WO2025171212A1 - Leaflet cutting apparatus - Google Patents

Abstract

The present disclosure relates to tissue cutting devices that can be used to cut through a leaflet, such as an anterior leaflet of a mitral valve. In an example, a tissue cutting apparatus comprises a shaft comprising a head portion, a flap pivotably coupled to the head portion, and a wire extending through the shaft and terminating with a cutting portion. The wire is slidably coupled to the flap and the cutting portion is configured to move along the flap. The flap is configured to move between an open state and a closed state, such that the flap proximal end is at a greater distance from the head portion in the open state than in the closed state.

Description

LEAFLET CUTTING APPARATUS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63/551,610, filed Feb 9, 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. Prostheses exist to correct problems associated with impaired heart valves. For example, prosthetic heart valves that include leaflets mounted in compressible and expandable frames can be delivered with less trauma to the patient than through open heart surgery.

SUMMARY

[0006] Prosthetic valves can be delivered to a malfunctioning native mitral valve, and expand against the native annulus and leaflets. In some cases, expansion of the prosthetic valve pushes the anterior leaflet of the mitral valve into the left ventricular outflow tract (LVOT), which may significantly limit outflow through the LVOT and the aortic valve. [0007] In one of its basic configurations, a leaflet cutting apparatus comprises a shaft and a flap pivotably coupled 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.

[0008] In some examples, the flap can comprise a flap proximal end, a flap base opposite to the flap proximal end, a first flap sidewall and a second flap sidewall extending between the flap base and the flap proximal end, a flap inner surface, and a flap outer surface opposite to the flap inner surface.

[0009] In some examples, the apparatus can comprise a wire extending through the shaft and comprising a cutting portion.

[0010] In some examples, the wire is optionally slidably coupled to the flap and the cutting portion is optionally configured to move along the flap.

[0011] In some examples, the flap is optionally configured to move between an open state and a closed state, such that the flap proximal end is at a greater distance from the head portion in the open state than in the closed state.

[0012] In some examples, the wire can comprise a first wire portion and a second wire portion continuously extending from the cutting portion and through the shaft.

[0013] In some examples, the wire can comprise a first wire portion and a second wire portion continuously extending from the cutting portion and through the shaft.

[0014] In some examples, the cutting portion is optionally configured to slide along the flap when the first wire portion and the second wire portion are proximally pulled through the shaft. [0015] In some examples, the wire can comprise an electrically conductive core configured to conduct electricity towards the cutting portion.

[0016] In some examples, the head portion can comprise a window configured to accommodate the flap in the closed state, the window optionally comprising a first window sidewall, a second window sidewall, and a window ceiling extending between the first and the second window sidewalls.

[0017] In some examples, when the flap is in the closed state, the first window sidewall is optionally aligned with the first flap sidewall, the second window sidewall is optionally aligned with the second flap sidewall, and the window ceiling is optionally aligned with the flap proximal end. [0018] In some examples, the wire is optionally movably coupled to at least one guide recess of the apparatus.

[0019] In some examples, the at least one guide recess can comprise an inner semi-circular channel through which the wire extends, and a slot extending between the inner semi-circular channel and a surface of the apparatus.

[0020] In some examples, the at least one guide recess can comprise a first guide recess formed on the flap.

[0021] In some examples, the first guide recess can optionally continuously extend along the first flap sidewall, the flap proximal end, and the second flap sidewall.

[0022] In some examples, the first wire portion can optionally continuously extend from the cutting portion along the first guide recess.

[0023] In some examples, the at least one guide recess can comprise a second guide recess formed on the head portion and extending along edges of the window.

[0024] In some examples, the second guide recess can optionally continuously extend along the first window sidewall, the window ceiling, and the second window sidewall.

[0025] In some examples, when the wire is pulled, the cutting portion is optionally configured to slide along a path extending proximally from a position proximate the flap base towards the proximal end of the flap, slide laterally at or parallel to the flap proximal end towards the second flap sidewall, and slide distally from a position at or proximate to the flap proximal end towards the flap base.

[0026] In some examples, the apparatus can comprise two tubular arms extending through the shaft, wherein the head portion can comprise two head openings through which the corresponding tubular arms are configured to extend away from or closer to the head portion. [0027] In some examples, the head openings are optionally positioned on opposite sides of the window.

[0028] In some examples, the head openings are optionally closer to the flap base than the flap proximal end.

[0029] In some examples, the head openings are optionally distal to the flap base.

[0030] In some examples, the tubular arms are optionally axially movable relative to the shaft. [0031] In some examples, when portions of the tubular arms residing in the shaft are distally pushed, distal ends of the tubular arms are optionally configured to move away from the head portion. [0032] In some examples, the tubular arms can comprise a first tubular arm and a second tubular arm, wherein the wire can optionally extend through the second tubular arm and is optionally axially movable relative to the second arm.

[0033] In some examples, the first wire portion and the second wire portion can optionally extend through the second tubular arm and past a tube opening of the first tubular arm towards the distal end of the second tubular arm.

[0034] In some examples, the distal ends of the tubular arms are optionally configured to be closer to the flap base than the flap proximal end when the tubular arms are extended away from the head portion.

[0035] In some examples, the first tubular arm is optionally fluidly coupled to an insulator fluid injection port, and is optionally configured to eject insulator fluid from the distal end of the first tubular arm.

[0036] In some examples, the first guide recess can optionally continuously extend along the flap inner surface, the flap proximal end, and the flap outer surface.

[0037] In some examples, wherein the first wire portion can optionally continuously extend from the cutting portion along the first guide recess.

[0038] In some examples, the apparatus comprises at least one insulator fluid injection tube disposed around a portion of the wire and having an opening at a distal end thereof, directed towards the cutting portion, wherein the at least one insulator fluid injection tube is optionally configured to eject insulator fluid through its opening.

[0039] In one of its basic methods, a method comprises positioning a head portion of a leaflet cutting apparatus distal to a leaflet of a valve. This basic method can preferably be provided with any one or more of the steps described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic method can preferably also be provided with any one or more of the steps shown in the figures and/or described in conjunction with the figures, either in addition to or alternatively to the steps of the examples described hereafter.

[0040] In some examples, the method comprises moving a flap pivotably coupled to the head portion, to an open state of the flap.

[0041] In some examples, the method comprises retracting the head portion so as to position a portion of the leaflet between the flap and the head portion, such that a cutting portion of a wire slidably coupled to the flap is distal to a free edge of the leaflet.

[0042] In some examples, the method comprises cutting through the leaflet via the cutting portion. [0043] In some examples, the cutting through the leaflet optionally comprises positioning the cutting portion such that an electrically conductive surface thereof is oriented towards a free edge of the leaflet when the leaflet is positioned between the flap and the head portion, prior to the cutting.

[0044] In some examples, the cutting through the leaflet optionally comprises providing an electric current to the cutting portion such that the electric current creates a cut through the leaflet when the cutting portion is contacting the leaflet.

[0045] In some examples, the method optionally comprises, after the positioning the leaflet between the flap and the head portion and before the cutting the leaflet, moving the flap towards a closed state, thereby tightly grasping the leaflet between the flap and the head portion.

[0046] In some examples, the moving the cutting portion along the flap optionally comprises moving the cutting portion along edges of the flap.

[0047] In some examples, the moving the cutting portion along edges of the flap optionally comprises proximally moving the cutting portion along a first sidewall of the flap towards a proximal end of the flap, laterally moving the cutting portion along the proximal end of the flap from the first sidewall to a second sidewall of the flap, and distally moving the cutting portion along the second sidewall from the proximal end of the flap towards a base of the flap. [0048] In some examples, the method optionally comprises pushing two tubular arms of the apparatus, thereby extending distal portions thereof, through head opening of the head portions, away from the head portions.

[0049] In some examples, the extending the distal portion of the tubular arms optionally comprises distancing distal ends of the tubular arms away from opposite sides of the flap.

[0050] In some examples, the method optionally comprises retaining the cut section tightly grasped between the flap and the head portion.

[0051] In some examples, the moving the cutting portion along the flap optionally comprises proximally moving the cutting portion along an inner surface of the flap, toward a proximal end of the flap.

[0052] In some examples, the cutting through the leaflet optionally comprises forming a slit splitting the leaflet.

[0053] 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

[0054] 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:

[0055] Fig. 1 A is a cross-sectional view the right-side of a human heart.

[0056] Fig. IB shows an exemplary prosthetic valve implanted in the native mitral valve.

[0057] Fig. 2 shows an exemplary leaflet cutting apparatus.

[0058] Figs. 3A and 3B are perspectives view of a distal portion of the apparatus, showing a flap of the apparatus in a closed state and an open state, respectively.

[0059] Fig. 4 shows a distal portion of an exemplary apparatus including a pull-member configured to move the flap to the open state.

[0060] Figs. 5A and 5B show an exemplary apparatus including a rod configured to move the flap between the closed state illustrated in Fig. 5A, and the open state illustrated in Fig. 5B.

[0061] Fig. 6 is a perspective view of a distal portion of an exemplary apparatus, equipped with a cutting portion configured to move along edges of the flap.

[0062] Fig. 7A is an enlarged view of region 7A of Fig. 6.

[0063] Fig. 7B is a view of the region of Fig. 7A, showing the cutting portion proximally moved relative to its position in Fig. 7A.

[0064] Fig. 8 shows an exemplary cutting portion having part thereof covered by insulating layers.

[0065] Fig. 9 shows an exemplary cutting portion entirely covered by an insulating layer except for an exposed electrically conductive surface.

[0066] Figs. 10A-10E illustrate steps in an exemplary method for utilizing the leaflet cutting apparatus, up to the point of grasping a leaflet between the flap and the head portion.

[0067] Figs. 11A-11E illustrate movement of the cutting portion of an exemplary apparatus to cut a section of the leaflet. [0068] Figs. 12A-12B illustrate steps of the method that can be performed after cutting the leaflet.

[0069] Fig. 13 shows an exemplary leaflet cutting apparatus including a contrast injection member.

[0070] Fig. 14A is a perspective view of a distal portion of an exemplary apparatus, having guide recesses through which portions of the wire can extend without the aid of sutures.

[0071] Fig. 14B is an enlarged perspective view of the flap of the apparatus of Fig. 14A. [0072] Fig. 14C is a cross-sectional view along line 14C- 14C of Fig. 14B.

[0073] Fig. 15 is a perspective view of a distal portion of an exemplary apparatus equipped with two tubular arms.

[0074] Figs. 16A-16B illustrate some steps in an exemplary method for utilizing the leaflet cutting apparatus of Fig. 15.

[0075] Fig. 17 is a perspective view of a distal portion of an exemplary apparatus in which one of the tubular arms is further utilized to eject insulator fluid from a distal opening thereof.

[0076] Fig. 18 is a perspective view of a distal portion of an exemplary apparatus comprising insulator fluid injection tubes disposed around the wire.

[0077] Fig. 19 is a perspective view of a distal portion of an exemplary apparatus, equipped with a cutting portion configured to move along an inner surface of the flap.

[0078] Figs. 20A-20C illustrate some steps in an exemplary method for utilizing the leaflet cutting apparatus of Fig. 19.

DETAILED DESCRIPTION

[0079] 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 be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology. [0080] 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.

[0081] 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.

[0082] 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".

[0083] 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.

[0084] 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, upper and 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. [0085] The terms "proximal" and "distal" are defined relative to the use position of a delivery apparatus. In general, the end of the delivery apparatus closest to the user of the apparatus is the proximal end, and the end of the delivery 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 delivery 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 delivery apparatus. The terms "longitudinal" and "axial" are interchangeable, and refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0086] The terms "axial direction", "radial direction", and "circumferential direction" have been used herein to describe the arrangement and assembly of components relative to the geometry of the frame of the prosthetic valve, or the geometry of an inflatable balloon that can be used to expand a prosthetic valve. Such terms have been used for convenient description, but the disclosed examples are not strictly limited to the description. In particular, where a component or action is described relative to a particular direction, directions parallel to the specified direction as well as minor deviations therefrom are included. Thus, a description of a component extending along an axial direction of the frame does not require the component to be aligned with a center of the frame; rather, the component can extend substantially along a direction parallel to a central axis of the frame.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] 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 different alphabetic 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.

[0092] 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.

[0093] Described herein are devices and methods for implanting prosthetic valves and modifying leaflets of an existing valvular structure in a patient’s heart. Prior to or during implantation of the prosthetic heart valve within the existing valvular structure, each device, such as a delivery apparatus that can optionally carry a prosthetic valve of a separate cutting apparatus, 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 commissure of the existing valvular structure. In some examples, the existing valvular structure can be a native mitral valve. The modification can avoid, or at least reduce the likelihood of, issues that leaflets of the existing valvular structure might otherwise cause once the prosthetic heart valve has been fully installed, for example, interference of flow from the left ventricle towards the aortic leaflet. While described with respect to a mitral valve, it should be understood that the disclosed examples can be adapted to deliver devices that can modify existing valvular structure, and in some implementations, implant prosthetic devices, to and/or in any of the native annuluses 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.).

[0094] Fig. 1A illustrates an anatomy of the right-side of a human heart 10. A cross-sectional view showing both the right-side and the left-side of the heart 10 is further illustrated in Fig. 10A, for example. The anatomical structure of the heart 10 and blood vessels extending therefrom will be described herein with reference to Figs. 1A and 10A collectively. The heart has a four-chambered conical structure that includes the right atrium 18, the right ventricle 20, the left atrium 26 and the left ventricle 28. 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. The native tricuspid valve 22 is positioned between the right atrium 18 and the right ventricle 20. Additionally, the native aortic valve 14 separates the left ventricle 28 from the aorta 12.

[0095] During the diastolic phase, or diastole, deoxygenated blood flows from the right atrium 18 into the right ventricle 20 through the tricuspid valve 22. During systole, leaflets of a normally functioning tricuspid valve 22 close to prevent the venous blood from regurgitating back into the right atrium 18. When the tricuspid valve 22 does not operate normally, blood can backflow or regurgitate into the right atrium 18.

[0096] The native mitral valve 30 comprises a mitral annulus 32 and a pair of mitral leaflets 39 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 the left 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.

[0097] 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. [0098] A prosthetic valve can be implanted in a malfunctioning native heart valve to prevent or inhibit blood backflow. Fig. IB shows an exemplary prosthetic valve 55 that can be implanted in a native heart valve, such as the mitral valve 30. 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. The expanded state may include a range of diameters to which the valve may expand, between the compressed state and a maximal diameter reached at a fully expanded state. Thus, a plurality of partially expanded states may relate to any expansion diameter between radially compressed or crimped state, and maximally expanded state. A prosthetic valve of the current disclosure (for example, prosthetic valve 55) may include any prosthetic valve configured to be mounted within the native aortic valve, the native mitral valve, the native pulmonary valve, and the native tricuspid valve.

[0099] It is understood that the prosthetic valves disclosed herein 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). Self-expandable 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 (such as the prosthetic valves described in U.S. Patent No. 10,603,165, International Application No. PCT/US 2021/052745 and U.S. Provisional Application Nos. 63/85,947 and 63/209904, each of which is incorporated herein by reference in its entirety), 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 the expansion and locking assemblies, to enable retrieval of the delivery apparatus once the prosthetic valve is properly positioned at the desired site of implantation. [0100] Fig. IB shows an example of a prosthetic valve 50, which can optionally be a balloon expandable valve or any other type of valve, illustrated in an expanded state. The prosthetic valve 50 can comprise an outflow end 56 and an inflow end 54. In some instances, the outflow end 56 is the distal end of the prosthetic valve 50, and the inflow end 54 is the proximal end of the prosthetic valve 50. Alternatively, depending for example on the delivery approach of the valve, the outflow end can be the proximal end of the prosthetic valve, and the inflow end can be the distal end of the prosthetic valve.

[0101] The term "outflow", as used herein, refers to a region of the prosthetic valve through which the blood flows through and out of the prosthetic valve 50.

[0102] The term "inflow", as used herein, refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve 50.

[0103] In the context of the present application, the terms "lower" and "upper" are used interchangeably with the terms "outflow" and "inflow", respectively. Thus, for example, the lower end of the prosthetic valve 50, when implanted in a native mitral valve 30 as shown in Fig. IB, is its outflow end, and the upper end of the prosthetic valve is its inflow end.

[0104] In the context of the present application, 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.

[0105] The terms "longitudinal" and "axial", as used herein, refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0106] The prosthetic valve 50 comprises an annular frame 52 movable between a radially compressed configuration and a radially expanded configuration, and a valvular structure 62 that comprises prosthetic valve leaflets 64 mounted within the frame 52. The frame 52 can optionally be made of various suitable materials, including plastically-deformable materials such as, but not limited to, stainless steel, a nickel based alloy (for example, a nickel-cobalt- chromium alloy such as MP35N alloy), polymers, or combinations thereof. When constructed of a plastically-deformable materials, the frame 52 can optionally be crimped to a radially compressed state on a balloon catheter, and then expanded inside a patient by an inflatable balloon or other types of expansion mechanisms, such as an expandable frame described in U.S. Provisional Application No. 63/335,739, which is incorporated by reference herein in its entirety. Alternatively or additionally, the frame 52 can optionally be made of shape-memory materials such as, but not limited to, nickel titanium alloy (for example, Nitinol). When constructed of a shape-memory material, the frame 52 can optionally be crimped to a radially compressed state and restrained in the compressed state by insertion into a shaft or equivalent mechanism of a delivery apparatus.

[0107] In the example illustrated in Fig. IB, the frame 52 can optionally be an annular, stentlike structure comprising a plurality of intersecting struts 58. In this application, the term "strut" encompasses axial struts, angled struts, laterally extendable struts, commissure windows, commissure support struts, support posts, and any similar structures described by U.S. Pat. Nos. 7,993,394 and 9,393,110, which are incorporated herein by reference. A strut 58 may be any elongated member or portion of the frame 52. The frame 52 can optionally include a plurality of strut rungs that can optionally collectively define one or more rows of cells 60. The frame 52 can optionally have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 54 to the outflow end 56 as shown, or the frame can optionally vary in diameter along the height of the frame, as disclosed in US Pat. No. 9,155,619, which is incorporated herein by reference.

[0108] The struts 58 can optionally include a plurality of angled struts and vertical or axial struts. At least some of the struts 58 can optionally be pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame 52 can optionally be formed from a single piece of material, such as a metal tube, via various processes such as, but not limited to, laser cutting, electroforming, and/or physical vapor deposition, while retaining the ability to collapse/expand radially in the absence of hinges and like.

[0109] A valvular structure 62 of the prosthetic valve 50 can optionally include a plurality of prosthetic valve leaflets 64 (for example, three leaflets), positioned at least partially within the frame 52, and configured to regulate flow of blood through the prosthetic valve 50 from the inflow end 54 to the outflow end 56. While three leaflets 64 arranged to collapse in a tricuspid arrangement, are shown in the example illustrated in Fig. 1A, it will be clear that a prosthetic valve 50 can optionally include any other number of leaflets 64. Adjacent leaflets 64 can optionally be arranged together to form commissures 66 that are coupled (directly or indirectly) to respective portions of the frame 52, thereby securing at least a portion of the valvular structure 62 to the frame 52. The prosthetic valve leaflets 64 can optionally be made from, in whole or part, biological material (for example, pericardium), bio-compatible synthetic materials, or other such materials. Further details regarding transcatheter prosthetic valves, including the manner in which leaflets 64 can optionally be coupled to the frame 52 of the prosthetic valve 50, can be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,652,202, and 11,135,56, all of which are incorporated herein by reference in their entireties. [0110] In some examples, the prosthetic valve 50 can optionally comprise at least one skirt or sealing member. For example, the prosthetic valve 50 can optionally include an inner skirt 70, which can optionally be secured to the inner surface of the frame 52. Such an inner skirt 70 can optionally be configured to function, for example, as a sealing member to prevent or decrease perivalvular leakage. An inner skirt 70 can optionally further function as an anchoring region for leaflets 64 to the frame 52, and/or function to protect the leaflets 64 against damage which may be caused by contact with the frame 52, for example during valve crimping or during working cycles of the prosthetic valve 50. An inner skirt 70 can optionally he disposed around and attached to the inner surface of frame 52, while the leaflets can optionally be sutured to the inner skirt along a scalloped line (not shown). An inner skirt 70 can optionally be coupled to the frame 52 via sutures or another form of coupler.

[0111] The prosthetic valve 50 can optionally comprise, in some examples, an outer skirt 68 mounted on the outer surface of frame 52, configured to function, for example, as a sealing member retained between the frame 52 and the surrounding tissue of the native annulus against which the prosthetic valve is mounted, thereby reducing risk of paravalvular leakage (PVL) past the prosthetic valve 50. The outer skirt 68 can optionally be coupled to the frame 52 via sutures or another form of coupler.

[0112] Any of the inner skirt and/or outer skirt can optionally be made of various suitable biocompatible materials, such as, but not limited to, various synthetic materials (for example, PET) or natural tissue (for example pericardial tissue). In some cases, the inner skirt 70 can optionally be formed of a single sheet of material that extends continuously around the inner surface of frame 52. In some cases, the outer skirt 68 can optionally be formed of a single sheet of material that extends continuously around the outer surface of frame 52.

[0113] The cells 60, defined by interconnected struts 58, define openings having any of a variety of shapes, such as diamond-shaped openings, hexagonal openings, and the like. While some of the cells 60 can optionally be covered by the inner skirt and/or the outer skirt, at least a portion of the cells 60 can optionally remain uncovered, such as cells 60 which are closer to the outflow end 56 of the prosthetic valve.

[0114] In some instances, as demonstrated in Fig. IB, a prosthetic valve 50 implanted in the native mitral valve 30 may displace the anterior leaflet 38 towards and into the left ventricle outflow tract (LVOT) 45, which may at least partly obstruct the LVOT 40, thereby reducing blood flow leaving the heart towards the aorta 12.

[0115] To avoid reduction of blood flow through a narrowed LVOT 40, the anterior leaflet 38 can optionally be modified by components of a leaflet cutting apparatus 100 prior to implantation of a prosthetic valve 50 within the native mitral valve 30. In some examples, the anterior leaflet 38 can optionally be modified by cutting or splitting at least a portion thereof using the cutting apparatus 100. The modification thus disrupts the impermeable obstruction that would otherwise be formed by the anterior leaflet 38, thereby allowing blood to cross uncovered open cells 60 of the prosthetic valve, towards the LVOT 40 and aorta 12.

[0116] Fig. 2 illustrates an exemplary leaflet cutting apparatus 100, which can optionally include a head portion 114 at a distal end portion of a shaft 112, a flap 130 that can optionally transition between a closed state and an open state, such as by moving towards and away from a corresponding window 120 of the head portion 114, and a wire 150 (examples of which are shown in Figs. 6-9 and 15-24) having a cutting portion 156 configured to cut through a leaflet retained between the flap 130 an a window 120.

[0117] In some examples, a leaflet cutting apparatus 100 can optionally include a handle 102 and an outer catheter 110. The shaft 112 can optionally extend through the outer catheter 110. The outer catheter 110 and the shaft 112 can optionally be configured to be axially movable relative to each other. For example, a distally oriented movement of the shaft 112 relative to the outer catheter 110, can optionally expose the head portion 114 from a lumen of the outer catheter 110.

[0118] In some examples, the apparatus 100 can optionally further include a nosecone 116 that can optionally be conical or frustoconical in shape, configured to facilitate advancement of the apparatus 100 through the patient's vasculature. A nosecone shaft (concealed from view in Fig. 2) can optionally extend proximally from the nosecone 116, such as through the shaft 112, towards and into the handle 102. Optionally, the nosecone 116 and nosecone shaft can collectively define a guidewire lumen (concealed from view in Fig. 2), terminating with a guidewire opening 119 (indicated, for example, in Figs. 15 and 17-18)) at a distal end 118 of the nosecone 116, through which a guidewire 80 (indicated, for example, in Figs. 10A- 10B) can pass.

[0119] In some examples, the nosecone 116 can optionally be integrally formed with the head portion 114. In some examples, the nosecone 116 can optionally be provided as a separate component that can optionally be either affixed to the head portion 114, or can optionally be configured to axially move closer or farther from the distal end of the head portion 114.

[0120] The proximal ends of various components of apparatus 100, such as outer catheter 110, shaft 112, wire 150, and/or the nosecone shaft, can optionally be coupled to the handle 102. During delivery through the patient's vasculature, the handle 102 can optionally be maneuvered by an operator (for example, a clinician or a surgeon) to axially advance or retract components of the leaflet cutting apparatus 100, such as the shaft 112, as well as to move the flap 130 between the closed and open state, to provide electric current to the cutting portion 156 of the wire 150, and/or to facilitate movement of the wire 150.

[0121] The handle 102 can optionally include a steering mechanism configured to adjust the curvature of the distal end portion of the leaflet cutting apparatus 100. In the illustrated example, the handle 102 can optionally include an adjustment member, such as the illustrated rotatable knob 106a, which in turn is operatively coupled to the proximal end portion of a pull wire (not shown). The pull wire can optionally extend distally from the handle 102 through the outer catheter 110 and has a distal end portion affixed to the outer catheter 110 at or near the distal end of the outer catheter 110. Rotating the knob 106a can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the leaflet cutting apparatus 100. Further details on steering or flex mechanisms for the apparatus can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein.

[0122] The handle can optionally include additional adjustment mechanisms controllable by additional knobs to maneuver additional components of the leaflet cutting apparatus 100, such as axial movement of the shaft 112 relative to the outer catheter 110, as well as activation and/or pulling of the wire 150, as will be elaborated in greater detail below. The terms "leaflet cutting apparatus 100" and "apparatus 100", as used herein, are interchangeable.

[0123] In some examples, the apparatus 100 can optionally comprise an electric current source 108 configured to generate and provide a predetermined electric current to the cutting portion 156 of the wire 150. In some examples, the electric current source 108 is optionally secured within handle 102, as illustrated in Fig. 2. In some examples, the electric current source 108 can optionally be external to handle 102.

[0124] Figs. 3A and 3B show perspective view of a distal portion of the apparatus 100, including a head portion 114 thereof, in a closed state and an open state, respectively, of the flap 130. The head portion 114 can optionally include a window 120 cut through a thickness of a wall of the head portion 114, the window 120 defining a window ceiling 124 at a proximal end of the window 120, and window sidewalls 122 extending distally from the window ceiling 124. The flap 130 defines a flap proximal end 142, flap sidewalls 140 extending distally from the flap proximal end 142, and a flap base 136 opposite to the flap proximal end 142, optionally aligned with a distal end of the window 120, opposite to the window ceiling 124. The flap further comprises an outer surface 134, facing away from the head portion 114, and an opposite inner surface 132 (indicated, for example, in Fig. 4). The flap inner surface 132 can optionally be textured, as illustrated for example in Figs. 14B-14C, to ensure proper engagement with a leaflet and prevent slippage of the leaflet grasped between the flap 130 and the head portion 114. This can be achieved by various manners, such as forming the inner surface 132 itself as a rough surface, or by covering the surface of the flap 130 with a textured layer.

[0125] The flap 130 can optionally be pivotably connected to the head portion 114. As mentioned above, the flap 130 is movable between a closed position, shown in Fig. 3 A, and an open position, shown in Fig. 3B, wherein the inner surface 132 and the flap proximal end 142 are closer to the window 120 than in the open state. In some examples, the outer surface 134 of the flap 1 0 can optionally be substantially flush with the outer surface of the head portion 114 in the closed state, as illustrated in Fig. 3 A. In some examples, the flap proximal end 142 can optionally be aligned with the window ceiling 124, and the flap sidewalls 140 can optionally be aligned with the window sidewalls 122, in the closed state of the flap. In the open state, the flap 130 can optionally be pivotably rotated to an angled orientation relative to the window 120, as illustrated in Fig. 3B. The flap 130 is configured to grasp a leaflet 34, such as an anterior leaflet 38, or any other leaflet of a native heart valve or a previously implanted prosthetic valve.

[0126] Various exemplary implementations for apparatus 100 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. For example, a distal portion of an apparatus 100^a shown in Fig. 4 is an exemplary implementation of leaflet cutting apparatus 100, and thus includes features described for apparatus 100 throughout the current disclosure, except that while apparatus 100 can optionally include any of a variety of mechanisms for moving the flap 130 between the open and closed states, leaflet cutting apparatus 100^a includes an exemplary mechanism in which the flap 130 is biased to the closed state in a free state thereof.

[0127] In some examples, the flap 130 can optionally include a flap internal extension 138, which can optionally be angled relative to the portion of the flap 130 extending between the flap proximal end 142 and the flap base 136, and can optionally extend from the flap base 136 into the head portion 114. [0128] In some examples, as shown for flap 130^a illustrated in Fig. 4, the flap internal extension 138 is hinged to the head portion 114^a, such as to a wall of the head portion 114^a or another component that can optionally be affixed to the head portion 114^a. The flap internal extension 138 can optionally be pivotably connected to the head portion 114^a by a pin 180 or any other type of hinge. In some examples, as further illustrated in Fig. 4, the apparatus 100^a can optionally further include a spring 176 configured to bias the flap 130^a to a closed state against the window 120 in a free state of the flap 130. In some examples, the spring 176 can optionally be a torsion spring disposed around the pin 180. It is to be understood that any other flapbiasing arrangement is contemplated, such as, for example, a compression spring (not shown) that can optionally be arranged between the flap and an inner opposite wall of the head portion. [0129] Apparatus 100^a further comprises a link 174 pivotably connected on one end thereof (such as a proximal end of the link 174) to the flap proximal end 142 (such as to an end of the flap proximal end 142), while the opposite end of the link 174 (such as its distal end) is connected, at a joint 172, to a pull-member 170 of the apparatus 100^a. The pull-member 170 can optionally be any of a wire, string, cable and the like. The pull-member 170 extends proximally from the joint 172, such as through the shaft 112, towards and into the handle 102, wherein the handle 102 is configured to selectively pull the pull-member 170 or release tension from the pull-member 170.

[0130] The joint 172 and pin 180 can optionally be radially aligned and axially distanced from each other. When the pull-member 170 is pulled in the proximal direction 82, it moves the joint 172 therewith, closer to the pin 180, thereby causing the flap 130^a to move to the open state, farther from the window 120, as illustrated in Fig. 4. When pull force is no longer applied to the pull-member 170, the spring, such as torsion spring 176, is free to bias the flap 130^a towards the window 120, back to the closed state.

[0131] Figs. 5A and 5B show a distal portion of an exemplary apparatus 100^b in a closed state and an open state, respectively, of the flap 130^b. Apparatus 100^b is an exemplary implementation of apparatus 100, and thus can optionally include any of the features described for apparatus 100, except that apparatus 100^b includes a mechanism configured to move a flap 130^b that is not necessarily biased to a specific position, between the closed and open states.

[0132] The internal extension 138 of flap 130^b can optionally include a slot 182, configured to receive a pin 180 attached to the head portion 114^b, such as to a wall of the head portion 114 itself, or to another component that can optionally be affixed to the head portion 114. The slot 182 is longer than a diameter of the pin 180, such that the pin 180 can move along a length of the slot 182. [0133] The apparatus 100^b further comprises a rod 178 attached to the flap internal extension 138 at a joint 172 distal to the slot 182, such as to a distal end of the flap internal extension 138. In some examples, the rod 178 is configured to selectively push or pull the joint 172 of flap internal extension 138. The rod 178 extends proximally from the joint 172, such as through the shaft 112, towards and into the handle 102, wherein the handle 102 can optionally be configured to selectively pull or push the rod 178. In some examples, the rod 178 can optionally be in the form of a wire, a cable, a shaft, and the like, which is flexible enough to bend along curved regions of the shaft 112 when passed through curved regions of the patient's vasculature, and can optionally have sufficient columnar strength to axially push the joint 172 of flap internal extension 138 without buckling or collapsing.

[0134] When the flap 130^b is in the closed state, the pin 180 can optionally be in an upper or proximal end of the slot 182, as illustrated in Fig. 5 A. When the rod 178 is pulled in the proximal direction 82, it moves the joint 172 therewith, thereby causing the flap 130^b to move to the open state, farther from the window 120, while the slot 182 of the flap 130^b is slid over the pin 180, positioning the pin at the opposite lower, or distal, end of the slot 182, as illustrated in Fig. 4. An opposite distally-oriented movement of the rod 178 will push the joint 172 in a distal direction therewith, moving the flap 130^b back towards the window 120, as shown for the closed position in Fig. 5A.

[0135] When the rod 178 is configured to selectively pull and push the joint 172, the flap 130^b does not need to be biased to a specific state, such as the closed state, but is rather actively moved by the rod 178 between the two states. Nevertheless, it is to be understood that a biasing member, such as a spring, can optionally be added to bias the flap 130 to the closed state, which can optionally be used in combination with the rod 178 described above, configured to assist in closing of the flap 130, thereby reducing the push force required by the rod 178. In some examples, when the flap 130^b is further biased to the closed state, such as by a spring or any other biasing member, the rod 178 can optionally be replaced by a pull-member 170 of the type described above with respect to Fig. 4, configured to pull the joint 172 to move the flap to the open state, or to release tension to allow it to revert to the closed state, without applying any push forces. Moreover, it is to be understood the in some examples, the pull-member 170 of apparatus 100^a can optionally be replaced by a rod 178 that can push the joint 172 of the link 174 in a distal direction, either in addition to a spring biasing the flap 130^a to a closed position, in a manner that can optionally reduce the required push forces, or without s spring, in which case the rod 178 can optionally be used to actively pull the joint 172 of link 174 to move it closer to the pin 180 to move the flap 130^a to the open state, or to pull the joint 172 of link 174 to move it farther from the pin 180 to move the flap 130^a to the closed state.

[0136] In some examples, the handle 102 can optionally include an adjustment member, such as the rotatable knob 106b illustrated in Fig. 2, configured to control opening/c losing of the flap 130. In some examples, the knob 106b can optionally be operatively coupled to a proximal end of a pull-member 170, such that rotating the knob 106b can increase or decrease the tension in the pull-member 170, thereby moving the flap 130 between the open and closed states. In some examples, the knob 106b can optionally he operatively coupled to a proximal end of a rod 178, such that rotating the knob 106b can pull or push the rod 178, thereby moving the flap 130 between the open and closed states.

[0137] The wire 150 of apparatus 100 can optionally extend distally from the handle 102, such as through the shaft 112, towards the head portion 114, wherein applying a pull force on proximal ends of the wire 150 is configured to move the cutting portion 156 along a path defined by guide recesses or channel formed along the flap 130, and optionally along edges of the window 120.

[0138] Fig. 6 is a perspective view of a distal portion of an exemplary apparatus 100^c shown in an open state of the flap 130^c. Fig. 7A is an enlarged view of region 7 A of Fig. 6, in aposition of the cutting portion 156 along the cutting path, prior to applying a pull force on wire 150. Fig. 7B is a view of the region of Fig. 7A, showing the cutting portion 156 moved, relative to its position in Fig. 7A, upon initial pulling of the pull wire 150. Apparatus 100^c is an exemplary implementation of apparatus 100, and thus can optionally include any of the features described for apparatus 100, except that wire 150 of apparatus 100^c extends along edges of both the flap 130 and the window 120 in a manner that defines an advancement path of the cutting portion 156, upon pulling of the wire 150, along at least part of a circumference of the flap 130 and window 120.

[0139] A leaflet cutting apparatus 100 can optionally include one or more guide recesses 160. In some examples, the apparatus 100 includes a guide recess 160 extending along part of the flap 130. In some examples, the apparatus 100 includes a guide recess 160 extending along edges of the flap 130. In some examples, the apparatus 100 includes a guide recess 160 extending along edges of the window 120. The one or more guide recesses 160 are configured to accommodate portions of the wire 150 extendable therethrough, such that upon pulling of the wire 150, the portion extending through the one or more recesses 160 can slide along the recesses 160, thus defining a path of movement of the cutting portion 156. [0140] In some examples, the wire 150 can optionally extend through a lumen of the shaft 112, towards the flap 130. In some examples, the wire 150 can optionally extend through a wire guide shaft 192 which extends through the shaft 112, wherein the wire guide shaft 192 can optionally terminate at a distal opening 194, optionally positioned in the head portion 114 as illustrated in Fig. 6, from which the wire 150 can optionally extend toward the flap 130 and/or window 120, optionally passing through guide recesses 160 thereof.

[0141] The cutting portion 156 can optionally be a generally U-shaped or V-shape end portion of the wire 150, with two wire portions 150a and 150b continuously extending therefrom, as illustrated, for example, in Fig. 7A. The wire portions 150a and 150b can optionally pass along the flap 130 and/or window 120, optionally through corresponding guide recesses 160, and then extend into the head portion 114 and along the shaft 112, optionally with both wire portions 150a and 150b passing through a wire guide shaft 192. It is to be understood that any reference to pulling the wire 150 in a proximal direction throughout the current description and claims, may refer to simultaneously pulling the proximal ends of both wire portions 150a and 150b, for example by a pulling mechanism inside the handle 102. Nevertheless, in some examples, the two wire portions 150a and 150b can optionally be connected to each other at a portion of the wire 150 passing through the shaft 112 towards the handle 102, such that proximally pulling a single wire portion may simultaneously move both wire portions 150a and 150b and the cutting portion 156 along the path defined by the flap 130 and/or window 120.

[0142] The cutting portion 156 can optionally be initially positioned at or proximate to the flap base 136, meaning that the cutting portion 156 is closer to the flap base 136 and farther from the flap proximal end 142 in an initial position, which can optionally be the position of the cutting portion 156 during advancement of apparatus 100 through the patient's vasculature, towards the site of treatment.

[0143] The window 120 can optionally include a first window sidewall 122a and a second window sidewall 122b at opposite sides of the window 120, and the flap 130 can optionally include a first flap side wall 140a and a second flap sidewall 140b at opposite sides of the flap 130. In some examples, the width of the flap, defined between the flap sidewalls 140a and 140b, is substantially equal to, or slightly less than, the width of the window 120 defined between window sidewalls 122a and 122b, allowing the window 120 to accommodate the flap 130 therein in the closed state.

[0144] In some examples, as shown for apparatus 100^c illustrated in Figs. 6-7B, a first guide recess 160a extends along edges of the flap 130^c, and a second guide recess 160b extends along edges of the window 120. The first guide recess 160a can optionally continuously extend along the first flap sidewall 140a, the flap proximal end 142, and the second flap sidewall 140b. The second guide recess 160b can optionally continuously extend along the first window sidewall 122a, the window ceiling 124, and the second window sidewall 122b.

[0145] In some examples, the first wire portion 150a can optionally extend from the cutting portion 156 along the first flap sidewall 140a, the flap proximal end 142, the second flap sidewall 140b, and then extend into the head portion 114. The second wire portion 150b can optionally similarly extend from the cutting portion 156 along the first window sidewall 122a, the window ceiling 124, the second window sidewall 122b, and then extend into the head portion 114.

[0146] In some examples, the first wire portion 150a can optionally extend from the cutting portion 156 into and along the first guide recess 160a, and the second wire portion 150b can optionally extend from the cutting portion 156 into and along the second guide recess 160b. The first wire portion 150a can optionally enter into the first guide recess 160a at an entry point which is closer to distal end of the first flap sidewall 140a (e.g., closer to the flap base 136), and exit the first guide recess 160a at an exit point which is closer to distal end of the second flap sidewall 140b (e.g., closer to the flap base 136), extending therefrom into the head portion 114 and proximally through the shaft 112, towards the handle 102. The second wire portion 150b can optionally enter into the second guide recess 160b at an entry point which is closer to distal end of the first window sidewall 122a, and exit the second guide recess 160b at an exit point which is closer to distal end of the second window sidewall 122b, extending therefrom into the head portion 114 and proximally through the shaft 112, towards the handle 102.

[0147] In some examples, the guide recess 160 comprises a groove 162 formed at the corresponding edge of the flap 130 or the window 120. A portion of the wire 150 extending through such a guide recess 160 will have part of the wire situated inside the groove 162, and part of it protruding outwards from the corresponding edge or groove 162 thereof. In some examples, a series of sutures 196 can optionally be used to attach the wire 150 to the corresponding edge of the flap 130 and/or window 120 along the grooves 162.

[0148] In the example illustrated for apparatus 100^c in Figs. 6-7B, a series of sutures 196 are looped around the first wire portion 150a to prevent it from spontaneously separating from the groove 162a of the first guide recess 160a, and a series of sutures 196 are similarly looped around the second wire portion 150b to prevent it from spontaneously separating from the groove 162b of the second guide recess 160b.

[0149] In some examples, the handle 102 can optionally include an adjustment member, such as the rotatable knob 106c illustrated in Fig. 2, configured to control retraction of the wire 150. In some examples, the knob 106c can optionally be operatively coupled to a proximal end of the wire 150, such as to the proximal end of both wire portion 150a, 150b, such that rotating the knob 106c can optionally facilitate retraction of the wire portions 150a, 150b, thereby pulling the cutting portion 156 along a path defined by the flap 130 and/or window 120, which can be optionally a path of the corresponding guide recess(es) 160.

[0150] The wire 150 is electrically conductive, configured to deliver electric current therealong, including to the cutting portion. In some examples, at least part of the cutting portion 156 has an exposed electrically conductive surface 158. In some examples, the electric current source 108 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 proximal portion to the cutting portion 156, such as via wire portion 150a, 150b. In some examples, an exposed electrically conductive surface of the cutting portion 156 is configured to output RF energy.

[0151] In some examples, the electric current source 108 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 108 comprises a user input device, such as a switch 107 (illustrated in Fig. 2) that can optionally turn the electric current source on and off. Thus, as will be described below, the electric current can preferably be provided only when the cutting portion 156 is positioned distal to an edge of a leaflet residing between the flap 130 and the window 120.

[0152] In some examples, the wire 150 can optionally include an electrically insulating layer 154 covering at least a portion of its electrically conductive core 152. In the example illustrated in Figs. 7A-7B, the wire 150 can optionally include insulating layers 154 that completely encompass a circumference of the first and second wire portions 150a, 150b. In some examples, the first and second wire portions 150a, 150b can optionally be completely covered by insulating layers 154, while the cutting portion 156 can optionally be completely exposed, as shown for cutting portion 150^c in Figs. 7A-7B.

[0153] When electric current is provided to the wire 150 and its cutting portion 156, the cutting portion 156 can optionally cut through a target tissue, such as a leaflet of a native heart valve or a leaflet of a previously implanted prosthetic valve. In some examples, the cutting portion 156 is further configured, when the electric current is supplied thereto, to cut through sutures 196 coupling the wire 150 to the corresponding edges of the flap 130 and/or window 120, such as along grooves 162. [0154] Fig. 7A illustrates an initial position of the cutting portion 156, proximate to the flap base 136, wherein the wire portions 150a and 150b are retained in position along the corresponding grooves 162a and 162b by sutures 196. The sutures 196 can optionally be looped around the wire portions 150a, 150b, and each loop of a suture 196 can optionally extend through the wall portion on the sides of the corresponding groove 162 and be attached to the wall material of the corresponding flap 130 or head portion 114, such as by an adherent, a knot, and the like. All sutures 196 in Fig. 7A, including distal most sutures 196a and 196b, are shown to be intact prior to retraction of the wire 150. RF energy can then be supplied to the cutting portion 156, and the wire 150 can be pulled to facilitate movement of the cutting portion 156 along its path, causing the cutting portion 156 to cut through the sutures 196 as it travels along the path of the grooves 162, as shown, for example, for sutures 196a and 196b cut by the cutting portion 156 in the illustration of Fig. 7B.

[0155] The V-shaped or U-shaped tip of the cutting portion 156 can optionally include an electrically conductive surface 158, oriented towards the wire portions 150a and 150b extending from the cutting portion 156, as illustrated in Figs. 8-9. Fig. 8 shows an exemplary wire 150^d with a cutting portion 156^d, which can be similar to the cutting portion 156^c described above with respect to Figs. 7A-7B, except that a shorter portion of the cutting portion 156^d is exposed. The insulating layers 154 can optionally extend from the wire portions 150a, 150b to further cover part of the legs extending from the tip of cutting portion 156^d.

[0156] Fig. 9 shows an exemplary wire 150^e with a cutting portion 156^e, which can optionally be similar to the cutting portion 156^d described with respect to Fig. 8, except that the insulating layer 154 further extends along the entire length of cutting portion 156^e, having a cut-out exposing only the electrically conductive surface 158, while the surface opposite thereto is fully covered, including at the tip of the cutting portion 156^e. This example of a cutting portion 156^e takes advantage of the fact that in some examples, the electrically conductive surface 158 may be sufficient to cut either a leaflet tissue and/or sutures, such as sutures 196, while all other regions of the wire 150^e and its cutting portion 156^e can optionally be electrically insulated, to reduce risk of damaging anatomical structures and/or other components of the apparatus 100 when electric current is supplied to the cutting portion 156^c.

[0157] While a fully exposed cutting portion 156^c is illustrated in Figs. 6-7B, it is to be understood that the apparatus 100^c can optionally include any other example of a cutting portion, including any of cutting portion 156^d or cutting portion 156^e. Moreover, it is to be understood that any example of an apparatus 100 disclosed herein, including any of apparatus 100^f, 100^g, or 100^h that will be described below, can optionally include any example of a cutting portion 156, including any of cutting portion 156^c, 156^d, or 156^e.

[0158] Figs. 10A- 10E illustrate some steps in a method for utilizing a leaflet cutting apparatus for cutting a target leaflet, such as the anterior leaflet 38 of a mitral valve 30. The distal end portion of the apparatus 100, which can optionally include a distal end portion of the outer catheter 110 and/or the head portion 114 of shaft 112, is configured to be inserted into a patient’s vasculature, such as within the inferior vena cava 16, and to be advanced towards and passed through the interatrial septum 24 of the subject (septum 24 indicated in Fig. 1 A).

[0159] In some examples, delivery of an apparatus 100 begins by advancing a semi-rigid guidewire 80 into a right atrium 18 of a heart 10 of the patient. The procedure is typically performed with the aid of imaging, such as fluoroscopy, transesophageal echo, and/or echocardiography. The guidewire 80 provides a guide for the subsequent advancement of the outer catheter 110 therealong and into the right atrium 18. Once distal end portion of the outer catheter 110 has entered the right atrium 18, the guidewire 80 is retracted from the subject's body.

[0160] For applications in which apparatus 100 is used to modify a leaflet of the mitral valve 30 of the patient, the outer catheter 110 is typically configured for initial advancement through the patient's vasculature into the right atrium 18 and through the septum 24, until the distal end portion of the outer catheter 110 is positioned in the left atrium 26. The distal end portion of the outer catheter 110 can be 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. [0161] In some examples, the apparatus 100 is advanced through the vasculature into the right atrium 18 using a suitable point of origin typically determined for a given patient. In some examples, the apparatus 100 is introduced into the femoral vein of the patient, through the inferior vena cava 16, into the right atrium 18, and into the left atrium 26 transseptally, typically through the fossa ovalis (hidden from view in Fig. 10A). In some examples, the apparatus 100 is introduced into the basilic vein, through the subclavian vein to the superior vena cava, into the right atrium 18, and into the left atrium 26 transseptally, typically through the fossa ovalis (not shown). In some examples, the apparatus 100 is introduced into the external jugular vein, through the subclavian vein to the superior vena cava, into the right atrium 18, and into the left atrium 26 transseptally, typically through the fossa ovalis (not shown).

[0162] In some examples, a resilient needle and a dilator (not shown) are advanced through the outer catheter 110 and/or through the shaft 112 and into the heart 10. In order to advance the apparatus 100 transseptally into the left atrium 26, the dilator is advanced to the septum 24, and the needle is pushed from within the dilator and is allowed to puncture the septum to create an opening that facilitates passage of the dilator and subsequently the outer catheter 110 and/or shaft 112 therethrough and into the left atrium 26.

[0163] During delivery into the left atrium 26 and towards the mitral leaflet 34, the head portion 114 can optionally be fully or partially retained inside the outer catheter 110. In some examples, the head portion 114 can be at least partially retained inside the outer catheter 110, while the nosecone 116 can be exposed, extending past the distal end of the outer catheter 1 10, to facilitate smooth passage of the apparatus 100 through the vasculature and anatomic structures. [0164] Upon approximation to the mitral leaflet 34, the shaft 112 can optionally be axially advanced relative to the outer catheter 110, so as to expose the head portion 114, as illustrated in Fig. 10B. The flap 130 is in a closed state as the head portion 114 is exposed, and the head portion can optionally be further advanced in the distal direction, through the mitral valve 30 and into the left ventricle 28, as shown in Fig. 10C. In some examples, the handle 102 can optionally include an adjustment member, such as the rotatable knob 106d illustrated in Fig. 2, configured to control axial movement of the shaft 112. In some examples, the knob 106d can optionally be operatively coupled to a proximal end of the shaft 112, such that rotating the knob 106d in one direction can facilitate advancement of the shaft 112, thereby exposing the head portion 114 out of the outer catheter 110, and rotating the knob 106d in the opposite direction can optionally facilitate retraction of the shaft 112, thereby reconcealing it inside the outer catheter 110.

[0165] Advancement of the head portion 114 into the left ventricle 28, with the flap 130 retained in the closed state, can optionally be performed until the flap 130 is positioned below the mitral leaflets 34, for example such that the flap proximal end 142 is distal to the free edge of the anterior leaflet 38, at which point the flap 130 can be moved to the open state, as shown in Fig. 10D. This creates a gap between the flap 130 and the window 120, into which a distal portion of the anterior leaflet 38 can optionally be inserted upon retraction of the shaft 112 and its head portion 114 in the proximal direction, as shown in Fig. 10E.

[0166] The flap 130 can optionally be moved to an open state, when positioned distal to the anterior leaflet 38 as shown in Fig. 10D, distancing the flap proximal end 142 away from the window ceiling 124 at a distance sufficient to conveniently position the distal end of the leaflet 38 therein, when the head portion 114 is proximally pulled to the position shown in Fig. 10E. In some examples, the opening and closing of the flap 130 can optionally be controllably adjusted by the user (e.g., clinician), to adjust the distance according to patient-specific anatomy.

[0167] In some examples, as further illustrated in Fig. 10E, once the leaflet 38 is positioned inside the gap between the flap 130 and the window 120, the flap 130 can optionally be moved towards the window 120, closed to a closed state (yet not necessarily fully closed against the window 120), to tightly press the anterior leaflet 38 between the flap 130 and the window 120. [0168] Figs. 11A-11E illustrate some steps in an exemplary method for utilizing a leaflet cutting apparatus 100, such as apparatus 100^c, for cutting a target leaflet. The steps illustrated in Figs. 11 A- HE can optionally be performed subsequent to the steps described above with respect to Figs. 10A-10E, to cut a section of the anterior leaflet 38, which can optionally be a U-shaped cut-out, or have any other shape, dictated by the path of advancement of the cutting portion 156.

[0169] When the leaflet 38 is properly positioned between the flap 130 and the window 120 as described above with respect to Fig. 10E, the cutting portion 156 of the wire 150, which is in close proximity to the flap base 136, is positioned distally to a free edge of the leaflet 38, with the electrically conductive surface 158 facing the free edge of the leaflet 38. Retraction of the wire 150 while electric current is provided to its cutting portion 156, causes the cutting portion 156 to cut through the leaflet as it travels along the path defined by the guide recess(es) 160.

[0170] As shown in Fig. 11 A, pulling the proximal ends of the wire portion 150a, 150b in a proximal direction 82 moves the cutting portion 156 in a proximal direction 82 along the first flap sidewall 140a, from its initial position, closer to the flap base 136, toward the free edge of the leaflet 38. Upon contacting the leaflet 38, the cutting portion 156 cuts through the leaflet, as shown in Fig. 1 IB, all the way up to the flap proximal end 142. Continued proximal pulling of the proximal ends of the wire portion 150a, 150b further moves the cutting portion 156 to cut through the leaflet 38 along the flap proximal end 142, traveling in a lateral direction 84 between the first flap sidewall 140a and the second flap sidewall 140b, as shown in Fig. 11C. Continued proximal pulling of the proximal ends of the wire portion 150a, 150b further moves the cutting portion 156 to cut through the leaflet 38 along the second flap sidewall 140b, traveling in the distal direction 86 as shown in Fig. HD, until the cutting portion passes the free edge of the leaflet 38, as shown in Fig. 1 IE, at which point the wire 150 can optionally be further pulled, or pulling of the wire 150 can optionally terminate, and at which point electric current no longer needs to be supplied to wire 150.

[0171] In the examples illustrated in Figs. 11A-11E, a fully U-shaped segment of tissue is cut and completely separated from the rest of the leaflet 38. However, it is to be understood that other shapes of a cut-out tissue are contemplated. For example, the flap 130 and/or window can optionally be formed to have any desired shape, such as V-shape, semi-circular or otherwise curved shapes, and the like. Moreover, in some examples, the path along which the cutting portion 156 is configured to travel can optionally be different from the shape of flap 130 and/or window 120. For example, while the guide recesses 160 illustrated in Fig. 6 is shown to extend along, or at least parallel to, edges of the flap 130 and/or window 120, in some examples, at least some portions of one or more guide recesses 160 can optionally extend through portions of the flap 130 and/or head portion 1 14 that are not necessarily parallel to the edges of the flap 130 and/or window 120.

[0172] Figs. 12A-12B illustrate some steps in an exemplary method for utilizing a leaflet cutting apparatus 100 for cutting a target leaflet, which can optionally be performed subsequent to cutting the leaflet. The steps illustrated in Figs. 12A-12B can optionally be performed subsequent to the steps described above with respect to Figs. 11 A- 1 IE, to retrieve the apparatus 100 from the patient's body. Once a cut-out tissue segment is completely cut and separated from the remainder of leaflet 38, as shown in Fig. HE, it is trapped between the flap 130 and the window 120 of the head portion 114 in a manner that can prevent it from being released into the blood stream. In some examples, as shown in Fig. 12A, the flap 130 can optionally be further moved radially inwards, to or further towards the closed state, to improve securement of the cut-out tissue segment of the leaflet to the head portion 114.

[0173] Subsequent to completion of the cutting procedure, the apparatus 100 can be retrieved from the patient's body, as shown in Fig. 12B, with the cut-out tissue segment safely secured to the head portion 114 and removed therewith. This procedure of cutting the anterior leaflet 38 helps prevent the anterior leaflet 38 from obstructing or otherwise interfering with the LVOT 40. As further illustrated in Fig. 12B, the shaft 112 can be proximally pulled to as to reconceal the head portion 114 and the cut-out tissue segment secured thereto, inside the outer catheter 110, subsequent to completion of the cutting procedure. After retrieval of the apparatus 100, a new prosthetic valve 50 can be implanted in the native mitral valve 30, as illustrated in Fig. IB, wherein blood can flow through uncovered cells 60 of the valve 50 and the cut-out segment of the anterior leaflet 38. In some examples, the apparatus 100 can be retrieved while the guidewire 80 remains in position, and the new prosthetic valve 50 can be delivered over the guidewire 80. In some examples, the shaft 112 can be retrieved while the outer catheter 110 remains in position, and the new prosthetic valve 50 can be delivered through the outer catheter 110. [0174] While methods of utilizing a leaflet 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 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 22, a leaflet of a native aortic valve 14, or a leaflet of a previously implanted prosthetic valve. For example, if modification of a leaflet of a tricuspid valve 22 is desired, advancement of an apparatus 100 towards the annulus of a tricuspid valve 22 can be performed in a similar manner to that described above with respect to the mitral valve 30, hut without penetrating the septum, with the distal end portion of the apparatus positioned in the right atrium 18, similarly advancing the head portion 114 through the tricuspid valve 22 towards the right ventricle 20.

[0175] In some examples, the leaflet cutting apparatus 100 can optionally include a contrast injection member 188 positioned next to the head portion 114, as shown in Fig. 13. The contrast injection member 188 can optionally have one or more holes 190 and be fluidly connected to a fluid channel extending through a lumen of the outer catheter 110. The fluid channel can optionally be fluidly coupled to a fluid injection port 104 located on the handle 102 of the apparatus 100, such as port 104a illustrated in Fig. 2. By injecting a dye into the fluid injection port 104a, the dye can flow through the fluid channel and be ejected out of the contrast injection member 188 through the one or more holes 190. The ejected dye can provide visual cue for proper engagement of the flap 130 and the leaflet grasped between the flap 130 and the head portion 114.

[0176] Fig. 14A is a perspective view of a distal portion of an exemplary apparatus 100^f shown in an open state of the flap 130^f. Fig. 14B is an enlarged perspective view of the flap 130^f of the apparatus 100^f of Fig. 14A. Fig. 14C is a cross-sectional view along line 14C-14C of Fig. 14B. Apparatus 100^f is an exemplary implementation of apparatus 100, and thus can optionally include any of the features described for apparatus 100, except that apparatus 100^f includes guide recesses 160 configured to slidably couple wire portions 150a, 150b to the flap 130 and/or window 120 without the need to use suture loops. In some examples, as shown in Figs. 14A-14B, a guide recess 160 includes a slot 164 leading to an inner semi-circular channel 166. The slot 164 is open ended at the surface along which the guide recess 160 is defined, and is continuous with the inner semi-circular channel 166, positioned inside the wall material of the corresponding flap 130 or head portion 114 surrounding the window 120, below the corresponding surface at the opposite end of the slot 164. [0177] For example, the guide recesses 160 illustrated in Figs. 14B-14C is shown to include a slot 164 extending from the flap inner surface 132 to an inner semi-circular channel 166 residing inside the flap 130^f. The center of the inner semi-circular channel 166 can optionally be laterally offset from a longitudinal axis of the slot 164, and sized to as to accommodate a corresponding portion of the wire 150. The width of the slot 164 can optionally be similar to, or slightly greater than, the diameter of the wire 150, to allow passage of the wire 150 therethrough, for example at the portion of the wire 150 leading to the cutting portion 156. The diameter of the inner semi-circular channel 166 can optionally be configured to slightly press against the portion of the wire 150 residing therein, so as to retain it in position and prevent the wire 150 from being spontaneously released therefrom, yet allow the wire 150 to smoothly slide therealong when proximally pulled to cut a leaflet, for example.

[0178] In some examples, the guide recesses 160 can optionally be formed in close proximity to the edges of the corresponding flap 130^f, such that the slot 164 is laterally offset by a relatively small distance from the corresponding flap sidewalls 140 and flap proximal end 142. It is to be understood that any type of first guide recess 160a disclosed herein to extend along a flap 130, including a guide recess 160 that comprises a groove 162 as illustrated in Figs. 6- 7B, or a guide recess 160 that comprises a slot 164 leading to an inner semi-circular channel 166 as illustrated in Figs. 14A-14C, can optionally be formed on any appropriate parts of the flap 130, such as over the flap sidewalls 140 and/or flap proximal end 142 as illustrated in Figs. 6-7B, or such as over the flap inner surface 132, optionally following the contour of the flap 130, as illustrated in Figs. 14A-14C.

[0179] One advantage associated with the type of guide recesses 160 described above to include the slot 164 and inner channel 166, is that the cutting portion 156 does not need to cut through suture 196, making it easier for the cutting portion to travel along the guide recesses 160 while cutting the leaflet. Another advantage is that the manufacturing procedure is simplified, without the need to add suture attachment.

[0180] In some examples, the head portion 114 further comprises a step 126 defined along the edges of the window 120, which can optionally extend from the window sidewalls 122 and ceiling 124, wherein the step 126 can optionally define a window outer surface 128 oriented outwardly, such as towards the flap inner surface 132, as illustrated in Fig. 14A. The second guide recess 160b, optionally having a configuration similar to that described above with respect to Figs. 14B-14C, having a slot 164 leading to an inner channel 166, can optionally be formed in the step 126, with the slot 164 exposed at the window outer surface 128. In some examples, the second guide recess 160b can optionally be aligned with the first guide recess 160a, such as by aligning the corresponding slots 164 of both recesses 160a, 160b in front of each other, in the closed state of the flap 130. Such a configuration can ensure a desired orientation of the cutting portion 156, such that the plane of the cutting portion 156 can optionally be substantially orthogonal to the plane of the window 120 and/or the plane of a leaflet 38 retained between the flap 130 and window 120.

[0181] While a step 126 defining a window outer surface 128 is illustrated in Fig. 14A as part of a head portion 114^f of apparatus 100^f, it is to be understood that the head portion 114 of any other exemplary apparatus 100 disclosed herein, can optionally be provided with a similar step 126 defining a window outer surface 128, including, for example, the head portion 114^c of apparatus 100^c.

[0182] It is to be understood that any reference to a cutting portion 136 sliding or traveling along edges of the flap 130 and/or window 120, throughout the specification and the claims, can refer to a sliding bath passing directly at the edges, such as over sidewalls 140 and a proximal end 142 of the flap 130 and/or sidewalls 122 and a ceiling 124 of the window 120, or to a path that runs substantially parallel to these edges, but may be somewhat distanced from the corresponding edges themselves. Similarly, any reference to guide recess(es) 160 extending along edges of the flap 130 and/or window 120, throughout the specification and the claims, can refer to guide recess(es) 160 formed directly on the edges, such as on sidewalls 140 and a proximal end 142 of the flap 130 and/or sidewalls 122 and a ceiling 124 of the window 120, or to guide recess(es) 160 defined at portions of the flap 130 and/or head portion 114, extending substantially parallel to these edges, optionally being somewhat distanced from the corresponding edges themselves.

[0183] Fig. 15 is a perspective view of a distal portion of an exemplary apparatus 100⁸ shown in an open state of the flap 130^s. Apparatus 100^s is an exemplary implementation of apparatus 100, and thus can optionally include any of the features described for apparatus 100, except that apparatus 100^g does not include guide recesses 160 the follow the contour of the flap 130 and/or window 120. Instead, the leaflet cutting apparatus 100^g includes two tubular arms 144 extending through the shaft 112⁸, wherein the tubular arms 144 can optionally extend radially away from the head portion 114^s, with the portions of the arms 144 extending away from the head portion 114^g positioned on opposite sides of the flap 130^g.

[0184] In some examples, the tubular arms 144 can optionally extend through a lumen of the shaft 112^s and the head portion 114^s, extending out of the head portion 114⁸ through corresponding head opening 148. In some examples, the head openings 148 are positioned distal to the flap proximal end 142. While the head openings 148 are shown to be positioned distal to the flap base 136 in Fig. 15, it is to be understood that in some examples, the head openings 148 can optionally be at the level of the flap base 136, or at an axial position between the flap base 136 and the flap proximal end 142, such as at a circumferential distance from the corresponding window sidewalls 122.

[0185] In some examples, the tubular arms 144 are axially movable relative to the shaft 112⁸. For example, during delivery of the apparatus 100^s and prior to opening the flap 130^s, as described above with respect to Figs. 10A-10C, the tubular arms 144 can optionally be mostly or entirely concealed inside the shaft 1 12 and/or head portion 114^g thereof, such that no part of the tubular arms 144 extends out of the head opening 148, or a relatively short portion of the tubular arms 144 can optionally extend from the head openings 148.

[0186] After opening the flap 130^s, and prior to initiating retraction of the wire 150 to cut a leaflet 38, the tubular arms 144 can optionally be distally advanced relative to the shaft 112^s and/or head portion 114^s, thereby exposing a longer portion of the tubular arms 144 extending out of the corresponding head openings 148, distancing open-ended distal ends 146 thereof, farther away from both sides of the flap 130^s.

[0187] A flexible retainer 168 can optionally extend through a first tubular arm 144a and terminate with a loop 169 extending out the distal end 146a of the first tubular arm 144a. The flexible retainer can optionally be in the form of a wire, suture, cable, string, and the like. Both wire portions 150a and 150b of apparatus 100^g can optionally extend through a second tubular arm 144b and out of the distal end 146b of the second arm 144b, with the exposed part of the wire portions 150a, 150b extending out of the second arm 144b towards the distal end 146a of the first arm 144a, with the cutting portion 156 coupled to the loop 169. In some examples, the loop 169 is an integral end of the flexible retainer 168, wherein the flexible retainer can optionally be in the form of a wire, sting or suture that extends longitudinally through the first tubular arm 144a and then outwardly from the distal end 146a, looping around the cutting portion 156, thereby forming loop 169, and extending therefrom back into the opening at the distal end 146a and the first arm 144a.

[0188] In some examples, a guide recess 160 can optionally be formed along at least a portion of the flap proximal end 142, which can optionally be any type of recess disclosed herein, such as a groove 162 or a slot 164 leading to an inner channel 166. The guide recess 160 of flap 130^s is configured to support the first wire portion 150a, such that the first wire portion 150a can optionally extend from the distal end 146b of the second arm 144b, over the flap proximal end 142, optionally along a guide recess 160 formed thereon, and towards the loop 169 extending from, or in close proximity to, the distal end 146a of the first arm 144a. When a guide recess 160 along the proximal end 142 of flap 130^g is provided as a groove 162, sutures 196 can be optionally added in the same manner described above with respect to Figs. 7A-7B, or the apparatus 100^g can optionally be provided without such suture 196, as the wire portion 150a can optionally be tightly pressed against the flap proximal end 142 by applying tension to the wire 150.

[0189] In some examples, the head portion 114^g further comprises a retaining channel 125 extending along at least part of the window ceiling 124, as illustrated in Fig. 15. The retaining channel 125 can optionally be a channel formed through the material of head portion 114^g with an entry opening and an exit opening at two sides of the window ceiling 124. The retaining channel 125 is configured to support the second wire portion 150b, such that the second wire portion 150b can optionally extend from the distal end 146b of the second arm 144b, towards and along the window ceiling 124, optionally passing through a retaining channel 125, and towards the loop 169, in close proximity to the distal end 146a of the first arm 144a. In some examples, the retaining channel can optionally be replaced by a guide recess 160 that can optionally be formed along at least a portion of the window ceiling, which can optionally be any type of recess disclosed herein, such as a groove 162 or a slot 164 leading to an inner channel 166. When a guide recess 160 along the window ceiling 124 is provided as a groove 162, sutures 196 can optionally be added in the same manner described above with respect to Figs. 7A-7B to prevent the first wire portion 150a from falling off the groove 162.

[0190] Figs. 16A-16B illustrate some steps in an exemplary method for utilizing a leaflet cutting apparatus 100, such as apparatus 100^g, for cutting a target leaflet. Steps illustrated in Figs. 16A-16B can optionally be performed subsequent to steps described above with respect to Figs. 10A-10E, to cut a section of the anterior leaflet 38.

[0191] Prior to retraction of the wire 150 to cut a section of the leaflet 38, the tubular arms 144 can be distally pushed, causing distal portions thereof to extend outwards through the head openings 148, in an outwardly oriented direction 88, distancing the distal ends 146 of the tubular arms 144 farther away from the head portion 114. While Fig. 16A illustrated deployment of the tubular arms 144 in an outwardly oriented direction 88 after positioning the leaflet 38 between the flap 130^s and the window 120, which can optionally be performed subsequent to the step described above with respect to Fig. 10E, it is to be understood that the tubular arms 144 can optionally be similarly deployed to extend outwardly in direction 88 out of the head portion 144⁸ prior to positioning of the leaflet 38 between the flap 130^g and the head portion 114^s, such as subsequent to positioning of the head portion 114^g distal to the mitral valve 30, as described above with respect to Fig. 10D, but before proximal retraction of the head portion 114^s to position the leaflet 38 in the position illustration in Fig. 10E.

[0192] Both wire portions 150a, 150b can optionally be axially movable through and relative to the second tubular arm 144b, and the flexible retainer 168 can optionally be axially movable, optionally in a passive manner, relative to the first tubular arm 144a. As shown in Fig. 16B, retraction of the wire 150 while electric current is provided to its cutting portion 156, causes the cutting portion 156 to cut through the leaflet as it travels along a path 90 defined between the distal end 146a of the first arm 144a, the regions of the flap proximal end 142 and window ceiling 124, and the distal end 146b of the second arm 144b. The tissue section cut from the leaflet 38 utilizing apparatus 100^g can optionally be relatively wider than that described above for an apparatus 100^c described with respect to Figs. 11A-1 IE. Following the cutting procedure of Figs. 16A-16B, retraction of the apparatus 100^g can optionally be performed in a similar manner to that described above with respect to Figs. 12A-12B, and a prosthetic valve 50 can optionally be subsequently implanted in a similar manner to that described above.

[0193] In some examples, the leaflet cutting apparatus 100 can optionally include one or more tubes through which insulator fluid can be injected towards the cutting member 156. In some examples, insulator fluid 94, such as nonionic 5% dextrose, can optionally be injected through the first tubular arm 144a, as shown in Fig. 17. The first tubular arm 144a can optionally be fluidly coupled, in such examples, to an insulator fluid injection port 104 located on the handle 102 of the apparatus 100, such as port 104b illustrated in Fig. 2. By injecting an insulator fluid 94 into the port 104b, the fluid can flow through the first tubular arm 144a and be ejected out of the open ended distal end 146a. The ejected insulator fluid 94 can optionally displace blood to confine RF current to leaflet being cut by the cutting portion 156.

[0194] In some examples, the apparatus 100 further comprises at least one injection tube 184 disposed around the wire 150. Fig. 18 shows an exemplary apparatus 100^s in which the wire portions 150a, 150b extend through insulator fluid injection tubes 184, terminating at distal opening 186 proximal to the cutting portion 156. The injection tubes 184 can optionally be fluidly coupled to a port of the handle, such as to port 104b, through which they can be fed with insulating fluid 94 in a similar manner. In some examples, the injection tubes 184 can optionally be disposed around the insulating layers 154 of the wire portions 150a, 150b. In some examples, the injection tubes 184 are configured to move along with the wire 150 such that the openings 186 remain in the same position relative to the cutting portion 156. This allows the injected insulation fluid 94 to be directed towards the moving portion of the cut tissue as the cutting portion 156 travels along the designated cutting path. While injection tubes 184 are illustrated around wire 150 of apparatus 100^g in Fig. 18, it is to be understood that injection tubes 184 can optionally be similarly added around the wire 150 of any other exemplary apparatus 100 disclosed herein, such as apparatus 100^c described above or apparatus 100^h which will be described below.

[0195] Fig. 19 is a perspective view of a distal portion of an exemplary apparatus 100^h shown in an open state of the flap 130^h. Apparatus 100^h is an exemplary implementation of apparatus 100, and thus can optionally include any of the features described for apparatus 100, except that in contrast to apparatus 100^c or apparatus 100^g, for example, the apparatus 100^h is not configured to cut a section of the leaflet, but rather to split the leaflet by forming a linear cut or slit. As illustrated in Fig. 19, the first wire portion 150a can optionally extend along part of the flap 130^h, while the second wire portion 150b can optionally extend through the head portion 114^h without being attached to any edge of the window 120.

[0196] In some examples, the cutting portion 156 can optionally be positioned at an intermediate position between the flap sidewalls 140, over the flap inner surface 132, at an initial position proximate the flap base 136. In some examples, the head portion 114^h can optionally include a through opening 198 positioned distal to the flap base 136, through which a portion of the wire 150 can extend. In the example illustrated in Fig. 19, the first wire portion 150a can optionally extend from the inside of the head portion 114^h outwards through the opening 198, then extend proximally from the opening 198, over the flap outer surface 134, bend over the flap proximal end 142, and extend distally over the flap inner surface 132, terminating at the cutting portion 156 proximate the flap base 136. In some examples, the first wire portion 150a is equally distanced from both of the flap sidewalls 140a and 140b.

[0197] In some examples, the portion of the wire 150 extending over the flap 130^h, can optionally pass along a guide recess 160 that can optionally be formed over the flap outer surface 134, the flap proximal end 142, and the flap inner surface 132, wherein the guide recess 160 can optionally be implemented according to any example described herein, such as by including a groove 162, optionally utilized with sutures 196, or by including a slot 164 leading to an inner channel 166. In some examples, the guide recess 160 is equally distanced from both of the flap sidewalls 140a and 140b.

[0198] Figs. 20A-20C illustrate some steps in an exemplary method for utilizing a leaflet cutting apparatus 100, such as apparatus 100^h, for cutting a target leaflet. Steps illustrated in Figs. 20A-20C can optionally be performed subsequent to steps described above with respect to Figs. 10A-10E, to split the anterior leaflet 38 but forming a linear cut. [0199] When the leaflet 38 is properly positioned between the flap 130 and the window 120 as described above with respect to Fig. 10E, the cutting portion 156 of the wire 150 of apparatus 100^h, which is in close proximity to the flap base 136 along the flap inner surface 132, is positioned distally to a free edge of the leaflet 38, with the electrically conductive surface 158 facing the free edge of the leaflet 38, as shown in Fig. 20A.

[0200] As shown in Fig. 20B, pulling the proximal ends of the wire portion 150a, 150b in a proximal direction 82 moves the cutting portion 156 in a proximal direction 82 along the flap inner surface 132, from its initial position, closer to the flap base 136, thereby cutting through the leaflet. The full cut of the leaflet 38 is formed when the cutting portion 156 reaches the flap proximal end 142, as shown in Fig. 20C, at which point the wire 150 can be further pulled, or pulling of the wire 150 can terminate, and at which point electric current no longer needs to be supplied to wire 150. Following the cutting procedure of Figs. 20A-20C, retraction of the apparatus 100^h can optionally be performed in a similar manner to that described above with respect to Figs. 12A-12B, and a prosthetic valve 50 can optionally be subsequently implanted in a similar manner to that described above.

[0201] While the cutting portion 156 of the wire 150 is described above as a portion configured to cut through tissue, such as a leaflet, via an electrically conductive surface thereof, configured to conduct electric current, in some examples, the cutting portion 156 can optionally include a sharp edge that can face the target tissue, such as at the position indicated for surface 158, wherein the sharp edge can optionally serve as a blade that mechanically cuts through tissue, such as a leaflet, and/or other materials, such as suture 196, as the wire 150 is pulled and the cutting portion 156 travels along the designated path, as described above.

[0202] 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

[0203] 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 example taken 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. [0204] Example 1. A leaflet cutting apparatus comprising: a shaft comprising a head portion; a flap pivotably coupled to the head portion, the flap comprising: a flap proximal end; a flap base opposite to the flap proximal end; a first flap sidewall and a second flap sidewall extending between the flap base and the flap proximal end; a flap inner surface; and a flap outer surface opposite to the flap inner surface; and a wire extending through the shaft and comprising a cutting portion, wherein the wire is slidably coupled to the flap and the cutting portion is configured to move along the flap; wherein the flap is configured to move between an open state and a closed state, such that the flap proximal end is at a greater distance from the head portion in the open state than in the closed state.

[0205] Example 2. The apparatus of any example herein, particularly of example 1, wherein the cutting portion is V-shaped or U-shaped.

[0206] Example 3. The apparatus of any example herein, particularly of example 1 or 2, wherein the wire comprises a first wire portion and a second wire portion continuously extending from the cutting portion and through the shaft.

[0207] Example 4. The apparatus of any example herein, particularly of any one of examples 1 to 3, wherein the cutting portion is configured to slide along the flap when a proximal end of the wire is proximally pulled.

[0208] Example 5. The apparatus of any example herein, particularly of example 3, the cutting portion is configured to slide along the flap when the first wire portion and the second wire portion are proximally pulled through the shaft.

[0209] Example 6. The apparatus of any example herein, particularly of any one of examples 1 to 5, wherein the wire comprises an electrically conductive core configured to conduct electricity towards the cutting portion.

[0210] Example 7. The apparatus of any example herein, particularly of example 6, wherein the cutting portion comprises an uncovered electrically conductive surface.

[0211] Example 8. The apparatus of any example herein, particularly of example 7, wherein, when a leaflet is grasped between the flap and the head portion, the electrically conductive surface is oriented towards a free edge of the leaflet.

[0212] Example 9. The apparatus of any example herein, particularly of example 6 or 7, wherein the cutting portion comprises an insulating layer covering regions that exclude the electrically conductive surface, while the electrically conductive surface is an exposed surface. [0213] Example 10. The apparatus of any example herein, particularly of any one of examples 7 to 9, wherein the electrically conductive surface is configured to output radio-frequency energy. [0214] Example 11. The apparatus of any example herein, particularly of example 3, wherein each of the first wire portion and the second wire portion comprises an electrically conductive core surrounded by an insulating layer.

[0215] Example 12. The apparatus of any example herein, particularly of any one of examples 6 to 11, further comprising an electric current source configured to provide electric current to the wire.

[0216] Example 13. The apparatus of any example herein, particularly of example 12, wherein the provided electric current is an alternating current.

[0217] Example 14. The apparatus of any example herein, particularly of example 13, wherein a frequency of the alternating current is a radio-frequency.

[0218] Example 15. The apparatus of any example herein, particularly of any one of examples 12 to 14, wherein the electric current source is configured, responsive to a user input, to alternately provide the electric current and not provide the electric current.

[0219] Example 16. The apparatus of any example herein, particularly of example 3, wherein the head portion comprises a window configured to accommodate the flap in the closed state, the window comprising a first window sidewall, a second window sidewall, and a window ceiling extending between the first and the second window sidewalls.

[0220] Example 17. The apparatus of any example herein, particularly of example 16, wherein, when the flap is in the closed state, the first window sidewall is aligned with the first flap sidewall, the second window sidewall is aligned with the second flap sidewall, and the window ceiling is aligned with the flap proximal end.

[0221] Example 18. The apparatus of any example herein, particularly of example 16 or 17, wherein the wire is movably coupled to at least one guide recess of the apparatus.

[0222] Example 19. The apparatus of any example herein, particularly of example 18, wherein the at least one guide recess comprises a groove over which the wire extends.

[0223] Example 20. The apparatus of any example herein, particularly of example 19, wherein the wire is coupled to the at least one guide recess by sutures looped around the wire.

[0224] Example 21. The apparatus of any example herein, particularly of example 20, wherein, when the wire is slid along the at least one guide recess, the cutting portion is configured to cut through one or more of the sutures.

[0225] Example 22. The apparatus of any example herein, particularly of example 21, wherein the sutures are attached to portions of the apparatus surrounding the corresponding guide recess, such that when one or more of the sutures are cut by the cutting portion, the cut portions of the sutures remain attached to the apparatus. [0226] Example 23. The apparatus of any example herein, particularly of example 18, wherein the at least one guide recess comprises an inner semi-circular channel through which the wire extends, and a slot extending between the inner semi-circular channel and a surface of the apparatus.

[0227] Example 24. The apparatus of any example herein, particularly of any one of examples 18 to 23, wherein the at least one guide recess comprises a first guide recess formed on the flap.

[0228] Example 25. The apparatus of any example herein, particularly of example 24, wherein the first guide recess continuously extends along the first flap sidewall, the flap proximal end, and the second flap sidewall.

[0229] Example 26. The apparatus of any example herein, particularly of example 25, wherein the first wire portion continuously extends from the cutting portion along the first guide recess. [0230] Example 27. The apparatus of any example herein, particularly of any one of examples

24 to 26, wherein the at least one guide recess comprises a second guide recess formed on the head portion and extending along edges of the window.

[0231] Example 28. The apparatus of any example herein, particularly of example 27, wherein the second guide recess continuously extends along the first window sidewall, the window ceiling, and the second window sidewall.

[0232] Example 29. The apparatus of any example herein, particularly of example 28, wherein the head portion further comprises a step extending from the first window sidewall, the window ceiling, and the second window sidewall, and wherein the second guide recess is formed on a window outer surface defined by the step.

[0233] Example 30. The apparatus of any example herein, particularly of example 29, wherein the second wire portion continuously extends from the cutting portion along the second guide recess.

[0234] Example 31. The apparatus of any example herein, particularly of any one of examples

25 to 30, wherein, when the wire is pulled, the cutting portion is configured to slide along a path extending proximally from a position proximate the flap base towards the proximal end of the flap, slide laterally at or parallel to the flap proximal end towards the second flap sidewall, and slide distally from a position at or proximate to the flap proximal end towards the flap base.

[0235] Example 32. The apparatus of any example herein, particularly of example 31, wherein, when a leaflet is positioned between the flap and the window, the cutting portion is configured to cut a section of the leaflet having the shape of the path along which the cutting portion is slid during pulling of the wire.

[0236] Example 33. The apparatus of any example herein, particularly of example 16 or 17, further comprising two tubular arms extending through the shaft, and wherein the head portion comprises two head openings through which the corresponding tubular arms are configured to extend away from or closer to the head portion.

[0237] Example 34. The apparatus of any example herein, particularly of example 33, wherein the head openings are positioned on opposite sides of the window.

[0238] Example 35. The apparatus of any example herein, particularly of example 33 or 34, wherein the head openings are closer to the flap base than the flap proximal end.

[0239] Example 36. The apparatus of any example herein, particularly of example 35, wherein the head openings are distal to the flap base.

[0240] Example 37. The apparatus of any example herein, particularly of any one of examples 33 to 36, wherein the tubular arms are axially movable relative to the shaft.

[0241] Example 38. The apparatus of any example herein, particularly of example 37, wherein, when portions of the tubular arms residing in the shaft are distally pushed, distal ends of the tubular arms are configured to move away from the head portion.

[0242] Example 39. The apparatus of any example herein, particularly of example 38, wherein the tubular arms comprise a first tubular arm and a second tubular arm, wherein the wire extends through the second tubular arm and is axially movable relative to the second arm.

[0243] Example 40. The apparatus of any example herein, particularly of example 39, wherein the first wire portion and the second wire portion extend through the second tubular arm and past a tube opening of the first tubular arm towards the distal end of the second tubular arm.

[0244] Example 41. The apparatus of any example herein, particularly of example 40, wherein the cutting portion is coupled to a loop extending from or coupled to the first tubular arm.

[0245] Example 42. The apparatus of any example herein, particularly of example 41, further comprising a flexible retainer attached to the loop and extending through the first tubular arm. [0246] Example 43. The apparatus of any example herein, particularly of example 42, wherein the flexible retainer is axially movable relative to the first tubular arm.

[0247] Example 44. The apparatus of any example herein, particularly of example 43, wherein, when the wire is pulled, the loop is configured to move along with the cutting portion.

[0248] Example 45. The apparatus of any example herein, particularly of any one of examples 40 to 44, wherein the distal ends of the tubular arms are configured to be closer to the flap base than the flap proximal end when the tubular arms are extended away from the head portion. [0249] Example 46. The apparatus of any example herein, particularly of example 45, wherein the cutting portion is positioned closer to the distal end of the first tubular arm than the flap proximal end when the tubular arms are extended away from the head portion.

[0250] Example 47. The apparatus of any example herein, particularly of example 46, wherein the first wire portion continuously extends from the cutting portion, towards and over the flap proximal portion, and towards the distal end of the first tubular arm.

[0251] Example 48. The apparatus of any example herein, particularly of example 47, wherein the first wire portion is slidably movable over the flap proximal end.

[0252] Example 49. The apparatus of any example herein, particularly of example 46 or 47, wherein the first wire portion extends along a guide recess defined over a portion of the flap proximal end.

[0253] Example 50. The apparatus of any example herein, particularly of any one of examples 47 to 49, wherein the second wire portion continuously extends from the cutting portion, towards and along the window ceiling, and towards the distal end of the first tubular arm.

[0254] Example 51. The apparatus of any example herein, particularly of example 50, wherein the second wire portion is slidably movable relative to the window ceiling.

[0255] Example 52. The apparatus of any example herein, particularly of example 50 or 51, wherein the second wire portion is slidably coupled to the window ceiling in a manner that prevents it from spontaneously falling of the window ceiling.

[0256] Example 53. The apparatus of any example herein, particularly of example 52, wherein the window ceiling comprises a retaining channel through which the second wire portion extends.

[0257] Example 54. The apparatus of any example herein, particularly of any one of examples 39 to 53, wherein the first tubular arm is fluidly coupled to an insulator fluid injection port, and is configured to eject insulator fluid from the distal end of the first tubular arm.

[0258] Example 55. The apparatus of any example herein, particularly of example 24, wherein the first guide recess continuously extends along the flap inner surface, the flap proximal end, and the flap outer surface.

[0259] Example 56. The apparatus of any example herein, particularly of example 55, wherein the first wire portion continuously extends from the cutting portion along the first guide recess. [0260] Example 57. The apparatus of any example herein, particularly of example 56, wherein the head portion further comprises a through-opening distal to the flap base, and wherein the first wire portion is configured to extend from the flap outer surface into the head portion through the through-opening. [0261] Example 58. The apparatus of any example herein, particularly of any one of examples 55 to 57, wherein the first guide recess is equally distanced from both of the flap first and second sidewalls.

[0262] Example 59. The apparatus of any example herein, particularly of any one of examples 55 to 58, wherein a portion of the first wire portion that is coupled to the flap is equally distanced from both of the flap first and second sidewalls.

[0263] Example 60. The apparatus of any example herein, particularly of any one of examples 55 to 59, wherein the cutting portion is positioned between the flap inner surface and the window, at a position closer to the flap base than to the flap proximal end.

[0264] Example 61. The apparatus of any example herein, particularly of example 60, wherein, when the wire is pulled, the cutting portion is configured to travel proximally towards the proximal end of the flap.

[0265] Example 62. The apparatus of any example herein, particularly of example 61, wherein, when a leaflet is positioned between the flap and the window, the cutting portion is configured to cut a slit through the leaflet when the wire is proximally pulled.

[0266] Example 63. The apparatus of any example herein, particularly of any one of examples 1 to 62, further comprising at least one insulator fluid injection tube disposed around a portion of the wire and having an opening at a distal end thereof, directed towards the cutting portion, wherein the at least one insulator fluid injection tube is configured to eject insulator fluid through its opening.

[0267] Example 64. The apparatus of any example herein, particularly of any one of examples 1 to 63, further comprising a contrast injection member configured to eject contrast fluid through one or more openings thereof.

[0268] Example 65. The apparatus of any example herein, particularly of any one of examples 1 to 64, further comprising an outer catheter disposed around the shaft, wherein the shaft is axially movable relative to the outer catheter.

[0269] Example 66. The apparatus of any example herein, particularly of any one of examples 1 to 65, further comprising a pull-member axially extending through the shaft and coupled at a joint to a link, wherein the link is rotatably connected to an internal extension of the flap at an end opposite to the joint, and wherein the flap is rotatably coupled to the head portion by a pin which is proximal to, and radially aligned with, the joint.

[0270] Example 67. The apparatus of any example herein, particularly of example 66, wherein, when the pull-member is proximally pulled, the joint and the pin move closer to each other, thereby moving the flap towards the open state. [0271] Example 68. The apparatus of any example herein, particularly of example 67, wherein the flap is biased towards the closed state when no pull force is applied to the pull-member.

[0272] Example 69. The apparatus of any example herein, particularly of example 68, further comprising a spring coupled to the flap and configured to bias the flap towards the closed state. [0273] Example 70. The apparatus of any example herein, particularly of any one of examples 1 to 65, further comprising a rod coupled at a joint to an internal extension of the flap.

[0274] Example 71. The apparatus of any example herein, particularly of example 70, wherein the flap is coupled to a pin of the head portion, wherein the pin extends through a slot of the internal extension of the flap.

[0275] Example 72. The apparatus of any example herein, particularly of example 70 or 71, wherein the flap is configured to move towards the open state when the rod is proximally pulled.

[0276] Example 73. The apparatus of any example herein, particularly of any one of examples 70 to 72, wherein the flap is configured to move towards the closed state when the rod is distally pushed.

[0277] Example 74. The apparatus of any example herein, particularly of any one of examples 1 to 73, wherein the flap inner surface is textured, configured to prevent slippage of a leaflet grasped by the flap.

[0278] Example 75. A method comprising: positioning a head portion of a leaflet cutting apparatus distal to a leaflet of a valve; moving a flap pivotably coupled to the head portion, to an open state of the flap; and retracting the head portion so as to position a portion of the leaflet between the flap and the head portion, such that a cutting portion of a wire slidably coupled to the flap is distal to a free edge of the leaflet; and cutting through the leaflet via the cutting portion.

[0279] Example 76. The method of any example herein, particularly of example 75, wherein the cutting through the leaflet comprises positioning the cutting portion such that an electrically conductive surface thereof is oriented towards a free edge of the leaflet when the leaflet is positioned between the flap and the head portion, prior to the cutting.

[0280] Example 77. The method of any example herein, particularly of example 76, wherein the cutting through the leaflet comprises providing an electric current to the cutting portion such that the electric current creates a cut through the leaflet when the cutting portion is contacting the leaflet.

[0281] Example 78. The method of any example herein, particularly of example 77, wherein the cutting is created by radio-frequency energy generated by the provided electric current. [0282] Example 79. The method of any example herein, particularly of example 77 or 78, wherein the provided electric current is an alternating current.

[0283] Example 80. The method of any example herein, particularly of example 79, wherein the frequency of the alternating current is a radio-frequency.

[0284] Example 81. The method of any example herein, particularly of any one of examples 77 to 80, wherein the electric current is provided by an electric current source.

[0285] Example 82. The method of any example herein, particularly of any one of examples 75 to 81 , further comprising, after the positioning the leaflet between the flap and the head portion and before the cutting the leaflet, moving the flap towards a closed state, thereby tightly grasping the leaflet between the flap and the head portion.

[0286] Example 83. The method of any example herein, particularly of any one of examples 75 to 82, wherein the cutting portion is V-shape or U-shaped along a plane which is orthogonal to the plane of the leaflet.

[0287] Example 84. The method of any example herein, particularly of any one of examples 75 to 83, wherein the cutting through the leaflet comprises moving the cutting portion along the flap.

[0288] Example 85. The method of any example herein, particularly of example 84, wherein the moving the cutting portion comprises pulling a proximal end of the wire.

[0289] Example 86. The method of any example herein, particularly of example 84 or 85, wherein the moving the cutting portion along the flap comprises moving the cutting portion along edges of the flap.

[0290] Example 87. The method of any example herein, particularly of example 86, wherein the moving the cutting portion along edges of the flap comprises proximally moving the cutting portion along a first sidewall of the flap towards a proximal end of the flap, laterally moving the cutting portion along the proximal end of the flap from the first sidewall to a second sidewall of the flap, and distally moving the cutting portion along the second sidewall from the proximal end of the flap towards a base of the flap.

[0291] Example 88. The method of any example herein, particularly of example 84 or 85, further comprising pushing two tubular arms of the apparatus, thereby extending distal portions thereof, through head opening of the head portions, away from the head portions.

[0292] Example 89. The method of any example herein, particularly of example 88, wherein the extending the distal portion of the tubular arms comprises distancing distal ends of the tubular arms away from opposite sides of the flap. [0293] Example 90. The method of any example herein, particularly of example 88 or 89, wherein, prior to the cutting the leaflet, the wire extends through a second tubular arm of the two tubular arms and past the distal end of the second tubular arms, towards a second end of a first tubular arm of the two tubular arms.

[0294] Example 91. The method of any example herein, particularly of example 90, wherein the cutting portion is coupled to a loop extending from the distal end of the first tubular arm.

[0295] Example 92. The method of any example herein, particularly of example 91, wherein the moving the cutting portion comprises moving the cutting portion along a path defined between the distal end of the second tubular arm and a proximal end of the flap, along the proximal end of the flap, and between the proximal end of the flap and the distal end of the second tubular arm.

[0296] Example 93. The method of any example herein, particularly of example 91 or 92, wherein the moving the cutting portion further comprises moving the loop therewith.

[0297] Example 94. The method of any example herein, particularly of any one of examples 86 to 93, wherein the cutting through the leaflet comprises cutting a section separated from the remainder of the leaflet.

[0298] Example 95. The method of any example herein, particularly of example 94, wherein the cut section of the leaflet is U-shaped.

[0299] Example 96. The method of any example herein, particularly of example 94 or 95, further comprising retaining the cut section tightly grasped between the flap and the head portion.

[0300] Example 97. The method of any example herein, particularly of example 96, further comprising, subsequent to cutting the section of the leaflet, removing the section of the leaflet from the patient’s body.

[0301] Example 98. The method of any example herein, particularly of example 84 or 85, wherein the moving the cutting portion along the flap comprises proximally moving the cutting portion along an inner surface of the flap, toward a proximal end of the flap.

[0302] Example 99. The method of any example herein, particularly of example 98, wherein the cutting through the leaflet comprises forming a slit splitting the leaflet.

[0303] Example 100. The method of any example herein, particularly of any one of examples 75 to 99, further comprising, after the cutting through the leaflet, retrieving the leaflet cutting apparatus.

[0304] Example 101. The method of any example herein, particularly of any one of examples 75 to 100, wherein the leaflet is an anterior leaflet of a mitral valve. [0305] 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.

[0306] 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 leaflet cutting apparatus comprising: a shaft comprising a head portion; a flap pivotably coupled to the head portion, the flap comprising: a flap proximal end; a flap base opposite to the flap proximal end; a first flap sidewall and a second flap sidewall extending between the flap base and the flap proximal end; a flap inner surface; and a flap outer surface opposite to the flap inner surface; and a wire extending through the shaft and comprising a cutting portion, wherein the wire is slidably coupled to the flap and the cutting portion is configured to move along the flap; wherein the flap is configured to move between an open state and a closed state, such that the flap proximal end is at a greater distance from the head portion in the open state than in the closed state.

2. The apparatus of claim 1 , wherein the wire comprises a first wire portion and a second wire portion continuously extending from the cutting portion and through the shaft.

3. The apparatus of any one of claims 1 to 2, wherein the cutting portion is configured to slide along the flap when a proximal end of the wire is proximally pulled.

4. The apparatus of any one of claims 1 to 3, wherein the wire comprises an electrically conductive core configured to conduct electricity towards the cutting portion.

5. The apparatus of claim 2, wherein the head portion comprises a window configured to accommodate the flap in the closed state, the window comprising a first window sidewall, a second window sidewall, and a window ceiling extending between the first and the second window sidewalls.

6. The apparatus of claim 5, wherein the wire is movably coupled to at least one guide recess of the apparatus.

7. The apparatus of claim 6, wherein the at least one guide recess comprises an inner semi-circular channel through which the wire extends, and a slot extending between the inner semi-circular channel and a surface of the apparatus.

8. The apparatus of any one of claims 6 to 7, wherein the at least one guide recess comprises a first guide recess formed on the flap.

9. The apparatus of claim 8, wherein the first guide recess continuously extends along the first flap sidewall, the flap proximal end, and the second flap sidewall.

10. The apparatus of claim 9, wherein the first wire portion continuously extends from the cutting portion along the first guide recess.

11. The apparatus of any one of claims 8 to 10, wherein the at least one guide recess comprises a second guide recess formed on the head portion and extending along edges of the window.

12. The apparatus of claim 1 1 , wherein the second guide recess continuously extends along the first window sidewall, the window ceiling, and the second window sidewall.

13. The apparatus of any one of claims 9 to 12, wherein, when the wire is pulled, the cutting portion is configured to slide along a path extending proximally from a position proximate the flap base towards the proximal end of the flap, slide laterally at or parallel to the flap proximal end towards the second flap sidewall, and slide distally from a position at or proximate to the flap proximal end towards the flap base.

14. The apparatus of claim 5, further comprising two tubular arms extending through the shaft, and wherein the head portion comprises two head openings through which the corresponding tubular arms are configured to extend away from or closer to the head portion.

15. The apparatus of claim 14, wherein the tubular arms are axially movable relative to the shaft.

16. The apparatus of claim 15, wherein, when portions of the tubular arms residing in the shaft are distally pushed, distal ends of the tubular arms are configured to move away from the head portion.

17. The apparatus of claim 16, wherein the tubular arms comprise a first tubular arm and a second tubular arm, wherein the wire extends through the second tubular arm and is axially movable relative to the second arm.

18. The apparatus of claim 17, wherein the first wire portion and the second wire portion extend through the second tubular arm and past a tube opening of the first tubular arm towards the distal end of the second tubular arm.

19. The apparatus of claim 18, wherein the cutting portion is coupled to a loop extending from or coupled to the first tubular arm.

20. The apparatus of any one of claims 17 to 19, wherein the first tubular arm is fluidly coupled to an insulator fluid injection port, and is configured to eject insulator fluid from the distal end of the first tubular arm.

21. The apparatus of claim 8, wherein the first guide recess continuously extends along the flap inner surface, the flap proximal end, and the flap outer surface.

22. The apparatus of any one of claims 1 to 21, further comprising at least one insulator fluid injection tube disposed around a portion of the wire and having an opening at a distal end thereof, directed towards the cutting portion, wherein the at least one insulator fluid injection tube is configured to eject insulator fluid through its opening.