Magnet-assisted ablation apparatus and method

Abstract

Apparatus and methods are described for performing ablation treatment on one or more layers of tissue of a subject. A first catheter (102) is placed on a first side of the one or more layers of tissue and a second catheter (104) is placed on a second side of the one or more layers of tissue. A plurality of first-catheter magnets (114) are configured to become aligned with a plurality of second-catheter magnets (114), to thereby align first-catheter ablation elements (112, 514) with second-catheter ablation elements (112, 514). The first-catheter ablation elements (112, 514) and the second-catheter ablation elements (112, 514) are configured to apply ablation respectively to the first and second side of the one or more layers of tissue, such as to generate a continuous line of ablation that extends transmurally through the one or more layers of tissue. Other applications are also described.

Description

[0001] MAGNET-ASSISTED ABLATION APPARATUS AND METHOD

[0002] CROSS-REFERENCES TO RELATED APPLICATIONS

[0003] The present application claims priority from US Provisional Patent Application 63 / 528,434 to Beinart et al., filed July 24, 2023, entitled "Bi-layer magnet-assisted ablation apparatus and method," which is incorporated herein by reference.

[0004] FIELD OF EMBODIMENTS OF THE INVENTION

[0005] The present invention, in some embodiments thereof, relates to an ablation apparatus and method and, more particularly, but not exclusively, to a magnet-assisted ablation apparatus and method.

[0006] BACKGROUND

[0007] Cardiac ablation has emerged as a promising technique for addressing specific manifestations of vascular disease, such as arrhythmias. Cardiac ablation involves the targeted destruction of abnormal tissues within the heart, typically delivered through specialized catheters. This procedure aims to eliminate or reduce abnormal electrical pathways or obstructive lesions that contribute to arrhythmias.

[0008] Traditionally, cardiac ablation techniques have utilized radiofrequency energy, which heats the targeted tissue to induce controlled thermal necrosis. This method has demonstrated efficacy in treating conditions such as atrial fibrillation and ventricular tachycardia by selectively targeting and destroying aberrant electrical pathways or focal sources of arrhythmias.

[0009] Recent advancements in cardiac ablation technology have expanded the therapeutic options available to clinicians. Innovations include the development of catheters capable of delivering different forms of energy, such as cryoablation and laser ablation, each offering unique advantages in terms of precision, safety, and efficacy in specific clinical scenarios. SUMMARY OF EMBODIMENTS

[0010] An aspect of some embodiments of the invention relates to a hybrid approach to cardiac ablation (e.g., atrial fibrillation (AF) ablation) that allows concomitant bilayer ablation between epicardial and endocardial layers by using a set of two devices. In some embodiments, the devices comprise one or more magnets to ensure alignment of devices that are placed on respective sides of the tissue to be ablated (e.g., outside the epicardial layer and inside the endocardial layer).

[0011] An aspect of some embodiments of the invention relates to devices and methods that enable successful ablation procedures that produce a continuous lesion (i.e., a line of tissue that is ablated such as to generate an elongated scar, referred to herein as “an ablation line” or a “line of ablation”), optionally forming a closed circle, e.g., completely encircling one or more veins, and stopping activation waves from propagating to the atrial body. In some embodiments, additional antral lines are not needed after treatment. In some embodiments, the ablation lesion generated by the device is continuous, without having a combination of scar and gaps of healthy tissue.

[0012] It is noted that “an ablation line” or a “line of ablation” should not be interpreted to denote tissue that is ablated in a straight line, and in fact, in some embodiments, an arc or a closed circle of tissue is ablated. Rather, a line of ablation should be interpreted to denote tissue that is ablated such as to generate an elongated scar (i.e., a scar having a length that is substantially greater than its width (for example, a scar for which the ratio of its length to its width is greater than 3:1, e.g., greater than 5:1, greater than 10: 1 or greater than 20: 1)), regardless of the shape of the elongate scar.

[0013] An aspect of some embodiments of the invention relates to multiple-location alignment between two devices performed by a plurality of magnets. In some embodiments, two devices are aligned to each other at multiple locations by providing a plurality of magnets to each of the devices. In some embodiments, the use of multiple magnets allows more than one type of alignment to be performed, for example, the alignment can be a direct alignment having one- to-one magnets aligning the two devices, or the alignment can be with a phase difference between the alignments at respective locations, thereby causing a phased alignment between the two devices in an axial direction. In some embodiments, the alignment is a perfect alignment. In some embodiments, ablation does not require both devices to be perfectly aligned with each other in order for the ablation procedure to provide a continuous ablation line (i.e., an ablation line that is without gaps). In some embodiments, a combination of the ablation areas generated by each of a plurality of unipolar electrodes that are aligned with each other, provides a continuous ablation line, for example by the ablation areas overlapping with each other. In some embodiments, one or both of the devices are configured such as to move (e.g., rotate and / or translate) a set of ablation elements (e.g., electrodes or cryogenic-agent applying openings), during the ablation, in order to generate a continuous ablation line, and optionally a closed circle of ablation.

[0014] It is noted that although some aspects of the present disclosure relate to the ablation of cardiac tissue, and some further aspects relate to bilayer ablation of the epicardial and endocardial layers of the cardiac tissue, the scope of the present disclosure includes the ablation of any tissue using the apparatus and methods described herein. Typically the ablation is applied from an inner and outer surface of one or more layers of tissue (e.g., two or more layers of tissue) and is configured to generate a transmural line of ablation, optionally forming a closed circle.

[0015] There is therefore provided, in accordance with some embodiments of the present invention, apparatus for performing ablation treatment on one or more layers of tissue of a subject, including: a first catheter configured to be placed on a first side of the one or more layers of tissue, the first catheter including a plurality of first-catheter ablation elements and a plurality of first- catheter magnets; a second catheter configured to be placed on a second side of the one or more layers of tissue, the second side of the one or more layers of tissue opposing the first side of the one or more layers of tissue, the second catheter including a plurality of second-catheter ablation elements and a plurality of second-catheter magnets, the plurality of first-catheter magnets are configured to become aligned with the plurality of second-catheter magnets, to thereby align the plurality of first-catheter ablation elements with the plurality of second-catheter ablation elements, and the plurality of first-catheter ablation elements and the plurality of second-catheter ablation elements are configured to apply ablation respectively to the first and second side of the one or more layers of tissue, such as to generate a continuous line of ablation that extends transmurally through the one or more layers of tissue.

[0016] In some embodiments, the plurality of first-catheter ablation elements and the plurality of second-catheter ablation elements are configured to apply ablation respectively to the first and second side of the one or more layers of tissue,, such as to generate a closed circle of ablation that extends transmurally through the first and second side of the one or more layers of tissue,.

[0017] In some embodiments: the one or more layers of tissue include an epicardial layer and an endocardial layer of cardiac tissue of the subject; the first catheter is configured to be placed outside the epicardial layer; the second catheter configured to be placed inside the endocardial layer; and the plurality of first-catheter ablation elements and the plurality of second-catheter ablation elements are configured to apply ablation respectively to the outside of the epicardial layer and to the inside of the endocardial layer, such as to generate a continuous line of ablation that extends transmurally through the epicardial and endocardial layers.

[0018] In some embodiments, the first-catheter ablation elements and the second-catheter ablation elements include first-catheter openings and second-catheter openings and the first- catheter openings and second-catheter openings are configured to apply a cryogenic agent respectively to the outside of the epicardial layer of the heart and to the inside of the endocardial layer of the heart.

[0019] In some embodiments, the first-catheter ablation elements and the second-catheter ablation elements include first-catheter electrodes and second-catheter electrodes and the first- catheter electrodes and second-catheter electrodes are configured to apply ablative energy respectively to the outside of the epicardial layer of the heart and to the inside of the endocardial layer of the heart.

[0020] In some embodiments, the first-catheter electrodes and second-catheter electrodes are configured to apply radiofrequency ablative energy respectively to the outside of the epicardial layer of the heart and to the inside of the endocardial layer of the heart.

[0021] In some embodiments, the first catheter has a bifurcation that leads to first and second branches, a first set of first-catheter electrodes and a first set of first-catheter magnets are disposed on the first branch and a second set of first-catheter electrodes and a second set of first-catheter magnets are disposed on the second branch.

[0022] In some embodiments, the first catheter is configured such that at a location in a pericardial cavity of a heart of the subject where a pericardium of the heart is connected to an epicardium of the heart, distal ends of the first and second branches of the catheter each approach the location from opposite sides of the location, such that heads of the distal ends of the first and second branches of the catheter face each other from opposite sides of the location.

[0023] In some embodiments, the first catheter includes a mechanism that is configured to align a head of the first branch with a head of the second branch.

[0024] In some embodiments, a first head-aligning magnet is disposed in the head of the first branch and a second head-aligning magnet is disposed in the head of the second branch, and the first head-aligning magnet and the second head-aligning magnet are configured to become aligned with each other, to thereby align the head of the first branch with the head of the second branch.

[0025] There is further provided, in accordance with some embodiments of the present invention, a method of performing ablation treatment in a heart of a subject, including: inserting a first elongated catheter outside a part of said heart that requires said ablation treatment; inserting a second elongated catheter inside of said part of said heart that requires said ablation treatment; aligning said first elongated catheter with said second elongated catheter along the lengths of said first and said second elongated catheters to define a closed ablation line on said part of said heart that requires said ablation treatment; and ablating said ablation line using one or both of said elongated catheters.

[0026] In some embodiments, said ablating said ablation line is performed without moving said one or both of said elongated catheters.

[0027] In some embodiments, said ablating said ablation line is performed simultaneously using said one or both of said elongated catheters.

[0028] In some embodiments, said aligning is an alignment of from about 20% to about 90% alignment.

[0029] In some embodiments, said aligning is a 100% alignment.

[0030] In some embodiments, said aligning includes a length of alignment of from about 0.5mm to about 50cm.

[0031] In some embodiments, said outside of said part of said heart that requires said ablation treatment is a space between a pericardium and an epicardium. In some embodiments, said ablating includes ablating until performing a transmural ablation.

[0032] In some embodiments, said aligning is performed by a magnetic alignment due to a plurality of magnets located on said first elongated catheter and said second elongated catheter.

[0033] In some embodiments, said inserting said first elongated catheter is performed by an epicardial approach.

[0034] In some embodiments, said inserting said second elongated catheter is performed by a transseptal approach.

[0035] In some embodiments, said ablating includes providing an energy of from about 20W to about 50W for from about 20 seconds to about 40 seconds.

[0036] In some embodiments, said ablating is performed by radiofrequency (RF) ablation.

[0037] In some embodiments, said ablating is performed by cryoablation.

[0038] In some embodiments, said ablating does not require for both of said first elongated catheter and said second elongated catheter to be perfectly aligned with each other.

[0039] In some embodiments, said ablating further includes ablating without said aligning being a perfect aligning.

[0040] In some embodiments, said aligning includes aligning said first elongated catheter with said second elongated catheter with an alignment of from about 20% to about 90%.

[0041] In some embodiments, said ablation line includes an overlap ablation area generated by a combination of a first ablation area from said first elongated catheter with a second ablation area from said second elongated catheter, said first ablation area and said second ablation area having an overlap of from about 20% to about 90% overlap.

[0042] There is further provided, in accordance with some embodiments of the present invention, an ablation device including: a first elongated catheter including: an elongated body including a proximal end and a distal end; a bifurcation located at said distal end of said elongated body; a first distal element connected to a first branch of said bifurcation and a second distal element connected to a second branch of said bifurcation; said first distal element and said second distal element including one or more electrodes distributed along a length of said first distal element and said second distal element; and said first distal element and said second distal element including one or more magnets distributed along a length of said first distal element and said second distal element; and a second elongated catheter including: an elongated body including a proximal end and a distal end; a third distal element connected to said distal end of said elongated body, said third distal element including one or more electrodes distributed along a length of said third distal element; and said third distal element including one or more magnets distributed along a length of said third distal element.

[0043] In some embodiments, said one or more electrodes is one long electrode.

[0044] In some embodiments, said one or more magnets is one long magnet.

[0045] In some embodiments, a length of said first distal element is different from a length of said second distal element.

[0046] In some embodiments, a length of said first distal element is longer from a length of said second distal element.

[0047] In some embodiments, a length of said first distal element is the same as a length of said second distal element.

[0048] In some embodiments, the ablation device further includes a handle for each of said first elongated catheter and said second elongated catheter, said handles configured to maneuver said first elongated catheter and said second elongated catheter respectively.

[0049] In some embodiments, said handle of said first elongated catheter includes one or more controlling elements for controlling a directionality of said first distal element and said second distal element.

[0050] In some embodiments, said first distal element and / or said second distal element and / or said third distal element include a length of from about 10 cm to about 18 cm.

[0051] In some embodiments, electrodes in said first distal element and / or said second distal element and / or said third distal element include a size of from about 3.5 mm to about 12 mm. In some embodiments, electrodes in said first distal element and / or said second distal element and / or said third distal element include a length long enough to fit the dimensions of a location in need for ablation treatment in a body of a subject.

[0052] In some embodiments, said first elongated catheter and / or said second elongated catheter include a length of from about 50 cm to about 80 cm.

[0053] In some embodiments, said first elongated catheter and / or said second elongated catheter include a length long enough so as to reach a location in need for ablation treatment in a body of a subject.

[0054] In some embodiments, said first elongated catheter and / or said second elongated catheter include a size of from about 7Fr to about 12Fr.

[0055] In some embodiments, said one or more magnets are from about 5 magnets to about 50 magnets.

[0056] In some embodiments, said one or more magnets include a length of from about 3mm to about 10cm.

[0057] In some embodiments, said first elongated catheter and / or said second elongated catheter are pre-shaped catheters.

[0058] In some embodiments, said pre-shaped catheters are configured to have a curved shape.

[0059] In some embodiments, said pre-shaped catheters are configured to have a distal element having a curved shape.

[0060] In some embodiments, said one or more electrodes are unipolar electrodes.

[0061] In some embodiments, said one or more electrodes are bipolar electrodes.

[0062] In some embodiments, the ablation device further includes a first delivery sheath for said first elongated catheter and a second delivery sheath for said second elongated catheter.

[0063] In some embodiments, said first delivery sheath and said second delivery sheath include said one or more magnets, and said first distal element, said second distal element and said third distal element include said one or more electrodes.

[0064] The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0065] Figure 1 is a schematic representation of an exemplary ablation device, according to some embodiments of the invention;

[0066] Figure 2 is a schematic representation of an exemplary catheter comprising a dualelectrode distal end, according to some embodiments of the invention;

[0067] Figure 3 is a schematic representation of an exemplary use of the exemplary ablation device, according to some embodiments of the invention;

[0068] Figures 4A, 4B, 4C, 4D, 4E, 4F, and 4G are schematic illustrations of respective steps of exemplary use of the exemplary ablation device, according to some embodiments of the invention;

[0069] Figure 5A is a flowchart showing steps of an exemplary ablation method, according to some embodiments of the invention;

[0070] Figure 5B is a schematic representation of an exemplary cryoablation catheter, according to some embodiments of the invention;

[0071] Figures 6A, 6B, and 6C are images of the use of a prototype device that was used in an experiment in which bilayer ablation was performed according to some embodiments of the invention;

[0072] Figures 6D, 6E, and 6G are images of the bilayer ablation performed by the prototype device, according to some embodiments of the invention; and

[0073] Figures 6H and 61 are histological images of the zones in which tissue was ablated by the prototype, according to some embodiments of the invention.

[0074] DETAILED DESCRIPTION OF EMBODIMENTS

[0075] The present invention, in some embodiments thereof, relates to an ablation apparatus and method and, more particularly, but not exclusively, to a magnet-assisted ablation apparatus and method.

[0076] Overview

[0077] An aspect of some embodiments of the invention relates to a hybrid approach to ablation (e.g., atrial fibrillation (AF) ablation) allowing concomitant bilayer ablation between epicardial and endocardial layers by using a set of two devices. In some embodiments, the devices comprise one or more magnets to ensure alignment of devices that are placed on respective sides of the tissue to be ablated (e.g., outside the epicardial layer and inside the endocardial layer).

[0078] An aspect of some embodiments of the invention relates to devices and methods that enable successful ablation procedures that produce a continuous lesion (i.e., a line of tissue that is ablated such as to generate an elongated scar, referred to herein as “an ablation line” or a “line of ablation”), optionally forming a closed circle, e.g., completely encircling one or more veins, and stopping activation waves from propagating to the atrial body. In some embodiments, additional antral lines are not needed after treatment. In some embodiments, the ablation lesion performed by the device is continuous, without having a combination of scar and gaps of healthy tissue.

[0079] It is noted that “an ablation line” or a “line of ablation” should not be interpreted to denote tissue that is ablated in a straight line, and in fact, in some embodiments, an arc or a closed circle of tissue is ablated. Rather, a line of ablation should be interpreted to denote tissue that is ablated such as to generate an elongated scar (i.e., a scar having a length that is substantially greater than its width (for example, a scar for which the ratio of its length to its width is greater than 3:1, e.g., greater than 5: 1, greater than 10: 1 or greater than 20: 1)), regardless of the shape of the elongate scar.

[0080] An aspect of some embodiments of the invention relates to multiple-location alignment between two devices performed by a plurality of magnets. In some embodiments, two devices are aligned to each other at multiple locations by providing a plurality of magnets to each of the devices. In some embodiments, the use of multiple magnets allows more than one type of alignment to be performed, for example, the alignment can be a direct alignment having one- to-one magnets aligning the two devices, or the alignments can be with a with a phase difference between the alignments at respective locations, thereby causing a phased alignment between the two devices in an axial direction. In some embodiments, the alignment is a perfect alignment. In some embodiments, ablation does not require both devices to be perfectly aligned with each other in order for the ablation procedure to provide a continuous ablation line (i.e., an ablation line that is without gaps). In some embodiments, a combination of the ablation areas generated by each of a plurality of unipolar electrodes that are aligned , provides a continuous ablation line, for example by the ablation areas overlapping with each other. In some embodiments, one or both of the devices are configured such as to move (e.g., rotate and / or translate) a set of ablation elements (e.g., electrodes or cryogenic -agent applying openings), during the ablation, in order to generate a continuous ablation line, and optionally a closed circle of ablation.

[0081] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the examples provided herein. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0082] It is also noted that although some aspects of the present disclosure relate to the ablation of cardiac tissue, and some further aspects relate to bilayer ablation of the epicardial and endocardial layers of the cardiac tissue, the scope of the present disclosure includes the ablation of any tissue using the apparatus and methods described herein. Typically the ablation is applied from an inner and outer surface of one or more layers of tissue (e.g., two or more layers of tissue) and is configured to generate a transmural line of ablation, optionally forming a closed circle.

[0083] Exemplary device

[0084] Referring now to Figure 1 showing a schematic representation of an exemplary ablation device, according to some embodiments of the invention. In some embodiments, an exemplary ablation device 100 comprises two independent catheters 102 / 104, each comprising a proximal end 106 and a distal end 108. In some embodiments, the proximal end comprises a handle 110 configured to be used by a user to perform one or more manipulations of the distal end(s) 108 of the device(s), activating the device(s) 100, deactivating the device(s) 100, activating / deactivating complementary hardware (see below) of the device(s) 100. In some embodiments, each catheter 102 / 104 comprises at the distal end 108 one or more distal end elements 109 having one or more electrodes 112 and one or more magnets 114 distributed along its length (two electrodes and three magnets are shown in each catheter in Figure 1). In some embodiments, each catheter 102 / 104 comprises an elongated body 116, which communicates with the handle 110 at proximal end 106 to the distal end elements comprising one or more electrodes 112 and the one or more magnets 114, located at the distal end 108.

[0085] In some embodiments, the one or more electrodes are unipolar electrodes. In some embodiments, where unipolar electrodes are used, the ablation procedure is performed from each side of the cardiac tissue (see below). In some embodiments, the one or more electrodes are one or more bipolar electrodes. In some embodiments, where one or more bipolar electrodes are used, the ablation procedure is performed concomitantly from both sides (see below).

[0086] In some embodiments, the alignment between the catheters and / or the one or more electrodes and / or the one or more magnets is a perfect alignment, meaning both catheters and / or the one or more electrodes on each catheter and / or the one or more magnets on each catheter are perfectly aligned with each other. In some embodiments, the alignment is not a perfect alignment. In some embodiments, the alignment is from about 50% to about 60%. Optionally from about 40% to about 70%, optionally from about 30% to about 80%, optionally from about 20% to about 90%. Optionally a 100% alignment. In some embodiments, when the alignment is not perfect, the device is configured to provide ablation treatment from each side to an area that is large enough so when there is not a perfect alignment, the ablation areas provided by respective electrodes overlaps so as to provide a continuous line of ablation, and without leaving unablated areas that would act as discontinuities in the line of ablation. In some embodiments, the overlap area of ablation is from about 50% to about 60%. Optionally from about 40% to about 70%, optionally from about 30% to about 80%, optionally from about 20% to about 90%. Optionally a 100% overlap.

[0087] In some embodiments, the length of the one or more magnets is from about 3mm to about 10cm. Optionally from about 10mm to about 5cm. Optionally from about 5mm to about 1cm.

[0088] In some embodiments, the length of aligned parts between magnets is from about 5cm to about 10 cm. Optionally from about 1mm to about 20cm. Optionally from about 0.5mm to about 50cm. In some embodiments, the length of the elongated body is fitted so as to reach the destined organ from outside the body, for example, the elongated body comprises a length of from about 50 cm to about 80 cm. Optionally from about 40 cm to about 90 cm. Optionally from about 30 cm to about 100 cm; for example 60 cm, 70cm, 75 cm, any interval number.

[0089] In some embodiments, the distal end 108 of the catheters are configured to be controlled from the handle 110 so as to maneuver the distal end 108 to help reach the desired location inside the body of the patient. In some embodiments, the catheters are configured such that additional maneuvers are performed once reached the location inside the body to correctly position the distal end 108 on the tissue itself. In some embodiments, the catheters are configured such that the mechanisms to maneuver the distal end are as known in the art.

[0090] In some embodiments, the distal end element 109 of one or both of the catheters is configured to be controlled from the handle 110 so as to move (e.g., rotate and / or translate) the set of electrodes during the ablation, in order to generate a continuous ablation line, and optionally a closed circle of ablation.

[0091] In some embodiments, the distal end element 109 comprising the one or more electrodes comprises a length of from about 10 cm to about 18 cm, optionally from about 8 cm to about 20 cm, optionally from about 5 cm to about 30 cm. In some embodiments, the distal end element 109 comprising the one or more electrodes comprises a length that fits the dimensions of the left atrium and / or the location that requires treatment. In some embodiments, the electrodes themselves comprise a size of from about 3.5 mm to about 12 mm, optionally from about 3mm to about 15mm, optionally from about 2.5 mm to about 20 mm.

[0092] In some embodiments, the sizes of the catheters are from about 7Fr to about 12Fr.

[0093] In some embodiments, the one or more electrodes 112 at the distal end comprise a single long electrode. In some embodiments, the one or more electrodes 112 at the distal end are a plurality of adjacent electrodes. In some embodiments, the length of the one or more electrodes 112 at the distal end 108 is as long as necessary to surround at least a part of an organ, for example to partially and optionally completely surround the epicardium of the left ventricle of the heart. In some embodiments, the length of the one or more electrodes 112 at the distal end 108 is as long as necessary to surround at least a part of an internal surface of an organ, for example to partially and optionally completely surround the endocardium of the left ventricle of the heart. In some embodiments, the length of the one or more electrodes 112 at the distal end 108 is as long as necessary to partially cover and optionally completely cover an external and / or and internal diameter of an organ, for example as long as the internal and / or external diameter of the left ventricle.

[0094] In some embodiments, an exemplary principle of use of the exemplary ablation device comprises the positioning of one of the catheters on the external surface of an organ (referred hereinafter as the external catheter), for example, on the outside surface of the left ventricle, in a way that it partially (optionally, completely) surrounds the tissue. Then bringing the second catheter from the inside of the organ (referred hereinafter as the internal catheter) and partially (optionally, completely) surrounding the internal diameter of the organ with the electrode (see below and Figure 3).

[0095] In some embodiments, each catheter comprises one or more magnets, and the magnets on one catheter comprise opposite polarities from the magnets on the other catheter. In some embodiments, magnets on the catheters comprise mixed polarities. In some embodiments, each catheter comprise the same number of magnets. In some embodiments, one catheter comprise more magnets than the other. In some embodiments, the external catheter comprises more magnets than the internal catheter, as shown for example in Figure 3. In some embodiments, the internal catheter comprises more magnets than the external catheter. In some embodiments, the plurality of magnets are from about 5 magnets to about 50 magnets. Optionally from about 3 magnets to about 100 magnets. Optionally from about 2 magnets to about 200 magnets.

[0096] In some embodiments, either or both catheters are pre-shaped catheters, configured to have a curved elongated body and / or distal end. In some embodiments, a potential advantage of having a pre-shaped elongated body / distal end is that it provides a natural curvature to the device, which eases the allocation of the device on the extemal / internal diameter of the organ.

[0097] Referring now to Figure 2, a schematic representation is shown of an exemplary catheter 202 that defines a bifurcation 201 leading to two branches, to which respective first and second distal end elements 203A and 203B are coupled, according to some embodiments of the invention. One or more electrodes 204 / 206 and one or more magnets 114 are distributed along the length of each of the first distal element and the second distal elements. Similar parts are provided with the same numbering as in Figure 1, for consistency, as is the case for other Figures in the present application. In some embodiments, similar to the exemplary catheter 104 disclosed in Figure 1, the catheter 202 comprises a proximal end 106, a distal end 108, an elongated body 116 and a handle 110 at the proximal end 106. In some embodiments, the difference between the exemplary catheter 104 shown in Figure 1 and the catheter 202 shown in Figure 2 is that the catheter 202 shown in Figure 2 comprises a distal end 108 comprising a bifurcation 203, from which two separated distal end elements having electrodes 204 / 206 extend distally, each comprising one or more magnets 114.

[0098] In some embodiments, each distal end element is maneuvered independently. In some embodiments, one distal end element is maneuvered, while the other is a non-maneuverable pre-shaped distal end element. In some embodiments, maneuverability is provided using known techniques in the art, for example, by using embedded wires in the elongated tubes controlled by knobs in the handle. In some embodiments, the direction of turn of the catheter and / or the distal end elements is fixed and comprises only one direction. In some embodiments, each distal end element is enabled to turn to more than one direction by actuating for example dedicated knobs in the handle.

[0099] In some embodiments, one or both of the distal end elements is configured to be controlled from the handle 110 so as to move (e.g., rotate and / or translate) the set of electrodes during the ablation, in order to generate a continuous ablation line, and optionally a closed circle of ablation.

[0100] In some embodiments, the device comprises one long distal end element and one short distal end element. In some embodiments, each distal end element comprises at its head 218 on its distal end an additional mechanism that allows perfect (or nearly perfect) alignment of the heads when they meet or when they are close to each other (as seen for example in Figure 4b), for example, the heads comprise dedicated magnets 220 configured to interact with each other. In some embodiments, a potential advantage of ensuring a perfect (or nearly perfect) alignment of the heads is that it potentially ensures the continuous line of ablation in the tissue. In some embodiments, the anatomy of the area where the catheters are deployed is used to assist with the alignment of the heads when inside the tissue.

[0101] Exemplary use of a guide sheath

[0102] In some embodiments, guide sheaths are used to reach the required organ. In some embodiments, once the guide sheaths are in place and / or in the vicinity of the area in need of treatment, the electrodes are brought via the guide sheaths to the location to deliver the ablation treatment (for example, electrode-based ablation treatment or cryo-based ablation treatment).

[0103] In some embodiments, the guiding sheaths comprise the one or more magnets and are responsible for the aligning. In some embodiments, once the alignments is achieved, the electrodes are brought via the guide sheaths to the location to deliver the ablation treatment (for example, electrode-based ablation treatment or cryo-based ablation treatment). Exemplary use of the exemplary ablation device

[0104] Referring now to Figure 3, a schematic representation of an exemplary use of the exemplary ablation device is shown, according to some embodiments of the invention. As explained above, in some embodiments, the exemplary ablation device comprises two independent catheters 302 / 304, each comprising a distal end comprising a long electrode 306 / 308 (or a plurality of electrodes adjacent one to another) and a plurality of magnets 310 on the electrode. In some embodiments, an exemplary principle of use of the exemplary ablation device comprises the positioning of one of the catheters 302 on the external surface of an organ 312 (referred hereinafter as the external catheter 302), for example, on the outside surface of the left ventricle, in way that it completely (optionally partially) surrounds the tissue, then bringing the second catheter 304 from the inside of the organ (referred hereinafter as the internal catheter 304) and surrounding the internal diameter of the organ with the electrode. In some embodiments, the magnets 310 located on the external catheter 302 and on the internal catheter 304 will cause the two catheters to align on the surface (external and internal) of the organ 312.

[0105] In some embodiments, once the two catheters 302 / 304 are aligned with each other, the ablation treatment 314 (schematically represented as lightings in Figure 3) can be performed along the whole diameter of the organ 312, since the electrode 306 / 308 extends along the whole distal end of the catheters 302 / 304 (therefore along the whole internal / external diameter of the organ 312).

[0106] Referring to Figures 4A-4G showing illustrations of an exemplary use of the exemplary ablation device, according to some embodiments of the invention. In some embodiments, a user brings the external catheter 402 into the pericardial cavity so as to be in contact with the epicardium, for example, via sub-xiphoid incision (also known as epicardial approach), optionally through the Coronary sinus (CS), as shown for example in Figure 4A. In some embodiments, the external catheter 402 used has a bifurcation and comprises two separated distal end elements 404 and 406 having electrodes, as shown for example in Figure 4 A. In some embodiments, both distal end elements are positioned around the external diameter of the left atrium until the most-distal end of each encounter each other, as shown for example in Figure 4B and Figure 4C. In some embodiments, the reason for using a bifurcated catheter, as described, is that there are locations in the pericardial cavity where the pericardium is connected to the epicardium, therefore not allowing the passage of the head of the catheter. In some embodiments, the distal ends of the catheter each approach the location at which the pericardium is connected to the epicardium from opposite sides of this location, such that the heads of each of the distal ends face each other from opposite sides of this location.

[0107] For some applications, as described hereinabove, the heads comprise dedicated magnets 220 (shown in Fig. 2), or a different mechanism, configured to cause the heads of each of the distal ends to align with each other across the location. In some embodiments, a good alignment of the heads of each of the distal ends provides for a continuous line of ablation in the tissue.

[0108] In some embodiments, once the external catheter 402 is in position, the internal catheter 408 is brought into the left atrium, for example, via femoral vein, into the inferior vena cava (IVC), then through the right atrium (RA) and into the left atrium (LA) through the septum 410 (also called transseptal approach), as shown for example in Figure 4D and Figure 4E. In some embodiments, the internal catheter is inserted until all the electrode of the internal catheter is inside the left atrium, as shown for example in Figure 4F and Figure 4G. In some embodiments, magnets 412 on the external catheter 402 help the internal catheter 408 to position itself as a result of magnets 414 located on the internal catheter becoming aligned with magnets 412, as shown for example in Figure 4F and Figure 4G.

[0109] Exemplary ablation method using the exemplary ablation device

[0110] Referring now to Figure 5A showing a flowchart of an exemplary ablation method, according to some embodiments of the invention. In some embodiments, the method commences by inserting an external catheter to be in contact with an external surface of a tissue to be ablated 502, for example the external surface of the left atrium. In some embodiments, the method continues by inserting an internal catheter to be in contact with an internal surface of the tissue to be ablated 504, for example the internal surface of the left atrium. In some embodiments, the method continues by allowing the magnets of the internal catheter to align with the magnets of the external catheter, thereby generating an ablation line 506. In some embodiments, then the ablation process is performed 508, from either one or both catheters, until the ablation of the area in the tissue is complete. In some embodiments, the catheters can then be extracted from the subject 510.

[0111] In some embodiments, the internal catheter is inserted first, and then the external catheter is inserted. In some embodiments, both the internal catheter and the external catheter are inserted at the same time. The scope of the present disclosure includes using the apparatus and methods described hereinabove such as to:

[0112] (a) ablate cardiac tissue across from opposing sides of two or more layers of the cardiac tissue (e.g., from outside the epicardium and from inside the endocardium, such that epicardial and endocardial layers are ablated),

[0113] (b) cause the ablation to be transmural across the two or more layers of cardiac tissue (i.e., such that there is a continuous mass of tissue that is ablated extending from the outside to the inside of the two or more layers of cardiac tissue),

[0114] (c) ablate tissue both from the inside and the outside of the two or more layers of cardiac tissue using a plurality of electrodes and / or a single elongate electrode, such that a continuous ablation line (i.e., an ablation line that is without gaps) is formed on each side of the tissue. For some applications, the continuous ablation forms a closed circle of ablated tissue.

[0115] As noted above, although some aspects of the present disclosure relate to the ablation of cardiac tissue, and some further aspects relate to bilayer ablation of the epicardial and endocardial layers of the cardiac tissue, the scope of the present disclosure includes the ablation of any tissue using the apparatus and methods described herein. Typically the ablation is applied from an inner and outer surface of one or more layers (e.g., two or more layers) of tissue and is configured to generate a transmural line of ablation, optionally forming a closed circle.

[0116] For some applications, unipolar electrodes are used on each side of the tissue, and the unipolar electrodes are configured to apply ablation that penetrates the tissue deeply enough such that the ablation is transmurally continuous across the two or more layers of tissue. Alternatively, bipolar electrodes are used and ablative energy (e.g., ablative radiofrequency energy) is applied across the tissue from the internal electrode(s) to the external electrode(s), or vice versa, such that the ablation is transmurally continuous across the two or more layers of tissue.

[0117] As described hereinabove, for some applications, a bifurcated catheter is used to apply energy from outside the epicardium, such that at locations in the pericardial cavity where the pericardium is connected to the epicardium, the distal ends of the catheter each approach the location at which the pericardium is connected to the epicardium from opposite sides of this location, such that the heads of each of the distal ends face each other from opposite sides of this location. Typically, the heads of each of the distal ends are configured to become aligned with each other (e.g., using magnets), thereby providing for a continuous line of ablation in the tissue.

[0118] Exemplary ablation program for the exemplary ablation device

[0119] In some embodiments, the ablation program comprises activating the ablation treatment using an energy of from about 20W to about 50W for from about 20 seconds to about 40 seconds. Optionally using an energy of from about 15W to about 60W for from about 15 seconds to about 60 seconds. Optionally, using an energy of from about 10W to about 80W for from about 10 seconds to about 80 seconds.

[0120] In some embodiments, ablation is performed using radiofrequency energy that applied via electrodes, as described hereinabove. In some embodiments, ablation is performed using cryoablation technologies, as shown for example in Figure 5B.

[0121] Referring now to Figure 5B, a schematic representation is shown of an exemplary cryoablation catheter 512, according to some embodiments of the invention. In some embodiments, the exemplary cryoablation catheter 512 comprises a proximal end 106 and a distal end 108. In some embodiments, the proximal end comprises a handle 110 configured to be used by a user to perform one or more manipulations of the distal end 108 of the device, activating the device, deactivating the device, activating / deactivating complementary hardware of the device. In some embodiments, the exemplary cryoablation catheter 512 comprises at the distal end 108 one or more openings 514 and a plurality of magnets 114 (three are shown). In some embodiments, the one or more openings 514 are used to deliver the cryo ablation treatment, typically by applying a cryogenic agent.

[0122] For some applications, a set of two cryoablation catheters 512 is used in order to cryoablate one or more layers of tissue (e.g., epicardial and endocardial layers of cardiac tissue) from opposite sides of the layer(s) of tissue, in accordance with the apparatus and methods described hereinabove. In some embodiments, the distal end 108 one or both of the catheters is configured to be controlled from the handle 110 so as to move (e.g., rotate and / or translate) the set of openings 514 (i.e., the cryogenic-applying openings) during the ablation, in order to generate a continuous ablation line, and optionally a closed circle of ablation.

[0123] The scope of the present disclosure includes applying any of the apparatus and / or methods that were described hereinabove with reference to the use of electrodes to perform ablation to the use of cryoablation to perform ablation, mutatis mutandis. For example, the scope of the present disclosure includes applying the apparatus and methods described hereinabove to cryoablation, such as to:

[0124] (a) ablate cardiac tissue across from opposing sides of two or more layers of the cardiac tissue (e.g., from outside the epicardium and from inside the endocardium, such that epicardial and endocardial layers are ablated),

[0125] (b) cause the ablation to be transmural across the two or more layers of cardiac tissue (i.e., such that there is a continuous mass of tissue that is ablated extending from the outside to the inside of the two or more layers of cardiac tissue),

[0126] (c) ablate tissue both from the inside and the outside of the two or more layers of cardiac tissue using a plurality of openings or a single elongate opening, such that a continuous ablation line (i.e., an ablation line that is without gaps) is formed on each side of the tissue. For some applications, the continuous ablation forms a closed circle of ablated tissue.

[0127] As noted above, although some aspects of the present disclosure relate to the ablation of cardiac tissue, and some further aspects relate to bilayer ablation of the epicardial and endocardial layers of the cardiac tissue, the scope of the present disclosure includes the ablation of any tissue using the apparatus and methods described herein. Typically the ablation is applied from an inner and outer surface of one or more layers of tissue (e.g., two or more layers of tissue) and is configured to generate a transmural line of ablation, optionally forming a closed circle.

[0128] For some applications, a bifurcated catheter is used to apply cryoablation from outside the epicardium, such that at locations in the pericardial cavity where the pericardium is connected to the epicardium, the distal ends of the catheter each approach the location at which the pericardium is connected to the epicardium from opposite sides of this location, such that the heads of each of the distal ends face each other from opposite sides of this location. Typically, the heads of each of the distal ends are configured to become aligned with each other (e.g., using magnets), thereby providing for a continuous line of ablation in the tissue.

[0129] In some embodiments, ablation is performed using any known ablation technology known in the art, for example radiofrequency ablation, cryoenergy, laser and / or electroporation.

[0130] In some embodiments, the ablation procedures comprise monitoring the impedance drop in order to monitor the ablation procedure. In some embodiments, the necessary intensity and / or time and / or a combination thereof of the necessary treatment to be provided is assessed a priori and / or during the treatment and / or just before activating the ablation treatment using one or more of Ultrasound data and local measurements of wall thickness.

[0131] Exemplary method of selecting a patient for performing an ablation treatment with the exemplary ablation device

[0132] In some embodiments, the ablation treatment is performed on subjects presenting persistent or long-term persistent atrial fibrillation as well as subjects with failed prior procedures, in whom the current therapy (drugs or ablations) is not sufficient.

[0133] As used herein with reference to quantity or value, the term “about” means “within ± 20 % of’.

[0134] The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.

[0135] The term “consisting of’ means “including and limited to”.

[0136] The term “consisting essentially of’ means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0137] As used herein, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

[0138] Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range. Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range / ranging / ranges between” a first indicate number and a second indicate number and “range / ranging / ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

[0139] Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

[0140] As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

[0141] As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

[0142] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0143] Various embodiments and aspects of the present invention as delineated hereinabove and as claimed in the claims section below find experimental support in the following examples. EXEMPLARY PROTOTYPES

[0144] Reference is now made to the following exemplary prototype, which together with the above descriptions illustrate some embodiments of the invention in a non-limiting fashion.

[0145] Referring to Figures 6 A, 6B, and 6C, a prototype of two sets 600 / 602 of circularly- arranged magnets, each embedded with 16 unipolar electrodes, was constructed. One set 600 of circularly-arranged magnets was placed on an endocardial side of a harvested swine heart 604 and a second set 602 of the circularly-arranged magnets was placed on an epicardial side of the harvested swine heart. Energy was delivered between each set of epicardial and endocardial electrodes for 30 seconds, in four different locations of the harvested swine heart. The locations were: the right atrial appendage (RAA), the left atrial appendage (LAA), the pulmonary veins (PV) and the right ventricle (RV).

[0146] Figures 6D-6G are photographs showing bilayer ablative lesions 610 that were generated by the exemplary prototype. Figures 6H and 61 are histological images of the zones 612 in which tissue was ablated by the prototype. (Figure 61 is an enlargement of the portion of Figure 6H that is indicated by the dashed rectangle.) As may be observed, a nearly complete bilayer transmural lesion was formed by the application of ablative energy by the unipolar electrodes from respective sides of the cardiac tissue.

[0147] As noted above, in accordance with some applications of the present invention, unipolar electrodes are used on each side of the tissue, and the unipolar electrodes are configured to apply ablation that penetrates the tissue deep enough such that the ablation is transmurally continuous across the two or more layers of tissue. Alternatively, bipolar electrodes are used and ablative energy (e.g., ablative radiofrequency energy) is applied across the tissue from the internal electrode(s) to the external electrode(s), or vice versa, such that the ablation is transmurally continuous across the two or more layers of tissue. Typically, using bipolar electrodes in the above-described manner ensures that the transmural ablation is continuous, without gaps such as those that may be observed in Figures 6H and 61. For some applications, using bipolar electrodes in the above-described manner improves the uniformity of the transmural ablation, relative to ablation that is achieved using monopolar electrodes, mutatis mutandis.

[0148] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0149] It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

CLAIMS1. Apparatus for performing ablation treatment on one or more layers of tissue of a subject, comprising: a first catheter configured to be placed on a first side of the one or more layers of tissue, the first catheter comprising a plurality of first-catheter ablation elements and a plurality of first-catheter magnets; a second catheter configured to be placed on a second side of the one or more layers of tissue, the second side of the one or more layers of tissue opposing the first side of the one or more layers of tissue, the second catheter comprising a plurality of second-catheter ablation elements and a plurality of second-catheter magnets, wherein the plurality of first-catheter magnets are configured to become aligned with the plurality of second-catheter magnets, to thereby align the plurality of first-catheter ablation elements with the plurality of second-catheter ablation elements, and wherein the plurality of first-catheter ablation elements and the plurality of second- catheter ablation elements are configured to apply ablation respectively to the first and second side of the one or more layers of tissue, such as to generate a continuous line of ablation that extends transmurally through the one or more layers of tissue.

2. The apparatus according to claim 1, wherein the plurality of first-catheter ablation elements and the plurality of second-catheter ablation elements are configured to apply ablation respectively to the first and second side of the one or more layers of tissue, such as to generate a closed circle of ablation that extends transmurally through the first and second side of the one or more layers of tissue,.

3. The apparatus according to claim 1 or 2, wherein: the one or more layers of tissue include an epicardial layer and an endocardial layer of cardiac tissue of the subject; the first catheter is configured to be placed outside the epicardial layer; the second catheter configured to be placed inside the endocardial layer; and the plurality of first-catheter ablation elements and the plurality of second-catheter ablation elements are configured to apply ablation respectively to the outside of the epicardial layer and to the inside of the endocardial layer, such as to generate a continuous line of ablation that extends transmurally through the epicardial and endocardial layers.

4. The apparatus according to any one of claims 1-3, wherein the first-catheter ablation elements and the second-catheter ablation elements comprise first-catheter openings andsecond-catheter openings and wherein the first-catheter openings and second-catheter openings are configured to apply a cryogenic agent respectively to the outside of the epicardial layer of the heart and to the inside of the endocardial layer of the heart.

5. The apparatus according to any one of claims 1-3, wherein the first-catheter ablation elements and the second-catheter ablation elements comprise first-catheter electrodes and second-catheter electrodes and wherein the first-catheter electrodes and second-catheter electrodes are configured to apply ablative energy respectively to the outside of the epicardial layer of the heart and to the inside of the endocardial layer of the heart.

6. The apparatus according to claim 5, wherein the first-catheter electrodes and second- catheter electrodes are configured to apply radiofrequency ablative energy respectively to the outside of the epicardial layer of the heart and to the inside of the endocardial layer of the heart.

7. The apparatus according to any one of claims 1-6, wherein the first catheter has a bifurcation that leads to first and second branches, wherein a first set of first-catheter electrodes and a first set of first-catheter magnets are disposed on the first branch and a second set of first- catheter electrodes and a second set of first-catheter magnets are disposed on the second branch.

8. The apparatus according to claim 7, wherein the first catheter is configured such that at a location in a pericardial cavity of a heart of the subject where a pericardium of the heart is connected to an epicardium of the heart, distal ends of the first and second branches of the catheter each approach the location from opposite sides of the location, such that heads of the distal ends of the first and second branches of the catheter face each other from opposite sides of the location.

9. The apparatus according to claim 7, wherein the first catheter comprises a mechanism that is configured to align a head of the first branch with a head of the second branch.

10. The apparatus according to claim 7, wherein a first head-aligning magnet is disposed in the head of the first branch and a second head-aligning magnet is disposed in the head of the second branch, and wherein the first head-aligning magnet and the second head-aligning magnet are configured to become aligned with each other, to thereby align the head of the first branch with the head of the second branch.

11. A method of performing ablation treatment in a heart of a subject, comprising:inserting a first elongated catheter outside a part of said heart that requires said ablation treatment; inserting a second elongated catheter inside of said part of said heart that requires said ablation treatment; aligning said first elongated catheter with said second elongated catheter along the lengths of said first and said second elongated catheters to define a closed ablation line on said part of said heart that requires said ablation treatment; and ablating said ablation line using one or both of said elongated catheters.

12. The method according to claim 11, wherein said ablating said ablation line is performed without moving said one or both of said elongated catheters.

13. The method according to claim 11 or claim 12, wherein said ablating said ablation line is performed simultaneously using said one or both of said elongated catheters.

14. The method according to any one of claims 11-13, wherein said aligning is an alignment of from about 20% to about 90% alignment.

15. The method according to any one of claims 11-14, wherein said aligning is a 100% alignment.

16. The method according to any one of claims 11-15, wherein said aligning comprises a length of alignment of from about 0.5mm to about 50cm.

17. The method according to any one of claims 11-16, wherein said outside of said part of said heart that requires said ablation treatment is a space between a pericardium and an epicardium.

18. The method according to any one of claims 11-17, wherein said ablating comprises ablating until performing a transmural ablation.

19. The method according to any one of claims 11-18, wherein said aligning is performed by a magnetic alignment due to a plurality of magnets located on said first elongated catheter and said second elongated catheter.

20. The method according to any one of claims 11-19, wherein said inserting said first elongated catheter is performed by an epicardial approach.

21. The method according to any one of claims 11-20, wherein said inserting said second elongated catheter is performed by a transseptal approach.

22. The method according to any one of claims 11-21, wherein said ablating comprises providing an energy of from about 20W to about 50W for from about 20 seconds to about 40 seconds.

23. The method according to any one of claims 11-22, wherein said ablating is performed by radiofrequency (RF) ablation.

24. The method according to any one of claims 11-23, wherein said ablating is performed by cryoablation.

25. The method according to any one of claims 11-24, wherein said ablating does not require for both of said first elongated catheter and said second elongated catheter to be perfectly aligned with each other.

26. The method according to any one of claims 11-25, wherein said ablating further comprises ablating without said aligning being a perfect aligning.

27. The method according to any one of claims 11-26, wherein said aligning comprises aligning said first elongated catheter with said second elongated catheter with an alignment of from about 20% to about 90%.

28. The method according to any one of claims 11-27, wherein said ablation line comprises an overlap ablation area generated by a combination of a first ablation area from said first elongated catheter with a second ablation area from said second elongated catheter, said first ablation area and said second ablation area having an overlap of from about 20% to about 90% overlap.

29. An ablation device comprising: a first elongated catheter comprising: an elongated body comprising a proximal end and a distal end; a bifurcation located at said distal end of said elongated body; a first distal element connected to a first branch of said bifurcation and a second distal element connected to a second branch of said bifurcation; said first distal element and said second distal element comprising one or more electrodes distributed along a length of said first distal element and said second distal element; andsaid first distal element and said second distal element comprising one or more magnets distributed along a length of said first distal element and said second distal element; and a second elongated catheter comprising: an elongated body comprising a proximal end and a distal end; a third distal element connected to said distal end of said elongated body, said third distal element comprising one or more electrodes distributed along a length of said third distal element; and said third distal element comprising one or more magnets distributed along a length of said third distal element.

30. The ablation device according to claim 29, wherein said one or more electrodes is one long electrode.

31. The ablation device according to claim 29 or claim 30, wherein said one or more magnets is one long magnet.

32. The ablation device according to any one of claims 29-31, wherein a length of said first distal element is different from a length of said second distal element.

33. The ablation device according to any one of claims 29-32, wherein a length of said first distal element is longer from a length of said second distal element.

34. The ablation device according to any one of claims 29-33, wherein a length of said first distal element is the same as a length of said second distal element.

35. The ablation device according to any one of claims 29-34, further comprising a handle for each of said first elongated catheter and said second elongated catheter, said handles configured to maneuver said first elongated catheter and said second elongated catheter respectively.

36. The ablation device according to any one of claims 29-35, wherein said handle of said first elongated catheter comprises one or more controlling elements for controlling a directionality of said first distal element and said second distal element.

37. The ablation device according to any one of claims 29-36, wherein said first distal element and / or said second distal element and / or said third distal element comprise a length of from about 10 cm to about 18 cm.

38. The ablation device according to any one of claims 29-37, wherein electrodes in said first distal element and / or said second distal element and / or said third distal element comprise a size of from about 3.5 mm to about 12 mm.

39. The ablation device according to any one of claims 29-38, wherein electrodes in said first distal element and / or said second distal element and / or said third distal element comprise a length long enough to fit the dimensions of a location in need for ablation treatment in a body of a subject.

40. The ablation device according to any one of claims 29-39, wherein said first elongated catheter and / or said second elongated catheter comprise a length of from about 50 cm to about 80 cm.

41. The ablation device according to any one of claims 29-40, wherein said first elongated catheter and / or said second elongated catheter comprise a length long enough so as to reach a location in need for ablation treatment in a body of a subject.

42. The ablation device according to any one of claims 29-41, wherein said first elongated catheter and / or said second elongated catheter comprise a size of from about 7Fr to about 12Fr.

43. The ablation device according to any one of claims 29-42, wherein said one or more magnets are from about 5 magnets to about 50 magnets.

44. The ablation device according to any one of claims 29-43, wherein said one or more magnets comprise a length of from about 3mm to about 10cm.

45. The ablation device according to any one of claims 29-44, wherein said first elongated catheter and / or said second elongated catheter are pre-shaped catheters.

46. The ablation device according to claim 45, wherein said pre-shaped catheters are configured to have a curved shape.

47. The ablation device according to any one of claims 29-46, wherein said pre-shaped catheters are configured to have a distal element having a curved shape.

48. The ablation device according to any one of claims 29-47, wherein said one or more electrodes are unipolar electrodes.

49. The ablation device according to any one of claims 29-47, wherein said one or more electrodes are bipolar electrodes.

50. The ablation device according to any one of claims 29-49, further comprising a first delivery sheath for said first elongated catheter and a second delivery sheath for said second elongated catheter.

51. The ablation device according to claim 50, wherein said first delivery sheath and said second delivery sheath comprise said one or more magnets, and said first distal element, said second distal element and said third distal element comprise said one or more electrodes.

Images