimed use of the kit according to anyone of the above described embodiments and to treat both the left and right atria of a heart, wherein the ablation catheter <NUM> of the ablation assembly <NUM> is used to ablate tissue in the right atrium using at least the first shape setting mandrel <NUM>, and the same ablation catheter <NUM> is used to also ablate tissue in the left atrium using at least the second shape setting mandrel <NUM>.

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

Configured to be percutaneously advanced into Left Atrium and Left Ventricle of Heart (through septum via transseptal sheath).

May be advanced through sheath previously placed in LA (e.g. deflectable or fixed cure sheath).

Elongate Catheter Body <NUM>, <NUM> May be steerable (unidirectional or bidirectional).

Side hole ports allow signal wires to pass from inside to outside.

Attached to proximal end of Handle with port for either saline delivery and/or a shape setting.

According to alternative embodiments, the present invention provides catheters <NUM>, or ablation assembly <NUM>, for performing various targeted tissue ablation in a subject. According to alternative embodiments, the catheters comprise an elongate shaft <NUM> having a proximal end <NUM> and distal end <NUM> and preferably a lumen, or inner lumen <NUM>, extending at least partially therebetween. The catheter is preferably of the type used for performing intracardiac procedures, typically being introduced from the femoral vein in a patient's leg or from a vessel in the patient's neck. The catheter is preferably introducible through a transport tube, such as a transeptal sheath, and also preferably has a steerable tip that allows positioning of the distal portion <NUM> such as when the distal end of the catheter is within a heart chamber. The catheters include ablation elements <NUM>, or tip ablation elements <NUM>, located at the distal end of the shaft (tip electrodes <NUM>), as well as ablation elements <NUM>, or shaft ablation elements <NUM>, located on or in the exterior surface of the shaft proximal to the distal end (tube electrodes or shaft electrodes <NUM>). The tip electrodes <NUM> may be fixedly attached to the distal end of the shaft, or may be mounted on an advancable and/or expandable carrier assembly. The carrier assembly may be attached to a control shaft that is coaxially disposed and slidingly received within the lumen of the shaft. The carrier assembly is deployable by activating one or more controls on a handle <NUM> of the catheter <NUM>, such as to engage one or more ablation elements against cardiac tissue, typically atrial wall tissue or other endocardial tissue. The shaft may include deflection means, such as means operably connected to a control on a handle of the catheter or through a center lumen where different shape mandrels <NUM> can be placed to change the catheter distal section shape. The deflection means may deflect the distal portion of the shaft in one or more directions, such as deflections with two symmetric geometries, two asymmetric geometries, or combinations of these. Asymmetries may be caused by different radius of curvature, different length of curvature, differences in planarity, other different <NUM>-D shapes, other different <NUM>-D shapes, and the like.

In particular, according to alternative embodiments, the present invention provides ablation catheters with multiple electrodes that provide electrical energy, such as Radio Frequency (RF) and/or IRreversible electroporation (IRE) which occurs when a strong, pulsed electrical field (PEF) causes permeabilization of the cell membrane, leading to cellular homeostasis disruption and cell death. Radiofrequency (RF) energy, in monopolar (unipolar), bipolar or combined unipolar-bipolar fashion, as well as methods for treating conditions such as paroxysmal atrial fibrillation, chronic atrial fibrillation, atrial flutter, supra ventricular tachycardia, atrial tachycardia, ventricular tachycardia, ventricular fibrillation, and the like, with these devices.

The normal functioning of the heart relies on proper electrical impulse generation and transmission. In certain heart diseases (e.g., atrial fibrillation) proper electrical generation and transmission are disrupted or are otherwise abnormal. In order to prevent improper impulse generation and transmission from causing an undesired condition, the ablation catheters and RF generators of the present invention may be employed.

One current non-claimed method of treating cardiac arrhythmias is with catheter ablation therapy. Physicians make use of catheters to gain access into interior regions of the body. Catheters with attached electrode arrays or other ablating devices are used to create lesions that disrupt electrical pathways in cardiac tissue. In the treatment of cardiac arrhythmias, a specific area of cardiac tissue having aberrant conductive pathways, such as atrial rotors, emitting or conducting erratic electrical impulses, is initially localized. A user (e.g., a physician) directs a catheter through a main vein or artery into the interior region of the heart that is to be treated. The ablating element (or elements) is next placed near the targeted cardiac tissue that is to be ablated. The physician directs energy, provided by a source external to the patient, from one ore more ablation elements to ablate the neighboring tissue and form a lesion. In general, the goal of catheter ablation therapy is to disrupt the electrical pathways in cardiac tissue to stop the emission and/or prevent the propagation of erratic electric impulses, thereby curing the focus of the disorder. For treatment of atrial fibrillation AF, currently available methods and devices have shown only limited success and/or employ devices that are extremely difficult to use or otherwise impractical.

The ablation systems of the present invention allow the generation of lesions of appropriate size and shape to treat conditions involving disorganized electrical conduction (e.g., AF). The ablation systems of the present invention are also practical in terms of ease-of-use and limiting risk to the patient (such as in creating an efficacious lesion while minimizing damage to untargeted tissue), as well as significantly reducing procedure times. The present invention addresses this need with, for example, arrangements of one or more tip ablation elements and one or more shaft ablation elements configured to create a linear lesion in tissue, such as the endocardial surface of a chamber of the heart, by delivery of energy to tissue or other means. The electrodes of the present invention may include projecting fins or other heat dissipating surfaces to improve cooling properties. The distal portions of the catheter shafts of the present invention may deflect in two or more symmetric or asymmetric geometries , such as asymmetric geometries with different radius of curvature or other geometric shape differences. The ablation catheters and RF generators of the present invention allow a clinician to treat a patient with AF in a procedure much shorter in duration than current AF ablation procedures. The lesions created by the ablation catheters and RF generators of the present invention are suitable for inhibiting the propagation of inappropriate electrical impulses in the heart for prevention of reentrant arrhythmias, while minimizing damage to untargeted tissue, such as the esophagus or phrenic nerve of the patient.

Referring to the figures, one embodiment of an energy delivery system for selectively ablating tissue, or ablation equipment or assembly <NUM>, is illustrated. In one aspect, the system can comprise at least one energy delivery device, or ablation catheter <NUM>, such as, but not limited to, a monopolar probe <NUM>, and at least one energy delivery source or power source, or single power source, <NUM>. In one aspect, at least a portion of the probe can be configured for insertion into a patient. In one aspect, the at least one energy source, or single power source <NUM>, can further comprise at least a non-thermal energy source <NUM> and a thermal energy source <NUM>. In one aspect, the system can comprise a mechanism for coupling the probe to one desired energy source of the at least one energy source <NUM>, or probe connector. In one aspect, although a monopolar probe is described herein, one of ordinary skill in the art will recognize that the energy delivery device used with the system described herein can be a different type of energy delivery device, such as, but not limited to, a bipolar probe <NUM>. In one aspect, the probe can be selected from a group consisting of: a monopolar electrode <NUM>, a bipolar electrode <NUM>, and an electrode array <NUM>, such as shaft electrodes <NUM>, mandrel electrodes <NUM>, and tip electrode <NUM>.

This can allow for utilization of an optimal energy delivery device for a given medical procedure. In one aspect, the monopolar probe <NUM> can comprise a handle <NUM>, a electrode having a proximal end, or electrode proximal end <NUM>, and a distal end, or electrode distal end <NUM>, and at least one connector of the probe. In one aspect, the electrode(s) can comprise at least one distal electrode <NUM> that is positioned therein at the distal end of the probe and round electrodes <NUM> positions on the body of the probe that is positioned in the heart chamber. In one aspect, the tip can be a rounded conical type shape and can be capable of sliding along the wall of the heart and said probe designed to allow the sliding to match the heart wall motion.

In one aspect, at least one monopolar probe, as described above, can be used with system. In another aspect, although not illustrated, at least two monopolar electrodes <NUM>, as described above, can be used with system. In one exemplary embodiment, it is contemplated that if more than one electrode is used in the system, the probes can be used in various configurations and shapes, such as, but not limited to, a parallel configuration or a spiral configuration. In one aspect, if two electrodes are used, it is contemplated that the distal electrode would be one and each of the body electrodes would be selected based on the length requirements of the ablation. In another exemplary aspect, the electrodes can be positioned such that the distal tip can be staggered in length compared to a body electrode. In one exemplary embodiment, if at least two electrodes are used in the system, the at least two electrodes can be spaced about <NUM>-<NUM> apart while mounted on the catheter body inserted into heart chamber and can provide a voltage of up to <NUM> volts. In yet another exemplary embodiment, the at least two electrodes can be spaced about <NUM> apart or greater be selecting alternate electrodes on catheter body and can have a voltage of up to about <NUM> volts. In one exemplary embodiment, the at least two electrodes can be spaced from each other such that they are approximately <NUM> apart while inserted into a target tissue and can provide a voltage of up to approximately <NUM> volts.

In one aspect, the at least one electrode of the monopolar probe can be configured to be electrically coupled to and energized by energy source. Further, although not shown, one of ordinary skill in the art would recognize that at least one grounding pad <NUM> can be used in conjunction with the at least one electrode to complete an electrical circuit <NUM>. Although a single electrode configuration is described herein, it is contemplated that other various needle <NUM> and/or electrode array formations could be used in any of the embodiments described herein. An array herein refers to an orderly arrangement of multiple probes <NUM>. In one aspect, this array could be a plurality or series of monopolar and/or bipolar probes arranged in various shapes, configurations, or combinations in order to allow for the ablation of multiple shapes and sizes of target regions of tissue. Various array patterns can reduce the need to reposition the electrode array during treatment by allowing multiple selectively activatable electrode patterns <NUM>. In one aspect, the electrodes can 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 can be made of various materials known in the art.

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 approximately <NUM> - <NUM> while inserted into tissue, such can be either linear length or circular length as in the case where the at least two electrodes are spaced up to approximately <NUM>-<NUM> mm apart on catheter body and distal tip. In another exemplary aspect, the electrodes can have an exposed electrode length of up to approximately <NUM>-<NUM>, such as in the case where the at least two electrodes are spaced approximately <NUM>-<NUM> apart. In yet another aspect, the electrodes can be spaced at various distances from one another. In one aspect, the electrodes can be spaced apart a distance of from about <NUM> to about to <NUM>. In another exemplary embodiment, the electrodes can be spaced apart a distance of from about <NUM> to about <NUM>. In yet another embodiment, the electrodes can be spaced apart a distance of between about <NUM> and about <NUM>. In one exemplary aspect the electrode surface area can vary. In one exemplary embodiment, the electrode surface area can vary from about <NUM>. 05cm2 to about 5cm2. In yet another exemplary embodiment, the electrodes can have a surface area of between about 1cm2 to about 2cm2.

In one aspect, the system can comprise a means <NUM>, <NUM> for selectively energizing a desired energy source to ablate at least a portion of the tissue adjacent to the at least one probe. In one aspect, the non-thermal energy source <NUM> of the at least one energy source or single power source <NUM>, can be selectively energized to apply non-thermal energy to at least a portion of the desired tissue region to ablate at least a portion of the desired tissue region <NUM>. 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 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, the 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 nonthermal energy from the non-thermal energy source to at least a portion of the desired tissue region to ablate at least a portion of the desired tissue region In one exemplary aspect, the at least one energy source can have at least one connector <NUM> that is configured for selective coupling to the at least one electrode / probe. In one aspect, the energy source can have a positive connector <NUM> and a negative connector <NUM>. More particularly, the at least one connector of the electrode / probe can be connected to the energy source via at least one of the positive connector and the negative connector.

In one exemplary embodiment, the power source or energy source can be a Argá model <NUM> electrosurgical generator capable of delivering up to <NUM> watts of RF power. One of ordinary skill in the art would recognize that a variety of generator models could be used with the system described herein. In one aspect, the generator can be powered by a battery <NUM>. In one aspect, the generator can be connected to a standard wall outlet that is capable of producing about <NUM> volts or about <NUM> volts. In one aspect, the power supply can be capable of being manually adjusted, depending on the voltage. In one exemplary embodiment, the generator can be capable of producing a minimum voltage of about <NUM> volts to about <NUM> volts. In one aspect, at least one of the power outlets, generators, and battery sources described herein can be used to provide voltage to the target tissue during treatment. In yet another exemplary embodiment, to achieve IRE ablation of the target region of tissue, the power source or generator can be used to deliver IRE energy to target tissue, including target tissue that can be somewhat difficult to reach. In one aspect, an exemplary embodiment of an IRE generator can include anywhere from <NUM> to <NUM> positive and negative connectors, though one of ordinary skill in the art would understand that other numbers of positive and negative connectors and different embodiments of connectors could be used and may be and necessary for optimal ablation configurations. A system in which a bipolar probe <NUM> is used. In one aspect, the bipolar probe <NUM> can comprise a handle <NUM>, electrode having a proximal end <NUM> and a distal end <NUM>, and at least one probe connector <NUM>. In one aspect, the electrode can comprise at least one electrode that is positioned therein at the distal end of the catheter and that is positioned at a distal most portion of the ablation elements. In one aspect, the electrode can further comprise a first electrode <NUM> that is positioned at the distal most portion of the catheter, a second electrode <NUM> that is positioned proximal of the distal electrode, and at least one spacer <NUM> that can be positioned between and adjacent to at least a portion of each of the first and second electrodes and the third, etc. electrode. In one aspect, at least a portion of a distal portion of the second electrode can abut at least a proximal portion of spacer and at least a distal portion of spacer can abut at least a portion of a proximal portion of the first electrode. In one aspect, similar to monopolar probe, the bipolar probe can be coupled to a thermal energy source <NUM>. During use of the system, the probe can be coupled to the energy source. More particularly, in one exemplary aspect, at least one connector of the probe <NUM> can be connected to the energy source via at least one of the positive connectors <NUM> and the negative connector <NUM>, as also described above.

Depending on various parameters, such as voltage (including application of DC or AC or both as well as voltage per square centimeter), current, pulse number <NUM>, pulse duration <NUM>, and the dwell between pulses applied to tissue, or gap of rime between adjacent pulses <NUM>, the tissue can be subjected to reversible electroporation, irreversible electroporation, or thermal damage (generally considered to be resistive heating). Nonthermal IRE ablation involves ablation where the primary method of cellular disruption leading to death is mediated via electroporation (rather than factors such as effects of or responses to heating). In certain embodiments, depending on the parameters mentioned (including time that the resulting temperature occurs), cellular death can be mediated via nonthermal IRE up to approximately ><NUM> degrees C. In certain embodiments cellular damage from thermal heating occurs above approximately ><NUM> degrees C. In various embodiments, the parameters resulting in nonthermal IRE can be changed to result in the death of cells via thermal heating. The parameters can also be changed to from one having nonthermal IRE effects to alternative settings where the changed parameters also have nonthermal IRE effects.

More particularly, in one aspect, the total number of pulses <NUM> and pulse trains <NUM> in various embodiments can be varied based on the desired treatment outcome and the effectiveness of the treatment for a given tissue. During delivery of non-thermal IRE energy to target tissue, a voltage can be generated that is configured to successfully ablate tissue. In one aspect, certain embodiments can involve pulses between about <NUM> microsecond and about <NUM>,<NUM> milliseconds, while others can involve pulses of about <NUM> microseconds and about <NUM>,<NUM> milliseconds. In yet another embodiment, the ablation pulse applied to the target tissue <NUM> can be between about <NUM> microseconds and <NUM> microseconds. In one aspect, the at least one energy source can be configured to release at least one pulse of energy for between about <NUM> microseconds to about <NUM> seconds and can be adjustable at <NUM> microsecond intervals. In certain embodiments the electrodes described herein can provide a voltage of about <NUM> volts per centimeter (V/cm) to about <NUM>,<NUM> V/cm to the target tissue. In other exemplary embodiments, the voltage can be about <NUM> V/cm to about <NUM> V/cm as well as from about <NUM> V/cm to about <NUM> V/cm. Other exemplary embodiments can involve voltages of about <NUM>,<NUM> V/cm to about <NUM>,<NUM> V/cm. In one exemplary aspect, the bipolar probe <NUM> can be used at a voltage of up to about <NUM> volts.

In one aspect, the number of pulses <NUM> that can be used in IRE ablation can vary. In certain exemplary embodiments the number of pulses <NUM> can be from about <NUM> pulse to about <NUM> pulses. In other exemplary embodiments, groups of about <NUM> pulse to about <NUM> pulses can be applied in succession following a gap of time between each pulse group or pulse train. In one exemplary embodiment the gap of time between groups of pulses can be about <NUM> second to about <NUM> seconds. In one aspect, pulses can be delivered to 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 varying lengths suitable for use in procedures such as, but not limited to, percutaneous, laparoscopic, and open surgical procedures. In one aspect, the at least one energy source can be configured to release at least one pulse of energy for between about <NUM> microseconds to about <NUM> seconds. In one exemplary aspect, the voltage described herein can be applied using the bipolar electrodes <NUM> in pulses of <NUM> microseconds in length to a target region of tissue. In one aspect, the voltage can be applied in pulses of about <NUM> microsecond in groups of pulses or pulse-trains of <NUM>, with an interval between pulses of about <NUM> milliseconds and a time between pulse-trains of about <NUM> seconds.

In one exemplary aspect, at least two monopolar electrodes <NUM> can be used to ablate target tissue, such that a zone of ablated tissue is produced that is approximately <NUM>-<NUM> x <NUM>-<NUM>. In one exemplary embodiment, two single electrodes can be configured so as to involve other ablation areas, including, but not limited to, an ablation area of approximately <NUM> x <NUM>. One of ordinary skill in the art would be understood that the ablation size and shape can be advantageously varied with placement of the electrode and various electrode types. In one aspect, during treatment, an additional area surrounding an outer edge of the target region of tissue is also ablated (ablation of unwanted or diseased tissue). This surrounding area of tissue can be ablated in order to ensure patient safety and the complete and adequate ablation of the target region of tissue. In one aspect, during the method of use, the catheter electrode tip <NUM> of the catheter is designed as not to puncture a patient's tissue. One of ordinary skill in the art would recognize that the target region of tissue can be any tissue from any organ where ablation can be used to ablate unwanted or diseased tissue, such as, but not limited to, cardiac tissue, digestive, skeletal, muscular, nervous, endocrine, circulatory, reproductive, integumentary, lymphatic, urinary tissue or organs, or other soft tissue or organs where selective ablation is desired. Soft tissue can include, but is not limited to, any tissue surrounding, supporting, or connecting other body structures and/or organs. For example, soft tissue can include muscles, tendons, ligaments, fascia, joint capsules, and other tissue. More specifically, target tissue can include, but is not limited to, areas of the heart, the prostate (including cancerous prostate tissue), the kidney (including renal cell, carcinoma tissue), as well as breast, lung, pancreas, uterus, and brain tissue, among others.

In one aspect, the energy source can be a thermal energy source. In one aspect, the non-thermal energy source can be selectively energizing for a desired period of time. More particularly, the period of time can be a predetermined period of time. In yet another aspect, the period of time can be a plurality of predetermined periods of time. In one aspect, the thermal energy source is selected from the group consisting of radiofrequency (RF), focused ultrasound, microwave, lasers, thermal electric heating, traditional heating methods with electrodes using DC or AC currents, and the application of heated fluids and cold therapies (such as cryosurgery). RF energy is known in the art for effective use in tumor ablation, though it is clear that any form of temperature-mediated continuous ablation could be used at settings known the art. In one aspect, after the energy delivery device is inserted into target organ <NUM>, tissue <NUM> is ablated, and the energy delivery device is withdrawn. In one aspect the thermal energy source <NUM> can be an alternating current thermal energy source. In yet another aspect, the thermal energy source <NUM> is a direct current thermal energy source.

In one aspect, the electrode(s) can start at the point of non-thermal ablation of the target region. In one aspect, thermal ablation can be initiated at the start of the electrode chain (length wise on the catheter), which in one embodiment is applied to prevent abrehent tissue conduction. As the energy delivery device or electrode is withdrawn, thermal energy can be applied through the electrode to the target tissue. In one aspect, the electrode is selectively energized with thermal energy or nonthermal to ablate tissue adjacent the electrode track and proximate to a boundary of the tissue ablated.

In one aspect, IRE treatment of 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 procedures and open surgical procedures. In one aspect ablation track can be ablated during the repositioning or dragging of a electrodes. In one aspect, after delivery of IRE energy to the target tissue, an ablated region of tissue remains. In one aspect, ablated region of tissue includes target tissue region and the surrounding area of tissue. In one exemplary embodiment, after treatment of the target tissue using IRE, treatment parameters can be reset to bring about thermal track ablation. In one aspect, after IRE treatment of the target tissue, the energy delivery device or electrodes is repositioned. In one aspect, upon termination of the energy delivery (and in some cases repositioning) of the energy delivery device ablate tissue in a different area/location, a tissue track is coagulated and bleeding can be prevented. In one aspect thermal energy, such as, but not limited to RF energy, can be applied to the ablation track during the ablation cycle. In another aspect the track ablation zone is created to stop bleeding. It is important to prevent bleeding so as no clots are formed, especially during procedures that could involve ablation in the left-side of the heart.

In one aspect, the generator, or single power source <NUM>, used during the thermal ablation procedure can be configured to have various ablation settings and capabilities. In one exemplary aspect, the Arga <NUM> generator described above can be used as an RF energy source. In one aspect, the RF energy source can be used to ablate tissue using <NUM>-<NUM> watts of power. In other exemplary aspects, one of ordinary skill in the art would recognize that smaller or larger amounts of power can be used in various embodiments, as necessary, in order to provide ablation. In one exemplary embodiment utilizing the 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.

In one aspect, if a thermal energy source is used, it could be used with a variety of techniques to bring about tissue ablation. In one exemplary aspect, additional embodiments can involve ablation performed using one or more of radiofrequency (RF), focused ultrasound, microwaves, lasers, thermal electric heating, traditional heating methods with electrodes using DC or AC currents, and application of heated fluids and cold therapies, such as, but not limited to, that used in cryosurgery. In one aspect h heat energy can be delivered in certain embodiments via pulses that can be in a range of about <NUM> microseconds to about <NUM> seconds. In other exemplary embodiments the at least one energy source can be configured to release or deliver at least one pulse of heat energy in a range of about <NUM> microseconds to about <NUM> second. In yet another exemplary embodiment, at least one energy source can release or deliver at least one pulse of energy for between about <NUM> microseconds to about <NUM> microseconds. In yet another exemplary embodiment, at least one pulse can be delivered in a range of from about <NUM> microsecond to about <NUM> microseconds.

In one exemplary embodiment thermal energy can be applied such that it produces fluctuations in temperature to effect treatment. In one aspect, the thermal energy provided to the tissue can heat the target tissue to between about <NUM> degree C and about <NUM> degrees C to bring about cell death. In one aspect the temperature can be adjusted such that it can be lesser or greater than this temperature range, depending on the exact rate of speed of removal of the heat generated via externally supplied fluid and/or blood from the target tissue. In one embodiment the temperature used is between about <NUM> degrees C and about <NUM> degrees C, although one of ordinary skill would recognize that temperatures above about <NUM> degrees C can cause tissue vaporization. In one exemplary embodiment, thermal energy can be used to ablate approximately <NUM>-<NUM> of tissue. In one aspect this tissue thickness can be varied depending upon various factors, such as, but not limited to, the condition of the target tissue, the various parameters used, and the treatment options.

In one embodiment the mechanisms through which the user sets the parameters for bringing about IRE effects are changed to bring about thermal results through thermal heating that is resistive heating. In certain embodiments the mechanisms are reset such that DC energy is applied to bring about thermal ablation. In one exemplary embodiment, ablation can be performed using DC current. In one aspect, the DC current can be used for heating 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 an electrical circuit. In one aspect, DC current can be applied such that the temperature of the tissue can be between about <NUM> degrees C and about <NUM> degrees C. In one aspect, the DC current can be applied such that thermal damage is induced at a temperature as low as about <NUM> degrees C. In yet another aspect, as the rate of probe removal increases, the DC current can be applied to the target tissue such that the temperature can be from about <NUM> degrees C to about <NUM> degrees <NPL>).

One of ordinary skill in the art would recognize that various lengths of DC pulses can be applied to bring about effective track ablation. In yet other embodiments, AC pluses can be applied as the energy delivery device is removed from the target tissue in stages. In summary, the method for selectively ablating tissue involves providing at least one energy source, such as a generator, described above. In one aspect, the at least one energy source, or single power source <NUM>, can comprise at least a non-thermal energy source <NUM> and a thermal energy source <NUM>, providing at least one probe, or at least one ablation catheter <NUM>, that is configured to be selectively manually operatively coupled to a desired energy source of the at least one energy source, positioning, via a electrode, at least a portion of the at least one electrode within a desired region of a target tissue. In one aspect, the selective coupling of the electrodes to the thermal energy source comprises the actuating a switch <NUM> to operatively select between the non-thermal energy source <NUM> and the thermal energy source <NUM>. Then at least one probe is selectively coupled to the non-thermal energy source, and the non-thermal energy source is selectively energized to apply non-thermal energy from the non-thermal energy source to at least a portion of the desired region to ablate at least a portion of the desired region, selectively coupling the at least one probe to the thermal energy source, withdrawing the at least probe from the desired region, and selectively energizing the thermal energy source to apply thermal energy during at least a portion of withdrawal 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 operatively decoupled from the non-thermal energy source.

Claim 1:
An ablation assembly (<NUM>) to treat target regions of a tissue (<NUM>) in organs (<NUM>) comprising:
- an ablation catheter (<NUM>) comprising an elongate shaft (<NUM>) having a longitudinal main direction (X-X), said elongate shaft (<NUM>) comprising at least a shaft distal portion (<NUM>), said shaft distal portion (<NUM>) comprising a shaft distal portion distal end (<NUM>);
said ablation catheter (<NUM>) comprising an inner lumen (<NUM>) arranged within the elongate shaft (<NUM>);
said ablation catheter (<NUM>) comprising a shaft ablation assembly (<NUM>) fixedly disposed at said shaft distal portion (<NUM>), the shaft ablation assembly (<NUM>) being configured to deliver both thermal energy for ablating said tissue (<NUM>) and non-thermal energy for treating said tissue (<NUM>);
- at least a shape setting mandrel (<NUM>) disposed within the ablation catheter (<NUM>), the shape setting mandrel (<NUM>) being insertable within the inner lumen (<NUM>) and removable from the inner lumen (<NUM>),
wherein the shape setting mandrel (<NUM>) is free to move in respect of the inner lumen (<NUM>) avoiding any constraint with said shaft distal portion (<NUM>) during the shape setting mandrel insertion,
wherein the shape setting mandrel (<NUM>) comprises at least a pre-shaped configuration and the shape setting mandrel (<NUM>) is reversibly deformable between at least a straight loaded configuration and said pre-shaped configuration,
wherein, when the shape setting mandrel (<NUM>) is fully inserted in the shaft distal portion (<NUM>), the shape setting mandrel (<NUM>) is configured to shape set said shaft distal portion (<NUM>) with said pre-shaped configuration,
wherein said shape setting mandrel (<NUM>) comprises a mandrel proximal portion (<NUM>), wherein said mandrel proximal portion (<NUM>) is disposed outside said inner lumen (<NUM>) so that said shape setting mandrel (<NUM>) is drivable by a user,
wherein said elongate shaft (<NUM>) comprises a shaft proximal end (<NUM>), wherein said ablation catheter (<NUM>) comprises a steering device (<NUM>) attached to said shaft proximal end (<NUM>), wherein said ablation catheter (<NUM>) comprises an handle (<NUM>), wherein said steering device (<NUM>) is connected to said handle (<NUM>) and is drivable in rotation with respect to said handle (<NUM>) so that a rotation of said steering device (<NUM>) with respect to said handle causes a rotation of said elongate shaft (<NUM>).