Cutting apparatus

Abstract

The present disclosure relates to cutting devices that can be used to cut through a portion of a leaflet connected to an adjacent leaflet by a leaflet connector. In an example, a cutting apparatus comprises a pair of arms configured to move between a closed state and an open state, a pair of grooves formed along the arms, a first wire, and a second wire. The first wire is covered by a first sleeve extending through a first one of the grooves, and includes a retention end. The second wire is covered by a second sleeve extending through a second one of the grooves, and includes a retention feature. The retention end and the retention feature are configured to connect with each other.

Description

CUTTING APPARATUSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 689,501, filed August 30, 2024, which is incorporated by reference herein.FIELD

[0002] The present disclosure relates to methods and devices for cutting through a target tissue that can be a leaflet, such as an anterior leaflet of a mitral valve.BACKGROUND

[0003] The heart is a muscular organ which pumps blood through the blood vessels of the circulatory system by contraction and expansion. In a healthy heart, blood flows in a single direction therethrough due to heart valves, which prevent backflow. During a normal heart contraction cycle, the heart valves open and close accordingly, while muscle heart tissues contracts. These muscle heart tissues can include various types of cavities and formations.

[0004] Ischemic heart disease can lead to valve regurgitation, such as mitral regurgitation. This is caused by the combination of weakened papillary muscles and dilation of the left ventricle, which displaces the papillary muscles and enlarges the annulus of the mitral valve. This prevents the leaflets from sealing properly when the valve is closed, resulting in blood flowing back from the left ventricle into the left atrium - a condition known as mitral regurgitation. This increases total stroke volume and decreases cardiac output, leading to the weakening of the left ventricle due to volume and pressure overload of the left atrium.

[0005] The same problem can occur in other parts of the heart and vascular system, and other valves. Various types of leaflet connectors can be used to clip the tips of the native leaflets to each other to prevent prolapse of one leaflet relative to the other, so as to produce a competent double-orifice valve. Such leaflet connectors can include a suture stitched through adjacent portions of the leaflet (e.g., Alfieri stitch), or various types of fixation clips such as a PASCAL device (Edwards Lifesciences, Irvine, Calif.), a MitraClip (Abbott Structural, Santa Clara, Calif.), and the like.SUMMARY

[0006] In some cases, undesirable mitral valve regurgitation can still exist or can arise again after stitching or otherwise clipping the mitral leaflets to each other, in which case it may bedesirable to implant a prosthetic valve inside of the malfunctioning native mitral valve. However, conventional prosthetic valve implantation procedures cannot be performed in the presence of a leaflet connector that creates a double-orifice mitral valve.

[0007] In one of its basic configurations, a cutting apparatus comprises a pair of arms configured to move between a closed state and an open state, a pair of channels extending through the pair of arms, and a wire. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0008] In some examples, each channel terminates at a distal opening proximate a free end of the corresponding arm through which the channel extends.

[0009] In some examples, the wire comprises a first wire portion extending through one of the pair of channels and out of the corresponding distal opening of the channel.

[0010] In some examples, the wire comprises a second wire portion extending through the other one of the pair of channels and extending through the distal opening of the corresponding other one of the channels.

[0011] In some examples, the wire comprises an intermediate wire portion continuously extending between the first wire portion and the second wire portion.

[0012] In some examples, when the pair of arms are in the closed state, proximally pulling at least one of the first wire portion and / or the second wire portion causes the intermediate wire portion to shorten and move in a distal direction towards the distal openings.

[0013] In some examples, the wire can optionally be electrically conductive.

[0014] In some examples, the wire intermediate portion can optionally be configured to cut through a target tissue when electric current is supplied thereto.

[0015] In some examples, the arms can comprise concave inner surfaces defining a gap formed therebetween in the closed state.

[0016] In some examples, the intermediate wire portion can be disposed in the gap between the arms.

[0017] In some examples, when the arms are extended through orifices formed between two mitral leaflets connected by a leaflet connector such that the distal openings of the channels are distal to the orifices, the intermediate wire portion can be sufficiently long such that at least part thereof can be proximal to the orifices.

[0018] In one of its basic configurations, a method for cutting a leaflet comprises extending a pair of arms of a cutting apparatus, in an open state of the arms, through orifices formed between two leaflets connected by a leaflet connector. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0019] In some examples, the method further comprises moving the arms to a closed state.

[0020] In some examples, the method further comprises cutting a portion of one of the leaflets by pulling a wire extending through channels formed in the arms, such that an intermediate portion of the wire, extending between distal openings of the channels, is shortened and distally moved to contact the leaflet and cut therethrough.

[0021] In some examples, the cutting optionally comprises providing an electric current to the intermediate portion of the wire such that the electric current creates a cut through the leaflet when the intermediate portion of the wire is contacting the leaflet.

[0022] In some examples, the extending the pair of arms through the orifices optionally comprises positioning the distal openings distal to the orifices.

[0023] In some examples, the moving the arms to the closed state optionally comprises maintaining at least part of the intermediate portion of the wire proximal to the orifices.

[0024] In one of its basic configurations, a cutting apparatus comprises a shuttle and a wire coupled to the shuttle. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0025] In some examples, the cutting apparatus further comprises a first arm which optionally comprises a distally opened slot at a distal portion of the first arm.

[0026] In some examples, the cutting apparatus further comprises a second arm which optionally comprises a proximally opened slot at a distal portion of the second arm.

[0027] In some examples, the shuttle comprises a first retention member residing in, and movable out of and into, the distally opened slot.

[0028] In some examples, the shuttle comprises a second retention member residing in, and movable out of and into, the proximally opened slot.

[0029] In some examples, the shuttle is pivotable about the first retention member when the first retention member resides in the distally opened slot.

[0030] In some examples, the shuttle is pivotable about the second retention member when the second retention member resides in the proximally opened.

[0031] In some examples, the wire is configured to cut through a target tissue disposed between the first arm and the second arm and contacted by the wire, when electric current is supplied to the wire.

[0032] In some examples, the wire can be electrically conductive.

[0033] In some examples, the apparatus optionally comprises a link pivotably coupled at a pivotable joint to the shuttle, wherein the wire is coupled to the link.

[0034] In some examples, the first retention member optionally comprises a pin.

[0035] In one of its basic configurations, a method for cutting a leaflet comprises approximating a cutting apparatus to a valve comprising two leaflets connected by a leaflet connector that defines two orifices between the connected leaflets, wherein the cutting apparatus comprises a shuttle. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0036] In some examples, the shuttle can optionally comprise a first retention member and a second retention member.

[0037] In some examples, the first retention member can optionally reside in a distally opened slot of a distal portion of a first arm of the cutting apparatus during the approximation of the cutting apparatus to the valve.

[0038] In some examples, the second retention member can optionally reside in a proximally opened slot of a distal portion of a second arm of the cutting apparatus during the approximation of the cutting apparatus to the valve.

[0039] In some examples, the method further comprises distally advancing the first arm and the second arm through the orifices such that the leaflet contacted by the shuttle causes the shuttle to pivot about the first retention member.

[0040] In some examples, the method further comprises proximally pulling the apparatus, thereby causing an electrically conductive wire coupled to the shuttle to contact the leaflet.

[0041] In some examples, the method further comprises cutting the leaflet by providing an electric current to the wire such that the electric current creates a cut through the leaflet when the wire is contacting the leaflet.

[0042] In some examples, the cutting apparatus optionally comprises a link pivotably coupled at a pivotable joint to the shuttle, and the wire can be coupled to the link.

[0043] In some examples, the causing the shuttle to pivot about the first retention member optionally comprises moving the second retention member out of the proximally opened slot.

[0044] In some examples, the distally advancing optionally comprises moving the leaflet into a gap defined between the first arm and the second arm.

[0045] In some examples, the moving the leaflet into the gap optionally comprises positioning the leaflet proximal to the shuttle.

[0046] In some examples, the method optionally comprises, after the positioning the leaflet proximal to the shuttle, allowing the shuttle to pivot about the first retention member until the second retention member enters into the proximally opened slot.

[0047] In some examples, the proximally pulling the apparatus optionally comprises pushing the leaflet against the shuttle so as to optionally cause the shuttle to pivot about the second retention member.

[0048] In some examples, the proximally pulling the apparatus optionally comprises wrapping the wire around at least a portion of the leaflet.

[0049] In some examples, the cutting optionally comprises further pulling of the cutting apparatus.

[0050] In some examples, the cutting optionally comprises applying tension to the wire.

[0051] In one of its basic configurations, a cutting apparatus comprises an outer member pivotably coupled to a distal end portion of a primary shaft, and an electrically conductive wire comprising a wire coupling region at which the wire is coupled to the outer member. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0052] In some examples, the cutting apparatus comprises an inner shaft extending through, and axially movable relative to, the primary shaft.

[0053] In some examples, the cutting apparatus comprises an inner member coupled to a distal end portion of the inner shaft.

[0054] In some examples, the wire extends through a channel collectively defined by the inner shaft and the inner member, and further extending out of the channel through an opening formed at the inner member towards the wire coupling region.

[0055] In some examples, the outer member is movable between an outer first state and an outer second state, such that the wire coupling region is distanced farther from a central axis of the primary shaft in the outer second state than in the outer first state.

[0056] In some examples, the wire coupling region can be closer to a free end portion of the outer member than to the distal end portion of the primary shaft.

[0057] In some examples, the outer member optionally comprises a flap.

[0058] In some examples, wherein the outer member can be configured to extend perpendicularly to the central axis in the outer second state.

[0059] In some examples, the wire can be configured to define an exposed wire portion extending between the opening formed at the inner member and the wire coupling portion, when the outer member is in the outer second state and when the inner member is distal to the outer member.

[0060] In some examples, the exposed wire portion can be angled relative to the central axis.

[0061] In some examples, the inner member can be pivotably coupled to the inner shaft, and can be movable between an inner first state and an inner second state, such that the wire coupling region can be distanced farther from a central axis of the primary shaft in the outer second state than in the outer first state.

[0062] In some examples, the outer member can be longer than the inner member.

[0063] In one of its basic configurations, a method for cutting a leaflet comprises positioning an outer member of a cutting apparatus proximal to an orifice formed between two leaflets connected by a leaflet connector. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0064] In some examples, the method further comprises moving the outer member from an outer first state to an outer second state, such that a wire coupling region at which an electricallyconductive wire is attached to the outer member is distanced farther from a central axis of a primary shaft to which the outer member is pivotably coupled.

[0065] In some examples, the method further comprises positioning an inner member of the cutting apparatus distal to the orifice, such that the wire forms an exposed wire portion extending between the inner member and the wire coupling region.

[0066] In some examples, the method further comprises cutting a leaflet of the two leaflets by providing an electric current to the exposed wire portion such that the electric current creates a cut through the leaflet when the exposed wire portion is contacting the leaflet.

[0067] In some examples, the outer member can be perpendicular to the central axis in the outer second state.

[0068] In some examples, the cutting apparatus optionally comprises an outer catheter disposed around the primary shaft, and wherein the moving the outer member to the outer second state optionally comprises exposing the second member out of the outer catheter.

[0069] In some examples, the inner member can be coupled to an inner shaft extending through the primary shaft.

[0070] In some examples, the inner member can be pivotably coupled to the inner shaft.

[0071] In some examples, optionally comprises, after the positioning the inner member distal to the orifice, moving the inner member from an inner first state to an inner second state, such that a free end portion of the inner member can be distanced farther from a central axis.

[0072] In some examples, the outer member can be longer than the inner member.

[0073] In some examples, the cutting optionally comprises moving the exposed wire portion from the orifice across a portion of the leaflet.

[0074] In one of its basic configurations, a cutting apparatus comprises a shaft and an electrically conductive wire comprising a distal wire portion attached to a head portion of the shaft. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0075] In some examples, the head portion defines a concave edge.

[0076] In some examples, the distal wire portion can be optionally attached to the head portion along an arc length of the concave edge of the head portion.

[0077] In some examples, the distal wire portion can comprise an exposed electrically conductive surface at an innermost portion thereof, defined by an innermost portion of the concave edge of the head portion.

[0078] In some examples, the innermost portion of the wire can be configured to cut through a target tissue when electric current is supplied thereto.

[0079] In some examples, optionally comprises an insulator fluid injection member configured to eject insulator fluid through a plurality of openings thereof.

[0080] In some examples, the openings optionally extend from a semi-circular portion of the insulator fluid injection member, such that when the openings are positioned next to the distal wire portion, the openings can be oriented towards the innermost portion.

[0081] In one of its basic configurations, a method for cutting a leaflet comprises extending a head portion of a cutting apparatus through an orifice formed between two leaflets connected by a leaflet connector, such that a concave edge of the head portion is facing a leaflet of the two leaflets. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0082] In some examples, the method further comprises cutting the leaflet by moving the head portion, along with a distal wire portion of an electrically conductive wire attached to the concave edge, towards and across a portion of the wire.

[0083] In some examples, the cutting optionally comprises providing an electric current to an innermost portion of the distal wire portion, which can be defined by an innermost portion of the concave edge to which the distal wire portion can be attached.

[0084] In some examples, the moving the head portion optionally comprises gathering tissue of the leaflet contacted by the distal wire portion towards the innermost portion of the distal wire portion.

[0085] In some examples, optionally comprises axially advancing an insulator fluid injection member so as to position a plurality of openings thereof next to the distal wire portion.

[0086] In some examples, optionally comprises ejecting insulator fluid towards the distal wire portion.

[0087] In one of its basic configurations, a cutting apparatus comprises a pair of arms configured to move between a closed state and an open state, and a pair of grooves formedalong the arms. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0088] In some examples, each groove can optionally define an opening at an inner surface of the corresponding arm.

[0089] In some examples, the cutting apparatus comprises a first wire covered by a first sleeve extending through a first one of the grooves.

[0090] In some examples, the first wire comprises a retention end.

[0091] In some examples, the cutting apparatus comprises a second wire covered by a second sleeve extending through a second one of the grooves.

[0092] In some examples, the second wire comprises a retention feature.

[0093] In some examples, the retention end and the retention feature are disengaged from each other and are configured to connect with each other.

[0094] In some examples, the first wire and the second wire can be axially movable relative to the sleeves disposed thereover.

[0095] In some examples, the sleeves can be axially movable relative to the grooves.

[0096] In some examples, each sleeve optionally defines an outer diameter that can be smaller than a size of the opening of the corresponding groove in which is it disposed.

[0097] In some examples, each of the first wire and the second wire optionally defines an outer diameter that can be smaller than the size of the opening of the corresponding groove.

[0098] In some examples, the retention end optionally comprises a tapered tip, and wherein the retention feature optionally comprises an orifice configured to accommodate the tapered tip.

[0099] In one of its basic configurations, a method for cutting a leaflet comprises extending a extending a pair of arms of a cutting apparatus, in an open state of the arms, through orifices formed between two leaflets connected by a leaflet connector, wherein the cutting apparatus further comprises a first wire covered by a first sleeve extending through a groove formed along a first one of the arms, and a second wire covered by a second sleeve extending through a groove formed along a second one of the arms. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basicconfiguration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0100] In some examples, the method further comprises moving the arms to a closed state.

[0101] In some examples, the method further comprises forming a wire coupling region by connecting a retention end of the first wire to a retention feature of the second wire.

[0102] In some examples, the method further comprises proximally pulling the sleeves to expose at least a portion of the first wire and / or the second wire extending along the arms.

[0103] In some examples, the method further comprises cutting a portion of one of the leaflets by proximally pulling at least one of the first wire and / or the second wire, such that the exposed portion of the first wire and / or the second wire is pulled out of the corresponding grooves to contact the leaflet and cut therethrough.

[0104] In some examples, each sleeve optionally defines an outer diameter that can be smaller than a size of an opening of the corresponding groove formed at an inner surface of the corresponding arm, so as to prevent the sleeve from slipping through the opening.

[0105] In some examples, each of first wire and the second wire optionally defines an outer diameter that can be smaller than the size of the opening of the corresponding groove, so as to optionally allow the corresponding wire to be pulled out of the corresponding groove after the proximally pulling the sleeves.

[0106] In some examples, the cutting optionally comprises providing an electric current to the exposed portion of the first wire and / or the second wire such that the electric current optionally creates a cut through the leaflet when the exposed portion of the first wire and / or the second wire is contacting the leaflet.

[0107] In some examples, the extending the pair of arms through the orifices optionally comprises positioning free ends of the arms distal to the orifices.

[0108] In some examples, optionally comprising, before the proximally pulling the sleeves, moving the wire coupling portion proximal to free ends of the arms distal to the orifices.

[0109] In some examples, the moving the wire coupling portion optionally comprises proximally pulling the second wire.

[0110] In some examples, the forming a wire coupling region optionally comprises pushing a tapered tip of the retention end into an orifice of the retention feature.

[0111] In one of its basic configurations, a cutting apparatus comprises a pair of electrically conductive wire arms and a capture basket. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of theexamples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0112] In some examples, each wire arm comprises an axial portion, a knee portion, and a side portion extending from the knee portion and terminating at an end portion that continuously connects the pair of wire arms.

[0113] In some examples, the capture basket can optionally be coupled to the side portions and extend distally therefrom.

[0114] In some examples, the side portions are configured to extend at an angle relative to the axial portions, in a free state of the side portions.

[0115] In some examples, the side portions are configured to be spaced from each other in their free state, forming a gap therebetween.

[0116] In some examples, the side portions can be movable between a compacted state and the free state, such that the angle between the side portions and the axial portions can be smaller in the free state than in the compacted state.

[0117] In some examples, the side portions can be configured to cut through a target tissue when electric current is supplied thereto.

[0118] In some examples, when the wire arms are extended through a one of two orifices formed between two mitral leaflets connected by a leaflet connector, and the side portions are extended distal to the mitral leaflets, the side portions can be sufficiently long to position the end portion distal to the other orifice of the two orifices, on the opposite side of the leaflet connector.

[0119] In some examples, when the leaflet connector comprises a clip, the gap between the side portions in their free state can be greater than a width of the clip.

[0120] In some examples, optionally comprises a pull member axially movable relative to the wire arms, wherein the pull member optionally comprises a pull shaft and a hook, wherein the hook can be configured to engage with the end portion of the wire arms.

[0121] In one of its basic configurations, a method for cutting leaflets of a valve comprises extending axial portions of a pair of electrically conductive wire arms of a cutting apparatus, through one of two orifices formed between two leaflets connected by a leaflet connector. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any oneor more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0122] In some examples, the method further comprises exposing side portions of the wire arms at a position below the mitral leaflets, thereby allowing the side portions to extend at an angle relative to the axial portions, towards the opposite orifice of the two orifices.

[0123] In some examples, the method further comprises cutting portions of the mitral leaflets on both sides of the leaflet connector by providing an electric current to the side portions while pulling the side portions towards the mitral leaflets.

[0124] In some examples, the method further comprises collecting cut portions of the mitral leaflets and the leaflet connector by a capture basket that is coupled to the side portions.

[0125] In some examples, the side portion optionally extend from knee portions and terminate at an end portion that continuously connects the pair of wire arms.

[0126] In some examples, optionally comprises, after the exposing the side portions, capturing the end portion by a hook of a pull member.

[0127] In some examples, the capturing optionally comprises distally extending the pull member through the opposite orifice of the two orifices.

[0128] In some examples, the pulling the side portions towards the mitral leaflets optionally comprises simultaneously pulling the axial portions and the pull member.

[0129] In some examples, the collecting optionally comprises allowing the cut portions of the mitral leaflets and the leaflet connector to fall into the capture basket.

[0130] In some examples, the leaflet connector optionally comprises a clip, wherein the exposing the side portions optionally comprises allowing the side portions to be spaced from each other forming a gap therebetween, the gap being wider than the clip.

[0131] In some examples, the exposing the side portions optionally comprises positioning the side portions distal to the clip.

[0132] In some examples, the pulling the side portions can optionally be performed such that the side portions can be disposed at opposite sides of the clip.

[0133] In one of its basic configurations, a cutting apparatus comprises a capture basket extending between a basket first end and a basket second end portion, and an electrically conductive wire comprising a wire loop coupled to the basket second end portion. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any oneor more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0134] In some examples, the cutting apparatus comprises an outer catheter.

[0135] In some examples, the cutting apparatus comprises a basket shaft extending through, and axially movable relative to, the outer catheter.

[0136] In some examples, the basket first end is attached to the basket shaft.

[0137] In some examples, the capture basket is movable between a compacted configuration and an expanded configuration, such that the basket second end portion defines a greater diameter in the expanded configuration relative to the compacted configuration.

[0138] In some examples, the wire loop can be configured to slide along a perimeter of the basket second end portion.

[0139] In some examples, the wire loop can be configured to cut through a target tissue when electric current is supplied thereto.

[0140] In some examples, when the capture basket is in the expanded configuration, a basket opening defined by the basket second end portion can be sufficiently large to optionally extend around a clip of a leaflet connector that connects two mitral leaflets.

[0141] In some examples, optionally comprises a plurality of engagement features extending radially inwards from an inner surface of the capture basket.

[0142] In one of its basic configurations, a method for cutting leaflets of a valve comprises introducing an outer catheter of a cutting apparatus through an apical puncture into the left ventricle. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0143] In some examples, the method further comprises extending a capture basket out of the outer catheter, thereby allowing the capture basket to move from a compacted configuration to an expanded configuration thereof.

[0144] In some examples, the method further comprises advancing the capture basket towards mitral leaflets of the mitral valve such that a basket second end portion thereof is disposed above a clip of a leaflet connector that connects the mitral leaflets.

[0145] In some examples, the method further comprises cutting portions of the mitral leaflets extending from both sides of the leaflet connector by providing an electric current to anelectrically conductive wire loop coupled to the basket second end portion, while cinching the basket second end portion.

[0146] In some examples, the method further comprises collecting cut portions of the mitral leaflets and the leaflet connector by the capture basket.

[0147] In some examples, the wire loop optionally comprises an electrically conductive uninsulated surface.

[0148] In some examples, the cinching optionally comprises reducing a diameter defined by the basket second end portion to a size smaller than a width of the clip.

[0149] In some examples, the collecting optionally comprises allowing the cut portions of the mitral leaflets and the leaflet connector to fall into the capture basket.

[0150] The aspects of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.BRIEF DESCRIPTION OF THE FIGURES

[0151] Some examples of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some examples may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an example in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.In the Figures:

[0152] Fig. 1 is a cross-sectional view the right-side of a human heart.

[0153] Fig. 2A shows an exemplary suture-based leaflet connector connecting mitral leaflets of a mitral valve.

[0154] Fig. 2B shows an exemplary leaflet connector comprising a clip connecting mitral leaflets of a mitral valve.

[0155] Fig. 3A shows an exemplary cutting apparatus with open arms positioned proximal to a mitral valve.

[0156] Fig. 3B shows the arms of the cutting apparatus of Fig. 3A passed through orifices of the mitral valve and having their free ends closed below the mitral valve.

[0157] Fig. 3C shows an intermediate wire portion of the apparatus of Fig. 3B tensioned and approximated towards the mitral leaflets.

[0158] Fig. 4A shows an exemplary cutting apparatus comprising a shuttle illustrated in a first position, proximal to a mitral valve.

[0159] Fig. 4B shows the apparatus of Fig. 4A distally advanced to push a mitral leaflet of the mitral valve against the shuttle, moved to a second position thereof.

[0160] Fig. 4C shows the apparatus of Fig. 4B with the mitral leaflet disposed between two arms of the apparatus and the shuttle, after reverting to the first position.

[0161] Fig. 4D shows the apparatus of Fig. 4C, proximally pulled to push the mitral leaflet against the shuttle and move it to a third position.

[0162] Fig. 4E shows the apparatus of Fig. 4D with a wire thereof wrapped around the mitral leaflet.

[0163] Fig. 5 is a cross-sectional view of an exemplary cutting apparatus that includes a wire coupled to a pivotable outer member, shown in an outer first state of the outer member.

[0164] Fig. 6A is a side view of the apparatus of Fig. 5, with the outer member exposed out of an outer catheter.

[0165] Fig. 6B is a side view of the apparatus of Fig. 6A, shown in an outer second state of the outer member.

[0166] Fig. 7A shows an exemplary cutting apparatus that includes an electrically conductive wire having a curved distal end portion extending through an orifice defined between mitral leaflets connected by a leaflet connector.

[0167] Fig. 7B shows the apparatus of Fig. 7A, further including an insulator fluid injection member.

[0168] Fig. 8A shows an exemplary cutting apparatus comprising electrically conductive wire extending through grooves of arms, illustrated in a closed state of the arms positioned proximal to a mitral leaflet.

[0169] Fig. 8A' is a cross-sectional view along line 8A'-8A’ of Fig. 8A.

[0170] Fig. 8A" is an enlarge view of region 8A" of Fig. 8A.

[0171] Fig. 8B shows the apparatus of Fig. 8A advanced to position both arms thereof, in an open state, on both sides of the leaflet.

[0172] Fig. 8C shows the apparatus of Fig. 8B, with the arms closed over the mitral leaflets and both wire coupled to each other at a wire coupling portion.

[0173] Fig. 8C is an enlarge view of region 80 of Fig. 80

[0174] Fig. 8D shows the apparatus of Fig. 8C, with the wire coupling portion proximally moved relative to free ends of the arms.

[0175] Fig. 8E shows the apparatus of Fig. 8D with the wire proximally pulled against the mitral leaflet.

[0176] Fig. 8F shows the apparatus of Fig. 8E after cutting of the mitral leaflet by the wire.

[0177] Fig. 9A shows an exemplary cutting apparatus comprising a pair of wire arms having side portions thereof extending below the mitral leaflet and across a leaflet connector.

[0178] Fig. 9B shows the apparatus of Fig. 9B, further comprising a pull member equipped with a hook engaged with an end portion of the wire arms.

[0179] Fig. 9C shows the side portions proximally pulled while cutting the mitral leaflets, with a clip of an exemplary leaflet connector at least partially positioned inside a capture basket coupled to the side portions.

[0180] Fig. 10A shows an exemplary cutting apparatus introduced transapically into the left ventricle.

[0181] Fig. 10B shows a capture basket of the apparatus of Fig. 10A disposed, in an expanded configuration thereof, around a clip of an exemplary leaflet connector.

[0182] Fig. 10C shows the apparatus of Fig. 10B, with a second end portion of the capture basket cinched around mitral leaflets connected by the leaflet connector.

[0183] Fig. 10D shows the apparatus of Fig. IOC including cut portions of the mitral leaflets and the leaflet connector retained inside the capture basket.DETAILED DESCRIPTION

[0184] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present, or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible examples to which the principles of the disclosed technology may be applied, it should berecognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology.

[0185] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0186] All features described herein are independent of one another and, except where structurally impossible, can be used in combination with any other feature described herein.

[0187] As used in this application and in the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the terms "have" or "includes" means "comprises". Further, the terms "coupled", "connected", and "attached", as used herein, are interchangeable and generally mean physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. As used herein, "and / or" means "and" or "or", as well as "and" and "or".

[0188] Directions and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as "inner", "outer", "upper", "lower", "inside", "outside", "top", "bottom", "interior", "exterior", "left", right", and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an "upper" part can become a "lower" part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same.

[0189] The term "plurality" or "plural" when used together with an element means two or more of the element. Directions and other relative references (for example, inner and outer, upperand lower, above and below, left and right, and proximal and distal) may be used to facilitate discussion of the drawings and principles herein but are not intended to be limiting.

[0190] The terms "proximal" and "distal" are defined relative to the use position of a cutting apparatus. In general, the end of the cutting apparatus closest to the user of the apparatus is the proximal end, and the end of the cutting apparatus farthest from the user (for example, the end that is inserted into a patient’s body) is the distal end. The term "proximal" when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the proximal end of the cutting apparatus. The term "distal" when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the distal end of the cutting apparatus. The terms "longitudinal" and "axial" are interchangeable, and refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0191] As used herein, the terms "integrally formed" and "unitary" refer to a construction that does not include any welds, fasteners, or other means for securing separately formed pieces of material to each other.

[0192] As used herein, operations that occur "simultaneously" or "concurrently" occur generally at the same time as one another, although delays in the occurrence of operation relative to the other due to, for example, spacing between components, are expressly within the scope of the above terms, absent specific contrary language.

[0193] As used herein, terms such as "first", "second", and the like are intended to serve as respective labels of distinct components, steps, etc. and are not intended to connote or imply a specific sequence or priority. For example, unless otherwise stated, a step of performing a second action and / or of forming a second component may be performed prior to a step of performing a first action and / or of forming a first component.

[0194] As used herein, the term "substantially" means the listed value and / or property and any value and / or property that is at least 75% of the listed value and / or property. Equivalently, the term "substantially" means the listed value and / or property and any value and / or property that differs from the listed value and / or property by at most 030%. For example, "at least substantially parallel" refers to directions that are fully parallel, and to directions that diverge by up to 27.5 degrees.

[0195] In the present disclosure, a reference numeral that includes an alphabetic label (for example, "a", "b", "c", etc.) is to be understood as labeling a particular example of the structure or component corresponding to the reference numeral. Accordingly, it is to be understood that components sharing like names and / or like reference numerals (for example, with differentalphabetic labels or without alphabetic labels) may share any properties and / or characteristics as disclosed herein even when certain such components are not specifically described and / or addressed herein.

[0196] Described herein are devices and methods for modifying leaflets of an existing valvular structure in a patient’s heart. A cutting apparatus disclosed herein can optionally be provided in the left atrium of a patient and can be used to pierce, lacerate, slice, tear, cut or otherwise modify a leaflet or a leaflet connector. In some examples, the leaflet can be a leaflet of native mitral valve, and a leaflet connector can optionally be a connector attaching portions of leaflets of a native mitral valve. The modification can avoid, or at least reduce the likelihood of, issues that interconnected leaflets might otherwise cause, for example, interference with new prosthetic valve implantation due to a double-orifice configuration of interconnected leaflet of the mitral valve. While described with respect to a mitral valve, it should be understood that the disclosed examples can be adapted modify leaflets and / or leaflet connectors in any of the native valves of the heart (for example, the aortic, pulmonary, mitral, and tricuspid annuluses), and can be used with any of various delivery approaches (for example, retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0197] Throughout the figures of the drawings, different superscripts for the same reference numerals are used to denote different examples of the same elements. Examples of the disclosed devices and systems may include any combination of different examples of the same elements. Specifically, any reference to an element without a superscript may refer to any alternative example of the same element denoted with a superscript. In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some components will be introduced via one or more drawings and not explicitly identified in every subsequent drawing that contains that component.

[0198] Fig. 1 illustrates an anatomy of the right-side of a human heart 10. The heart has a fourchambered conical structure that includes the right atrium, the right ventricle, the left atrium 26 and the left ventricle 28 (right atrium and right ventricle are not shown in Fig. 1). The wall separating between the left and right sides of the heart is referred to as the septum 24. The native mitral valve 30 is positioned between the left atrium 26 and the left ventricle 28. Additionally, the native aortic valve 14 separates the left ventricle 28 from the aorta 12.

[0199] The native mitral valve 30 comprises a mitral annulus 32 and a pair of mitral leaflets 34 extending downward from the annulus 32. The leaflets 34 of the mitral valve 30 include an anterior leaflet 38 and a posterior leaflet 36. When operating properly, the anterior leaflet 38 and the posterior leaflet 36 function together as a one-way valve to allow blood flow from theleft atrium 26 to the left ventricle 28. Specifically, during diastole, when the muscles of the left atrium 26 and the left ventricle 28 dilate, oxygenated blood flows from the left atrium 26, through the mitral valve 30, into the left ventricle 28. During systole, when the muscles of the left atrium 26 relax and the left ventricle 28 contracts, the blood pressure within the left ventricle 28 increases so as to urge to two mitral leaflets 34 to coapt, thereby preventing blood flow from the left ventricle 28 back to the left atrium 26. At the same time, contraction of the left ventricle 28 forces the oxygen rich blood through the aortic valve 14 and aorta 12 into the body through the circulatory system.

[0200] Valvular heart disease can affect functioning of native heart valves, including the mitral valve 30. Mitral regurgitation occurs when the native mitral valve 30 fails to close properly and blood flows back into the left atrium 26 from the left ventricle 28 during systole. Possible causes of this include leaflet prolapse, dysfunctional papillary muscles, issues with chordae tendineae, and / or stretching of the mitral valve annulus due to left ventricle dilation.

[0201] Figs. 2A-2B show exemplary manners by which mitral valve repair can be accomplished, by using a leaflet connector 50 to clip the tips of the posterior leaflet 36 and the anterior leaflet 38 to each other, to prevent prolapse of one leaflet relative to the other. Various exemplary implementations for prosthetic devices and / or components thereof can be referred to, throughout the specification, with superscripts, for ease of explanation of features that refer to such exemplary implementations. It is to be understood, however, that any reference to structural or functional features of any device, apparatus or component, without a superscript, refers to these features being commonly shared by all specific exemplary implementations that can be also indicated by superscripts. In contrast, features emphasized with respect to an exemplary implementation of any device, apparatus or component, referred to with a superscript, may be optionally shared by some but not necessarily all other exemplary implementations.

[0202] An exemplary leaflet connector 50a, illustrated in Fig. 2A, can comprise a suture 52 used to stitch adjacent segments of both of the mitral leaflets 34 together in a "bow-tie" or "edge-to-edge" technique (e.g., Alfieri stitch), so as to produce a competent valve with two orifices 54a and 54b, one on each side of the position of the suture 52. Other types of leaflet connectors 50binclude fixation clips 56 that can be delivered in a transcatheter approach, such as a PASCAL device (Edwards Lifesciences, Irvine, Calif.), a MitraClip (Abbott Structural, Santa Clara, Calif.), and the like. Fig. 2B shows an exemplary leaflet connector 50bcomprising a clip 56 which can have an expanded and a closed or collapsed configuration. For example, clip 56 can be sized or collapsed to fit into a delivery catheter in a closed configuration. Clip56 can, in some examples, be expanded during an implantation procedure to attach the leaflet connector 50bto the mitral valve 30.

[0203] Clip 56 can include a central spacer 60 and a pair of paddles 58. Central spacer 60 forms a central portion of the leaflet connector 50b. Central spacer 60 can be generally elongated, cylindrical, or tapered in shape. Central spacer 60 is configured to extend through an opening between the mitral leaflets 34 and maintain a separation between the pair of paddles 58 that bridges the opening between the leaflets 34. Clip 56 can further include a pair of clasps (hidden from view in Fig. 2B) which are elongated projections extending radially outward from central spacer 60, configured to grip the mitral leaflet 34. Paddles 58 extend radially outward from central spacer 60 and are configured to contact or press against the clasps.

[0204] In some cases, undesirable mitral valve regurgitation can still exist or can arise again after stitching or otherwise clipping the mitral leaflets to each other, in which case it may be desirable to implant a prosthetic valve (not shown) inside of the malfunctioning native mitral valve. The term "prosthetic valve", as used herein, refers to any type of a prosthetic valve deliverable to a patient's target site over a catheter, which is radially expandable and compressible between a radially compressed, or crimped, state, and a radially expanded state. Thus, the prosthetic valve can be crimped on or retained by an implant delivery apparatus (not shown) in the radially compressed state during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site.

[0205] A prosthetic valve for implantation inside a malfunctioning native heart valve may be used with a variety of implant delivery apparatuses. Balloon expandable valves generally involve a procedure of inflating a balloon within a prosthetic valve, thereby expanding the prosthetic valve within the desired implantation site. Once the valve is sufficiently expanded, the balloon is deflated and retrieved along with a delivery apparatus (not shown). Selfexpandable valves include a frame that is shape-set to automatically expand as soon an outer retaining shaft or capsule (not shown) is withdrawn proximally relative to the prosthetic valve. Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion. The mechanical actuation mechanism usually includes a plurality of expansion and locking assemblies releasably coupled to respective actuation assemblies of a delivery apparatus, controlled via a handle (not shown) for actuating the expansion and locking assemblies to expand the prosthetic valve to a desired diameter. The expansion and locking assemblies may optionally lock the valve's diameter to prevent undesired recompression thereof, and disconnection of the actuation assemblies from theexpansion and locking assemblies, to enable retrieval of the delivery apparatus once the prosthetic valve is properly positioned at the desired site of implantation.

[0206] Conventional prosthetic valve implantation procedures cannot be performed in the presence of a leaflet connector 50 of any type, as the leaflet connector 50 creates a doubleorifice mitral valve. To enable new prosthetic valve implantation inside of an existing heart valve that includes a leaflet connector 50 affixed to the tips of the native leaflets, one or more portions of the existing heart valve, such as one or more existing leaflets and / or portions of a leaflet connector, such as stitches of a connector implemented as a suture 52, can be cut so as to separate the two existing leaflets or leaflet portions from each other, prior to implantation of a new prosthetic valve. Any cutting apparatus described throughout the current disclosure, is advantageously configured to cut a portion of a leaflet adjacent to an existing leaflet connector (such as a suture or a fixation clip), and / or cut through portions of a leaflet connector 50 (such as stitches of a connector implemented as a suture 52), thereby recreating a single mitral orifice, while the leaflet connector 50 which is still affixed to the uncut native leaflet can be pushed sideways during new prosthetic valve expansion, without interfering with the new prosthetic valve implantation procedure.

[0207] While described herein with respect to a mitral valve and mitral leaflets, it is to be understood that any cutting apparatus disclosed herein can be used for cutting leaflets of other heart valves (e.g., tricuspid valve, aortic valve, pulmonary valve), as well as other tissues in other anatomical regions.

[0208] In the context of the present specification, the terms "lower" and "upper" are used interchangeably with the terms "distal to" and "proximal to", respectively. Thus, for example, a lowermost component can refer to a distal-most component, and an uppermost component can similarly refer to a proximal-most component.

[0209] The terms "longitudinal" and "axial", as used herein, refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0210] Figs. 3A-3C show stages of an exemplary method of utilizing an exemplary cutting apparatus 100. The cutting apparatus 100 comprises a pair of arms 106 that can be also referred to as forceps or jaws, at a distal end of an elongated shaft 104 that can optionally extend from a handle (not shown) of the apparatus 100. In some examples, the cutting apparatus 100 can optionally further include an outer catheter 102. The shaft 104 can optionally extend through the outer catheter 102. The outer catheter 102 and the shaft 104 can optionally be configured to be axially movable relative to each other. The terms "cutting apparatus" and "apparatus", asused herein with respect to any cutting apparatus 100, 200, 300, 400 or 500, are interchangeable.

[0211] The arms 106 can be fully concealed or covered by the outer catheter 102 when navigating the cutting apparatus 100 through the patient’s vasculature. At the target location (for example, when a distal end of the outer catheter 102 is adjacent to the mitral valve 30), the arms 106 can be deployed out of the outer catheter 102. Deployment of the arms 106 can be achieved, for example, by holding the outer catheter 102 steady while pushing the shaft 104 in a distal direction, or holding the shaft 104 steady while moving the outer catheter 102 in a proximal direction, or pushing the shaft 104 in the distal direction while simultaneously pulling the outer catheter 102 in the proximal direction.

[0212] The arms 106 are configured to move between an open state and a closed state. The arms terminate at free ends 108 which are closer to each other, and can be optionally in contact with each other, in the closed state, and are farther spaced from each other in the open state. In some examples, a locking mechanism (not shown) can be optionally included to keep the arms in the closed state and prevent inadvertent opening of the arms 106. In some examples, radiopaque markers can be added to the arms 106 so that positions of the arms 106 can be visible under fluoroscopy.

[0213] As illustrated in Figs. 3A-3C, the arms 106 are generally curved in shape, such that concave inner surfaces 107 of the arms, oriented towards each other, define an inner gap 140 between the arms 106 or intermediate portions thereof, in the closed state.

[0214] Various types of actuation mechanisms can be implemented to move the arms 106 between the open and closed states. In the example illustrated in Figs. 3A-3C, an exemplary actuation mechanism of the arms 106 is shown to include a four-bar linkage 120 which has four rigid bars 122 that are interconnected by four pivot joints 124a-d. The arms 106 can include extension portions 110 at proximal end portions thereof, opposite to the free ends 108. Extension portions 110 of the two arms 106 can be respectively connected two middle joints 124b, 124c. The extension portions 110 of both arms 106 are also connected to a distal joint 124d so that the two arms 106 can pivot relative to one another at the distal joint 124d. A proximal joint 124a can be connected to the shaft 104, either directly or via a component affixed to a distal end of the shaft 104. Optionally, a holding shaft (not shown) can be disposed around the shaft 104 and attached to the distal joint 124d. Pushing the shaft 104 in the distal direction (for example, relative to the holding shaft, when the arms 106 are exposed out of the outer catheter 102) can move the proximal joint 124a closer to the distal joint 124d, thereby forcing the arms 106 to move away from one another, that is, moving the arms 106 to the open state.Conversely, pulling the shaft 104 in the proximal direction (for example, relative to a holding shaft) can move the proximal joint 124a farther away from the distal joint 124d, thereby moving the arms 106 toward each other, that is, moving the arms 106 to the closed state.

[0215] While a four-bar linkage 120 is illustrated and described above as part of the actuation mechanism, it is to be understood that other types of actuation mechanism can be similarly implemented to facilitate controllable movement of arms 106 between the open and closed states.

[0216] Each of the arms 106 can optionally include a channel 1 12 extending therethrough between a proximal opening 116 and a distal opening 114. In some examples, the proximal opening can be formed at or in close proximity to the corresponding extension portion 110 of the arm 106. In some examples, the distal opening 114 can be formed at or in close proximity to the corresponding free end 108 of the arm 106.

[0217] The cutting apparatus 100 further includes a wire 150 having an intermediate portion 156 configured to extend between the arms 106, wherein at least part of the intermediate portion 156 is configured to cut through a leaflet 34 and / or a leaflet connector 50. In some examples, the apparatus 100 can optionally comprise an electric current source (not shown) configured to generate and provide a predetermined electric current to the wire 150. The electric current source is optionally secured within a handle of the apparatus, or it can optionally be external to the handle.

[0218] The wire 150 of apparatus 100 defines a first wire portion 152 that can optionally extend distally from the handle of apparatus 100, such as through the outer catheter 102, and pass through the proximal opening 116 of one of the arms 106 into and through the corresponding channel 112, towards and out of the corresponding distal opening 114. The wire then defines the intermediate wire portion 156 extending from the end of the first wire portion 152 at the corresponding distal opening 114 of one of the arms 106, optionally to the distal opening 114 of the opposite arm 106. Optionally, a second wire portion 154 of the wire 150 can be defined, passing through the channel 112 of the opposite arms 106, and extending out of the corresponding proximal opening 116, such as through the outer catheter 102, back towards the handle.

[0219] Any cutting apparatus disclosed herein, such as cutting apparatus 100, 200, 300, 400, 500, 600 and / or 700, when used to modify a mitral valve 30, can be optionally configured to be inserted into a patient’s vasculature, such as within the inferior vena cava into the right atrium (not shown) and through the septum 24, until the distal end portion of the apparatus is positioned in the left atrium 26. The distal end portion of an outer catheter of the apparatus canbe then optionally steered such that it is positioned in a desired spatial orientation within the left atrium 26. Such an optional steering procedure can be performed with the aid of imaging, such as fluoroscopy, transesophageal echo, and / or echocardiography.

[0220] In some examples, the apparatus is advanced through the vasculature into the right atrium using a suitable point of origin typically determined for a given patient. In some examples, the apparatus is introduced into the femoral vein of the patient, through the inferior vena cava, into the right atrium, and into the left atrium 26 transseptally, typically through the fossa ovalis (not shown). In some examples, the apparatus is introduced into the basilic vein, through the subclavian vein to the superior vena cava, into the right atrium, and into the left atrium 26 transseptally, typically through the fossa ovalis (not shown). In some examples, the apparatus is introduced into the external jugular vein, through the subclavian vein to the superior vena cava, into the right atrium, and into the left atrium 26 transseptally, typically through the fossa ovalis (not shown).

[0221] An example method for cutting a leaflet 34 of a mitral valve 30 utilizing cutting apparatus 100 is illustrated in Figs. 3A-3C. Fig. 3 A shows that upon approximation to the mitral valve 30, for example while a distal portion of the cutting apparatus 100 is positioned within the left atrium 26, the arms 106 can be optionally exposed out of an outer catheter 102 and moved to an open state. Opening of the arms 106 can be optionally performed while the arms 106 and / or free ends 108 thereof, are proximal to the mitral valve 30.

[0222] As further shown in Fig. 3A, during delivery and / or opening of the arms 106, the intermediate wire portion 156 can optionally have a length that is greater than the shortest distance between the distal openings 114 of the arms 106. Optionally, the intermediate wire portion 156 can extend along and / or follow the contour of inner sides of the arms 106, between both proximal openings 116.

[0223] The arms 106 can be generally aligned with the orifices 54 formed between the leaflets 34 on both sides of the leaflet connector 50, such that the apparatus 100 and / or arms 106 thereof can be distally pushed in direction 80, passing the arms 106 through the orifices 54 such that the free ends 108 of arms 106 and / or the corresponding distal openings 114 are positioned distal to the leaflets 34 and / or leaflet connector 50. In this position, the arms 106 can be moved to the closed position, bringing the free ends 108 and distal openings 114 closer to each other below (or distal to) the leaflets 34 and / or leaflet connector 50, as illustrated for example in Fig. 3B.

[0224] As further shown in Fig. 3B, the length of the intermediate wire portion 156 is configured to leave a slack of the intermediate wire portion 156 proximal to the leafletconnector 50 while the distal openings 114 are positioned distal to the leaflet connector 50 in the closed state of the arms 106.

[0225] The wire 150 is electrically conductive, configured to deliver electric current therealong, including to the intermediate wire portion 156. In some examples, at least part of the intermediate wire portion 156 has an exposed or uninsulated electrically conductive surface. In some examples, an electric current source (not shown) generates an electric current, and outputs the generated electric current to the wire 150. In some examples, the generated electric current is an alternating current. In some examples, the frequency of the alternating current is a radio-frequency (RF), i.e. from about 20 kHz to 300 GHz. In some examples, the wire 150 conducts electricity from the first wire portion 152 to the intermediate wire portion 156. In some examples, an exposed or uninsulated electrically conductive surface of the intermediate wire portion 156 is configured to output RF energy.

[0226] In some examples, the electric current source is configured, responsive to a user input, to alternately provide the electric current and not provide the electric current. For example, the electric current source can optionally include a user input device, such as a switch that can optionally turn the electric current source on and off. Thus, the electric current can be provided only when the intermediate wire portion 156 is moved towards leaflets or stitches of a leaflet connector configured to be cut thereby.

[0227] In some examples, the wire 150 can optionally include an electrically insulating layer (not shown) covering at least a portion of an electrically conductive core of the wire. In some examples, the wire 150 can optionally include insulating layers that completely encompass a circumference of the first and / or second wire portions 152, 154. In some examples, the first and second wire portions 152, 154 can optionally be completely covered by insulating layers, while the intermediate wire portion 156 can optionally be completely or partially uninsulated. In some examples, only a relatively short length at the center of intermediate wire portion 156 remains uninsulated, at least along a distally-oriented side thereof.

[0228] When electric current is provided to the wire 150 and its intermediate wire portion 156, the intermediate wire portion 156 (or an uninsulated part thereof) can optionally cut through a target tissue, such as a portion of an anterior leaflet 38, and / or through stitches 52 of a leaflet connector 50 in the case of a suture-based leaflet connector.

[0229] As shown in Fig. 3C, a pull force applied on proximal ends of the wire 150, such as by simultaneously pulling, in direction 82, the first and second wire portion 152, 154, while maintaining the arms 106 in position around the leaflet connector 50, will serve to shorten the length of the intermediate wire portion 156, approximating the portion of the intermediate wireportion 156 which is proximal to the leaflets 34 and leaflet connector 50 towards the distal openings 114, up to contact with at least one of the leaflets 34 and / or the leaflet connector 50.

[0230] Retraction of the wire 150 while electric current is provided to its intermediate wire portion 156, causes the intermediate wire portion 156 to cut through the portion of the leaflet 38 and / or stitches 52 of a suture-based leaflet connector 50acontacted by the intermediate wire portion 156 as it travels distally and shortens in length between the corresponding arms 106.

[0231] Stated otherwise, upon contact of the intermediate wire portion 156 with the tissue of a leaflet 34 and / or a suture 52 of a leaflet connector 50, the intermediate wire portion 156 can cut through the tissue and / or suture. This can be achieved by electrically energizing the intermediate wire portion 156 so as to heat and cut the tissue and / or suture as it travels in a distal direction 80 during continued pulling of the first wire portion 152 and optionally the second wire portion 154.

[0232] In some examples, the first and second wire portions 152 and 154 can optionally be connected to each other at a portion of the wire 150 passing through the outer catheter 102 towards the handle, such that proximally pulling a single wire portion may simultaneously move both wire portions 152 and 154 and shorten the intermediate wire portion 156.

[0233] Subsequent to completion of the cutting procedure, the apparatus 100 can be retrieved from the patient's body, optionally maintaining the arms 106 in the closed state, retracted into the outer catheter 102. After retrieval of the apparatus 100, a prosthetic valve can be optionally implanted in the native mitral valve 30.

[0234] While the distal openings 114 are shown to be formed on inner surfaces of the arms 106 adjacent free ends 108, it is to be understood that in some examples, the distal openings 114 can be formed at the free ends 108 themselves. Formation of the distal openings 114 at the inner surfaces of arms 106 instead of directly at the free ends 108 can avoid frictional interference during pulling of the wire 150 through the distal openings 114 which can otherwise occur in the closed state of the arms 106.

[0235] While simultaneous pulling of both the first wire portion 152 and second wire portion 154 in direction 82 is described and illustrated with respect to Fig. 3C, it is to be understood that one portion of the wire 150 can be held steady while the other portion is proximally pulled. For example, the first wire portion 152 can be proximally pulled while the second wire portion 154 is held in place, or the second wire portion 154 can be proximally pulled while the first wire portion 152 is held in place.

[0236] While two wire portions 152 and 154 are described and illustrated with respect to Figs. 3A-3B, it is to be understood that in some examples, a wire 150 can include a first wire portion152 and an intermediate wire portion 156, while being devoid of a second wire portion 154 extending towards the handle. For example, the wire can include a first wire portion 152 extending through a channel 112 formed in a corresponding one of the arms 106, while the opposite arm can be optionally devoid of a similar channel 112 and of proximal and / or distal openings. The intermediate wire portion 156 can continuous extend from the first wire portion 152 existing the distal opening 114, while the opposite end of the intermediate wire portion 156 can be affixed (such as by being glued, welded, and the like) to the opposite arm 106, optionally at the level of the distal opening 1 14 of the first arm 106 (example not shown). In such an example, the application of a pulling force on the first wire portion 152 can similarly serve to shorten the intermediate wire portion 156 can move it closer and through the tissue and / or stitches to be cut.

[0237] Fig. 4A-4E show stages of an exemplary method of utilizing an exemplary cutting apparatus 200. The cutting apparatus 200 comprises a first arm 206 and a second arm 212 at a distal end of a shaft 204 that can optionally extend from a handle (not shown) of the apparatus 200. The apparatus 200 further comprises a shuttle 218 configured to pivotably engage any of the first arm 206 and / or the second arm 212. The first arm 206 comprises a distally opened slot 210 at a distal portion 208 of the first arm 206. The second arm 212 comprises a proximally opened slot 216 at a distal portion 214 of the second arm 212. The distal portion 208 of the first arm 206 and the distal portion 214 of the second arm 212 are spaced from each other, defining a gap 240 therebetween. While the first arm 206 and the second arm 212 are shown in Figs. 4A-4E to have a generally linear shape extending in the axial direction, it is to be understood that this is shown by way of illustration and not limitation, and that the first arm 206 and the second arm 212 can be curved or have any other shape.

[0238] The shuttle 218 can optionally include a first retention member 220 and a second retention member 222. In some examples, the first retention member 220 is a pin. In some examples, the second retention member 222 is a pin. The first retention member 220 is configured to move into and out of the distally opened slot 210, while the second retention member 222 is configured to move into and out of the proximally opened slot 216.

[0239] In some examples, the cutting apparatus 200 can optionally further include an outer catheter 202. The shaft 204 can optionally extend through the outer catheter 202. The outer catheter 202 and the shaft 204 can optionally be configured to be axially movable relative to each other. In some examples, the first and second arms 206, 212 can be optionally integrally formed extension of the shaft 204. In some examples, the first and second arms 206, 212 canbe integrally formed with each other. In some examples, the first and second arms 206, 212 can be affixed to the shaft 204.

[0240] The first and second arms 206, 212 along with the shuttle 218 engaged therewith can be fully concealed or covered by the outer catheter 202 when navigating the cutting apparatus 200 through the patient’ s vasculature. At the target location (for example, when a distal end of the outer catheter 202 is adjacent to the mitral valve 30), the first and second arms 206, 212 along with the shuttle 218 engaged therewith can be deployed out of the outer catheter 202. Deployment of the first and second arms 206, 212 along with the shuttle 218 engaged therewith can be achieved, for example, by holding the outer catheter 202 steady while pushing the shaft 204 in a distal direction, or holding the shaft 204 steady while moving the outer catheter 202 in a proximal direction, or pushing the shaft 204 in the distal direction while simultaneously pulling the outer catheter 202 in the proximal direction.

[0241] The shuttle 218 is configured to move between a first position, a second position, and a third position. In the first position shown, for example, in Fig. 4A, the shuttle 218 is engaged with both the first and second arms 206, 212, such that the first retention member 220 is situated in the distally opened slot 210 and the second retention member 222 is situated in the proximally opened slot 216. As further shown in Fig. 4A, the shuttle 218 extends in the first position between the distal portions 208 and 214 of the first arm 206 and the second arm 212, respectively, so as to close the entry into the gap 240 defined between both arms 206, 212.

[0242] In the second position shown, for example, in Fig. w, the shuttle 218 is engaged with the first arm 206 and is spaced from the second arm 212, such that the first retention member 220 is situated in the distally opened slot 210 while the second retention member 222 moves out of and away from the proximally opened slot 216. As further shown in Fig. 4B, the shuttle 218 can optionally extend proximally from the distal portion 208 of the first arm 206 in the second position, optionally at an angle relative to the first arm 206.

[0243] In the third position shown, for example, in Fig. 4D, the shuttle 218 is engaged with the second arm 212 and is spaced from the first arm 206, such that the second retention member 222 is situated in the proximally opened slot 216 while the first retention member 220 moves out of and away from the distally opened slot 210. As further shown in Fig. 4D, the shuttle 218 can optionally extend distally from the distal portion 214 of the second arm 212 in the third position, optionally at an angle relative to the second arm 212.

[0244] The cutting apparatus 200 further includes a wire 250 coupled, directly or indirectly, to the shuttle 218, wherein at least part of wire 250 is configured to cut through a leaflet 34 and / or a leaflet connector 50. In some examples, the apparatus 200 can optionally comprise an electriccurrent source (not shown) configured to generate and provide a predetermined electric current to the wire 250. The electric current source is optionally secured within a handle of the apparatus, or it can optionally be external to the handle. The wire 250 of apparatus 200 can optionally extend distally from the handle of apparatus 200 towards the shuttle 218, such as through the outer catheter 102, and connect with the shuttle 218 either directly (not shown) or via one or more intermediate components connected to the shuttle 218, such as a link 224 shown in the example illustrated in Figs. 4A-4E.

[0245] In some examples, the apparatus 200 can optionally further comprise a link 224 pivotably coupled to one end of the shuttle 218, such as via pivot joint 226. In the example illustrated in Figs. 4A-4E, the link 224 is shown to be coupled to an end of the shuttle 218 that is closer to the first retention member 220. The wire 250 can be optionally coupled to the link 224 at an end opposite to the pivot joint 226. In some examples, the link 224 can include an aperture 228 through which the wire 250 can be optionally looped, as illustrated in Figs. 4A- 4E, though it is to be understood that the wire 250 can be coupled by any other suitable manner to the link 224, such as by gluing, welding, and the like.

[0246] An example method for cutting a leaflet 34 of a mitral valve 30 utilizing cutting apparatus 200 is illustrated in Fig. 4A-4E. Fig. 4A shows a distal portion of the cutting apparatus 100 approximated to the mitral valve 30, for example while positioned within the left atrium 26, wherein the first and second arms 206, 212 and the shuttle 218 engaged therewith in the first position during delivery, can be maintained inside the outer catheter 202.

[0247] As shown in Fig. 4B, the first and second arms 206, 212 and the shuttle 218 can be optionally exposed out of the outer catheter 202 and moved distally towards the target leaflet, such as the anterior leaflet 38, optionally by advancing the shaft 204 in the distal direction 80. When the shuttle 218 is pushed against the leaflet 38, the leaflet 38 causes the shuttle 218 to move from the first position to the second position while being pivoted about the first retention member 220, allowing entry of the leaflet 38 into the gap 240 formed between the arms 206, 212.

[0248] When the leaflet 38 further slides along the shuttle 218 until it no longer is in contact with the shuttle 218, the shuttle 218 is free to revert to the first position, as shown in Fig. 4C, while at least a portion of the leaflet 38 is retained proximal to the shuttle 218 and between the arms 206, 212, as shown in Fig. 4C.

[0249] At this stage, as shown in Fig. 4D, the shaft 204 can be pulled in the opposite proximal direction 82, moving the shuttle 218 towards the leaflet 38 such that the leaflet 38 causes the shuttle 218 to move from the first position to the third position while being pivoted about thesecond retention member 222, allowing exit of the leaflet 38 out of the gap 240 formed between the arms 206, 212. In the course of this movement the shuttle 218 carries the wire 250 around the leaflet 38 such that a portion of the wire 250 is wrapped around at least a portion of the leaflet 38 as shown in Fig. 4E.

[0250] The wire 250 is electrically conductive, configured to deliver electric current therealong, including to the portion of the wire 250 wrapped around the leaflet 38 shown in Fig. 4E. In some examples, at least part of the wire 250 configured to be in contact with the leaflet 38 has an exposed electrically conductive surface. In some examples, an electric current source (not shown) generates an electric current, and outputs the generated electric current to the wire 250. In some examples, the generated electric current is an alternating current. In some examples, the frequency of the alternating current is a radio-frequency (RF), i.e. from about 20 kHz to 300 GHz. In some examples, an exposed electrically conductive surface of the wire 250 is configured to output RF energy.

[0251] In some examples, the electric current source is configured, responsive to a user input, to alternately provide the electric current and not provide the electric current. For example, the electric current source can optionally include a user input device, such as a switch that can optionally turn the electric current source on and off. Thus, the electric current can be provided only when the wire 250 is wrapped around a portion of a leaflet or around stitches of a leaflet connector configured to be cut thereby. In some examples, the wire 250 can optionally include an electrically insulating layer (not shown) covering at least a portion of an electrically conductive core of the wire.

[0252] When electric current is provided to the wire 250, the portion of the wire 250 which is wrapped around the target tissue can optionally cut through a target tissue, such as a portion of an anterior leaflet 38, and / or through stitches 52 of a leaflet connector 50 in the case of a suturebased leaflet connector.

[0253] In some examples, the wire can be pulled in the proximal direction 82 from the position shown in Fig. 4E to apply tension to the wire 250 while being electrified, thereby facilitating cutting of a leaflet and / or stitches of a leaflet connector. In some examples, the shaft 204 can be pulled in the proximal direction 82 from the position shown in Fig. 4E to facilitate cutting of a leaflet and / or stitches of a leaflet connector while the wire 250 is being electrified.

[0254] Subsequent to completion of the cutting procedure, the apparatus 200 can be retrieved from the patient's body, optionally with the arms 206, 212 and the shuttle 218 retracted into the outer catheter 202. After retrieval of the apparatus 200, a prosthetic valve can be optionally implanted in the native mitral valve 30.

[0255] Fig. 5 is a cross-sectional view of an exemplary cutting apparatus 300. Figs. 6A and 6B show the cutting apparatus 300 in different states of pivotable members thereof. The cutting apparatus 100 comprises an outer member 312 pivotably coupled to a distal end portion 306 of a primary shaft 304. The outer member 312 is coupled to the distal end portion 306 of primary shaft 304 at an outer pivot joint 314, and is configured to pivotably move between an outer first state in which the outer member 312 extends distally from the distal end portion 306 of primary shaft 304 as shown, for example, in Figs. 5 and 6A, and an outer second state in which the outer member 312 extends radially away from the distal end portion 306 of primary shaft 304 as shown, for example, in Fig. 6B.

[0256] The outer member 312 extends from the outer pivot joint 314 to a free end portion 316 thereof and defines an inner surface 322 and an outer surface 324. In some examples, the inner and outer surfaces 322, 324 can be optionally generally curved, such that the outer member 312 can optionally be in the shape of a substantially curved flap having a circumferential width that spans less that 180° around the central axis CA of the primary shaft 304. In some examples, the outer member 312 can optionally be substantially aligned with, or parallel to, the central axis CA in the outer first state. In some examples, the outer member 312 can optionally be substantially perpendicular to the central axis CA of the primary shaft 304 in the outer second state.

[0257] In some examples, the cutting apparatus 300 can optionally further include an inner member 326 coupled to a distal end portion 310 of an inner shaft 308. In some examples, the inner member 326 can be pivotably coupled to the inner shaft 308. The inner shaft 308 can optionally extend through the primary shaft 304, such as through a lumen of the primary shaft 304. The primary shaft 304and the inner shaft 308 can optionally be configured to be axially movable relative to each other.

[0258] The inner member 326 is coupled to the distal end portion 310 of inner shaft 308 at an inner pivot joint 328, and is configured to pivotably move between an inner first state in which the inner member 326 extends distally from the distal end portion 310 of inner shaft 308 as shown, for example, in Figs. 5 and 6A, and an inner second state in which the inner member 326 extends radially away from the distal end portion 310 of inner shaft 308 as shown, for example, in Fig. 6B.

[0259] The inner member 326 extends from the inner pivot joint 328 to a free end portion 332 thereof. In some examples, the inner member 326 can optionally include a conical or frustoconical portion terminating at the free end portion 332 and defining an outer tapering surface 330. In some examples, the inner member 326 can optionally be substantially alignedwith, or parallel to, a central axis of the inner shaft 308 in the inner first state, wherein the inner shaft 308 can optionally be coaxial with the primary shaft 304, sharing a common central axis CA. In some examples, the inner member 326 can optionally be substantially perpendicular to a central axis of the inner shaft 308 in the inner second state.

[0260] In some examples, the cutting apparatus 300 can optionally further include an outer catheter 302. The primary shaft 304 can optionally extend through the outer catheter 302. The outer catheter 302 and the primary shaft 304 can optionally be configured to be axially movable relative to each other.

[0261] The cutting apparatus 300 further includes a wire 350 coupled to the outer member 312, wherein at least part of wire 350 is configured to cut through a leaflet 34 and / or a leaflet connector 50. In some examples, the apparatus 300 can optionally comprise an electric current source (not shown) configured to generate and provide a predetermined electric current to the wire 350. The electric current source is optionally secured within a handle of the apparatus, or it can optionally be external to the handle. The wire 350 of apparatus 300 can optionally extend distally from the handle of apparatus 300 towards the outer member 312, such as through the primary shaft 304, and connect with the outer member 312 at a wire coupling region 318. In some examples, the wire coupling region 318 can optionally be relatively closer to the free end portion 316 of the outer member 312 than to the outer pivot joint 314.

[0262] In some examples, when the outer member 312 is in the outer first state, the wire 350 can optionally extend towards the wire coupling region 318 along an inner side of the outer member 312 facing the inner surface 322. In some examples, the outer member 312 can optionally include a bore 320 extending at the wire coupling region 318 between the inner surface 322 and the outer surface 324, such that the wire 350 can optionally extend into and / or through the bore 320 at the wire coupling region 318. The wire 350 can be coupled to the outer member 312 at the wire coupling region 318 by any suitable method, such as by an adherent, by soldering, welding, and the like.

[0263] In some examples, the wire 350 can optionally extend through the inner shaft 308 and / or the inner member 326. For example, the inner shaft 308 and the inner member 326 can optionally collectively define a channel 334 extending therethrough, as shown, for example, in Fig. 5. The channel 334 terminates at an opening 336, which can optionally be a side opening 336 formed over the tapering surface 330 of the inner member 326, optionally on a side of the tapering surface 330 facing the inner surface 322 of the outer member 312. The wire 350 can optionally extend, in such examples, through the channel 334, exit the channel 334 at theopening 336, and further extend from the opening 336 to the wire coupling region 318, as illustrated, for example, in Fig. 5.

[0264] An example method for cutting a leaflet 34 of a mitral valve 30 utilizing cutting apparatus 300 can include approximating a distal portion of the apparatus 300 to the mitral valve 30, for example while positioned within the left atrium 26, wherein the outer member 312 and / or inner member 326 can be maintained inside the outer catheter 302 during delivery. In some examples, the free end portion 332 of the inner member 326 can optionally be proximal to the free end portion 316 of the outer member 12 during delivery, as illustrated, for example, in Fig. 5. In some examples, the free end portion 332 of the inner member 326 can optionally be axially aligned with the free end portion 316 of the outer member 312 during delivery.

[0265] As shown in Fig. 6A, the outer member 312 can be exposed out of the outer catheter 302, optionally by advancing the primary shaft 304 in the distal direction 80 relative to the outer catheter 302, and / or by pulling the outer catheter 302 relative to the primary shaft 304. As further shown in Fig. 6A, the inner member 326 can be positioned distally to the outer member, optionally by advancing the inner shaft 308 in the distal direction 80 relative to the primary shaft 304. Positioning of the inner member 326 distally to the outer member 312 can be optionally performed prior to, simultaneous with, or after exposing the outer member 312 out of the outer catheter 302.

[0266] When exposed out of the outer catheter 302, the outer member 312 can be passively or actively moved from the outer first state to the outer second state, as shown for example in Fig. 6B. In some examples, as further illustrated in Figs. 6A-6B, the apparatus 300 can optionally further include a biasing member 342 configured to bias the outer member 312 to the outer second state in a free state of the outer member 312. In some examples, the biasing member 342 can optionally be a spring. In some examples, the biasing member 342 can optionally be a torsion spring disposed around a pin forming the outer pivot joint 314. It is to be understood that any other biasing arrangement for the outer member 312 is contemplated. When the outer member 312 is configured to be biased to the outer second state, it can be forced to maintain the outer first state by an outer enclosure disposed thereover, such as the outer catheter 302, during delivery and / or retrieval of the apparatus 300, and can be passively moved to the outer second state when exposed from the outer catheter 302.

[0267] When positioned distally to the outer member 312, the inner member 326 can be actively or passively moved from the inner first state to the inner second state, as shown for example in Fig. 6B. In some examples, the apparatus 300 can optionally include a pull-member 338 that can distally extend from a handle (not shown) of the apparatus 300 and has a distalend 340 affixed to the inner member 326 at a position which is radially offset from the inner pivot joint 328. In some examples, the distal end 340 of the pull-member 338 can affixed to the tapering surface 330 of the inner member 326, optionally at a side of the tapering surface 330 facing the inner surface 322 of the outer member 312. The pull member can be in the form of a pull wire, cable, suture, and the like. In some examples, the pull-member 338 can optionally extend along a gap formed between the inner shaft 308 and the primary shaft 304.

[0268] When the pull-member 338 is pulled in a proximal direction 82 while the inner member 326 is distal to the outer member 312, the distal end 340, which is radially offset from the inner pivot joint 328, pull on the inner member 326 at the point of attachment, forcing it to pivot about the joint 328 to actively move from the inner first state to the inner second state, as shown for example in Fig. 6B.

[0269] While the outer member 312 is shown in the example illustrated in Figs. 6A-6B to be biased by a biasing member 342 to the outer second state, it is to be understood that in some examples, the outer member 312 can be configured to be actively moved between the outer first and second states. For example, the apparatus 300 can optionally include a pull member (not shown) attached to the outer surface 324 of the outer member 312, which can be structurally and functionally similar to any example of the pull-member 338 described herein, and can be similarly actuated to similarly actively move the outer member 312 from the outer first state to the outer second state.

[0270] While the inner member 326 is shown in the example illustrated in Figs. 6A-6B to be actively movable by a pull-member 338 from the inner first state to the inner second state, it is to be understood that in some examples, the inner member 326 can be configured to be biased to the inner second state in a free state thereof. For example, the apparatus 300 can optionally include a biasing member (not shown) which can be structurally and functionally similar to any example of the biasing member 342 disclosed herein, for example provided in the form of a torsion spring disposed of a pin of the inner pivot joint 328. Such a biasing member can passively move the inner member 326 from the inner first state to inner outer second state as soon as it is no longer disposed inside of the primary shaft 304 and is not prohibited from being biased radially outwards by the outer member 312.

[0271] In some examples, the method of utilization of cutting apparatus 300 can include orienting the distal portion of the apparatus 300 towards an orifice 54 between the leaflet 34 on one side of the leaflet connector 50, optionally prior to exposing the outer member 312 out of the outer catheter 302 and / or positioning the inner member 326 distal to the outer member 312. The length of the outer member 312, defined between the outer pivot joint 314 and thefree end portion 316, can be optionally greater than the length of the inner member 326, defined between the inner pivot joint 328 and the free end portion 332, such that both the outer member 312 and the inner member 326 are in their inner and outer second states, respectively, an exposed wire portion 352, defined as the portion of the wire 352 extending between both members 312 and 326, assumes an angled orientation, as shown for example in Fig. 6B.

[0272] The method can optionally include positioning of the outer member 312, in its outer second state, proximal to the annulus 32 of the mitral valve 30, and positioning of the inner member 326 in its inner second state, distal to the annulus 32 of the mitral valve 30, such that the inner shaft 308 can optionally extent at least partially through the orifice 54 defined between the leaflet 34 on one side of the leaflet connector 50.

[0273] The wire 350 is electrically conductive, configured to deliver electric current therealong, including to the exposed wire portion 352. In some examples, at least part of the exposed wire portion 352 has an exposed electrically conductive surface. In some examples, an electric current source (not shown) generates an electric current, and outputs the generated electric current to the wire 350. In some examples, the generated electric current is an alternating current. In some examples, the frequency of the alternating current is a radiofrequency (RF), i.e. from about 20 kHz to 300 GHz. In some examples, the wire 350 conducts electricity to the exposed wire portion 352. In some examples, an exposed electrically conductive surface of the exposed wire portion 352 is configured to output RF energy.

[0274] In some examples, the electric current source is configured, responsive to a user input, to alternately provide the electric current and not provide the electric current. For example, the electric current source can optionally include a user input device, such as a switch that can optionally turn the electric current source on and off. Thus, the electric current can be provided only when the exposed wire portion 352 is in contact, or is about to contact, leaflets or stitches of a leaflet connector configured to be cut thereby.

[0275] In some examples, the wire 350 can optionally include an electrically insulating layer (not shown) covering at least a portion of an electrically conductive core of the wire. When electric current is provided to the wire 350 and its exposed wire portion 352, the exposed wire portion 352 can optionally cut through a target tissue, such as a portion of an anterior leaflet 38, and / or through stitches 52 of a leaflet connector 50 in the case of a suture-based leaflet connector.

[0276] In some examples, when the outer member 312 is moved from the outer first state to the outer second state while positioned proximal to the annulus 32 of the mitral valve 30, and the inner member 326 is moved from the inner first state to the inner second state whilepositioned distal to the annulus 32 of the mitral valve 30, the outer member 312 can have sufficient length so as to extend across a leaflet 34 (e.g., across an anterior leaflet 38) or across stitches of a leaflet connector 50), such that when the exposed wire portion 352 is designed to assumed an angled orientation as shown in Fig. 6B, at least part of the exposed wire portion 352 can directly contact and press against the leaflet or stitches of a leaflet connector. When the exposed wire portion 352is tensioned between the outer 312 and inner 326 members in their respective second state, while electric current is provided to its intermediate wire portion 156, the exposed wire portion 352 can cut through the portion of the leaflet 38 and / or stitches 52 of a suture-based leaflet connector 50acontacted thereby and pressed there-against.

[0277] Stated otherwise, upon contact of the exposed wire portion 352 with the tissue of a leaflet 34 and / or a suture 52 of a leaflet connector 50, the exposed wire portion 352 can cut through the tissue and / or suture. This can be achieved by electrically energizing the exposed wire portion 352 so as to heat and cut the tissue and / or suture as it moves across the leaflet or stitches of a leaflet connector to assume a tensioned angled orientation of the type illustrated, for example, in Fig. 6B.

[0278] In some examples, the exposed wire portion 352 is not necessarily configured to assume an angled orientation between the inner member 326 and the outer member 312 in their second states, or it can have an angled orientation that does not necessarily spans the entire width of a leaflet to be cut. In some examples, after tensioning the wire between the inner member 326 and the outer member 312 in their second states, the distal portion of the apparatus 300 is moved sideways from one orifice 54a to the opposite orifice 54b on the other side of the leaflet connector 50, while electric current is provided to exposed wire portion 352, causing it to cut through the leaflet and / or stitches contacted by the exposed wire portion 352 as it travels between both orifices 54.

[0279] Subsequent to completion of the cutting procedure, the apparatus 300 can be retrieved from the patient's body, optionally while maintaining the outer member 312 and the inner member 326 in their outer and inner first states, respectively, concealed inside of the outer catheter 302. After retrieval of the apparatus 200, a prosthetic valve can be optionally implanted in the native mitral valve 30.

[0280] Fig. 7A shows an exemplary cutting apparatus 400. The cutting apparatus 400 comprises a head portion 406 at a distal end of a shaft 404. The head portion 406 can optionally define a concave edge 408 having an innermost portion 410 that can be optionally positioned at the middle of the concave edge 408. In some examples, the cutting apparatus 400 can optionally further include an outer catheter 402. The shaft 404 can optionally extend throughthe outer catheter 402. The outer catheter 402 and the shaft 404 can optionally be configured to be axially movable relative to each other. In some examples, the head portion 406 can be integrally formed with the shaft 404. In some examples, the head portion 406 can be a separate component affixed to the shaft 404.

[0281] The cutting apparatus 400 further includes a wire 450 coupled to the head portion 406, wherein at least part of wire 450 is configured to cut through a leaflet 34 and / or a leaflet connector 50. In some examples, the apparatus 400 can optionally comprise an electric current source (not shown) configured to generate and provide a predetermined electric current to the wire 450. The electric current source is optionally secured within a handle of the apparatus, or it can optionally be external to the handle. The wire 450 of apparatus 400 can optionally extend distally from the handle of apparatus 400, such as through the outer catheter 402 and / or along the shaft 404, and have a distal wire portion 452 attached along an arc length LA to an edge of the head portion 406, such as to the concave edge 408, such that the distal wire portion 452 can also assume a concave shape that defines an innermost portion 454 aligned with the innermost portion 410 of the head portion's concave edge 408.

[0282] An example method for cutting a leaflet 34 of a mitral valve 30 utilizing cutting apparatus 400 can include approximating a distal portion of the apparatus 400 to the mitral valve 30, for example while positioned within the left atrium 26, wherein the head portion 406 and the distal wire portion 452 attached thereto can be maintained inside the outer catheter 402 during delivery. The distal portion of the apparatus 400 can be aligned with an orifice 54a between the leaflet 34 on one side of the leaflet connector 50, after which the head portion can be exposed out of the outer catheter 402, optionally by advancing the primary shaft 304 in the distal direction 80 relative to the outer catheter 302, such that the head portion 406 extends through the orifice 54a, while the distal wire portion 452 is oriented towards the leaflet connector 50 and / or a portion of a leaflet 38 extending from the leaflet connector 50, as illustrated for example in Fig. 7A.

[0283] The wire 450 is electrically conductive, configured to deliver electric current therealong, including to the distal wire portion 452. In some examples, at least part of the distal wire portion 452, such as the innermost portion 454, has an exposed or uninsulated electrically conductive surface. In some examples, an electric current source (not shown) generates an electric current, and outputs the generated electric current to the wire 450. In some examples, the generated electric current is an alternating current. In some examples, the frequency of the alternating current is a radio-frequency (RF), i.e. from about 20 kHz to 300 GHz. In some examples, the wire 450 conducts electricity to the distal wire portion 452. In some examples,an exposed or uninsulated electrically conductive surface of the distal wire portion 452, such as at the innermost portion 454, is configured to output RF energy.

[0284] In some examples, the electric current source is configured, responsive to a user input, to alternately provide the electric current and not provide the electric current. For example, the electric current source can optionally include a user input device, such as a switch that can optionally turn the electric current source on and off. Thus, the electric current can be provided only when the distal wire portion 452 is in contact, or is about to contact, leaflets or stitches of a leaflet connector configured to be cut thereby.

[0285] In some examples, the wire 450 can optionally include an electrically insulating layer (not shown) covering at least a portion of an electrically conductive core of the wire. When electric current is provided to the wire 450 and its distal wire portion 452, the distal wire portion 452 can optionally cut through a target tissue, such as a portion of an anterior leaflet 38, and / or through stitches 52 of a leaflet connector in the case of a suture-based leaflet connector 50a.

[0286] After the head portion 406 is extended through an orifice 54a on one side of the leaflet connector 50, it can be moved sideways towards the opposite orifice 54b on the other side of the leaflet connector 50, while electric current is provided to distal wire portion 452, causing it to cut through the leaflet and / or stitches contacted by the exposed wire portion 52 as it travels between both orifices 54a and 54b. Stated otherwise, upon contact of the distal wire portion 452 with the tissue of a leaflet 34 and / or a suture 52 of a leaflet connector 50a, the distal wire portion 452 can cut through the tissue and / or suture. This can be achieved by electrically energizing the distal wire portion 452 so as to heat and cut the tissue and / or suture as it moves across the leaflet or stitches of a leaflet connector. An exemplary path of movement along a cutting line 70 is shown in Fig. 7 A, indicated along an anterior leaflet 38. However, it is to be understood that the cutting line 70 can similarly pass through stitches 52 of a suture-based leaflet connector 50a.

[0287] The concave configuration of the distal wire portion 452 can advantageously assist in gathering the tissue material of a leaflet meant to be cut thereby, towards the innermost portion 454. Maintaining adequate electric currency sufficient to cut through tissue material, along an elongated portion of a conductive wire, is challenging. Thus, focusing the exposed or uninsulated portion meant to contact and cut through tissue material at a smaller region can be more practical. However, limiting the exposed or uninsulated cutting portion to a short region of the wire may require precise alignment of such a region with the target tissue to be cut. Advantageously, when a distal wire portion 452 having a length that is sufficiently long to contact a target tissue without the need for precise axial alignment, is concavely shaped, it cangather the target tissue contacted thereby, as the distal wire portion 452 is pushed against the tissue, and slidably move the gathered tissue towards its innermost portion 454, such that electric energy can be focused to a short region focused at the innermost portion 454 of the wire 450, thereby allowing it to effectively cut the tissue (or stitches), without the need to spread the current along an elongated region of the wire and without the need to maneuver the apparatus to align the target tissue (or stitches) with a relatively short cutting region.

[0288] In some examples, insulator fluid, such as nonionic 5% dextrose, can optionally be injected towards an uninsulated portion of a wire to facilitate cutting of a tissue thereby. In some examples, the cutting apparatus 400 can optionally include an insulator fluid injection member 490 positioned next to the distal wire portion 452, as shown in Fig. 7B. The insulator fluid injection member 490 can optionally have one or more holes 492 and be fluidly connected to a fluid channel extending through a lumen of the outer catheter 402. The fluid channel can optionally be fluidly coupled to a fluid injection port located on the handle (not shown) of the apparatus 400. The distal portion of injection member 490 can be curved (e.g., pigtail shaped) to orient the plurality of holes 492 towards the innermost portion 454 of the distal wire portion 452. The ejected insulator fluid can optionally displace blood to confine RF current to leaflet 34 being cut by the wire 450. While described and illustrated in Fig. 7B with respect to a cutting apparatus 400, it is to be understood that a similar insulator fluid injection member can be optionally added to any other exemplary cutting apparatus disclosed herein, such as cutting apparatus 100, 200, 300, 500, 600 or 700, so as to direct insulator fluid towards a portion of a wire of the corresponding apparatus configured to cut through tissue of a leaflet 34, mutatis mutandis.

[0289] Figs. 8A-8F show stages of an exemplary method of utilizing an exemplary cutting apparatus 500. The cutting apparatus 500 comprises a pair of arms 506 that can be also referred to as forceps or jaws 506, at a distal end of an elongated shaft 504 that can optionally extend from a handle (not shown) of the apparatus 500. In some examples, the cutting apparatus 500 can optionally further include an outer catheter 502. The shaft 504 can optionally extend through the outer catheter 502. The outer catheter 502 and the shaft 504 can optionally be configured to be axially movable relative to each other.

[0290] The arms 506 can be fully concealed or covered by the outer catheter 502 when navigating the cutting apparatus 500 through the patient’s vasculature. At the target location (for example, when a distal end of the outer catheter 502 is adjacent to the mitral valve 30), the arms 506 can be deployed out of the outer catheter 502. Deployment of the arms 506 can be achieved, for example, by holding the outer catheter 502 steady while pushing the shaft 504 ina distal direction, or holding the shaft 504 steady while moving the outer catheter 502 in a proximal direction, or pushing the shaft 504 in the distal direction while simultaneously pulling the outer catheter 502 in the proximal direction.

[0291] The arms 506 are configured to move between an open state and a closed state. The arms terminated at free ends 508 which are closer to each other, and can be optionally in contact with each other, in the closed state, and are farther spaced from each other in the open state. In some examples, a locking mechanism (not shown) can be optionally included to keep the arms in the closed state and prevent inadvertent opening of the arms 506. Tn some examples, radiopaque markers can be added to the arms 506 so that positions of the arms 506 can be visible under fluoroscopy.

[0292] Various types of actuation mechanisms can be implemented to move the arms 506 between the open and closed states. In the example illustrated in Figs. 8A-8F, an exemplary actuation mechanism of the arms 506 is shown to include a four-bar linkage 520 which has four rigid bars 522 that are interconnected by four pivot joints 524a-d. The arms 506 can include extension portions 510 at proximal end portions thereof, opposite to the free ends 508. Extension portions 510 of the two arms 506 can be respectively connected two middle joints 524b, 524c. The extension portions 510 of both arms 506 are also connected to a distal joint 524d so that the two arms 506 can pivot relative to one another at the distal joint 524d. A proximal joint 524a can be connected to the shaft 504, either directly or via a component affixed to a distal end of the shaft 504. Optionally, a holding shaft (not shown) can be disposed around the shaft 504 and attached to the distal joint 524d. Pushing the shaft 504 in the distal direction (for example, relative to the holding shaft, when the arms 506 are exposed out of the outer catheter 502) can move the proximal joint 524a closer to the distal joint 524d, thereby forcing the arms 506 to move away from one another, that is, moving the arms 506 to the open state. Conversely, pulling the shaft 504 in the proximal direction (for example, relative to a holding shaft) can move the proximal joint 524a farther away from the distal joint 524d, thereby moving the arms 506 toward each other, that is, moving the arms 506 to the closed state.

[0293] While a four-bar linkage 520 is illustrated and described above as part of the actuation mechanism, it is to be understood that other types of actuation mechanism can be similarly implemented to facilitate controllable movement of arms 506 between the open and closed states.

[0294] Fig. 8A' is a cross-sectional view along line 8A'-8A' of Fig. 8A. The arms 506 define inner surfaces 512 facing each other, and outer surfaces 514 facing away from each other. Each of the two arms 506a and 506b further includes a groove 516 exposed by an opening 518 on asurface of the arm 506. In some examples, an opening 518 of the groove 516 can be defined at the inner surface 512 of the corresponding arm 506, as shown for example in Fig. 8A’. The grooves 516 can optionally extend along the length of the corresponding arms 506, and be open ended at the free ends 508 of the arms 506.

[0295] As illustrated in Figs. 8A-8E, the arms 506 are generally curved in shape, such that concave inner surfaces 512 of the arms define an inner gap 540 between the arms 506 or intermediate portions thereof, in the closed state.

[0296] The cutting apparatus 500 further includes a first wire 550 having a retention end 552, and a second wire 556 having a retention feature 558. At least part of the first wire 550 and / or the second wire 556 is configured to cut through a leaflet 34 and / or a leaflet connector 50. In some examples, the apparatus 500 can optionally comprise an electric current source (not shown) configured to generate and provide a predetermined electric current to the first wire 550 and / or the second wire 556. The electric current source is optionally secured within a handle (not shown) of the apparatus, or it can optionally be external to the handle.

[0297] The first and second wires 550, 556 can optionally extend distally from the handle of apparatus 500, such as through the outer catheter 502, towards and through the grooves 516a, 516b of the arms 506a, 506b, terminating at the free ends 508a, 508b of the arms.

[0298] Each of the first and second wires 550, 556 is covered by a sleeve 530, which can comprise and / or be made from an electrically insulating material. As shown in Fig. 8A', each groove 516 is sized to accommodate a sleeve 530 disposed over the corresponding first or second wire 550, 556. Each groove 516 defines a groove diameter DG that is substantially equal to or slightly greater than an outer diameter Ds of the sleeve. The lateral size OG of the groove's opening 518, defined as the distance between opposite edges of the groove 516 formed along the same inner surface 512 of the arm 506, is smaller than the sleeve outer diameter Ds, thereby maintaining the sleeve 530 inside of the groove 516 and preventing it from slipping out through the groove's opening 518.

[0299] Each of the sleeves 530 is configured to slide along the corresponding groove 516. For example, each sleeve 530 can extend from a handle (not shown) of the apparatus 500, wherein the handle can optionally include a mechanism for proximally pulling the sleeve 530. Any of the first wire 550 and / or the second wire 550 can be configured to slide through, and relative to, the corresponding sleeve 530 disposed thereover. For example, any of the first wire 550 and / or the second wire 550 can extend from a handle (not shown) of the apparatus 500, wherein the handle can optionally include a mechanism for axially moving the first wire 550 and / or the second wire 550 through the corresponding sleeve 530.

[0300] The first wire 550 and second wire 556 are released from each other, but configured to be attachable to each other. For example, the retention end 552 of the first wire 550 is configured to connect with the retention feature 558 of the second wire 556.

[0301] An example method for cutting a leaflet 34 of a mitral valve 30 utilizing cutting apparatus 500 is illustrated in Figs. 8A-8F. Fig. 8A shows a distal portion of the cutting apparatus 500 approximated to the mitral valve 30, for example by being positioned within the left atrium 26. Fig. 8A" shows an enlarged view of the portion of apparatus 500 that includes the free ends 508 of the arms 506, with the arms 506 shown with partial transparency to expose the grooves 516 and the wires 550, 556 extending therethrough.

[0302] During delivery and approximation to the target mitral valve 30, the arms 506 are maintained in a closed state inside of the outer catheter 502, while the first wire 550 and the second wire 556 are decoupled from each other. For example, the retention end 552 of the first wire 550 can be optionally positioned in the groove 516a next to free end 508a of a first arm 506a, and the retention feature 558 of the second wire 556 can be optionally positioned in the groove 516b next to free end 508b of a second arm 506b.

[0303] In some examples, the retention end 552 is configured to engage with the retention feature 558 by a snap-fit mechanism. For example, the retention end 552 of the first wire 550 can optionally comprise a tapered tip 554, and the retention feature 558 of the second wire 556 can optionally include an orifice 560 configured to accommodate the tapered tip 554, the orifice 560 defining a lip 562 that prevents the tapered tip 554 from accidentally slipping out of the orifice 560.

[0304] Fig. 8B shows a subsequent step of moving the arms 506 to the open state, optionally after exposing them out of the outer catheter 502. Opening of the arms 506 can be optionally performed while the arms 506 and / or free ends 508 thereof, are proximal to the mitral valve 30. The arms 506 can be generally aligned with the orifices 54 formed between the leaflets 34 on both sides of the leaflet connector 50, such that the apparatus 500 and / or arms 506 thereof can be distally pushed, passing the arms 506 through the orifices 54 such that the free ends 508 of arms 506 and / or the corresponding retention end 552 and retention feature 558 disposed therein, are positioned distal to the leaflets 34 and / or leaflet connector 50. In this position, the arms 506 can be moved to the closed position, as shown in Fig. 8C, bringing the free ends 508 and the corresponding retention end 552 and retention feature 558 disposed therein closer to each other below (or distal to) the leaflets 34 and / or leaflet connector 50.

[0305] In the closed state of the arms 506, one of the wires can optionally be pushed towards the other wire to connect their retention ends. In the example illustrated in Fig. 8C, the firstwire 550 is pushed while the second wire 556 can be optionally kept in position, so as to push the retention end 552 into the retention feature, as shown in the enlarged view of Fig .80. A step formed at a transition between a narrow neck portion and a wider base of the tapered tip 554 abuts the lip 562 to maintain engagement. While a snap-fit mechanism of engagement between a retention end 552 and a retention feature 558 is illustrated, it is to be understood that any other suitable type of controllable coupling therebetween is contemplated.

[0306] When the retention end 552 of the first wire 550 and the retention feature 558 of the second wire 556 are engaged with each other, they collectively define a wire coupling portion 580, causing both the first wire 550 and the second wire 556 to move in unison. For example, if a proximal portion of the first wire 550 is proximally pulled, it will drag the second wire 556 therewith. Similarly, if a proximal portion of the second wire 556 is proximally pulled, it will drag the first wire 550 therewith.

[0307] The wires 550, 556 are axially movable through, and relative to, the sleeves 530. Optionally, one of the wires 550, 556 can be proximally pulled while the other wire is released to move therewith, so as to move the wire coupling portion 580 away from the free ends 508, while the sleeves 530 can be optionally maintained in position. In some examples, this can be performed to move the wire coupling portion 580 to close proximity with the distal joint 524d of the four-bar linkage 520, or proximal to the distal joint 524d, such that only one of the wires 550, 556 extends along most or all of the length of both arms 506.

[0308] In the example illustrated in Fig. 8D, the second wire 556 is pulled in the proximal direction 82, dragging the wire coupling portion 580 and the first wire 550 therewith. Pulling of the second wire 556 can be optionally continued until the wire coupling portion 580 is positioned proximal to the distal joint 524d, and in the example illustrated in Fig. 8D, the wire coupling portion 580 is shown to be pulled to a position proximal to the arms 506, such as proximal to their extension portion 510 and / or proximal to the middle joints 524b, 524c of the four-bar linkage 520, such that the first wire 550 is the only wire that extend along the entire lengths of both arms 506a, 506b.

[0309] As further shown in Fig. 8D, both sleeves 530a and 530b are pulled in the proximal direction 82, while the wires 550, 556 are maintained in position, thereby unsheathing at least pat of the first wire 550 and the second wire 556. Pulling of the sleeves 530 can be optionally performed subsequent to the repositioning of the wire coupling portion 580. The sleeves 530 can be proximally pulled to expose a portion of the wire, such as the first wire 556 in the example illustrated in Fig. 8D, extending along at least part of the length of the arms 506. Insome examples, the sleeves 530 can optionally be sufficiently pulled the exposed a portion of the wire (e.g., first wire 550) extending between the free ends 508 and the distal joint 524d.

[0310] The diameter Dw of any of the first wire 550 and second wire 556 is smaller than the size OG of the groove's opening 518. Thus, when any of the wires 550, 556 is unsheathed from the sleeves 530, the exposed portion(s) of the wire(s) can extend through the openings 518 out of the respective grooves 516a, 516b.

[0311] At least one of the wires 550, 556 is electrically conductive, configured to deliver electric current therealong. In the illustrated example, at least the first wire 550, which is the wire having the unsheathed portion extending along the arms 506 in the example illustrated in Fig. 8D, is electrically conductive. In some examples, both the first wire 550 and the second wire 556 are electrically conductive. In some examples, at least part of the unsheathed portion of the wire(s), such as the unsheathed portion of the first wire 550, has an exposed electrically conductive surface. In some examples, an electric current source (not shown) generates an electric current, and outputs the generated electric current to the first wire 550 and / or the second wire 556. In some examples, the generated electric current is an alternating current. In some examples, the frequency of the alternating current is a radio-frequency (RF), i.e. from about 20 kHz to 300 GHz. In some examples, an exposed electrically conductive surface of the unsheathed portion of a wire, such as the first wire 550, is configured to output RF energy.

[0312] In some examples, the electric current source is configured, responsive to a user input, to alternately provide the electric current and not provide the electric current. For example, the electric current source can optionally include a user input device, such as a switch that can optionally turn the electric current source on and off. Thus, the electric current can be provided only when the unsheathe portion of the wire(s), such as the unsheathed portion of the first wire 550, is moved towards leaflets or stitches of a leaflet connector configured to be cut thereby.

[0313] In some examples, any of the first wire 550 and / or second wire 556 can optionally include an electrically insulating layer (not shown) covering at least a portion of an electrically conductive core of the wire. In some examples, any of the first wire 550 and / or second wire 556 can optionally include insulating layers that completely encompass a circumference of the first wire 550 and / or second wire 556. In some examples, the second wire 556 and a portion of the first wire 550 that extends proximal to the arms 506 can optionally be completely covered by insulating layers, while the unsheathed portion of the first wire 550 can optionally be completely or partially exposed.

[0314] When electric current is provided to the first wire 550 and its unsheathed portion, the unsheathed portion of the first wire 550 can optionally cut through a target tissue, such as aportion of an anterior leaflet 38, and / or through stitches 52 of a leaflet connector 50 in the case of a suture-based leaflet connector.

[0315] As shown in Fig. 8E, a pull force applied on proximal ends of the first and second wires 550, 556, such as by simultaneously pulling, in direction 82, the first wire 550 and the second wire 556. while maintaining the arms 506 in position around the leaflet connector 50, will pull the unsheathed portion of the first wire 550 out of the grooves 516 of the arms 506 and towards the portion of the leaflet 38 (or stitches 52) disposed between the closed arms 506, up to contact with at least one of the leaflets 34 and / or the leaflet connector 50.

[0316] Continued retraction of the wires 550, 556 while electric current is provided to the first wire 550, causes the unsheathed portion of the first wire 550 extending between the arms 506 to cut through the portion of the leaflet 38 and / or stitches 52 of a suture-based leaflet connector 50acontacted by the unsheathed portion of the first wire 550 as it travels proximally and shortens in length between the corresponding arms 506, as shown in Fig. 8F.

[0317] Stated otherwise, upon contact of the unsheathed portion of the first wire 550 with the tissue of a leaflet 34 and / or a suture 52 of a leaflet connector 50, the unsheathed portion of the first wire 550 can cut through the tissue and / or suture. This can be achieved by electrically energizing the unsheathed portion of the first wire 550 so as to heat and cut the tissue and / or suture as it travels in a proximal direction 82 during continued pulling of the first wire 550 and optionally the second wire 556.

[0318] Subsequent to completion of the cutting procedure, leaving a cut portion 38' of the leaflet next to the arms 506, as indicated in Fig. 8F, the apparatus 500 can be retrieved from the patient's body, optionally maintaining the arms 506 in the closed state, retracted into the outer catheter 502. After retrieval of the apparatus 500, a prosthetic valve can be optionally implanted in the native mitral valve 30.

[0319] While simultaneous pulling of both the first wire 550 and second wire 556 in direction 82 is described and illustrated with respect to Fig. 8E, it is to be understood that one of the wires 550, 556 can be held steady while the other is proximally pulled. For example, the first wire 550 can be proximally pulled while the second wire 556 is held in place, or the second wire 556 can be proximally pulled while the first wire 550 is held in place.

[0320] While the second wire 556 is described and illustrated with respect to Fig. 8D to be proximally pulled to reposition the wire coupling portion 580 such that the first wire 550 extends along most or all of the length of the arms 506, it is to be understood that in some examples, the first wire 550 can be proximally pulled to reposition the wire coupling portion 580 such that the second wire 556 extends along most or all of the length of the arms 506, inwhich case a portion of the second wire 556 can be unsheathed and electrified to cut through the tissue and / or stitches in a similar manner to that described above with respect to an unsheathed portion of the first wire, mutatis mutandis. In some examples, no repositioning of the wire coupling portion 580 is performed, such that when the sleeves 530 are proximally pulled, the portions of both the first wire 550 and the second wire 556 extending along the arms 506 are optionally unsheathed, and both can be similarly electrified and used for cutting through the tissue and / or stitches.

[0321] Figs. 9A-9C show stages of an exemplary method of utilizing an exemplary cutting apparatus 600. The cutting apparatus 600 comprises a pair of wire arms 650a, 650b defining a bent, curved, hooked, or generally “L” shaped configuration at a distal portion thereof, the wire arms 650 can be optionally continuous with each other and connected to each other at an end portion 658. Each wire arm 650 can include an axial portion 652 that can extend substantially vertically (or axially) through an outer catheter 602, a knee portion 654 and a side portion 656 configured to extend horizontally (e.g., substantially perpendicularly to the axial portion 652) from the knee portion 654 and terminating at the end portion 658. As shown in Fig. 9A, parts of the wire arms 650, such as the side portions 656, can be arc-shaped. For example, the side portions 656 can have a "saddle" or wave shape in which each side portion 656 dips downward (e.g., in a distal direction, away from the axial portions) and the end portion 658 bends upwards (e.g., in a proximal direction).

[0322] In some examples, the wire arms 650 can comprise, or be coupled to, a shape memory material which is shape set to assume an angled orientation of the side portions 656, relative to the axial portion 652, in a free state thereof. During delivery, the wire arms 650 can be maintained in a compacted state inside an outer catheter 602 of the apparatus 600, with the side portions 656 optionally retained in a linear or almost linear configuration inside of the outer catheter 602, and can be free to assume their free pre-shaped or bent configuration, as shown in Fig. 9A, when exposed out of the outer catheter 602.

[0323] While two separate wire arms 650 having separate axial portions 652 are described herein and illustrated in Fig. 9A-9C, it is to be understood that in some examples, a single axial portion 652 of a wire arm 650 can be attached, at a distal end thereof, to a wire loop extending at an angle relative to the axial portion, the loop defining the pair of side portions 656 and the end portion 658.

[0324] The cutting apparatus 600 further comprises a capture basket 610 coupled to the side portions 656 and extending distally therefrom as shown in Fig. 9A. In some examples, the basket 610 can be composed of plurality of interconnected, braided and / or woven wires thatdefine pores therebetween, having a pore size designed to maintain capture portions of tissues cut from target mitral leaflets 34, and / or a cut-away leaflet connector 50, therein.

[0325] In use, the outer catheter 602 can be advanced through an orifice 54a on one side of the clip 54, terminating distal to the leaflet connector 50. The distal portion of the wire arms 650, including side portions 656, are then exposed out of the outer catheter 602, optionally by proximally pulling the outer catheter 602, such that the side portions 656 are free to bend sideways below and across the leaflet connector 50, positioning the end portion 658 generally below (e.g., distal to) the opposite orifice 54b, as shown in Fig. 9A.

[0326] The wire arms 650a, 650b are further pre- shaped to distance the side portions 656 away from each other, in their free state, so as to form a gap G between side portions 656a and 656b. The capture basket 610 is open ended between the side portions 656 of the wire arms 650. When the apparatus 600 is designed to cut through mitral leaflets 34 connected by a leaflet connector 50bequipped with a clip 56, the gap G can be optionally sized to allow insertion of the clip 56 into the basket 610 through the gap G.

[0327] In some examples, the cutting apparatus 600 can further optionally comprise a pull member 620 axially relative to the wire arms 650, such as by being axially movable through outer catheter 602. As shown in Fig. 9B, the pull member 620 can include a pull shaft 622 that can extend axially through the outer catheter 602, and a hook 624 at a distal end of the pull shaft 622, configured to engage with (e.g., capture on) the end portion 658 of wire arms 650.

[0328] After deployment of the side portions 656 distal to the mitral valve 30, the pull member 620 can be distally advanced towards the end portion 658, directed towards and optionally through the opposite orifice 54b, and manipulated to capture the end portion 658 with hook 624, as illustrated in Fig. 9B. In some examples, the pull member 620 can be rotationally maneuvered so as to orient the hook radially inwards, to facilitate catching of the end portion 658. Thereafter, the wire arms 650 and the optional pull member 620 can be proximally pulled towards the leaflets 34, such as by proximally pulling the axial portions 652 of the wire arms 650, and the pull shaft 622 of the pull member 620.

[0329] In some examples, the apparatus 600 can optionally comprise an electric current source (not shown) configured to generate and provide a predetermined electric current to the wire arms 650. The electric current source is optionally secured within a handle of the apparatus, or it can optionally be external to the handle.

[0330] The wire arms 650 are electrically conductive, configured to deliver electric current therealong, including to the side portions 656. In some examples, at least part of each side portion 656 has an exposed or uninsulated electrically conductive surface. In some examples,an electric current source (not shown) generates an electric current, and outputs the generated electric current to the wire arms 650. In some examples, the generated electric current is an alternating current. In some examples, the frequency of the alternating current is a radiofrequency (RF), i.e. from about 20 kHz to 300 GHz. In some examples, the wire arms 650 conduct electricity from the axial portions 652 to the side portions 656. In some examples, an uninsulated electrically conductive surface of each side portion 656 is configured to output RF energy.

[0331] In some examples, the electric current source is configured, responsive to a user input, to alternately provide the electric current and not provide the electric current. For example, the electric current source can optionally include a user input device, such as a switch that can optionally turn the electric current source on and off. Thus, the electric current can be provided only when the side portions 156 are pulled towards leaflets 34.

[0332] In some examples, the wire arms 650 can optionally include an electrically insulating layer (not shown) covering at least a portion of an electrically conductive core of the wire arms. In some examples, the wire arms 650 can optionally include insulating layers that completely encompass a circumference of the axial portions 652a, 652b. In some examples, the axial portions 652a, 652b can optionally be completely covered by insulating layers, while the side portions 156 can optionally be at least partially uninsulated. In some examples, the knee portions 654a, 654b can be completely covered by insulating layers. In some examples, the end portion 658 can be completely covered by insulating layers. In some examples, the side portions 656a, 656b can optionally be insulated along distal sides thereof (e.g., along a side to which the capture basket 610 is connected) and uninsulated along proximal side thereof (e.g., along sides facing the leaflets 34 in the state shown in Fig. 9A, for example).

[0333] When the wire arms 650 and pull member 620 are proximally pulled, as shown in Fig. 9B, the side portions 656a and 656b are approximated to the distal surfaces of the mitral leaflets 34, optionally on both sides of the clip 56 in the case of an exemplary clip-type leaflet connector 50b, such that at least part of the clip 56 is inserted into the capture basket 610.

[0334] When electric current is provided to the wire arms 650 and their side portions 156, the side portions 156 (or uninsulated parts thereof) can optionally cut through a target tissue, such as mitral leaflets 34, as shown in Fig. 9C. Continued proximal movement of the wire arms 650 while being electrified will eventually cut through portions of the leaflets 34 on both sides of the leaflet connector 50, such that the cut tissue portions and the leaflet connector 50 can fall into the capture basket 610, after which the wire arms 650, along with the basket 610, can be reinserted into the outer catheter 602, optionally closing the side portions 656 around the basket610 to retain the cut tissue portions and leaflet connector 50 therein, and the apparatus 600 can be fully retrieved from the patient’s body.

[0335] Figs. 10A-10D show stages of an exemplary method of utilizing an exemplary cutting apparatus 700. The cutting apparatus 700 comprises a basket shaft 704 and an expandable capture basket 706 at a distal end thereof, the expandable capture basket 706 configured to transition between an expanded configuration and a compacted configuration. The apparatus 700 further comprises an outer catheter 702 through which the basket shaft 704 can axially extend. The capture basket 706 extends from a basket first end 708, at which it is attached to the basket shaft 704, to an opposite basket second end portion 710, which can be open ended in the expanded configuration of the capture basket 706. In some examples, when the capture basket 706 is in the expanded configuration, the capture basket 706 can taper from a greater diameter defined by the basket second end portion 710 to a narrower tip formed by the basket first end 708.

[0336] In some examples, the capture basket 706 can be composed of plurality of interconnected, braided and / or woven wires that define pores therebetween, having a pore size designed to maintain capture portions of tissues cut from target mitral leaflets 34, and / or a cutaway leaflet connector 50, therein. In some examples, capture basket 706 and / or the wires from which it is formed can comprise a shape memory material (e.g., Nitinol). The wires can be braided on a mandrel of a desired basket size, then heat set so that the braided shape returns to the expanded basket configuration after being compressed. In some examples, the basket 706 can be laser cut from a shape-memory material (e.g., Nitinol) which is then shape-set to assume an expanded state in a free state thereof.

[0337] An exemplary procedure by which a cutting apparatus 700 can be advanced toward the mitral valve 34 can optionally utilize a transapical access route. While the cutting apparatus 700 is currently disclosed and illustrated in Figs. 10A-10D for a transapical access route, those of skill in art will understand that certain modifications will enable procedures utilizing alternative access routes.

[0338] As shown in Fig. 10A, an exemplary transapical delivery procedure commences by introduction of the outer catheter 702 into the left ventricle 28 through an apical puncture 18. Although not shown, introduction of the outer catheter 702 to the apical puncture 18 typically occurs via an intercostal incision, often termed a "mini-thoracotomy". Local exposure of the exterior of the heart is then attained using subcutaneous incisions along with tissue spreaders and the like. The apical puncture 18 itself is initially formed using a small needle, and the puncture thereby formed is enlarged using a dilator. Purse string sutures or an access valve canbe installed at the left ventricular apex so that the outer catheter 702 may be advanced into the left ventricle without significant loss of blood.

[0339] During delivery and insertion of the apparatus 700 into the left ventricle 28, the capture basket 706 can be maintained in a compacted configuration inside of the outer catheter 702, such as by having the basket second end portion 710 at or proximal to the distal end of the outer catheter 702, as shown in Fig. 10A.

[0340] The capture basket 706 can be then extended out of the outer catheter 702, thereby allowed to assume its expanded configuration, as shown in Fig. 10B. This can be accomplished by pushing the basket shaft 704 relative to the outer catheter 702, and / or pulling the outer catheter 702 relative to the basket shaft 704.

[0341] The basket second end portion 710 defines a basket opening 740 configured to face the mitral leaflet 30 and leaflet connector 50. When the apparatus 700 is designed to cut through mitral leaflets 34 connected by a leaflet connector 50bequipped with a clip 56, the basket opening 740 can be optionally sized to allow insertion of the clip 56 into the basket 706 through the basket opening 740, in the expanded configuration of the basket 706.

[0342] The cutting apparatus 700 further includes a wire 750 having wire loop 752 coupled to the basket second end portion 710, wherein at least part of the wire loop 752 is configured to cut through tissue of mitral leaflets 34. In some examples, the apparatus 700 can optionally comprise an electric current source (not shown) configured to generate and provide a predetermined electric current to the wire 750. The electric current source is optionally secured within a handle of the apparatus, or it can optionally be external to the handle.

[0343] The wire 750 of apparatus 700 can optionally define wire portions 754a, 754b that can optionally extend axially from the handle of apparatus 700, such as through the outer catheter 702, and along the capture basket 706, to define the wire loop 752 which is looped around the perimeter of the basket second end portion 710. In some examples, the capture basket 706 can include a plurality of eyelets 712 (indicated, for example, in Fig. 10B) at its second end portion 710, through which the wire loop 752 can optionally extend.

[0344] The wire 750 is electrically conductive, configured to deliver electric current therealong, including to the wire loop 752. In some examples, at least part of the wire loop 752 has an exposed or uninsulated electrically conductive surface. In some examples, an electric current source (not shown) generates an electric current, and outputs the generated electric current to the wire 750. In some examples, the generated electric current is an alternating current. In some examples, the frequency of the alternating current is a radio-frequency (RF), i.e. from about 20 kHz to 300 GHz. In some examples, the wire 750 conducts electricity fromat least one portion 754 to the wire loop 752. In some examples, an exposed or uninsulated electrically conductive surface of the wire loop 752 is configured to output RF energy.

[0345] In some examples, the electric current source is configured, responsive to a user input, to alternately provide the electric current and not provide the electric current. For example, the electric current source can optionally include a user input device, such as a switch that can optionally turn the electric current source on and off. Thus, the electric current can be provided only when the wire loop 752 is moved towards mitral leaflet 34 so as to contact the leaflet 34.

[0346] In some examples, the wire 750 can optionally include an electrically insulating layer (not shown) covering at least a portion of an electrically conductive core of the wire. In some examples, the wire 750 can optionally include insulating layers that completely encompass a circumference of the wire portions 754. In some examples, the wire portions 754 can optionally be completely covered by insulating layers, while the wire loop 752 can optionally be completely or partially uninsulated.

[0347] In some examples, the capture basket 706 can be initially exposed out of the outer catheter 702 can allowed to self-expand inside the left ventricle 28 at a position distal to the mitral valve 30 and the leaflet connector 50, after which the basket shaft 704 can be further pushed towards the mitral valve 30 and the leaflet connector 50, optionally so as to position a clip 56 of a leaflet connector 50binside the basket 706, while the basket second end portion 710 and / or wire loop 752 is positioned around portions of the leaflets 34 clipped by the leaflet connector 50b, optionally above the level of the leaflet connector 50b, as shown in Fig. 10B.

[0348] As shown in Fig. 10C, the wire loop 752 can be then cinched around the portions of the mitral leaflets 34 extending from the leaflet connector 50b, compressing the basket opening 740 to a diameter that is less than its diameter in the fully expanded configuration. This can be achieved by pulling on one or both of the wire portions754, such as relative to the basket 706 and / or basket shaft 704. Thus, cinching of the wire loop 752 requires one or both wire portions 754 to be pulled while the basket second end portion 710 is kept in position and is not axially pulled therewith.

[0349] When electric current is provided to the wire 750 and its wire loop 752, the wire loop 752 (or an uninsulated part thereof) can cut through the tissue portions of the leaflets 34 contacted thereby during cinching of the wire loop 752. Stated otherwise, upon contact of the wire loop 752 with the tissue of the leaflets 34, the wire loop 752can cut through the tissue. This can be achieved by electrically energizing the wire loop 752 so as to heat and cut the tissue as it contracts in diameter during continued pulling of the one or both wire portions 754.

[0350] In some examples, the capture basket 706 can optionally further comprise a plurality of engagement features 714 extending from an inner surface thereof, configured to engage with tissue portions of leaflets 34 and / or portions of a leaflet connector 50 contacted thereby. The engagement features 714 can comprise, in some examples, tines, barbs, spikes, or other structures that can penetrate into, or otherwise engage with, tissue or other materials contacted thereby. In some examples, the engagement features 714 can be optionally angularly oriented towards the basket first end 708. When the inner surface of the capture basket 706 comes into contact with leaflet tissue and / or surfaces of a leaflet connector 50, optionally during contraction of the basket 706 therearound, the engagement features 714 can stabilize and improve retainment of the tissue and / or leaflet connector 50 inside of the basket 706 and prevent slippage during cinching of the wire loop 752 and cutting of the tissue thereby.

[0351] As shown in Fig. 10D, continued cinching of the wire loop 752 while being electrified will eventually cut through portions of the leaflets 34 on both sides of the leaflet connector 50, such that the cut tissue portions and the leaflet connector 50 can fall into the capture basket 706, after which the basket 706 can be reinserted into the outer catheter 702, such as by retraction of the basket shaft 704 relative to the outer catheter 702, and / or advancement of the outer catheter 702 relative to the basket shaft 704 and over the basket 706, and the apparatus 700 can be fully retrieved from the patient's body.

[0352] While methods of utilizing a cutting apparatus 100 are described and illustrated herein with respect to cutting an anterior leaflet 38 of the native mitral valve 30, it is to be understood that any method for using apparatus 100, 200, 300, 400. 500, 600 or 700 can be similarly used for cutting any other tissue or leaflet, such as the posterior leaflet 36 of a native mitral valve 30, a leaflet of a native tricuspid valve, a leaflet of a native aortic valve, or a leaflet of a previously implanted prosthetic valve.

[0353] Any of the tools, devices, apparatuses, etc. herein can optionally be sterilized (for example, with heat, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can optionally include sterilization of the associated assembly, device, apparatus, etc. as one of the steps of the method. Examples of radiation for use in sterilization include, without limitation, gamma radiation and ultra-violet radiation. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide and hydrogen peroxide.Some Examples of the Disclosed Implementations

[0354] Some examples of above-described implementations are enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the exampletaken in combination and, optionally, in combination with one or more features of one or more examples below are examples also falling within the disclosure of this application.

[0355] Example 1. A cutting apparatus comprising: a pair of arms configured to move between a closed state and an open state; a pair of channels extending through the pair of arms, each channel terminating at a distal opening proximate a free end of the corresponding arm through which the channel extends; and a wire comprising: a first wire portion extending through one of the pair of channels and out of the corresponding distal opening of the channel, a second wire portion extending through the other one of the pair of channels and extending through the distal opening of the corresponding other one of the channels, and an intermediate wire portion continuously extending between the first wire portion and the second wire portion; wherein, when the pair of arms are in the closed state, proximally pulling at least one of the first wire portion and / or the second wire portion causes the intermediate wire portion to shorten and move in a distal direction towards the distal openings.

[0356] Example 2. The apparatus of any example herein, particularly of example 1, wherein the wire is electrically conductive.

[0357] Example 3. The apparatus of any example herein, particularly of any one of examples of 1-2, wherein the wire intermediate portion comprises a distally oriented electrically conductive uninsulated surface.

[0358] Example 4. The apparatus of any example herein, particularly of any one of examples 1-3, wherein the wire intermediate portion is configured to cut through a target tissue when electric current is supplied thereto.

[0359] Example 5. The apparatus of any example herein, particularly of any one of examples 1-4, further comprising a shaft, wherein the pair of arms is coupled to a distal portion of the shaft.

[0360] Example 6. The apparatus of any example herein, particularly of example 5, further comprising an outer catheter disposed around the shaft, wherein the shaft is axially movable relative to the outer catheter.

[0361] Example 7. The apparatus of any example herein, particularly of any one of examples 1-6, further comprising a four-bar linkage configured to move the pair of arms between the closed and open states.

[0362] Example 8. The apparatus of any example herein, particularly of any one of examples 1-7, wherein the arms comprise concave inner surfaces defining a gap formed therebetween in the closed state.

[0363] Example 9. The apparatus of any example herein, particularly of example 8, wherein the intermediate wire portion is disposed in the gap between the arms.

[0364] Example 10. The apparatus of any example herein, particularly of any one of examplesI-9, wherein, when the arms are extended through orifices formed between two mitral leaflets connected by a leaflet connector such that the distal openings of the channels are distal to the orifices, the intermediate wire portion is sufficiently long such that at least part thereof is proximal to the orifices.

[0365] Example 1 1. A method for cutting a leaflet comprising: extending a pair of arms of a cutting apparatus, in an open state of the arms, through orifices formed between two leaflets connected by a leaflet connector; moving the arms to a closed state; and cutting a portion of one of the leaflets by pulling a wire extending through channels formed in the arms, such that an intermediate portion of the wire, extending between distal openings of the channels, is shortened and distally moved to contact the leaflet and cut therethrough.

[0366] Example 12. The method of any example herein, particularly of example 11, wherein the wire comprises a first wire portion extending through one of the arms and a second wire portion extending through the other arm, wherein the intermediate portion of the wire continuously extends between the first wire portion and the second wire portion.

[0367] Example 13. The method of any example herein, particularly of example 12, wherein the pulling the wire comprises simultaneously pulling the first wire portion and the second wire portion.

[0368] Example 14. The method of any example herein, particularly of any one of examplesI I-13, wherein the cutting comprises providing an electric current to the intermediate portion of the wire such that the electric current creates a cut through the leaflet when the intermediate portion of the wire is contacting the leaflet.

[0369] Example 15. The method of any example herein, particularly of example 14, wherein the cutting is created by radio-frequency energy generated by the provided electric current.

[0370] Example 16. The method of any example herein, particularly of any one of examples 14-15, wherein the provided electric current is an alternating current.

[0371] Example 17. The method of any example herein, particularly of example 16, wherein the frequency of the alternating current is a radio-frequency.

[0372] Example 18. The method of any example herein, particularly of any one of examples 11-17, wherein the extending the pair of arms through the orifices comprises positioning the distal openings distal to the orifices.

[0373] Example 19. The method of any example herein, particularly of any one of examples 11-18, wherein the moving the arms to the closed state comprises maintaining at least part of the intermediate portion of the wire proximal to the orifices.

[0374] Example 20. The method of any example herein, particularly of any one of examples 11-19, wherein the moving the arms to the closed state comprises actuating a four-bar linkage of the cutting apparatus.

[0375] Example 21. A cutting apparatus comprising: a first arm comprising a distally opened slot at a distal portion of the first arm; a second arm comprising a proximally opened slot at a distal portion of the second arm; a shuttle comprising: a first retention member residing in, and movable out of and into, the distally opened slot; and a second retention member residing in, and movable out of and into, the proximally opened slot; and a wire coupled to the shuttle; wherein the shuttle is pivotable about the first retention member when the first retention member resides in the distally opened slot; wherein the shuttle is pivotable about the second retention member when the second retention member resides in the proximally opened slot; and wherein the wire is configured to cut through a target tissue disposed between the first arm and the second arm and contacted by the wire, when electric current is supplied to the wire.

[0376] Example 22. The apparatus of any example herein, particularly of example 21, wherein the wire is electrically conductive.

[0377] Example 23. The apparatus of any example herein, particularly of any one of examples 21-22, wherein the wire comprises a proximally oriented electrically conductive surface.

[0378] Example 24. The apparatus of any example herein, particularly of any one of examples 21-23, further comprising a shaft, wherein the first arm and the second arm coupled to a distal portion of the shaft.

[0379] Example 25. The apparatus of any example herein, particularly of example 24, further comprising an outer catheter disposed around the shaft, wherein the shaft is axially movable relative to the outer catheter.

[0380] Example 26. The apparatus of any example herein, particularly of any one of examples 21-25, further comprising a link pivotably coupled at a pivotable joint to the shuttle, wherein the wire is coupled to the link.

[0381] Example 27. The apparatus of any example herein, particularly of any one of examples 21-26, wherein the first arm and the second arm are spaced from each other so as to define a gap configured to accommodate the target tissue therein.

[0382] Example 28. The apparatus of any example herein, particularly of any one of examples 21-27, wherein the first retention member comprises a pin.

[0383] Example 29. The apparatus of any example herein, particularly of any one of examples 21-28, wherein the second retention member comprises a pin.

[0384] Example 30. A method for cutting a leaflet comprising: approximating a cutting apparatus to a valve comprising two leaflets connected by a leaflet connector that defines two orifices between the connected leaflets, wherein the cutting apparatus comprises a shuttle which comprises a first retention member residing in a distally opened slot of a distal portion of a first arm of the cutting apparatus, and a second retention member residing in a proximally opened slot of a distal portion of a second arm of the cutting apparatus; distally advancing the first arm and the second arm through the orifices such that the leaflet contacted by the shuttle causes the shuttle to pivot about the first retention member; proximally pulling the apparatus, thereby causing an electrically conductive wire coupled to the shuttle to contact the leaflet; and cutting the leaflet by providing an electric current to the wire such that the electric current creates a cut through the leaflet when the wire is contacting the leaflet.

[0385] Example 31. The method of any example herein, particularly of example 30, wherein the cutting is created by radio-frequency energy generated by the provided electric current.

[0386] Example 32. The method of any example herein, particularly of any one of examples 30-31, wherein the provided electric current is an alternating current.

[0387] Example 33. The method of any example herein, particularly of example 32, wherein the frequency of the alternating current is a radio-frequency.

[0388] Example 34. The method of any example herein, particularly of any one of examples 30-33, wherein the cutting apparatus further comprises a link pivotably coupled at a pivotable joint to the shuttle, and wherein the wire is coupled to the link.

[0389] Example 35. The method of any example herein, particularly of any one of examples 30-34, wherein the causing the shuttle to pivot about the first retention member comprises moving the second retention member out of the proximally opened slot.

[0390] Example 36. The method of any example herein, particularly of any one of examples 30-35, wherein the distally advancing comprises moving the leaflet into a gap defined between the first arm and the second arm.

[0391] Example 37. The method of any example herein, particularly of example 36, wherein the moving the leaflet into the gap comprises positioning the leaflet proximal to the shuttle.

[0392] Example 38. The method of any example herein, particularly of example 37, further comprising, after the positioning the leaflet proximal to the shuttle, allowing the shuttle to pivot about the first retention member until the second retention member enters into the proximally opened slot.

[0393] Example 39. The method of any example herein, particularly of any one of examples 30-38, wherein the proximally pulling the apparatus comprises pushing the leaflet against the shuttle so as to cause the shuttle to pivot about the second retention member.

[0394] Example 40. The method of any example herein, particularly of example 39, wherein the causing the shuttle to pivot about the second retention member comprises moving the first retention member out of the distally opened slot.

[0395] Example 41. The method of any example herein, particularly of any one of examples 30-40, wherein the proximally pulling the apparatus comprises wrapping the wire around at least a portion of the leaflet.

[0396] Example 42. The method of any example herein, particularly of any one of examples 30-41, wherein the cutting comprises further pulling of the cutting apparatus.

[0397] Example 43. The method of any example herein, particularly of any one of examples 30-42, wherein the cutting comprises applying tension to the wire.

[0398] Example 44. A cutting apparatus comprising: an outer member pivotably coupled to a distal end portion of a primary shaft; an inner shaft extending through, and axially movable relative to, the primary shaft; an inner member coupled to a distal end portion of the inner shaft; and an electrically conductive wire extending through a channel collectively defined by the inner shaft and the inner member, and further extending out of the channel through an opening formed at the inner member towards a wire coupling region at which the wire is coupled to the outer member; wherein the outer member is movable between an outer first state and an outer second state, such that the wire coupling region is distanced farther from a central axis of the primary shaft in the outer second state than in the outer first state.

[0399] Example 45. The apparatus of any example herein, particularly of example 44, wherein the wire coupling region is closer to a free end portion of the outer member than to the distal end portion of the primary shaft.

[0400] Example 46. The apparatus of any example herein, particularly of any one of examples 44-45, wherein the outer member comprises a flap.

[0401] Example 47. The apparatus of any example herein, particularly of example 46, wherein an inner surface of the flap and an outer surface of the flap are circumferentially curved.

[0402] Example 48. The apparatus of any example herein, particularly of any one of examples 46-47, wherein a circumferential width of the flap spans less than 180° around the central axis of the primary shaft.

[0403] Example 49. The apparatus of any example herein, particularly of any one of examples 44-48, further comprising an outer catheter disposed around the primary shaft, wherein the primary shaft is axially movable relative to the outer catheter.

[0404] Example 50. The apparatus of any example herein, particularly of example 49, further comprising a biasing member configured to bias the outer member to the outer second state.

[0405] Example 51. The apparatus of any example herein, particularly of example 50, wherein the biasing member comprises a torsion spring.

[0406] Example 52. The apparatus of any example herein, particularly of any one of examples 44-51, wherein the outer member is configured to extend perpendicularly to the central axis in the outer second state.

[0407] Example 53. The apparatus of any example herein, particularly of any one of examples 44-52, wherein the wire is configured to define an exposed wire portion extending between the opening formed at the inner member and the wire coupling portion, when the outer member is in the outer second state and when the inner member is distal to the outer member.

[0408] Example 54. The apparatus of any example herein, particularly of example 53, wherein the exposed wire portion is angled relative to the central axis.

[0409] Example 55. The apparatus of any example herein, particularly of any one of examples 44-54, wherein the inner member comprises a tapering surface that tapers towards a free end portion of the inner member.

[0410] Example 56. The apparatus of any example herein, particularly of example 55, wherein the opening of the channel is formed over the tapering surface, at a position closer to the free end portion of the inner member than to the inner shaft.

[0411] Example 57. The apparatus of any example herein, particularly of any one of examples 44-56, wherein the inner member is pivotably coupled to the inner shaft, and is movable between an inner first state and an inner second state, such that the wire coupling region is distanced farther from a central axis of the primary shaft in the outer second state than in the outer first state.

[0412] Example 58. The apparatus of any example herein, particularly of example 57, wherein the outer member is longer than the inner member.

[0413] Example 59. The apparatus of any example herein, particularly of any one of examples 57-58, further comprising a pull member attached to the inner member and configured to move the inner member from the inner first state to the inner second state when the pull member is proximally pulled.

[0414] Example 60. A method for cutting a leaflet comprising: positioning an outer member of a cutting apparatus proximal to an orifice formed between two leaflets connected by a leaflet connector; moving the outer member from an outer first state to an outer second state, such that a wire coupling region at which an electrically conductive wire is attached to the outer member is distanced farther from a central axis of a primary shaft to which the outer member is pivotably coupled; positioning an inner member of the cutting apparatus distal to the orifice, such that the wire forms an exposed wire portion extending between the inner member and the wire coupling region; and cutting a leaflet of the two leaflets by providing an electric current to the exposed wire portion such that the electric current creates a cut through the leaflet when the exposed wire portion is contacting the leaflet.

[0415] Example 61. The method of any example herein, particularly of example 60, wherein the cutting is created by radio-frequency energy generated by the provided electric current.

[0416] Example 62. The method of any example herein, particularly of any one of examples 60-61, wherein the provided electric current is an alternating current.

[0417] Example 63. The method of any example herein, particularly of example 62, wherein the frequency of the alternating current is a radio-frequency.

[0418] Example 64. The method of any example herein, particularly of any one of examples 60-63, wherein the outer member is perpendicular to the central axis in the outer second state.

[0419] Example 65. The method of any example herein, particularly of any one of examples 60-64, wherein the moving the outer member to the outer second state comprises allowing a biasing member of the cutting apparatus to passively move the outer member to the outer second state.

[0420] Example 66. The method of any example herein, particularly of example 65, wherein the biasing member comprises a spring.

[0421] Example 67. The method of any example herein, particularly of any one of examples 65-66, wherein the cutting apparatus further comprises an outer catheter disposed around the primary shaft, and wherein the moving the outer member to the outer second state comprises exposing the second member out of the outer catheter.

[0422] Example 68. The method of any example herein, particularly of any one of examples 60-67, wherein the inner member is coupled to an inner shaft extending through the primary shaft.

[0423] Example 69. The method of any example herein, particularly of example 68, wherein the wire extends through a channel collectively defined by the inner shaft and the inner member.

[0424] Example 70. The method of any example herein, particularly of example 69, wherein the wire extends out of the channel towards the wire coupling region via an opening formed on the inner member.

[0425] Example 71. The method of any example herein, particularly of any one of examples 68-70, wherein the positioning the inner member distal to the orifice comprises distally moving the inner shaft relative to the primary shaft.

[0426] Example 72. The method of any example herein, particularly of any one of examples 68-71 , wherein the inner member is pivotably coupled to the inner shaft.

[0427] Example 73. The method of any example herein, particularly of example 72, further comprising, after the positioning the inner member distal to the orifice, moving the inner member from an inner first state to an inner second state, such that a free end portion of the inner member is distanced farther from a central axis.

[0428] Example 74. The method of any example herein, particularly of example 73, wherein the moving the inner member to the inner second position comprises proximally pulling a pull member attached to the inner member.

[0429] Example 75. The method of any example herein, particularly of any one of examples 72-74, wherein the outer member is longer than the inner member.

[0430] Example 76. The method of any example herein, particularly of any one of examples 60-75, wherein the cutting comprises moving the exposed wire portion from the orifice across a portion of the leaflet.

[0431] Example 77. A cutting apparatus comprising: a shaft comprising a head portion defining a concave edge; and an electrically conductive wire comprising a distal wire portion attached to the head portion along an arc length of the concave edge of the head portion; wherein the distal wire portion comprises an exposed electrically conductive surface at an innermost portion thereof, defined by an innermost portion of the concave edge of the head portion.

[0432] Example 78. The apparatus of any example herein, particularly of example 77, further comprising an outer catheter disposed around the shaft, wherein the shaft is axially movable relative to the outer catheter.

[0433] Example 79. The apparatus of any example herein, particularly of any one of examples 77-78, wherein the innermost portion of the wire is configured to cut through a target tissue when electric current is supplied thereto.

[0434] Example 80. The apparatus of any example herein, particularly of any one of examples 77-79, further comprising an insulator fluid injection member configured to eject insulator fluid through a plurality of openings thereof.

[0435] Example 81. The apparatus of any example herein, particularly of example 80, wherein the insulator fluid injection member is axially movable relative to the wire.

[0436] Example 82. The apparatus of any example herein, particularly of any one of examples 80-81, wherein the openings extend from a semi-circular portion of the insulator fluid injection member, such that when the openings are positioned next to the distal wire portion, the openings are oriented towards the innermost portion.

[0437] Example 83. A method for cutting a leaflet comprising: extending a head portion of a cutting apparatus through an orifice formed between two leaflets connected by a leaflet connector, such that a concave edge of the head portion is facing a leaflet of the two leaflets; and cutting the leaflet by moving the head portion, along with a distal wire portion of an electrically conductive wire attached to the concave edge, towards and across a portion of the wire.

[0438] Example 84. The method of any example herein, particularly of example 83, wherein the cutting comprises providing an electric current to an innermost portion of the distal wire portion, which is defined by an innermost portion of the concave edge to which the distal wire portion is attached.

[0439] Example 85. The method of any example herein, particularly of example 84, wherein the cutting is created by radio-frequency energy generated by the provided electric current.

[0440] Example 86. The method of any example herein, particularly of any one of examples 84-85, wherein the provided electric current is an alternating current.

[0441] Example 87. The method of any example herein, particularly of example 86, wherein the frequency of the alternating current is a radio-frequency.

[0442] Example 88. The method of any example herein, particularly of any one of examples 84-87, wherein the moving the head portion comprises gathering tissue of the leaflet contacted by the distal wire portion towards the innermost portion of the distal wire portion.

[0443] Example 89. The method of any example herein, particularly of any one of examples 84-88, further comprising axially advancing an insulator fluid injection member so as to position a plurality of openings thereof next to the distal wire portion.

[0444] Example 90. The method of any example herein, particularly of example 89, further comprising ejecting insulator fluid towards the distal wire portion.

[0445] Example 91. A cutting apparatus comprising: a pair of arms configured to move between a closed state and an open state; a pair of grooves formed along the arms, each groove defining an opening at an inner surface of the corresponding arm; a first wire covered by a first sleeve extending through a first one of the grooves, the first wire comprising a retention end;and a second wire covered by a second sleeve extending through a second one of the grooves, the second wire comprising a retention feature; wherein the retention end and the retention feature are disengaged from each other and are configured to connect with each other.

[0446] Example 92. The apparatus of any example herein, particularly of example 91, wherein the first wire is electrically conductive.

[0447] Example 93. The apparatus of any example herein, particularly of any one of examples 91-92, wherein the second wire is electrically conductive.

[0448] Example 94. The apparatus of any example herein, particularly of any one of examples 91-93, further comprising a shaft, wherein the pair of arms is coupled to a distal portion of the shaft.

[0449] Example 95. The apparatus of any example herein, particularly of example 94, further comprising an outer catheter disposed around the shaft, wherein the shaft is axially movable relative to the outer catheter.

[0450] Example 96. The apparatus of any example herein, particularly of any one of examples 91-95, further comprising a four-bar linkage configured to move the pair of arms between the closed and open states.

[0451] Example 97. The apparatus of any example herein, particularly of any one of examples 91-96, wherein the inner surfaces of the arms are concave so as to define a gap formed therebetween in the closed state.

[0452] Example 98. The apparatus of any example herein, particularly of any one of examples 91-97, wherein the first wire and the second wire are axially movable relative to the sleeves disposed thereover.

[0453] Example 99. The apparatus of any example herein, particularly of any one of examples 91-98, wherein the sleeves are axially movable relative to the grooves.

[0454] Example 100. The apparatus of any example herein, particularly of any one of examples 91-99, wherein each sleeve defines an outer diameter that is smaller than a size of the opening of the corresponding groove in which is it disposed.

[0455] Example 101. The apparatus of any example herein, particularly of example 100, wherein each of the first wire and the second wire defines an outer diameter that is smaller than the size of the opening of the corresponding groove.

[0456] Example 102. The apparatus of any example herein, particularly of any one of examples 91-101, wherein the retention end comprises a tapered tip, and wherein the retention feature comprises an orifice configured to accommodate the tapered tip.

[0457] Example 103. A method for cutting a leaflet comprising: extending a pair of arms of a cutting apparatus, in an open state of the arms, through orifices formed between two leaflets connected by a leaflet connector, wherein the cutting apparatus further comprises a first wire covered by a first sleeve extending through a groove formed along a first one of the arms, and a second wire covered by a second sleeve extending through a groove formed along a second one of the arms; moving the arms to a closed state; forming a wire coupling region by connecting a retention end of the first wire to a retention feature of the second wire; proximally pulling the sleeves to expose at least a portion of the first wire and / or the second wire extending along the arms; and cutting a portion of one of the leaflets by proximally pulling at least one of the first wire and / or the second wire, such that the exposed portion of the first wire and / or the second wire is pulled out of the corresponding grooves to contact the leaflet and cut therethrough.

[0458] Example 104. The method of any example herein, particularly of example 103, wherein each sleeve defines an outer diameter that is smaller than a size of an opening of the corresponding groove formed at an inner surface of the corresponding arm, so as to prevent the sleeve from slipping through the opening.

[0459] Example 105. The method of any example herein, particularly of example 104, wherein each of first wire and the second wire defines an outer diameter that is smaller than the size of the opening of the corresponding groove, so as to allow the corresponding wire to be pulled out of the corresponding groove after the proximally pulling the sleeves.

[0460] Example 106. The method of any example herein, particularly of any one of examples 103-105, wherein the cutting comprises providing an electric current to the exposed portion of the first wire and / or the second wire such that the electric current creates a cut through the leaflet when the exposed portion of the first wire and / or the second wire is contacting the leaflet.

[0461] Example 107. The method of any example herein, particularly of example 106, wherein the cutting is created by radio-frequency energy generated by the provided electric current.

[0462] Example 108. The method of any example herein, particularly of any one of examples 107-106, wherein the provided electric current is an alternating current.

[0463] Example 109. The method of any example herein, particularly of example 108, wherein the frequency of the alternating current is a radio-frequency.

[0464] Example 110. The method of any example herein, particularly of any one of examples 103- 109, wherein the extending the pair of arms through the orifices comprises positioning free ends of the arms distal to the orifices.

[0465] Example 111. The method of any example herein, particularly of any one of examples 103-110, wherein the moving the arms to the closed state comprises actuating a four-bar linkage of the cutting apparatus.

[0466] Example 112. The method of any example herein, particularly of any one of examples 103-109, further comprising, before the proximally pulling the sleeves, moving the wire coupling portion proximal to free ends of the arms distal to the orifices.

[0467] Example 113. The method of any example herein, particularly of example 112, wherein the moving the wire coupling portion comprises positioning the wire coupling portion proximal to the arms.

[0468] Example 114. The method of any example herein, particularly of any one of examples 112-113, wherein the moving the wire coupling portion comprises proximally pulling the second wire.

[0469] Example 115. The method of any example herein, particularly of any one of examples 103-114, wherein the proximally pulling at least one of the first wire and / or the second wire comprises simultaneously pulling the first wire and the second wire.

[0470] Example 116. The method of any example herein, particularly of any one of examples 103-115, wherein the forming a wire coupling region comprises pushing a tapered tip of the retention end into an orifice of the retention feature.

[0471] Example 117. A cutting apparatus comprising: a pair of electrically conductive wire arms, each wire arm comprising: an axial portion; a knee portion; and a side portion extending from the knee portion and terminating at an end portion that continuously connects the pair of wire arms; and a capture basket coupled to the side portions and extending distally therefrom; wherein the side portions are configured to extend at an angle relative to the axial portions, in a free state of the side portions; and wherein the side portions are configured to be spaced from each other in their free state, forming a gap therebetween.

[0472] Example 118. The apparatus of any example herein, particularly of example 117, wherein the side portions are movable between a compacted state and the free state, such that the angle between the side portions and the axial portions is smaller in the free state than in the compacted state.

[0473] Example 119. The apparatus of any example herein, particularly of any one of examples 117-118, wherein the angle between the side portions and the axial portions is in a range of 70 to 110 degrees.

[0474] Example 120. The apparatus of any example herein, particularly of any one of examples 117-119, wherein each side portion comprises a proximally oriented electrically conductive uninsulated surface.

[0475] Example 121. The apparatus of any example herein, particularly of any one of examples 117-120, wherein the side portions are configured to cut through a target tissue when electric current is supplied thereto.

[0476] Example 122. The apparatus of any example herein, particularly of any one of examples 1 17-121 , further comprising an outer catheter disposed around wire arms, wherein the wire arms are axially movable relative to the outer catheter.

[0477] Example 123. The apparatus of any example herein, particularly of any one of examples 117-122, wherein, when the wire arms are extended through a one of two orifices formed between two mitral leaflets connected by a leaflet connector, and the side portions are extended distal to the mitral leaflets, the side portions are sufficiently long to position the end portion distal to the other orifice of the two orifices, on the opposite side of the leaflet connector.

[0478] Example 124. The apparatus of any example herein, particularly of example 123, wherein, when the leaflet connector comprises a clip, the gap between the side portions in their free state is greater than a width of the clip.

[0479] Example 125. The apparatus of any example herein, particularly of any one of examples 117-124, further comprising a pull member axially movable relative to the wire arms, wherein the pull member comprises a pull shaft and a hook, wherein the hook is configured to engage with the end portion of the wire arms.

[0480] Example 126. A method for cutting leaflets of a valve, the method comprising: extending axial portions of a pair of electrically conductive wire arms of a cutting apparatus, through one of two orifices formed between two leaflets connected by a leaflet connector; exposing side portions of the wire arms at a position below the mitral leaflets, thereby allowing the side portions to extend at an angle relative to the axial portions, towards the opposite orifice of the two orifices; cutting portions of the mitral leaflets on both sides of the leaflet connector by providing an electric current to the side portions while pulling the side portions towards the mitral leaflets; and collecting cut portions of the mitral leaflets and the leaflet connector by a capture basket that is coupled to the side portions.

[0481] Example 127. The method of any example herein, particularly of example 126, wherein the extending the axial portions comprises extending an outer catheter past the two orifices, while the wire arms are entirely retained inside the outer catheter.

[0482] Example 128. The method of any example herein, particularly of example 127, wherein the exposing the side portions comprises axially moving at least one of the outer catheter and the wire arms relative to the other.

[0483] Example 129. The method of any example herein, particularly of any one of examples 126-128, wherein the side portions comprise proximally oriented electrically conductive uninsulated surfaces.

[0484] Example 130. The method of any example herein, particularly of any one of examples 126-129, wherein the side portions extend from knee portions and terminate at an end portion that continuously connects the pair of wire arms.

[0485] Example 131. The method of any example herein, particularly of example 130, further comprising, after the exposing the side portions, capturing the end portion by a hook of a pull member.

[0486] Example 132. The method of any example herein, particularly of example 131, wherein the capturing comprising distally extending the pull member through the opposite orifice of the two orifices.

[0487] Example 133. The method of any example herein, particularly of any one of examples 131-132, wherein the pulling the side portions towards the mitral leaflets comprises simultaneously pulling the axial portions and the pull member.

[0488] Example 134. The method of any example herein, particularly of any one of examples 126-133, wherein the collecting comprises allowing the cut portions of the mitral leaflets and the leaflet connector to fall into the capture basket.

[0489] Example 135. The method of any example herein, particularly of any one of examples 126-134, wherein the cutting is created by radio-frequency energy generated by the provided electric current.

[0490] Example 136. The method of any example herein, particularly of any one of examples 126-135, wherein the provided electric current is an alternating current.

[0491] Example 137. The method of any example herein, particularly of example 136, wherein the frequency of the alternating current is a radio-frequency.

[0492] Example 138. The method of any example herein, particularly of any one of examples 126-137, wherein the leaflet connector comprises a clip, and wherein the exposing the side portions comprises allowing the side portions to be spaced from each other forming a gap therebetween, the gap being wider than the clip.

[0493] Example 139. The method of any example herein, particularly of example 138, wherein the exposing the side portions comprises positioning the side portions distal to the clip.

[0494] Example 140. The method of any example herein, particularly of any one of examples 138-139, wherein the pulling the side portions is performed such that the side portions are disposed at opposite sides of the clip.

[0495] Example 141. A cutting apparatus comprising: an outer catheter; a basket shaft extending through, and axially movable relative to, the outer catheter; a capture basket extending between a basket first end, at which the capture basket is attached to the basket shaft, and a basket second end portion; and an electrically conductive wire comprising a wire loop coupled to the basket second end portion; wherein the capture basket is movable between a compacted configuration and an expanded configuration, such that the basket second end portion defines a greater diameter in the expanded configuration relative to the compacted configuration.

[0496] Example 142. The apparatus of any example herein, particularly of example 141, wherein the capture basket is self-expandable.

[0497] Example 143. The apparatus of any example herein, particularly of any one of examples 141-142, wherein the capture basket comprises a shape-memory material.

[0498] Example 144. The apparatus of any example herein, particularly of example 143, wherein the shape-memory material comprises Nitinol.

[0499] Example 145. The apparatus of any example herein, particularly of any one of examples 141-144, wherein the wire loop is configured to slide along a perimeter of the basket second end portion.

[0500] Example 146. The apparatus of any example herein, particularly of any one of examples 141-145, wherein the basket second end portion comprises a plurality of eyelets through which the wire loop extends.

[0501] Example 147. The apparatus of any example herein, particularly of any one of examples 141-146, wherein the wire further comprises two wire portions axially extending from the wire loop along the capture basket and the basket shaft.

[0502] Example 148. The apparatus of any example herein, particularly of any one of examples 141-147, wherein the wire loop is configured to cut through a target tissue when electric current is supplied thereto.

[0503] Example 149. The apparatus of any example herein, particularly of any one of examples 141-148, wherein, when the capture basket is in the expanded configuration, a basket opening defined by the basket second end portion is sufficiently large to extend around a clip of a leaflet connector that connects two mitral leaflets.

[0504] Example 150. The apparatus of any example herein, particularly of any one of examples 141-149, further comprising a plurality of engagement features extending radially inwards from an inner surface of the capture basket.

[0505] Example 151. The apparatus of any example herein, particularly of example 150, wherein the engagement features are angularly oriented towards the basket first end.

[0506] Example 152. A method for cutting leaflets of a valve, the method comprising: introducing an outer catheter of a cutting apparatus through an apical puncture into the left ventricle; extending a capture basket out of the outer catheter, thereby allowing the capture basket to move from a compacted configuration to an expanded configuration thereof; advancing the capture basket towards mitral leaflets of the mitral valve such that a basket second end portion thereof is disposed above a clip of a leaflet connector that connects the mitral leaflets; cutting portions of the mitral leaflets extending from both sides of the leaflet connector by providing an electric current to an electrically conductive wire loop coupled to the basket second end portion, while cinching the basket second end portion; and collecting cut portions of the mitral leaflets and the leaflet connector by the capture basket.

[0507] Example 153. The method of any example herein, particularly of example 152, wherein the introducing comprises maintaining the capture basket in the compacted configuration inside of the outer catheter.

[0508] Example 154. The method of any example herein, particularly of any one of examples 152-153, wherein the extending the capture basket out of the outer catheter comprises axially moving at least one of the outer catheter and a basket shaft attached to the capture basket, relative to the other.

[0509] Example 155. The method of any example herein, particularly of any one of examples 152-154, wherein the wire loop comprises an electrically conductive uninsulated surface.

[0510] Example 156. The method of any example herein, particularly of any one of examples 152-155, wherein the wire loop extends through a plurality of eyelets attached to the basket second end portion.

[0511] Example 157. The method of any example herein, particularly of any one of examples 152-156, wherein the cinching comprises pulling at least one wire portion axially extending from the wire loop.

[0512] Example 158. The method of any example herein, particularly of any one of examples 152-156, wherein the cinching comprises simultaneously pulling two wire portions axially extending from the wire loop.

[0513] Example 159. The method of any example herein, particularly of any one of examples 152-158, wherein the cinching comprises reducing a diameter defined by the basket second end portion to a size smaller than a width of the clip.

[0514] Example 160. The method of any example herein, particularly of any one of examples 152-158, wherein the collecting comprises allowing the cut portions of the mitral leaflets and the leaflet connector to fall into the capture basket.

[0515] Example 161. The method of any example herein, particularly of any one of examples 152-160, wherein the cutting is created by radio-frequency energy generated by the provided electric current.

[0516] Example 162. The method of any example herein, particularly of any one of examples 152-161, wherein the provided electric current is an alternating current.

[0517] Example 163. The method of any example herein, particularly of example 162, wherein the frequency of the alternating current is a radio-frequency.

[0518] Example 164. The method of any example herein, particularly of any one of examples 152-163, wherein the cinching further comprises engaging tissue of the mitral leaflet and / or engaging the leaflet connector by a plurality of engagement features extending radially inwards from an inner surface of the capture basket.

[0519] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate examples, may also be provided in combination in a single example. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single example, may also be provided separately or in any suitable sub-combination or as suitable in any other described example of the disclosure. No feature described in the context of an example is to be considered an essential feature of that example, unless explicitly specified as such.

[0520] In view of the many possible examples to which the principles of the disclosure may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope. Rather, the scope is defined by the following claims. We therefore claim all that comes within the scope and spirit of these claims.

Claims

WE CLAIM:

1. A cutting apparatus comprising: a pair of arms configured to move between a closed state and an open state; a pair of channels extending through the pair of arms, each channel terminating at a distal opening proximate a free end of the corresponding arm through which the channel extends; and a wire comprising: a first wire portion extending through one of the pair of channels and out of the corresponding distal opening of the channel, a second wire portion extending through the other one of the pair of channels and extending through the distal opening of the corresponding other one of the channels, and an intermediate wire portion continuously extending between the first wire portion and the second wire portion; wherein, when the pair of arms are in the closed state, proximally pulling at least one of the first wire portion and / or the second wire portion causes the intermediate wire portion to shorten and move in a distal direction towards the distal openings.

2. The apparatus of claim 1 , wherein the wire is electrically conductive.

3. The apparatus of any one of claims 1-2, wherein the wire intermediate portion is configured to cut through a target tissue when electric current is supplied thereto.

4. The apparatus of any one of claims 1-3, wherein the arms comprise concave inner surfaces defining a gap formed therebetween in the closed state.

5. The apparatus of claim 4, wherein the intermediate wire portion is disposed in the gap between the arms.

6. The apparatus of any one of claims 1-5, wherein, when the arms are extended through orifices formed between two mitral leaflets connected by a leaflet connector such that the distal openings of the channels are distal to the orifices, the intermediate wire portion is sufficiently long such that at least part thereof is proximal to the orifices.

7. A cutting apparatus comprising:a pair of arms configured to move between a closed state and an open state; a pair of grooves formed along the arms, each groove defining an opening at an inner surface of the corresponding arm; a first wire covered by a first sleeve extending through a first one of the grooves, the first wire comprising a retention end; and a second wire covered by a second sleeve extending through a second one of the grooves, the second wire comprising a retention feature; wherein the retention end and the retention feature are disengaged from each other and are configured to connect with each other.

8. The apparatus of claim 7, wherein the first wire and the second wire are axially movable relative to the sleeves disposed thereover.

9. The apparatus of any one of claims 7-8, wherein the sleeves are axially movable relative to the grooves.

10. The apparatus of any one of claims 7-9, wherein each sleeve defines an outer diameter that is smaller than a size of the opening of the corresponding groove in which is it disposed.

11. The apparatus of claim 10, wherein each of the first wire and the second wire defines an outer diameter that is smaller than the size of the opening of the corresponding groove.

12. The apparatus of any one of claims 7-11, wherein the retention end comprises a tapered tip, and wherein the retention feature comprises an orifice configured to accommodate the tapered tip.

13. A method for cutting a leaflet comprising : extending a pair of arms of a cutting apparatus, in an open state of the arms, through orifices formed between two leaflets connected by a leaflet connector, wherein the cutting apparatus further comprises a first wire covered by a first sleeve extending through a groove formed along a first one of the arms, and a second wire covered by a second sleeve extending through a groove formed along a second one of the arms; moving the arms to a closed state; forming a wire coupling region by connecting a retention end of the first wire to a retention feature of the second wire;proximally pulling the sleeves to expose at least a portion of the first wire and / or the second wire extending along the arms; and cutting a portion of one of the leaflets by proximally pulling at least one of the first wire and / or the second wire, such that the exposed portion of the first wire and / or the second wire is pulled out of the corresponding grooves to contact the leaflet and cut therethrough.

14. The method of claim 13, wherein each sleeve defines an outer diameter that is smaller than a size of an opening of the corresponding groove formed at an inner surface of the corresponding arm, so as to prevent the sleeve from slipping through the opening.

15. The method of claim 14, wherein each of first wire and the second wire defines an outer diameter that is smaller than the size of the opening of the corresponding groove, so as to allow the corresponding wire to be pulled out of the corresponding groove after the proximally pulling the sleeves.

16. The method of any one of claims 13-15, wherein the cutting comprises providing an electric current to the exposed portion of the first wire and / or the second wire such that the electric current creates a cut through the leaflet when the exposed portion of the first wire and / or the second wire is contacting the leaflet.

17. The method of any one of claims 13-16, wherein the extending the pair of arms through the orifices comprises positioning free ends of the arms distal to the orifices.

18. The method of any one of claims 13-16, further comprising, before the proximally pulling the sleeves, moving the wire coupling portion proximal to free ends of the arms distal to the orifices.

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