Devices and methods for valvular structure replacement

Abstract

The present disclosure relates to replacement valves and delivery assemblies configured to replace valvular structures of existing heart valves. In an example, a delivery assembly comprises a replacement valve and a delivery apparatus. The replacement valve comprises a self-expandable support frame having a cutting edge, and a plurality of leaflets configured to regulate flow through the replacement valve, wherein the cutting edge is configured to cut through host leaflet of an existing heart valve. The delivery apparatus can include a retrieval device configured to move from a compacted configuration to a deployed configuration at a position distal to the replacement valve, when the replacement valve is deployed out of a delivery catheter of the delivery apparatus.

Description

DEVICES AND METHODS FOR VALVULAR STRUCTURE REPLACEMENTCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 570,606, filed March 27, 2024, which is incorporated by reference herein.FIELD

[0002] The present disclosure relates to devices and assemblies for cutting or excising a valvular structure of an existing heart valve, and to methods and assemblies for implantation of a replacement valve in an existing heart valve after removal of the existing valvular structure.BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches, such as transcatheter aortic valve replacement (TAVR), are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable.

[0004] Transcatheter aortic valve replacement (TAVR) is one example of a minimally-invasive surgical procedure used to replace a native aortic valve. In one specific example of the procedure, an expandable prosthetic heart valve is mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’ s vasculature (for example, through a femoral artery and the aorta) to the heart. The prosthetic heart valve is positioned within the native valve and expanded to its functional size.

[0005] A variant of TAVR is valve-in- valve (ViV) TAVR, where a new prosthetic heart valve replaces a previously implanted prosthetic valve. In one specific example of the procedure, a new expandable prosthetic heart valve ("guest valve") is delivered to the heart in a crimped state, as described above for the "native" TAVR. The guest valve is positioned within the previously implanted prosthetic valve ("host valve") and then expanded to its functional size. The host valve in a ViV TAVR procedure can be a surgically implanted prosthetic valve or a transcatheter prosthetic valve.SUMMARY

[0006] Implantation of a new prosthetic valve inside a previously implanted (or host) prosthetic valve, as performed in conventional ViV procedures, leads to a reduction of effective orifice area (EOA) of the new prosthetic valve, since the frame and worn-out calcified leaflets of the host prosthetic valve remain in place, such that the new prosthetic valve may open to a smaller diameter than the pre-existing host prosthetic valve in order to allow it to be inserted into the remaining lumen. Depending on the original size of the host prosthetic valve, and the degree of calcification and obstruction, new prosthetic valve implantation during a conventional ViV procedure may not lead to an EOA that is compatible with good cardiac function.

[0007] In one of its basic configurations, a replacement valve comprises a support frame comprising a first end, the first end comprising a cutting edge. 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 support frame is self-expandable.

[0009] In some examples, the support frame can comprise a plurality of cusp portions.

[0010] In some examples, the support frame can comprise a plurality of commissure support portions.

[0011] In some examples, each commissure support portion can comprise a pair of support struts joined by an apex region.

[0012] In some examples, the support struts can optionally continuously extend from the cusp portions.

[0013] In some examples, the replacement valve can comprise a valvular structure coupled to the support frame.

[0014] In some examples, the valvular structure can comprise a plurality of leaflets configured to regulate flow through the replacement valve.

[0015] In some examples, the cutting edge can optionally be configured to cut through host leaflets of an existing heart valve.

[0016] In some examples, the first end of the frame can be optionally oriented in a distal direction at least along part of the cusp portions.

[0017] In some examples, the first end of the support frame can optionally be oriented in the distal direction along the apex regions.

[0018] In some examples, the first end of the support frame along one of the pair of support struts of any of the commissure support portions can optionally be facing the first end of the support struts along the other one of the pair of support struts of the same commissure support portion.

[0019] In some examples, the cutting edge can comprise a sharp edge.

[0020] In some examples, the cutting edge can comprise an electrically conductive surface optionally configured to conduct electric energy for severing the leaflets of the existing heart valve when contacted thereby.

[0021] In some examples, the replacement valve can optionally comprise an electrically insulating layer covering at least a portion of the support frame, excluding the electrically conductive surface.

[0022] In one of its basic configurations, a delivery assembly comprises a delivery apparatus and a replacement valve comprising a support frame, the support frame comprising a cutting edge. 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.

[0023] In some examples, the support frame can comprise a first and which optionally comprises the cutting edge.

[0024] In some examples, the replacement valve can comprise a valvular structure coupled to the support frame.

[0025] In some examples, the valvular structure can comprise a plurality of leaflets configured to regulate flow through the replacement valve.

[0026] In some examples, the delivery apparatus can comprise a delivery shaft configured to retain the replacement valve in a compressed configuration when the replacement valve is inside the delivery shaft.

[0027] In some examples, the delivery apparatus can comprise a retrieval device movable between a compacted configuration and a deployed configuration.

[0028] In some examples, the cutting edge can optionally be configured to cut through host leaflets of an existing heart valve.

[0029] In some examples, the retrieval device can optionally be axially movable relative to the replacement valve.

[0030] In some examples, the retrieval device can optionally be configured to move from the compacted configuration to the deployed configuration at a position distal to the replacement valve, when the replacement valve is deployed out of the delivery shaft.

[0031] In some examples, the retrieval device can optionally be self-expandable.

[0032] In some examples, the retrieval device can comprise a mesh configured to prevent cut portions of the host leaflet from passing upstream therethrough.

[0033] In some examples, the delivery apparatus can comprise a filter optionally configured to transition from a compacted configuration to a deployed configuration thereof at a position proximal to the replacement valve, when the replacement valve is deployed out of the delivery shaft.

[0034] In some examples, the assembly can comprise one or more releasable coupling arms optionally configured to releasably couple the replacement valve to the delivery apparatus.

[0035] In some examples, the support frame can comprise a plurality of cusp portions and a plurality of commissure support portions.

[0036] In some examples, the first end of the frame can optionally be oriented in a distal direction at least along part of the cusp portions.

[0037] In some examples, the cutting edge can comprise a sharp edge.

[0038] In some examples, the cutting edge can comprise an electrically conductive surface optionally configured to conduct electric energy for severing the leaflets of the existing heart valve when contacted thereby.

[0039] In one of its basic methods, a method comprises advancing a delivery assembly to a host prosthetic 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 delivery assembly optionally comprises a delivery apparatus.

[0041] In some examples, the delivery assembly apparatus optionally comprises a delivery shaft.

[0042] In some examples, the delivery assembly optionally comprises a replacement valve.

[0043] In some examples, the advancing a delivery assembly to a host prosthetic valve optionally comprises maintaining the replacement valve in a compressed configuration thereof inside the delivery shaft.

[0044] In some examples, the replacement valve optionally comprises a support frame.

[0045] In some examples, the support frame optionally comprises a cutting edge.

[0046] In some examples, the host prosthetic valve can comprise a frame.

[0047] In some examples, the host prosthetic valve can comprise a plurality of host leaflets mounted inside the frame.

[0048] In some examples, the method comprises deploying the replacement valve out of the delivery shaft at a position proximal to the host leaflets.

[0049] In some examples, the delivery apparatus optionally comprises a retrieval device.

[0050] In some examples, the method optionally comprises deploying the retrieval device at a position distal to the host leaflets.

[0051] In some examples, the method comprises cutting the host leaflets by advancing the replacement valve towards and against the host leaflets;

[0052] In some examples, the method optionally comprises collecting cut portions of the host leaflet with the retrieval device by proximally retracting the retrieval device.

[0053] In some examples, the method optionally comprises retrieving the delivery apparatus along with the cut portions of the host leaflets, wherein the replacement valve remains expanded against the frame of the host prosthetic valve during the retrieval.

[0054] In some examples, the replacement valve optionally comprises a valvular structure coupled to the support frame.

[0055] In some examples, the valvular structure optionally comprises a plurality of leaflets configured to regulate flow through the replacement valve.

[0056] In some examples, the deploying the replacement valve optionally comprises allowing the support frame to self-expand when exposed out of the delivery shaft.

[0057] In some examples, the cutting the host leaflets optionally comprises maintaining the replacement valve coupled to the delivery apparatus by a plurality of releasable coupling arms.

[0058] In some examples, the method optionally comprises, prior to the retrieving the delivery apparatus, decoupling the replacement valve from the delivery apparatus by releasing the releasable coupling arms.

[0059] In some examples, the method optionally comprises, prior to the cutting the host leaflets, advancing the retrieval device, in a compacted state thereof, through the replacement valve and the host prosthetic valve, and moving the retrieval device to a deployed configuration distal to the host leaflets.

[0060] In some examples, the method optionally comprises, prior to the cutting the host leaflets, deploying a filter at a position proximal to the host prosthetic valve.

[0061] In some examples, the cutting the host leaflets can optionally comprise cutting cusp end portions of the host leaflets by cusp portions of the support frame pushed there-against.

[0062] In some examples, wherein the cutting edge can optionally comprise a sharp edge, and wherein the cutting the host leaflets comprises distally pushing the sharp edge at a force sufficient to cut through regions of the host leaflets contacted thereby.

[0063] In some examples, the cutting edge can optionally comprise an electrically conductive surface, wherein the cutting the host leaflets can optionally comprise conducting electric energy, via the delivery assembly, to the electrically conductive surface.

[0064] In one of its basic configurations, a delivery assembly comprises a replacement valve and a delivery apparatus comprising a leaflet removal device. 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.

[0065] In some examples, the replacement valve can comprise a self-expandable support frame.

[0066] In some examples, the replacement valve can comprise a valvular structure coupled to the support frame.

[0067] In some examples, the valvular structure can comprise a plurality of leaflets configured to regulate flow through the replacement valve.

[0068] In some examples, the delivery apparatus can comprise a delivery shaft configured to retain the replacement valve in a compressed configuration when the replacement valve is inside the delivery shaft.

[0069] In some examples, the delivery apparatus can comprise an inner shaft axially movable through and relative to the delivery shaft.

[0070] In some examples, the leaflet removal device can comprise at least one clip.

[0071] In some examples, the clip can comprise a first clip arm.

[0072] In some examples, the clip can comprise a second clip arm.

[0073] In some examples, the clip can comprise a first cage coupled to the first clip arm and optionally extending proximally therefrom.

[0074] In some examples, the clip can comprise a second cage coupled to the second clip arm and optionally extending proximally therefrom.

[0075] In some examples, the leaflet removal device can optionally be movable between an open configuration when positioned inside the inner shaft and a closed configuration when exposed out of the inner shaft.

[0076] In some examples, a radial distance between the first clip arm and the second clip arm can be optionally greater in the open configuration than in the closed configuration.

[0077] In some examples, at least one of the first clip arm and / or the second clip arm optionally comprises a cutting edge configured to cut through host leaflets of an existing heart valve.

[0078] In some examples, the first clip arm and the second clip arm can optionally be joined to each other at proximal joints.

[0079] In some examples, the first clip arm and the second clip arm can optionally be pivotably movable relative to each other about the proximal joints.

[0080] In some examples, the first clip arm and the second clip arm can optionally be configured to close against one of the host leaflets in a manner that prevents the host leaflet from slipping away from the clip in the closed configuration.

[0081] In some examples, when one of the host leaflets is disposed inside the clip in the closed configuration, the first cage and the second cage can optionally be configured to prevent the corresponding host leaflet from passing therethrough.

[0082] In some examples, each of the first cage and the second cage can comprise a mesh.

[0083] In some examples, each of the first cage and the second cage can comprise a plurality of strings.

[0084] In some examples the radial distance between the first clip arm and the second clip arm in the open configuration can optionally be configured to allow passage of a corresponding one of the host leaflets therebetween.

[0085] In some examples, the second cage can optionally be configured to be loose enough when a corresponding one of the host leaflets is retained inside the clip, so as to optionally allow the corresponding host leaflet to move towards and away from the remaining host leaflets to optionally allow continued functioning of the host leaflets with respect to regulating flow of blood through the existing heart valve.

[0086] In some examples, the at least one cutting edge can comprise a sharp edge.

[0087] In some examples, the at least one cutting edge can comprise an electrically conductive surface optionally configured to conduct electric energy for severing the leaflets of the existing heart valve when contacted thereby.

[0088] In some examples, the delivery apparatus can comprise a filter optionally configured to transition from a compacted configuration to a deployed configuration thereof at a positionproximal to the replacement valve, when the replacement valve is deployed out of the delivery shaft.

[0089] In one of its basic methods, a method comprises advancing a delivery assembly comprising a delivery apparatus and a replacement valve to a host prosthetic 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.

[0090] In some examples, the host prosthetic valve can comprise a frame.

[0091] In some examples, the host prosthetic valve can comprise a plurality of host leaflets mounted inside the frame.

[0092] In some examples, the method comprises deploying a leaflet removal device of the delivery apparatus at a position proximal to the host leaflets.

[0093] In some examples, the method comprises advancing at least one clip of the leaflet removal device, in an open configuration of the leaflet removal device, towards and around a corresponding one of the host leaflets, such that a first clip arm of the clip and a first cage extending proximally therefrom is positioned between the corresponding host leaflet and the frame of the host prosthetic valve, and such that a second clip arm of the clip and a second cage extending proximally therefrom are disposed radially inwards to the corresponding host leaflet.

[0094] In some examples, the method comprises closing the second clip arm and the first clip arm against the corresponding host leaflet.

[0095] In some examples, the method comprises cutting the corresponding host leaflet by at least one cutting edge of at least one of the first clip arm and / or the second clip arm.

[0096] In some examples, the method can comprise removing a cut portion of the corresponding host leaflet from the host prosthetic valve by proximally retracting the clip in which it is retained.

[0097] In some examples, the deploying the leaflet removal device can comprise allowing the leaflet removal device to self-expand when exposed out of an inner shaft of the delivery apparatus.

[0098] In some examples, the deploying the leaflet removal device can comprise pivotably moving the second clip arm and first clip arms away from each other to a radial distance therebetween sufficient optionally to allow insertion of the corresponding host leaflet therebetween.

[0099] In some examples, the closing the second clip arm and the first clip arm can comprise maintaining the second cage loose enough to optionally allow the corresponding host leaflet to move towards and away from the remaining host leaflets to optionally allow continued functioning of the host leaflets with respect to regulating flow of blood through the host prosthetic valve.

[0100] In some examples, the closing the second clip arm and the first clip arm can comprise preventing the corresponding host leaflet from slipping away from the clip.

[0101] In some examples, the closing the second clip arm and the first clip arm can comprise preventing the corresponding host leaflet from passing through the second cage or the first cage.

[0102] In some examples, each of the first cage and the second cage can comprise a mesh.

[0103] In some examples, each of the first cage and the second cage can comprise a plurality of strings.

[0104] In some examples, the at least one cutting edge can comprise a sharp edge.

[0105] In some examples, the at least one cutting edge can comprise an electrically conductive surface, wherein the cutting the corresponding host leaflet can comprise conducting electric energy, via the delivery assembly, to the electrically conductive surface.

[0106] In some examples, the conducting electric energy can comprise conducting radiofrequency energy.

[0107] 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

[0108] 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:

[0109] Fig. 1A is a perspective view of an exemplary prosthetic valve.

[0110] Fig. IB is a perspective view of a frame of the prosthetic valve of Fig. 1 A.

[0111] Fig. 2 shows exemplary leaflets of a valvular structure of a prosthetic valve.

[0112] Fig. 3A shows an exemplary host prosthetic valve implanted in a native heart valve.

[0113] Fig. 3B shows an example of a new prosthetic valve implanted within a previously implanted host prosthetic valve.

[0114] Fig. 4 shows a distal portion of an exemplary delivery assembly that includes a retrieval device.

[0115] Fig. 5 is a perspective view of an exemplary replacement valve.

[0116] Fig. 6 shows an exemplary support frame of a replacement valve, having a rectangularly- shaped cross-section.

[0117] Fig. 7A is a cross-sectional view of an exemplary rectangularly-shaped support frame comprising a sharp edge.

[0118] Fig. 7B is a cross-sectional view of an exemplary rectangularly- shaped support frame comprising an electrically conductive surface.

[0119] Fig. 8 shows an exemplary support frame of a replacement valve, having a circularly- shaped cross-section.

[0120] Fig. 9 is a cross-sectional view of an exemplary circularly-shaped support frame comprising an electrically conductive surface.

[0121] Fig. 10 shows a distal portion of an exemplary delivery assembly with the replacement valve partially expanded proximal to a host prosthetic valve.

[0122] Fig. 11 A shows a distal portion of the delivery assembly of Fig. 10 with the replacement valve positioned between the host leaflets and the frame of the host prosthetic valve.

[0123] Fig. 1 IB shows an enlarged view a region of Fig. 11 A.

[0124] Fig. 12 shows a distal portion of the delivery assembly of Fig. 11A with a retrieval device partially deployed distal to the host prosthetic valve.

[0125] Fig. 13 shows a distal portion of the delivery assembly of Fig. 12 with the retrieval device fully deployed distal to the host prosthetic valve.

[0126] Fig. 14 shows a distal portion of the delivery assembly of Fig. 13 with the host leaflet separated from the frame of the host prosthetic valve and the replacement valve released from the delivery apparatus.

[0127] Fig. 15 shows the replacement valve mounted inside the frame of the host prosthetic valve.

[0128] Fig. 16 shows a distal portion of an exemplary delivery assembly that includes a leaflet removal device.

[0129] Fig. 17A shows an exemplary leaflet removal device in an open configuration.

[0130] Fig. 17B shows the leaflet removal device of Fig. 17 A in a closed configuration.

[0131] Fig. 18 shows an exemplary leaflet removal device comprising coupling extensions.

[0132] Fig. 19A shows a distal portion of an exemplary delivery assembly with the leaflet removal device partially deployed proximal to a host prosthetic valve.

[0133] Fig. 19B shows a distal portion of the delivery assembly of Fig. 19A with the leaflet removal device fully deployed proximal to a host prosthetic valve.

[0134] Fig. 19C shows a distal portion of the delivery assembly of Fig. 19B with the leaflet removal device positioned between the host leaflets and the frame of the host prosthetic valve.

[0135] Fig. 20 shows a distal portion of the delivery assembly of Fig. 19C with the replacement valve mounted inside the host prosthetic valve.

[0136] Fig. 21 A shows a host leaflet partially inserted into a clip of a leaflet removal device in the open configuration.

[0137] Fig. 21B shows the host leaflet fully inserted into a clip of Fig. 21A in the open configuration.

[0138] Fig. 21C shows the clip of Fig. 21B closed against the host leaflet.

[0139] Fig. 21D shows an exemplary clip having a loose second cage.

[0140] Fig. 22 shows an exemplary clip comprising pull wires coupled to a second clip arm thereof.

[0141] Figs. 23A-23E show cross-sectional views of various exemplary leaflet removal devices comprising one or more cutting edges oriented towards regions of a host leaflet retained between the inner and first clip arms.DETAILED DESCRIPTION

[0142] 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 thetechnologies 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.

[0143] 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.

[0144] 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.

[0145] 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".

[0146] 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.

[0147] 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.

[0148] 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.

[0149] 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.

[0150] 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.

[0151] 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.

[0152] 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 asecond 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.

[0153] 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 25%. For example, "at least substantially parallel" refers to directions that are fully parallel, and to directions that diverge by up to 22.5 degrees.

[0154] 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.

[0155] 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.

[0156] Figs. 1A and IB show perspective views of an exemplary prosthetic valve 10 with and without soft components attached thereto, respectively. 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 prostheticvalve of the current disclosure 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.

[0157] It is understood that the prosthetic valve 10 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 / US2021 / 052745 and U.S. Provisional Application Nos. 63 / 085,947 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.

[0158] Figs. 1A-1B show an example of a prosthetic valve 10, which can optionally be a balloon expandable valve or any other type of valve, illustrated in an expanded state. The prosthetic valve 10 can optionally comprise an annular frame 16 defining an outflow end 14 and an inflow end 12. In some instances, the outflow end 14 is the proximal end of the frame 16, and the inflow end 12 is the distal end of the frame 16. Alternatively, depending for example on the delivery approach of the valve, the outflow end can be the distal end of the frame, and the inflow end can be the distal end of the frame.

[0159] The term "outflow", as used herein, refers to a region of the prosthetic valve through which the blood flows through and out of a prosthetic valve.

[0160] The term "inflow", as used herein, refers to a region of the prosthetic valve through which the blood flows into a prosthetic valve.

[0161] In the context of the present application, the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow”, respectively. Thus, for example, thelower end of the prosthetic valve is its inflow end and the upper end of the prosthetic valve is its outflow end.

[0162] 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.

[0163] The terms “longitudinal” and “axial”, as used herein, refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0164] The annular frame 16 of prosthetic valve 10 is movable between a radially compressed configuration and a radially expanded configuration, and a valvular structure 30 of the prosthetic valve 10 is mounted within the frame 16. The frame 16 can optionally be made of various suitable materials, including plastically-deformable materials such as, but not limited to, stainless steel, a nickel-based alloy (e.g., a nickel-cobalt-chromium alloy such as MP35N alloy), polymers, or combinations thereof. When constructed of a plastically-deformable materials, the frame 16 can optionally be crimped to a radially compressed state on a balloon catheter, and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism.

[0165] In the example illustrated in Figs. 1 A-1B, the frame 16 is an annular, stent-like structure comprising a plurality of intersecting struts 18. 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 18 may be any elongated member or portion of the frame 16. Optionally, the frame 16 can include a plurality of strut rungs that can collectively define one or more rows of cells 24. The frame 16 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 12 to the outflow end 14 as shown, or the frame can vary in diameter along the height of the frame, as disclosed in US Pat. No. 9,155,619, which is incorporated herein by reference.

[0166] The end portions of the struts 18 are forming apices 20 at the outflow end 14 and apices 22 at the inflow end 12. The struts 18 can optionally intersect at additional junctions 26 formed between the outflow apices 20 and the inflow apices 22. The junctions 26 can be equally or unequally spaced apart from each other, and / or from the apices 20, 22, between the outflow end 14 and the inflow end 12.

[0167] At least some of the struts 18 can be pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame 16 can optionally be formedfrom 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 the like.

[0168] A valvular structure 30, shown also for example in Fig. 2, can include a plurality of leaflets 32 (e.g., three leaflets), positioned at least partially within the frame 16, and configured to regulate flow of blood through the prosthetic valve 10 from the inflow end 12 to the outflow end 14. An existing or previously implanted prosthetic valve can be also referred to herein as a host prosthetic valve 10. A valvular structure of a host prosthetic valve 10 is also referred to herein as a host valvular structure 30, comprising a plurality of host leaflet 32. While three host leaflets 32 arranged to collapse in a tricuspid arrangement, are shown in the example illustrated in Figs. 1A-1B and 2, it will be clear that a prosthetic valve 10 can include any other number of leaflets 32. Adjacent host leaflets 32 can be arranged together to form commissures 40 that are coupled (directly or indirectly) to respective portions of the frame 16, thereby securing at least a portion of the host valvular structure 30 to the frame 16.

[0169] The leaflets 32 can be made from, in whole or part, biological material (e.g., pericardium), bio-compatible synthetic materials, or other such materials. Further details regarding transcatheter prosthetic valves, including the manner in which the valvular structures 30 can be coupled to the frame 16 of the prosthetic valve 10, 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 11,135,056, all of which are incorporated herein by reference in their entireties.

[0170] As shown for example in Fig. 2, three separate leaflets 32 can collectively define the valvular structure 30 in some cases. Each leaflet 32 can optionally have a rounded cusp end portion 34 opposite a free edge 36, and a pair of generally oppositely-directed commissure attachment portions 38, which can optionally be, in some examples, in the form of tabs separating the cusp end portion 34 and the free edge 36. The cusp end portion 34 can optionally form, in some examples, a single scallop, such as by having a rounded edge concavely curved toward the inflow end 12 of the valve. Each host leaflet 32 further comprises an inner surface 42, defined as the surface facing the central axis Ca of the host prosthetic valve 10 (indicated in Fig. 1A), and an outer surface 44, opposite thereto so as to face the frame 16.

[0171] When such leaflets 32 are coupled to the frame and to each other, the lower edge of the resulting valvular structure 30 desirably has an undulating, curved scalloped shape. By forming the leaflets with this scalloped geometry, stresses on the leaflets 32 are reduced which, in turn, improves durability of the prosthetic valve. Moreover, by virtue of the scalloped shape, folds and ripples at the belly of each leaflet, which can cause early calcification in those areas, canbe eliminated or at least minimized. The scalloped geometry also reduces the amount of tissue material used to form the valvular structure, thereby allowing a smaller, more even crimped profile at the inflow end of the valve.

[0172] The leaflets 32 define a non-planar coaptation plane (not annotated) when their free edges 36 co-apt with each other to seal blood flow through the prosthetic valve 10. Host leaflets 32 can optionally be secured to one another at their tabs 38 to form commissures 40 of the host valvular structure 30, which can be secured, directly or indirectly, to structural elements connected to the frame 16 or integrally formed as portions thereof, such as commissure posts, commissure windows, and the like.

[0173] In some examples, the prosthetic valve 10 can optionally comprise at least one skirt or sealing member. Fig. 1 A shows an example of a prosthetic valve 10 that includes an inner skirt 46, which can optionally be secured to an inner surface of the frame 16. Such an inner skirt 46 can be configured to function, for example, as a sealing member to prevent or decrease perivalvular leakage. An inner skirt 46 can further function as an anchoring region for valvular structure 30 to the frame 16, and / or function to protect the leaflets 32 against damage which may be caused by contact with the frame 16, for example during valve crimping or during working cycles of the prosthetic valve 10. The inner skirt 46 can optionally be coupled to the frame 16 via sutures or another form of coupler.

[0174] The prosthetic valve 10 can optionally comprise, in some examples, an outer skirt 48 mounted on the outer surface of frame 16, configure to function, for example, as a sealing member retained between the frame 16 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 10. The outer skirt 48 can optionally be coupled to the frame 16 via sutures or another form of coupler.

[0175] Any of the inner skirt 46 and / or outer skirt 48 can optionally be made of various suitable biocompatible materials, such as, but not limited to, various synthetic materials (e.g., PET) or natural tissue (e.g. pericardial tissue). In some examples, the inner skirt 46 can optionally be formed of a single sheet of material that extends continuously around the inner surface of frame 16. In some examples, the outer skirt 48 can optionally be formed of a single sheet of material that extends continuously around the outer surface of frame 16.

[0176] Fig. 3A shows one example of the host prosthetic valve 10 implanted in a native heart valve 60. In the example illustrated in Fig. 3A, the prosthetic valve 10 is implanted in a native aortic valve 60. In other examples, a host prosthetic valve 10 can be implanted at other locations (e.g., a mitral valve, a tricuspid valve, and / or a pulmonary valve), including within previously-implanted prosthetic valve, using any appropriate delivery approach (e.g., transfemoral, transapical, transaortic, transseptal, etc.).

[0177] During implantation of the host prosthetic valve 10, the prosthetic valve 10 is positioned within a central region defined between native leaflets 64. The prosthetic valve 10 is then radially expanded against the native leaflet 64. As illustrated, the native leaflets 64 form a tube around the frame 16 of the host prosthetic valve 10 after the prosthetic valve 10 is radially expanded to the working diameter. As further illustrated, expansion of the prosthetic valve 10 displaces the native leaflets 64 outwards.

[0178] For an existing implanted prosthetic valve, the valvular structure may naturally degrade over time thereby requiring repair or replacement in order to maintain adequate heart functions. In a Valve- in- Valve (ViV) procedure, a new prosthetic heart valve is mounted within the existing, degrading prosthetic heart valve in order to restore proper function. Fig. 3B illustrates an exemplary prosthetic valve 10a that can be implanted within a previously implanted prosthetic valve 10a (for example, after a ViV procedure). In this example, the prosthetic valve 10b is a guest valve or new valve, and the prosthetic valve 10a is the host valve or old valve. In this example, the host prosthetic valve 10a was previously implanted within the orifice of the native heart valve 60. Each of the prosthetic valves 10a, 10b can have the general structure of the prosthetic valve 10 described with reference to Figs. 1A-2, though in some examples, each of the prosthetic valves 10a, 10b can be a different type of prosthetic valve. For example, a balloon expandable guest valve 10b can be implanted inside a previously implanted mechanically expandable or self-expandable host valve 10a.

[0179] During implantation of the prosthetic valve 10b, the prosthetic valve 10b is positioned within a central region defined between the leaflets 32a of the prosthetic valve 10a, which now take the role of host leaflets. The prosthetic valve 10b is then radially expanded against the host leaflets 32a. As illustrated, the radial expansion of the prosthetic valve 10a results in outward displacement of the host leaflets 32a. As further illustrated, the host leaflets 32a are displaced such that the host leaflets 32a are sandwiched between the frame 16b of the guest prosthetic valve 10b and the frame 16a of the host prosthetic valve 10a.

[0180] While the host prosthetic valve 10a could expand to an outer diameter that corresponds to the size of the annulus 62 of the native heart valve 60, the maximal diameter to which the guest prosthetic valve 10b can be expanded is further limited by the components of the host prosthetic valve 10a, such as the thickness of the frame 16a and leaflets 32a of the host prosthetic valve 10a, and when present, inner 46 and / or outer 48 skirts thereof.

[0181] Leaflets of the host prosthetic valve 10a can thicken over time due to calcification and / or accumulation of other minerals and constituents over the span of years, which may in turn result in an even smaller inner diameter inside of which the guest prosthetic valve 10b is implanted, which in turn may lead to a smaller effective orifice area (EOA) through which blood can flow, having an impact on the pressure drop across the valve. The risk illustrated in Fig. 3B may be higher when more than one repair or replacement procedure of the valve is required during the lifetime of a patient. For example, when a host prosthetic valve is implanted in a younger patient, the valvular structure may stop functioning properly after a certain period of time (for example, 10-15 years from implantation), requiring a ViV procedure, which can also fail in due course and require an additional interventional procedure. A Valve-in-Valve- in-Valve (ViViV) procedure may result in an even smaller EOA of the newly implanted prosthetic valve.

[0182] To avoid at least some of the reduction in EOA of a newly implanted valve, the valvular structure of the existing prosthetic valve can be percutaneously excised and removed from the patient’s body. This allows a replacement valve that includes a replacement valvular structure to be implanted inside a frame of the host valve, which is devoid of the host valvular structure.

[0183] Fig. 4 shows a distal portion of an exemplary delivery assembly 200 that includes a delivery apparatus 202 adapted to deliver a replacement valve 100. The delivery apparatus 202 is further configured to remove host leaflets of a host valvular structure after excising the host valvular structure by the delivery assembly 200.

[0184] The delivery apparatus 202 can optionally include a handle (not shown) and an elongated delivery shaft 220 shaft extending distally therefrom. Although not illustrated, the handle of the delivery apparatus 202 can optionally include one or more control mechanisms (such as knobs or other actuating mechanisms) for controlling different components of the delivery apparatus 202 in order to expand and / or deploy the replacement valve 100 and / or other components of the delivery apparatus 202.

[0185] In some examples, the delivery shaft 220 can be adapted to retain the replacement valve 100 in a crimped state therein, during delivery towards the host prosthetic valve. In some examples, the replacement valve 100 can optionally be retained in a crimped state inside a distal end portion 222 of the delivery shaft 220 during delivery towards the site of implantation. In some examples, the distal end portion 222 can optionally be a continuous integral portion of the delivery shaft 220. In some examples, the distal end portion 222 can optionally include a capsule attached a distal end of the delivery shaft 220.

[0186] In some examples, the delivery assembly 202 can optionally include one or more releasable coupling arms 224 configured to assist in axial positioning of the replacement valve 100 during implantation inside a host prosthetic valve. In some examples, the releasable coupling arms 224 can optionally be part of the delivery apparatus 202, as illustrated in Fig. 4, in which case the releasable coupling arms 224 of the delivery apparatus 202 can be releasably coupled to the replacement valve 100. In some examples, the releasable coupling arms can optionally be part of the replacement valve (examples not shown), in which case the releasable coupling arms of the replacement valve can be releasably coupled to a component of the delivery apparatus. While three releasable coupling arms 224 are illustrated in Fig. 4, it is to be understood that any other number is contemplated, including a single releasable coupling arm, two releasable coupling arms, or more than three positioning arms.

[0187] The replacement valve 100, an example of which is also illustrated in Fig. 5, comprises a replacement valvular structure 130 coupled to a support frame 106 extending between an inflow end 102 and an outflow end 104. In some instances, the outflow end 104 is the proximal end of the support frame 106, and the inflow end 102 is the distal end of the support frame 106. Alternatively, depending for example on the delivery approach of the valve, the outflow end can be the distal end of the support frame, and the inflow end can be the distal end of the support frame.

[0188] In some examples, the support frame 106 is a self-expandable support frame, configured to expand from a compressed or crimped state to an expanded state under the inherent resiliency or elastic force of the support frame. In some examples, the support frame 106 can optionally be formed of a shape memory material (e.g., a nickel-titanium alloy, such as Nitinol) such that the frame can be shape-set to a particular configuration and then elastically deformed to one or more other configurations. As one example, the support frame 106 can optionally be formed of Nitinol and shape-set in the radially-expanded state. The support frame 106 can be elastically deformed to the radially-compressed state prior to delivery into the patient's body, and allowed to self-expand when an enclosure in which the replacement valve 100 is retained during delivery, such as a delivery shaft 220 or a capsule at a distal end portion 222 thereof, is removed from the support frame 106 upon reaching the site of treatment.

[0189] In some examples, the support frame can optionally be formed of a plastically- deformable material (e.g., stainless steel or cobalt-chromium alloy) such that the support frame can be formed in a particular configuration and then plastically deformed to one or more configurations which are radially smaller or larger than the configuration in which the support frame is formed.

[0190] In some examples, the support frame 106 can optionally be formed from a single piece of material (e.g., a metal tube). This can be accomplished, for example, via laser cutting, electroforming, and / or physical vapor deposition. Nevertheless, in some examples, the support frame can optionally be constructed by forming individual components and coupling the individual components together (e.g., via welding, brazing, and / or other means for bonding).

[0191] The replacement valvular structure 130 comprises a plurality of replacement leaflets 132 (e.g., three leaflets), positioned at least partially within the support frame 106, and configured to regulate flow of blood through the replacement valve 100. While three leaflets 132 arranged to collapse in a tricuspid arrangement similar to the native aortic valve, are shown in the example illustrated in Fig. 4, it will be clear that a replacement valve 100 can include any other number of replacement leaflets 132, such as two leaflets configured to collapse in a bicuspid arrangement similar to the native mitral valve, or more than three leaflets, depending upon the particular application. The replacement leaflets 132 can be generally similar to host leaflets 32 described above, and can be made of a flexible material, derived from biological materials (e.g., bovine pericardium or pericardium from other sources), bio-compatible synthetic materials, or other suitable materials as known in the art and described, for example, in U.S. Pat. Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,652,202, and 11,135,056, all of which are incorporated by reference herein.

[0192] Similar to host leaflet 32, each replacement leaflet 132 can optionally have a rounded cusp end portion 134 (indicated in Fig. 5) opposite a free edge 136, and a pair of generally oppositely-directed commissure attachment portions 138. The cusp end portion 134 can optionally form, in some examples, a single scallop, such as by having a rounded edge concavely curved toward the inflow end 102 of the replacement valve. Each replacement leaflet 132 further comprises an inner surface 142 defined as the surface facing the remaining leaflets 132 of the valvular structure 130, and an outer surface 144 opposite thereto.

[0193] In some examples, the support frame 106 can optionally have an undulating shape. Optionally, the support frame 106 can include a plurality (e.g., three) large radius arcuate cusp portions 108 to which the cusp end portions 134 of the replacement leaflets 132 can be attached, while the ends of each pair of adjacent cusp portions 108 converge somewhat asymptotically to form upstanding support struts 112 that terminate in apex regions 114, each extending in the opposite direction as the arcuate cusp portions 108 and having a relatively smaller radius. Each couple of adjacent support struts 112 joined by an apex region 114 together define a commissure support portion 110 to which commissure attachment portions 138 of adjacent replacement leaflets 132 can optionally be attached, thus forming commissures 140 of thereplacement valve 100. The cusp portions 108 and the support struts 112 of the support frame 106 can be sized and shaped so as to correspond to the curvature of the cusp end portions 134 and commissure attachment portions 138 of the replacement leaflets 132.

[0194] The support frame 106 can have any of various cross-sectional shapes, such as a square, rectangular, circular, or combinations thereof. Various examples for replacement valves 100, delivery assemblies 200, and / or components thereof, can be referred to, throughout the specification, with superscripts, for ease of explanation of features that refer to such exemplary examples. It is to be understood, however, that any reference to structural or functional features of any assembly, device or component, without a superscript, refers to these features being commonly shared by all specific exemplary examples that can be also indicated by superscripts. In contrast, features emphasized with respect to an exemplary implementation of any assembly, device or component, including replacement valve 100 and / or delivery assembly 200, referred to with a superscript, may be optionally shared by some but not necessarily all other exemplary examples.

[0195] For example, replacement valve 100aillustrated in Fig. 5 is an exemplary implementation of replacement valve 100, and thus can include any of the features described above for replacement valve 100, except that while support frame 106 of a replacement valve 100 can have any of a variety of cross-sectional shapes, the support frame 106bof replacement valve 100b, shown also in Fig. 6 without a valvular structure coupled thereto, has a rectangularly- shaped cross-section which is longer in the lateral direction than the radial thickness of the support frame. In some examples, the support frame 106bcan optionally be cut or otherwise formed from tubing or a sheet of material.

[0196] In some examples, the support frame 106bcan optionally include apertures 116 extending radially through a thickness thereof. The leaflets 132 can optionally be secured to the support frame 106bvia sutures 152 (shown in Fig. 5, for example) extending through the apertures 116 in the support frame 106b. In some examples, the cusp end portions 134 of the replacement leaflets 132 can optionally be secured to the frame 106bby sutures 152 extending through apertures 116 in the cusp portion 108 of the frame 106b. In some examples, the commissure attachment portions 138 of the replacement leaflets 132 can optionally be secured to the commissure support portions 110 by sutures 152 extending through apertures 116 in the commissure support portion 110 of the frame 106b.

[0197] In some examples, the support frame 106 further comprises slits (not shown) extending from the second side 120 toward the first side 118, allowing insertion of the cusp end portions 134 (and optionally the commissure attachment portions 138 as well) into the slits in a mannerthat enables parts of the leaflets 132 to be wrapped around at least part of the support frame 106. When such slits are combined with apertures 116, a cross-section of the support frame 116 can optionally include, at certain portions thereof, a four-bar structure at the regions of intersection between the slits and the apertures 116.

[0198] Figs. 7A and 7B show cross-sectional views of exemplary support frames 106 taken along plane 7-7 of Fig. 6. A support frame 106 defines a first end 118 facing the inflow end 102 at least along the cusp portions 108, a second end 120 facing the outflow end 104 at least along the cusp portions 108, an inner side 122 facing a central axis that can be defined by the replacement valve 100 (which can coincide with the axial central axis Ca of the host prosthetic valve 10 when the replacement valve 100 is mounted therein), and an outer side 124 opposite to the inner side 122, which can face the frame 16 of the host prosthetic valve 10 when the replacement valve 100 is mounted therein.

[0199] The first end 118 of the support frame 106 can optionally be oriented towards the inflow end 102 along the cusp portion 108 of the support frame 106, while the first ends 118 along adjacent upstanding support struts 112 can be facing each other. The second end 120 of the support frame 106 can optionally be oriented towards the outflow end 104 along the cusp portion 108 of the support frame 106, while the second ends 120 along adjacent upstanding support struts 112 can optionally be oriented away from each other.

[0200] The thickness of the support frame 106 is defined as the radial distance between the inner side 122 and the outer side 124. The cross-sectional height of the support frame 106 can be defined in a direction perpendicular to its thickness, such as between the first end 118 and the second end 120. In some examples, such as when the support frame 106 has a substantially rectangular cross-section as illustrated in Figs. 5-7B, the cross-sectional height of the support frame 106 can be greater than its thickness. In some examples, the cross-sectional height of the support frame 106 is at least two times greater than its thickness. In some examples, the cross- sectional height of the support frame 106 is at least three times greater than its thickness. In some examples, the cross-sectional height of the support frame 106 is at least five times greater than its thickness. In some examples, the cross-sectional height of the support frame 106 is about ten times as great as its thickness. In some examples, the height of the support frame 106 equal to or greater than 1 millimeter (mm.). In some examples, the height of the support frame 106 equal to or greater than 1.5 mm. In some examples, the height of the support frame 106 equal to or greater than 2 mm.

[0201] In some examples, the support frame 106 of replacement valve 100 is configured to cut through tissue, such as through leaflets of a valve in which the replacement valve 100 is to beimplanted. In some examples, the support frame 106 of replacement valve 100 is configured to cut through leaflets 32 of a host valvular structure 30 of a host prosthetic valve 10. In some examples, the support frame 106 of replacement valve 100 is configured to cut through leaflets 32 of a host valvular structure 30 of a host prosthetic valve 10 along their cusp end portions 34. In some examples, the support frame 106 of replacement valve 100 is further configured to cut through commissures 40 of a host prosthetic valve 10.

[0202] In some examples, the first end 118 of the support frame 106 comprises a cutting edge configured to cut through tissue, such as through leaflets of a valve in which the replacement valve 100 is to be implanted. In some examples, the first end 118 of the support frame 106 comprises a cutting edge configured to cut through leaflets 32 of a host valvular structure 30 of a host prosthetic valve 10. In some examples, the first end 118 of the support frame 106 comprises a cutting edge configured to cut through leaflets 32 of a host valvular structure 30 of a host prosthetic valve 10 along their cusp end portions 34. In some examples, the first end 118 of the support frame 106 comprises a cutting edge configured to cut through commissures 40 of a host prosthetic valve 10. In some examples, the first end 118 of the support frame 106 comprises a cutting edge configured to cut through synthetic materials from which host leaflets 32 of a host prosthetic valve 10 can optionally be formed. A cutting edge can be also referred to as an exposed cutting edge, meaning that the replacement valve does not include a covering or any other layer that conceals or covers the cutting edge, such that a cutting edge can be utilized to cut through the host leaflets 32.

[0203] Fig. 7A shows a cross-section of an exemplary support frame 106b, which is similar to any example described herein for support frame 106a, except that the first end 118 of the support frame 106bcomprises a sharp edge or a blade 126 serving as the cutting edge, which can optionally be formed as a single or double beveled cutting edge 126.

[0204] Fig. 7B shows a cross-section of an exemplary support frame 106c, which is similar to any example described herein for support frame 106a, except that the first end 118 of the support frame 106ccomprises an electrically conductive surface 128 configured to cut tissue and / or other soft components of the host prosthetic valve 10 contacted thereby, by application of electrical energy (e.g., RF energy). In some examples, the support frame 106cfurther includes an electrically insulating layer 150 covering at least a portion of the support frame 106cwhile the electrically conductive surface 128 remains a non-insulated portion of the support frame 106c. In some examples, the second end 120 and at least a portion of the inner side 122 and the outer side 124 of the support frame 106care covered by an insulating layer150, while at least a portion of the first end 118, and optionally the entirety of first end 118, can remain exposed.

[0205] Fig. 8 shows an exemplary support frame 106d. The support frame 106dis an exemplary implementation of support frame 106, and thus can include any of the features described above for support frame 106, except that the support frame 106dcan have a substantially circular cross-section, and can be optionally formed from one or more pieces of wire.

[0206] Fig. 9 shows a cross-section of an exemplary support frame 106e, which is similar to any example described herein for support frame 106d, except that the first end 1 18 of the support frame 106ecomprises an electrically conductive surface 128 configured to cut tissue and / or other soft components of the host prosthetic valve 10 contacted thereby, by application of electrical energy (e.g., RF energy), in a similar manner to that described above with respect to support frame 106c. Thus, in some examples, the support frame 106efurther includes an electrically insulating layer 150 covering at least a portion of the support frame 106ewhile the electrically conductive surface 128 remains a non-insulated portion of the support frame 106e. In some examples, the second end 120 and at least a portion of the inner side 122 and the outer side 124 of the support frame 106eare covered by an insulating layer 150, while at least a portion of the first end 118, and optionally the entirety of first end 118, can remain exposed.

[0207] While an exemplary support frame 106ehaving a round cross-section with a cutting edge optionally implemented as an electrically conductive surface 128 is shown in Fig. 9, it is to be understood that in some examples, a support frame having a mostly rounded shape can also include a first end 118 that has a sharp edge or a blade serving as the cutting edge, similar to the sharp edge 126 described above with respect to support frame 106b, wherein the cross- sectional contour of such a support frame can be substantially rounded along its second end 120 and its inner 122 and outer 124 sides.

[0208] In some examples, a support frame 106 can optionally further include coupling extensions 146 extending proximally from its apex regions 114, as shown in Fig. 8. In some examples, releasable coupling arms 224 of the delivery apparatus 202 include angularly-spaced prongs 226, such as the three prongs 226 illustrated in Fig. 4. The delivery apparatus 202 can optionally further include, in some examples, a plurality of angularly-spaced retaining wires 230, as illustrated in Fig. 11B, corresponding to the coupling extensions 146 of the support frame 106.

[0209] Each prong 226 cooperates with a corresponding retaining wire 230 to form a releasable connection with a coupling extension 146 of the support frame 106. In some examples, the distal end portion of each prong 226 includes an opening 228. In some examples, each couplingextension 146 can optionally include an opening 148 that is sized to receive a corresponding retaining wire 230. When assembled, as shown in Figs. 11A-11B, each coupling extension 146 is inserted through an opening 228 of a prong 226 and a retaining wire 230 is inserted through the opening 148 of the coupling extension 146 so as to retain the coupling extension 146 from backing out of the opening 228.

[0210] It is to be understood that any exemplary support frame 106 disclosed herein, including a support frame 106 having a circular or rounded cross-section as illustrated in Fig. 8, or a support frame 106 having a substantially rectangular cross-section as illustrated in Fig. 4, can optionally include coupling extension 146 configured to be releasably coupled to corresponding prongs 226 and retaining wires 230 of the delivery apparatus 202, unless stated otherwise. It is to be understood that in some examples, any support frame 106 disclosed herein can optionally be devoid of coupling extension 146 and / or include other components or mechanisms to releasably couple it to the delivery apparatus 202, examples of which will be described in greater detail below.

[0211] In some examples, the delivery apparatus 202 can optionally further include an outer shaft 210, as illustrated in Fig. 4. The delivery shaft 220, as well as other shafts of the delivery apparatus 202 as will be disclosed herein, can optionally extend through a lumen of the outer shaft 210. In some examples, the outer shaft 210 can optionally be a steerable shaft. The handle (not shown) of the delivery apparatus 202 can optionally include a steering mechanism configured to adjust the curvature of the distal end portion of an outer steerable shaft 210. For example, the handle can optionally include an adjustment member, such as a rotatable knob, which in turn is operatively coupled to the proximal end portion of a pull wire (not shown). The pull wire can extend distally from the handle through the outer shaft 210 and has a distal end portion affixed to the outer shaft 210 at or near the distal end of the outer shaft 210. Rotating the knob can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the outer shaft 210. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein.

[0212] As mentioned, the delivery assembly 200 is configured to cut through existing leaflets, such as host leaflets 32 of a host prosthetic valve 10, and remove the excised leaflet from the patient's body, prior to, or during, implantation of a replacement valve 100 therein. The excised leaflets may include calcified deposits that can be released into the blood stream during the cutting operation. In some examples, the delivery apparatus 202 comprises a filter 214configured to capture such calcifications and other debris, including optional tissue portions that can be torn of the host leaflets during cutting thereof.

[0213] In some examples, as shown in Fig. 4, the delivery apparatus 202 comprises a filter shaft 212 having the filter 214 attached to a distal end thereof. The filter shaft 212 can extend through the outer shaft 210, optionally around the delivery shaft 220. In some examples, the filter 214 is self-expandable, configured to be retained in a compacted configuration inside the outer shaft 210, and to self-expand to a deployed configuration, for example against the native anatomy, when released from the outer shaft 210. For example, the filter 214 can optionally comprise a shape memory material, such as nickel-titanium alloy and the like.

[0214] In some examples, the filter 214 can be configured to capture particles greater than a predefined size from blood flowing through the filter 214. For example, filter 214 can optionally have a membrane with a mesh structure with a predetermined mesh size. In some examples, the membrane of the filter 214 is configured to self-expand to a diameter that is about the same as or slightly larger than the diameter of the surrounding vessel (for example, the patient’s ascending aorta) so that all blood flowing therethrough passes through the filter 214.

[0215] In some examples, the delivery apparatus 202 further comprises a retrieval device 238 configured to expand at a position distal to the replacement valve 100. Fig. 4 shows an exemplary delivery assembly 200athat includes an exemplary delivery apparatus 202a. The delivery apparatus 202ais an exemplary implementation of delivery apparatus 202, and thus can include any of the features described herein for delivery apparatus 202, except that the delivery apparatus 202afurther comprises a retrieval device 238. In some examples, the delivery apparatus 202acan optionally comprise an inner shaft 232 having a distal end portion 234, wherein the inner shaft 232 can extend through a lumen of the delivery shaft 220, and can optionally be axially passed through the replacement valve 100, such as between the leaflets 132 of the valvular structure 130 of the replacement valve 100. The retrieval device 238 can optionally be configured to extend from the distal end portion 234 of the inner shaft 232.

[0216] In some examples, at least some, and optionally all, of the shafts of the delivery apparatus 202a, can optionally be telescopically movable relative to each other. For example, any of the outer shaft 210, filter shaft 212, delivery shaft 220, and / or inner shaft 232, can be optionally coaxial with each other and can be configured to be axially movable relative to each other.

[0217] In some examples, the retrieval device 238 can optionally be coupled to a distal end portion of a gripping shaft 242 of the delivery apparatus 202a. Optionally, the gripping shaft242 can extend through a lumen of the inner shaft 232, and can be axially movable relative to the inner shaft 232. In some examples, the retrieval device 238 is self-expandable, configured to be retained in a compacted configuration inside the inner shaft 232, and to self-expand to a deployed configuration, for example against the native anatomy, when released from the inner shaft 232. For example, the retrieval device 238 can optionally comprise a shape memory material, such as nickel-titanium alloy and the like.

[0218] In some examples, the retrieval device 238 can be configured to capture or collect leaflets that have been cut from a host valve. In some examples, the retrieval device 238 can optionally comprise a mesh 240 or frame, as illustrated in Fig. 4. The mesh 240 can optionally be coupled to a distal end portion of the gripping shaft 242. The mesh 240 can have a mesh structure with a predetermined mesh size. In some examples, the mesh 240 is configured to self-expand to a diameter that is about the same or larger than the diameter of the host prosthetic valve 10 or a valvular structure 30 thereof, so that when the mesh 240 is expanded, it can trap host leaflets 32 cut from the host prosthetic valve 10.

[0219] Since the mesh 240 of the retrieval device 238 can be designed to primarily capture cut leaflets 32 or torn tissue sections thereof, which can be significantly greater in size that debris released downstream toward the filter 214 when the leaflets 32 are cut, the mesh size of the retrieval device 238 can optionally be significantly larger than that of the filter 214. Nevertheless, the retrieval device 238 and / or a mesh 240 thereof can optionally be further configured to collect debris released during cutting of the leaflets, which can flow in some occasions upstream and not only downstream, in which case the retrieval device 238 can have a finer mesh size, which can optionally be similar to that of the filter 214.

[0220] The retrieval device 238 and / or mesh 240 thereof can optionally transition between a compacted state, when it resides inside of restraining structure such as the inner shaft 232, and an expanded deployed configuration, when it is released from the inner shaft 232. For example, when the retrieval device 238 is attached to a distal end of a gripping shaft 242, the gripping shaft 242 can be retracted inside the inner shaft 232 to retain the retrieval device 238 in a compacted state inside of the inner shaft 232 during delivery. When deployment is required, the gripping shaft 242 can optionally be distally advanced relative to the inner shaft 232, so as to expose the retrieval device 238 and allow expansion thereof, as illustrated in Fig. 4. In some examples, the retrieval device 238 and / or mesh 240 thereof can optionally be configured to assume an inverted convex shape in its free or deployed state, as illustrated in Fig. 4. However, it is to be understood that the dome-shaped deployed configuration of the retrieval device 238is shown in Fig. 4 by way of illustration and not limitation, and that other deployed shapes of the retrieval device 238 are contemplated, such as a more planar or disc-shaped configuration.

[0221] It is to be understood that any reference to a retrieval device 238 that includes a mesh 240 is not meant to be limiting, and that any structure of the retrieval devices 238 that defines a cage-like structure configured to trap and / or collect cut host leaflets is contemplated, such as, for example, in the form of a expandable (e.g., self-expandable) frame that includes intersecting struts defining cells having a cell size configured to trap and / or collect cut leaflets or torn segments thereof.

[0222] In some examples, a delivery assembly 200aincludes a replacement valve 100 having a support frame 106 with a cutting edge, such as at or along a first end 118 thereof, configured to cut through leaflets 32 and / or commissures 40 of a host prosthetic valve 10. The support frame 106 of the replacement valve 100 of delivery assembly 200acan include any of the features described herein with respect to exemplary support frames 106a, 106b, 106c, and / or 106d.

[0223] Figs. 10-14 illustrate some steps in a method for utilizing a delivery assembly 200afor cutting host leaflets 32 of a host prosthetic valve 10, and implanting a replacement valve 100 against the frame 16 of the host prosthetic valve 10. The distal end portion of the delivery assembly 200ais configured to be inserted into a patient’s vasculature, such as within an ascending aorta or any other position (including, for example, within the left atrium for treatment of a mitral valve, and the like), and to be advanced towards the host prosthetic valve 10. Positioning the delivery assembly 200arelative to the host prosthetic valve 10 may comprise advancing the delivery assembly 200atowards the host prosthetic valve 10 over a guidewire (not shown).

[0224] During delivery, the replacement valve 100 can be retained in a crimped or compressed configuration inside the outer shaft 210 (optionally inside a filter shaft 212 that can extend between the delivery shaft 220 and the outer shaft 210), the filter 214 can optionally be retained in a compacted configuration inside the outer shaft 210, and the retrieval device 238 can optionally be retained in a compacted configuration inside the inner shaft 232 or any other appropriate shaft of the delivery apparatus 202a.

[0225] After positioning the distal end portion of delivery assembly 200aproximal to the host prosthetic valve 10, the replacement valve 100 can be at least partially exposed out of the delivery shaft 220, allowing it to at least partially expand at a position that can be in close proximity to, and optionally still proximal to, the host valvular structure 30 of the host prosthetic valve 10, as illustrated in Fig. 10. In some examples, exposure of the replacementvalve 100 can optionally be accomplished by axially moving at least one of the replacement valve 100 and the delivery shaft 220 relative to the other, such as by proximal retraction of the delivery shaft 220 relative to the replacement valve 100, and / or distal advancement of the replacement valve 100 relative to, and out of, the distal end portion 222 of the delivery shaft 220. In some examples, such as when a filter shaft 212 is disposed around the delivery shaft 220, exposure of the replacement valve 100 can optionally be accomplished by axially moving at least one of the replacement valve 100 and the filter shaft 212 relative to the other, such as by proximal retraction of the filter shaft 212 relative to the replacement valve 100, and / or distal advancement of the replacement valve 100 relative to, and out of, the of the filter shaft 212.

[0226] In some examples, the distal end portion 222 of the delivery shaft 220 is positioned distal to the distal end of the outer shaft 210 prior to, or simultaneously with, deployment of the replacement valve 100. This can optionally be accomplished by axially moving at least one of the outer shaft 210 and the delivery shaft 220 relative to the other, such as by proximal retraction of the outer shaft 210 relative to the delivery shaft 220, and / or distal advancement of the distal end portion 222 of the delivery shaft 220 relative to, and out of, the outer shaft 210. Positioning of the distal end portion 222 of the delivery shaft 220 distal to the outer shaft 210 can be optionally performed prior to, simultaneously with, or after, positioning at least a portion of the replacement valve 100 distal to the distal end portion 222 of the delivery shaft 220.

[0227] In some examples, the distal end portion 222 of the delivery shaft 220 is positioned distal to the distal end of the filter shaft 212 and / or the filter 214 attached thereto, prior to, or simultaneously with, deployment of the replacement valve 100. This can optionally be accomplished by axially moving at least one of the filter shaft 212 and the delivery shaft 220 relative to the other, such as by proximal retraction of the filter shaft 212 relative to the delivery shaft 220, and / or distal advancement of the distal end portion 222 of the delivery shaft 220 relative to, and out of, the filter shaft 212 and / or the filter 214 attached thereto. Positioning of the distal end portion 222 of the delivery shaft 220 distal to the filter shaft 212 and / or the filter 214 can be optionally performed prior to, simultaneously with, or after, positioning at least a portion of the replacement valve 100 distal to the distal end portion 222 of the delivery shaft 220.

[0228] In some examples, the filter 214 can optionally be deployed at a position proximal to the host valvular structure 30 of the host prosthetic valve 10, and / or proximal to the position of deployment of replacement valve 100. In order to deploy the filter 214, it can be exposed out of the outer shaft 210 in a manner that can allow it, in some examples, to self-expand. Exposure of the filter 214 can optionally be accomplished by axially moving at least one of the outershaft 210 and the filter shaft 212 relative to the other, such as by proximal retraction of the outer shaft 210 relative to the filter shaft 212, and / or distal advancement of the filter shaft 212 along with the filter 214 attached thereto relative to, and out of, the outer shaft 210. Deployment of the filter 214 can be performed prior to initiating cutting of the host leaflets 32, optionally prior to, simultaneously with, exposure and / or partial or full deployment of the replacement valve 100.

[0229] In some examples, the cusp portions 108 of the support frame 106 can be positioned, when the replacement valve 100 is at least partially deployed, between the corresponding host leaflets 32 and the frame 16 of the host prosthetic valve 10, as illustrated in Fig. 10. The replacement valve 100 can be then allowed to expand further against the frame 16 of the host prosthetic valve 10, and the delivery apparatus 202acan be utilized to advance the replacement valve 100 further in the distal direction, bringing the cusp portions 108 of the support frame 106 closer to the cusp end portions 34 of the host leaflets 32, as illustrated in Fig. 11 A.

[0230] In some examples, the replacement valve 100 can optionally be fully expanded against the frame 16 of the host prosthetic valve 10, and the support frame 106 can slide along an inner surface of the frame 16 and / or an inner skirt 46 of the host prosthetic valve 10 during distally- oriented advancement of the replacement valve 100 therein. In some examples, the replacement valve 100 is sufficiently expanded such that as the cusp portions 108 of the support frame 106 approach the cusp end portions 34 of the host leaflets 32, the commissure support portions 110 of the support frame 106 are also advanced to move closer to the commissures 40 of the host prosthetic valve 10.

[0231] During delivery of the replacement valve 100 through the patient's vasculature, deployment of the replacement valve 100 out of the delivery shaft 220, and advancement of the replacement valve 100 inside of the host prosthetic valve 10 and towards the cusp end portions 34 of the host leaflets 32, the replacement valve 100 can optionally be coupled to the delivery apparatus 202 via releasable coupling arms 224, which can be optionally implemented as prongs 226 and retaining wires 230 releasably coupled to corresponding coupling extensions 146 of the replacement valve 100, as illustrated in Figs. 11A-11B for example, though any other type of releasable coupling arms is similarly contemplated.

[0232] The releasable coupling arms 224 can provide a connection between the replacement valve 100 and the delivery apparatus 202 that is secure and rigid enough to retain the position of the replacement valve 100 relative to the delivery apparatus 202 against the flow of the blood as the position of the replacement valve 100 is adjusted relative to a desired position in the host prosthetic valve 10. Thus, the releasable coupling arms 224 can optionally be components ofthe delivery apparatus 202 which are controllably movable in the axial direction, relative to the delivery shaft 220, such that distal advancement of the coupling arms 224 can expose the replacement valve 100 out of the delivery shaft 220 and optionally advance it further relative to and / or inside of the host prosthetic valve 10. Similarly, the delivery shaft 220 can optionally be axially movable relative to the coupling arms 224, such that proximal retraction of the delivery shaft 220 relative to the coupling arms 224 can expose the replacement valve 100 and at least a portion of the coupling arms 224.

[0233] In some examples, further advancement of the replacement valve 100 relative to and / or inside of the host prosthetic valve 10 can optionally be accomplished by simultaneously moving the delivery shaft 220 and the coupling arms 224 in the distal direction.

[0234] The method can optionally further include deployment of a retrieval device 238 of the delivery apparatus 202adistal to the host prosthetic valve 10, as shown in Fig. 12. The inner shaft 232 can optionally be distally advanced through the host prosthetic valve 10, positioning its distal end portion 234 distal to the inflow end 12 of the host prosthetic valve 10, while the retrieval device 238 is maintained in a compacted configuration, such as by being kept inside the inner shaft 232 which serves as a constraining structure in such a case. Once the distal end portion 234 of the inner shaft 232 is positioned distal to the host prosthetic valve 10, the retrieval device can be controllably deployed.

[0235] In some examples, deployment of the retrieval device comprises exposing the retrieval device 238 out of the inner shaft 232 in a manner that can allow it or a mesh 240 thereof to self-expand. In some examples, exposure of the filter 214 can be accomplished by axially moving at least one of the inner shaft 232 and the gripping shaft 242 relative to the other, such as by proximal retraction of the inner shaft 232 relative to the gripping shaft 242, and / or distal advancement of the gripping shaft 242 along with the retrieval device 238 or mesh 240 thereof attached thereto, relative to, and out of, the inner shaft 232. Deployment of the retrieval device 238 can be performed prior to initiating cutting of the host leaflets 32, optionally prior to, simultaneously with, or after, deployment of the replacement valve 100 and / or advancement thereof inside the host prosthetic valve 10.

[0236] While a self-expandable retrieval device 238 attached to a gripping shaft 242 extendable through an inner shaft 232 is described, it is to be understood that any other type of deployment mechanism for a retrieval device 238 is contemplated, including any appropriate mechanism to allow the retrieval device 238 to transition between compacted and deployed configurations, either relying on self-expansion properties of the retrieval device 238, orrelying on mechanical actuation mechanisms for expanding and / or compressing the retrieval device 238.

[0237] The method further includes, after deployment of the retrieval device 238 distal to the host prosthetic valve 10, separating the host leaflets 32 from the frame 16 of the host prosthetic valve 10 by cutting through portions of the host leaflets 32 coupled to the frame 16. The host leaflets 32 can be coupled to the frame 16 of the host prosthetic valve 10 directly, such as by being sutured to struts 18 of the frame 16, or indirectly, such as by being sutured to intermediate components. For example, the host leaflets 32 can be sutured to an inner skirt 46, which is, in turn, coupled (e.g., sutured) to the frame 16. Thus, separation of the host leaflets 32 from the frame 16 of the host prosthetic valve 10 can refer to separation of host leaflets 32 which are directly coupled to the frame 16, or separation of host leaflets 32 from intermediate components, such as an inner skirt 46, which are in turn coupled to the frame.

[0238] In some examples, the host leaflets 32 can be cut away from intermediate components disposed between the host leaflets 32 and the frame 16, such as by cutting the host leaflets 32 away from the inner skirt 46, while the inner skirt 46 (or other intermediate components) can remain coupled to the frame 16 after the cutting. In some examples, at least a portion of an intermediate component can be cut away from the frame 16 along with the host leaflets 32. For example, separating the host leaflets 32 from the frame 16 can include cutting through inner skirt material, such that at least part of the inner skirt 46, and in some examples, the entirety of the inner skirt 46, may optionally be cut away from the frame 16 along with the host leaflets 32.

[0239] In some examples, cutting the leaflets 32 away from the frame 16 of the host prosthetic valve 10 is accomplished by distally pushing the cutting edge along the first end 118 of the support frame 106 of the replacement valve 100 against the host valvular structure 30, in close proximity to the regions of attachment of the host valvular structure 30 to the frame 16 of the host prosthetic valve 10. The support frame 106 can optionally be allowed to fully expand against the inner diameter of the host prosthetic valve 10, proximal to the regions of attachment of the host valvular structure 30 to the frame 16, after which the replacement valve 100 is distally pushed up to contact of the first end 118 of the support frame 106 with the host valvular structure. Continued axial movement of the replacement valve 100 in the distal direction, upon contacting the host leaflets 32, optionally in close proximity to the frame 16 of the host prosthetic valve 10, facilitates cutting of the host leaflet material by the cutting edge of the support frame 106.

[0240] Continued distal advancement of the replacement valve 100 to bring the support frame 106 and cutting edge thereof to contact with the host valvular structure 30, and cutting through portions of the host valvular structure 30, can be accomplished, in some examples, by distally pushing the releasable coupling arms 224 while they are still coupled to the support frame 106.

[0241] When the cutting edge at the first end 118 of the support frame 106 comprises a sharp edge 126 (e.g., a blade), the replacement valve 100 can optionally be distally pushed at a sufficient pushing force to allow the sharp edge 126 to cut through the host leaflets 32. When the cutting edge at the first end 1 18 of the support frame 106 comprises an electrically conductive surface 128, the electrically conductive surface 128 can optionally be supplied with a level of current and / or radio frequency energy to be applied by the electrically conductive surface 128 to the host leaflet material to bum, vaporize, lacerate, slice, tear, cut, or otherwise separate the host leaflet.

[0242] In some examples, the support frame 106 can optionally be electrically connected, by one or more components of the delivery apparatus 202, to a power source (not shown) that can be activated to provide electrical energy, such as radiofrequency (RF) energy, to the support frame 106. In some examples, the power source can optionally be configured to provide other forms of energy (for example, microwave, light, ultrasonic, etc.) to the support frame 106. In some examples, a conduction path can extend from a power source (which can be external to the patient's body), towards an along the releasable coupling arms 224. In such examples, both the support frame 106 and the releasable coupling arms 224 comprise electrically conductive material, such as metals. Since the releasable coupling arms 224 are coupled, during the cutting operation, to the support frame 106, they can optionally conduct current to the support frame 106. In some examples, prongs 226 of the releasable coupling arms 224 are configured to conduct current to the support frame 106. In some examples, retaining wires 230 of the releasable coupling arms 224 are configured to conduct current to the support frame 106.

[0243] In some examples, the power source is included in the handle of the delivery apparatus 202. In some examples, the power source is external to the handle of the delivery apparatus 202. In some examples, the handle includes a knob configured to activate or deactivate the power source. In some examples, the cutting edge of the support frame 106 comprises both a sharp edge 126 and an electrically conductive surface 128, which can be an electrically conductive surface of the sharp edge.

[0244] Since the first end 118 equipped with the cutting edge of the support frame 106 is facing the host valvular structure 30, such as along regions of attachment thereof to the frame 16 of the host prosthetic valve 10, distal advancement of the replacement valve 100 serves to cut thehost valvular structure 30 along such regions of attachment. Thus, distal advancement of the cusp portions 108 of the support frame 106 can optionally cut through the host leaflets 32 along their cusp end portion 34 (e.g., cutting along the scalloped line of the host prosthetic valve 10). In some examples, during such distal advancement of the replacement valve 100, the commissure support portions 110 of the are similarly advanced to cut through the commissures 40 of the host prosthetic valve 10.

[0245] In order to cut the host valvular structure 30 away from the frame 16, the support frame 106 of the replacement valve 100 may be angularly aligned with the host valvular structure 30 during the cutting operation, such that the cusp portions 108 of the support frame 106 are aligned with the cusp end portions 34 of the host leaflets 32, and the commissure support portions 110 of the support frame 106 are aligned with the commissures 40 of the host valvular structure 30. In some examples, the delivery apparatus 202 can optionally include an angular orientation mechanism (not shown) that can allow a user of the delivery assembly 200 to actively control the angular orientation of the replacement valve 100 relative to the host prosthetic valve 10. In some examples, alignment is achieved passively, such that during advancement of the replacement valve from the outflow end 14 along the inner pockets formed between the host leaflets 32 and the frame 16, portions of the support frame 106, such as the cusp portions 108, can optionally slide along the surfaces and borders of the host leaflets 32 in a manner that passively aligns the support frame 106 with the host valvular structure 30 prior to initiation of the cutting operation.

[0246] Cutting through both the commissures 40 and the cusp end portions 34 of the host leaflets 32 serves to completely separate them from the frame 16. As the host leaflets 32 are completely separated, they may, in some examples, fall out of the frame 16 of the host prosthetic valve 10, optionally into or over the retrieval device 238, as illustrated in Fig. 14. The retrieval device 238, deployed distal to the host prosthetic valve 10, prevents the cut host leaflets 32 from being carried further in the upstream or distal direction. It is to be understood that cut host leaflets 32 traveling in an upstream direction towards and / or into retrieval device 238, at a position that can be distal to the inflow end 12 of the host prosthetic valve 10, are shown in Fig. 14 by way of illustration and not limitation, and that in some examples, the separated host leaflets 32 can remain partially or fully inside of the host prosthetic valve 10, such as between its inflow end 12 and outflow end 14, or they can travel along with the blood flow downstream, in which case the cut host leaflets 32 will be caught by the deployed filter 214.

[0247] In order to remove the cut host leaflets 32 from the patient's body, the retrieval device 238 can optionally be proximally pulled to collect and / or remove the cut host leaflets 32. For example, even if the host leaflets 32 remain inside the boundaries of the frame 16 of the host prosthetic valve 10 after being cut away therefrom, the retrieval device 238 can optionally engage with, collect, and / or trap the host leaflets 32 as it is proximally pulled through the frame 16 of the host prosthetic valve 10, as well as between the replacement leaflets 132 of the replacement valve 100.

[0248] In some examples, the retrieval device can be proximally pulled towards the deployed filter, in a manner that can trap the cut host leaflets 32 between the retrieval device 238 and the filter 214. In some examples, the retrieval device 238 can be at least partially compressed so as to contain the cut host leaflets 32 and preventing them from escaping. In some examples, the delivery apparatus 202 can optionally include a recompression mechanism (not shown) configured to compress the retrieval device 238 around the cut host leaflets 32. In some examples, the retrieval device 238 can be utilized to collect and move the cut host leaflets 32 towards the filter 214, and the filter can be compressed around the cut host leaflets 32 to contain them and prevent them from escaping.

[0249] After completion of the cutting operation by the replacement valve 100, the replacement valve 100 can optionally be released from the delivery apparatus 202. In some examples, the replacement valve 100 can optionally be released from the releasable coupling arms 224 of a delivery apparatus 202 after cutting the host leaflets 32, as shown in Fig. 14. Releasing the replacement valve 100 can optionally comprise, in some examples, proximal retraction of the releasable coupling arms 224 from the coupling extensions 146 of the support frame 106, such that the retaining wires 230 can be withdrawn from the openings 148 of the coupling extensions 146, and retraction of the prongs 226 removes the coupling extensions 146 from the openings 228 of the prongs 226, thus completely disconnecting the replacement valve 100 from the delivery apparatus 202.

[0250] In some examples, the axial position of the replacement valve 100 is further adjusted after the cutting operation and prior to decoupling the replacement valve 100 from the delivery apparatus 202. For example, after completion of the cutting operation, the releasable coupling arms 224 can remain attached to the replacement valve 100, and utilized to axially move the replacement valve to a desired position inside the frame 16 of the host prosthetic valve 10. The replacement valve 100 can be maneuvered in this manner to advance it further in the distal direction, closer to the inflow end 12 of the host prosthetic valve 10, after cutting the host leaflets 32.

[0251] In some cases, the procedure of cutting away the leaflets of a previously implanted valve and implanting a replacement valve 100 therein, in a similar manner to that described herein, can optionally be repeated several times during the patient's lifetimes, for example when the first prosthetic valve is implanted in relatively young patients, and replacement valve implantation may be required due to failure of the implanted valve after a period of several successfully years of functioning. In such cases, it may be of advantage to position the newly implanted replacement valve at a position which is as distal as possible within the frame of the host valve, to avoid a risk of numerous frames implanted each time at a position proximal to the previous frame, eventually extending past the outflow end of a frame that can properly support the newly implanted replacement valve.

[0252] Releasing of the replacement valve 100 from the delivery apparatus 202 can be performed prior to, simultaneously with, or after collecting the cut host leaflets 32 by a retrieval device 238 pulled across the remaining host prosthetic valve 10 and the newly implanted replacement valve 100. Once the cut host leaflets 32 are collected by the retrieval device 238, and the replacement valve 100 is released from the delivery apparatus 202, the delivery apparatus 202 can be retrieved from the patient's body, along with the cut host leaflets 32, which can be retained by the retrieval device 238 and / or filter 214, leaving the replacement valve 100 implanted within the frame 16 of the host prosthetic valve 10, as shown in Fig. 15.

[0253] In some examples, the delivery apparatus 202 further comprises a leaflet removal device 254 configured to cut and collect host leaflets 32 of a host prosthetic valve 10. Fig. 16 shows an exemplary delivery assembly 200fthat includes an exemplary delivery apparatus 202f. The delivery apparatus 202fis an exemplary implementation of delivery apparatus 202, and thus can include any of the features described herein for delivery apparatus 202, except that the delivery apparatus 202ffurther comprises a leaflet removal device 254. In some examples, the delivery apparatus 202fcan comprise an inner shaft 250 having a distal end portion 252, wherein the inner shaft 250 can optionally extend through a lumen of the delivery shaft 220, and can be axially passed through the replacement valve 100, such as between the leaflets 132 of the valvular structure 130 of the replacement valve 100. The leaflet removal device 254 can be configured to extend from the distal end portion 252 of the inner shaft 250.

[0254] In some examples, at least some, and optionally all, of the shafts of the delivery apparatus 202f, can be telescopically movable relative to each other. For example, any of the outer shaft 210, filter shaft 212, delivery shaft 220, and / or inner shaft 250, can be optionally coaxial with each other and can be configured to be axially movable relative to each other.

[0255] The leaflet removal device 254 can optionally include one or more clips 256. While three clips 256a, 256b and 256c are illustrated in Fig. 16, any other number is contemplated, such as a single clip (as illustrated, for example, in Figs. 21 A- 22), two clips, or more than three clips. Each clip 256 includes a first clip arm 258 and a second clip arm 260 which are movable towards and away from each other. The leaflet removal device 254 is configured to transition between open and closed configurations, wherein the first 258 and second 260 clip arms are spaced from each other in the open configuration, and are closed against each other in the closed configuration. Each of the first clip arm 258 and second clip arm 260 can be curved or cusp-shaped, generally matching the shape of the cusp end portions 34 of host leaflets 30. The first clip arm 258 and second clip arm 260 can optionally be joined at proximal ends thereof at proximal joints 262, such that the outer 258 and inner 260 clip arms are pivotable relative to each other about the proximal joints 262.

[0256] Thus, each couple of first 258 and second 260 clip arms, which are pivotably movable relative to each other at corresponding proximal joints 262, collectively define a single clip 256, wherein the first and second arms 258, 260 of each clip 256 can optionally have a generally curved shape configured to generally match the curvature of cusp end portion 34 of a target host leaflet 32, and can optionally extend relatively linearly towards the proximal joints 262 so as to extend next to commissures 40 at both sides of the host valvular structure 30, while the proximal joints 262 of the clip 256 are optionally disposed at or proximal the free edge 36 of the target host leaflet 32, or can be optionally abut or be disposed proximal to commissures 40 on both sides of the target host leaflet 32, when the clip 256 is clipped over the host leaflet 32, as will be described in greater detail below.

[0257] When the leaflet removal device 254 includes a plurality of clips 256, such as the three clips 256 illustrated in Fig. 16, the first clip arms 258 of the plurality of clips 256 can be continuous which each other, together forming a unitary scalloped-shaped structure, and the second clip arms 260 of the plurality of clips 256 can be continuous which each other, together forming a similar unitary scalloped-shaped structure, wherein the proximal joints 262 can be commonly disposed between adjacent of clips 256.

[0258] Each clip 256 further comprises a first cage 270 attached to, and proximally extending from, the first clip arm 258, and a second cage 272 attached to, and proximally extending from, the second clip arm 260. In some examples, the first 270 and second 272 cages can optionally extend proximally beyond the axial position of the proximal joints 262. When the first 258 and second 260 clip arms move towards or away from each other, the planes defined by the first270 and second 272 cages will similarly move towards or away from each other therewith, at least along the portions of the cages 270, 272 which are distal to the proximal joints 262.

[0259] In some examples, the leaflet removal device 254 can optionally be coupled to a retaining member 280 (shown, for example, in dashed lines in Fig. 19C) disposed inside and / or extending through the inner shaft 250 of the delivery apparatus 202f. The retaining member 280 can optionally include or be attached to an elongated shaft extending through a lumen of the inner shaft 250, and can optionally be axially movable relative to the inner shaft 250. In some examples, the leaflet removal device 254 is self-expandable, configured to he retained in a compacted configuration inside the inner shaft 250, and to self-expand to a deployed configuration when released from the inner shaft 250. In some examples, the first clip arms 258 and second clip arms 260 are self-expandable, configured to be retained in a compacted configuration inside the inner shaft 250, and to self-expand to a deployed configuration when released from the inner shaft 250. For example, any of the first clip arms 258 and second clip arms 260 can optionally comprise a shape memory material, such as nickel-titanium alloy and the like.

[0260] Figs. 17A and 17B show an exemplary leaflet removal device 254 in an open configuration and a closed configuration, respectively. The leaflet removal device 254 is configured to clamp over a leaflet, such as a host leaflet 32. For example, a clip 256 can be clamped over a host leaflet 32, such that the first clip arm 258 and the first cage 270 are facing the outer surface 44 of the leaflet 32, and the second clip arm 260 and second cage 272 are facing the inner surface 42 of the leaflet 32. In order to position the clip arms 258, 260 and cages 270, 272 on both sides of the leaflet, a radial gap is formed between first 258 and second 260 clip arms, as shown in Fig. 17A, sufficiently sized to pass a leaflet 32 therethrough. Once the clip arms 258, 260 are disposed over both sides of the leaflet 32, optionally advanced towards the cusp end portion 34 of the leaflet 32, the leaflet removal device 254 can optionally be closed, such that the clip arms 258, 260 clamp against the leaflet 32, optionally clamping the cusp end portion 34 of the leaflet therebetween.

[0261] In some examples, the leaflet removal device 254 can optionally be biased, in a free state thereof, to the closed configuration. In some examples, the first clip arms 258 and second clip arms 260 can optionally be biased towards each other, as illustrated in Fig. 17B. In some examples, the radial gap between the first clip arm 258 and second clip arm 260 in the open configuration, shown in Fig. 17A, is greater than the thickness of a host leaflet 32 configured for placement inside the clip 256. It is to be understood that the first clip arms 258 and second clip arm 260 are not necessarily in full contact in the closed configuration when no leaflet isplaced therebetween, but are rather configured to clamp against a leaflet 32 in a manner that may prevent the leaflet 32 from slipping away. In some examples, the radial gap or distance between the first clip arm 258 and second clip arm 260 in the closed configuration, such as that shown in Fig. 17B, is smaller than the thickness of a host leaflet 32 configured for placement inside the clip 256.

[0262] In some examples, a clip 256 of the leaflet removal device 254 is configured to cut through tissue, such as through leaflets. In some examples, at least one of the first clip arm 258 and / or the second clip arms 260 comprises a cutting edge configured to cut through tissue, such as through leaflets of a valve in which the replacement valve 100 is to be implanted. Clamping of the first 258 and second 260 clip arms over the leaflet 32 can optionally be accompanied by cutting the leaflet. After the leaflet is fully cut, it remains entrapped between the first cage 270 and second cage 272, while the clip arms 258, 260 are closed against each other in a manner that prevent the leaflets from escaping the clip 256.

[0263] The first cage 270 and the second cage 272 can include any type of flexible structure configured to retain a cut leaflet 32 therebetween. Fig. 16 shows an exemplary leaflet removal device 254f, which is similar to any example described herein for a leaflet removal device 254, except that each first cage 270 and second cage 272 of the leaflet removal device 254fcomprises a frame or a mesh 274. When implemented as a mesh, the mesh 274 can optionally have a mesh density sufficient to keep a cut leaflet between the outer 270 and inner 272 cages. When implemented as a frame, the frame can optionally be constructed of intersecting struts that define cells, wherein the cells of such a frame will define openings sized to keep a cut leaflet between the outer 270 and inner 272 cages. Moreover, when implemented as a frame, the struts may be thin enough to curve or bend during deployment of the leaflet removal device. In some examples, any of the first cage 270 and / or second cage 272 comprises a fabric, such as a skirt having weft and warp filaments, wherein the density of the weft and warp filaments can optionally be selected to allow such a skirt fabric to further serve as a filtering material.

[0264] Since a host leaflet 32 can have a relatively large surface area, mesh opening or cells opening sizes of outer 270 or inner 272 cages can be relatively large in size. Nevertheless, in some examples, a finer mesh density of smaller cell size can optionally be implemented, for example if the outer 270 and inner 272 cages are further configured to trap potential calcified deposits or debris that may be released during cutting of the leaflets.

[0265] Figs. 17A-17B show an exemplary leaflet removal device 254g, which is similar to any example described herein for a leaflet removal device 254, except that each first cage 270 and second cage 272 of the leaflet removal device 254fcomprises a plurality of axially-extendingstrings 276, laterally spaced from each other at distances configured to keep a cut leaflet between the outer 270 and inner 272 cages. A string 276 can be any thin and flexible elongated components, such as a suture, a filament, a wire, and the like.

[0266] Fig. 18 shows an exemplary leaflet removal device 254h, illustrated without the first and second cages for clarity. The leaflet removal device 254his an exemplary implementation of leaflet removal device 254, and thus can include any of the features described above for leaflet removal device 254, except that the leaflet removal device 254hcan further include coupling extension 264, configured to couple the leaflet removal device 25411to a component of the delivery apparatus 202 that can be configured to facilitate axial movement of the leaflet removal device 254, such as to a retaining members shown in Figs. 19-20. Each coupling extension 264 can optionally include an axial strut 266 proximally extending from a corresponding proximal joint 262, and a head portion 268 at a proximal end of the axial strut 266. The head portion 268 can optionally have a wider profile than that of the axial strut 266, and comprise a round, circular, D-shape, mushroom-shape, or any other shape that can be received inside a complementary recessed portion 282 of the retaining member 280 (see Figs. 19-20).

[0267] When the head portions 268 are placed inside the recessed portion 282, they remain engaged with the retaining member 280 and prevented from springing outwards as long as the retaining member 280 is kept inside the inner shaft 250. This allows the retaining member 280 to serve as a push / pull member that can facilitate axial translation of the leaflet removal device 254 in the distal and proximal directions.

[0268] The delivery apparatus 202fcan optionally include an outer shaft 210, a filter shaft 212 with a filter 214, and a delivery shaft 220, according to any of the examples described for these components herein. The delivery assembly 200ffurther comprises a replacement valve 100 that can optionally be similar to any exemplary replacement valve 100 disclosed above, except that a replacement valve 100 can, but does not necessarily have to, include a cutting edge. Thus, in some examples, a delivery assembly 200fcan optionally include a replacement valve 100 having a support frame 106 devoid of a cutting edge. The leaflet removal device 254 of delivery apparatus 202fcan include any of the features described herein with respect to exemplary leaflet removal devices 254f, 254s, and / or 254hdescribed above, as well as any of exemplary leaflet removal devices 2541, 254', 254k, 2541, and / or 254nthat will be described below with respect to Figs. 22-23E.

[0269] Figs. 19A-20 illustrate some steps in a method for utilizing a delivery assembly 200ffor cutting host leaflets 32 of a host prosthetic valve 10, and implanting a replacement valve100 against the frame 16 of the host prosthetic valve 10. The distal end portion of the delivery assembly 200fis configured to be inserted into a patient’s vasculature, such as within an ascending aorta or any other position (including, for example, within the left atrium for treatment of a mitral valve, and the like), and to be advanced towards the host prosthetic valve 10. Positioning the delivery assembly 200frelative to the host prosthetic valve 10 may comprise advancing the delivery assembly 200ftowards the host prosthetic valve 10 over a guidewire (not shown).

[0270] During delivery, the replacement valve 100 can optionally be retained in a crimped or compressed configuration inside the outer shaft 210 (optionally inside a filter shaft 212 that can extend between the delivery shaft 220 and the outer shaft 210), the filter 214 can optionally be retained in a compacted configuration inside the outer shaft 210, and the leaflet removal device 254 can optionally be retained in a compacted configuration inside the inner shaft 250 or any other appropriate shaft of the delivery apparatus 202f.

[0271] After positioning the distal end portion of delivery assembly 200fproximal to the host prosthetic valve 10, the leaflet removal device 254 can optionally be at least partially exposed out of the inner shaft 250, allowing it to at least partially expand at a position that can be in close proximity to, and optionally still proximal to, the host valvular structure 30 of the host prosthetic valve 10, as illustrated in Fig. 19A. In some examples, exposure of leaflet removal device 254 can be accomplished by axially moving at least one of the leaflet removal device 254 and the inner shaft 250 relative to the other, such as by proximal retraction of the inner shaft 250 relative to the leaflet removal device 254, and / or distal advancement of the leaflet removal device 254 relative to, and out of, the distal end portion 252 of the inner shaft 250.

[0272] In some examples, such as when the delivery shaft 220 is disposed around the inner shaft 250, exposure of the leaflet removal device 254 can be accomplished by axially moving at least one of the leaflet removal device 254 and the delivery shaft 220 relative to the other, such as by proximal retraction of the delivery shaft 220 relative to the replacement valve 100, and / or distal advancement of the leaflet removal device 254 relative to, and out of, the distal end portion 222 of the delivery shaft 220.

[0273] In some examples, such as when the inner shaft 250 is nested inside a filter shaft 212 (which can be disposed, for example, around the delivery shaft 220), exposure of the leaflet removal device 254 can be accomplished by axially moving at least one of the leaflet removal device 254 and the filter shaft 212 relative to the other, such as by proximal retraction of the filter shaft 212 relative to the leaflet removal device 254, and / or distal advancement of the leaflet removal device 254 relative to, and out of, the filter shaft 212.

[0274] In some examples, the distal end portion 252 of the inner shaft 250 is positioned distal to the distal end of the outer shaft 210 prior to, or simultaneously with, deployment of the leaflet removal device 254. This can be accomplished by axially moving at least one of the outer shaft 210 and the inner shaft 250 relative to the other, such as by proximal retraction of the outer shaft 210 relative to the inner shaft 250, and / or distal advancement of the distal end portion 252 of the inner shaft 250 relative to, and out of, the outer shaft 210. Positioning of the distal end portion 252 of the inner shaft 250 distal to the outer shaft 210 can be optionally performed prior to, simultaneously with, or after, positioning at least a portion of the leaflet removal device 254 distal to the distal end portion 252 of the inner shaft 250.

[0275] In some examples, the distal end portion 252 of the inner shaft 250 is positioned distal to the distal end of the filter shaft 212 and / or the filter 214 attached thereto, prior to, or simultaneously with, deployment of the leaflet removal device 254. This can be accomplished by axially moving at least one of the filter shaft 212 and the inner shaft 250 relative to the other, such as by proximal retraction of the filter shaft 212 relative to the inner shaft 250, and / or distal advancement of the distal end portion 252 of the inner shaft 250 relative to, and out of, the filter shaft 212 and / or the filter 214 attached thereto. Positioning of the distal end portion 252 of the inner shaft 250 distal to the filter shaft 212 and / or the filter 214 can be optionally performed prior to, simultaneously with, or after, positioning at least a portion of the leaflet removal device 254 distal to the distal end portion 252 of the inner shaft 250.

[0276] In some examples, the distal end portion 252 of the inner shaft 250 is positioned distal to the distal end portion 222 of the delivery shaft 220 prior to, or simultaneously with, deployment of the leaflet removal device 254. This can be accomplished by axially moving at least one of the delivery shaft 220 and the inner shaft 250 relative to the other, such as by proximal retraction of the delivery shaft 220 relative to the inner shaft 250, and / or distal advancement of the distal end portion 252 of the inner shaft 250 relative to, and out of, the delivery shaft 220. Positioning of the distal end portion 252 of the inner shaft 250 distal to the delivery shaft 220 can be optionally performed prior to, simultaneously with, or after, positioning at least a portion of the leaflet removal device 254 distal to the distal end portion 252 of the inner shaft 250.

[0277] As shown in Fig. 19B, the leaflet removal device 254 can optionally be retained in an open configuration when positioned proximal to the host valvular structure 30. The gaps between the outer 258 and inner 260 clip members in the open configuration are sufficient to allow for convenient insertion of the host leaflets 32 therebetween.

[0278] As shown in Fig. 19C, the leaflet removal device 254 can be then advanced in a distal direction, positioning the first clip arms 258 and first cages 270 between the corresponding host leaflets 32 and the frame 16 of the host prosthetic valve 10, while the second clip arms 260 and the second cages 272 are positioned radially inwards to the host leaflets 32.

[0279] When the leaflet removal device 254 is coupled to a retaining member 280 via coupling extensions 264, the axial struts 266 can optionally have sufficient length to maintain the head portions 268 coupled to the retaining member 280 inside the inner shaft 250 at all times. In some examples, the leaflet removal device 254 can optionally be axially movable relative to the inner shaft 250 without components that can be unintentionally disconnected.

[0280] In some examples, coupling extensions 264 of the leaflet removal device 254 can optionally be permanently affixed to an axially movable component of the delivery apparatus 202, such as a retaining member, by bluing, welding, soldering, and the like. In this manner, even if a retaining member is exposed out of the inner shaft, it does not pose a risk of accidental disengagement of the leaflet removal device 254 therefrom. In some examples, axial struts 266 extending from the proximal joints 262 can optionally extend through a lumen of the inner shaft 250 all the way to the handle, and can be axially moved in a proximal or distal direction to translate the leaflet removal device 254 therewith, without being connected to any other intermediate component.

[0281] The first clip arms 258 and second clip arms 260 can optionally have curved or arcuate portions, which can be similar in shape to the cusp portions 108 of the support frame 106 of a replacement valve described above. Each pair of adjacent curved cusp-shaped portions of the first clip arms 258 and second clip arms 260 can optionally converge somewhat asymptotically to form upstanding vertical portions that terminate in the proximal joints 262, together forming U-shaped configurations that can optionally be similar in shape to commissure support portions 110 of the support frame 106 of a replacement valve described above.

[0282] Advancement of the leaflet removal device 254 in the open configuration can continue until the cusp-shaped portions of the first clip arms 258 and / or second clip arms 260 are at, or in close proximity to, the cusp end portions 34 of the host leaflets 32, as shown in Fig. 19C, at which point the leaflet removal device 254 can optionally move to the closed configuration, clipping the host leaflets 32 between the clip arms 258, 260. In this position, the U-shaped proximal portions of the clip arms 258, 260 and proximal joints 262 can optionally extend around the commissures 40 of the host prosthetic valve 10.

[0283] While the leaflet removal device 254 is shown in Fig. 19B to be fully expanded after deployment, prior to positioning of the host leaflets 32 inside its corresponding clips 256, it isto be understood that in some examples, the lower or distal cusp-shaped portions of clip arms 258, 260 can optionally be partially deployed as they begin to move distally past the free edges 36 along opposite sides of the host leaflets 32. In some examples, the clip arms 258, 260 of the leaflet removal device 254 are biased to the closed configuration, while partial deployment of the clip arms 258, 260, similar to the partial deployment or expansion illustrated in Fig. 19A, can optionally force them to extend away from each other, resulting in an open configuration of the leaflet removal device 254 in the partially deployed state. As the clip arms 258, 260 are placed along opposite sides of the host leaflets 32, and advanced along the leaflets in a manner that positions them at or in close proximity to the cusp end portions 34 of the host leaflets 32, the clip arms 258, 260 can optionally be further expanded and allowed to transition to the closed configuration, clipping over the host leaflets 32.

[0284] When the lower cusp-shaped portions of the clip arms 258, 260 are at or in close proximity to the cusp end portions 34 of the host leaflets 32, the leaflet removal device 254 can optionally be utilized, in some examples, to cut the host leaflets 32 away from the frame 16 of the host prosthetic valve 10. In some examples, the lower cusp-shaped portions of the clip arms 258, 260 can optionally be utilized to cut through the host leaflets 32 along their cusp end portion 34 (e.g., cutting along the scalloped line of the host prosthetic valve 10). In some examples, the U-shaped proximal portions of the clip arms 258, 260 and proximal joints 262 can optionally be similarly utilized to cut through the commissures 40 of the host prosthetic valve 10.

[0285] After cutting the host leaflets 32 away from the frame 16, the cut-away portions of the host leaflets 32 are trapped in the clips 256, between the second cages 272 and the corresponding first cages 270, while the clip arms 258, 260 remain closed against each other. The leaflet removal device 254 can be then optionally retracted to remove the cut-away leaflets away from the frame 16 of the host prosthetic valve 10, either prior to, simultaneous with, or after implantation of a replacement valve 100 inside the frame 16 of the host prosthetic valve 10. After implantation of the replacement valve 100 inside the frame 16 and decoupling thereof from the delivery apparatus 202f, for example in a manner that can be similar to the release of a replacement valve 100 from the delivery apparatus 202adescribed above, the delivery apparatus 202fcan be optionally retrieved from the patient’s body, along with the cut-away host leaflets 32 retained by the leaflet removal device 254, leaving the replacement valve 100 implanted within the frame 16 of the host prosthetic valve 10.

[0286] In some examples, a replacement valve 100 can be deployed out of the delivery shaft 220 in a similar manner to that described above with respect to utilization of a deliveryassembly 200a, mutatis mutandis. In some examples, the replacement valve 100 can optionally be deployed out of the delivery shaft 220 and expanded against the frame 16 of the host prosthetic valve 10 prior to retraction of the leaflet removal device 254 from the host prosthetic valve 10. In some examples, the replacement valve 100 can optionally be expanded against the frame 16 of the host prosthetic valve 10 such that the support frame 106 of the replacement valve 100 is distal to the clip arms 258, 260, as illustrated in Fig. 20 for example. In some examples, the replacement valve 100 can optionally be expanded against the frame 16 of the host prosthetic valve 10 such that the support frame 106 of the replacement valve 100 is distal to the host valvular structure 30, for example by positioning the cusp portions 108 of the support frame 106 distal to the cusp end portions 34 of the host leaflets 32. In some examples, the replacement valve 100 can optionally be detached from the delivery apparatus 202fprior to retraction of the leaflet removal device 254 from the host prosthetic valve 10, as also illustrated in Fig. 20.

[0287] In some examples, the replacement valve 100 can optionally be deployed out of the delivery shaft 220 and expanded against the frame 16 of the host prosthetic valve 10 after retraction of the leaflet removal device 254 from the host prosthetic valve 10, removing cut host leaflet 32 therewith.

[0288] Figs. 21A-21D illustrate some steps in an exemplary method for utilizing a leaflet removal device 254. A single clip 256 is illustrated in Figs. 21A-21D for simplicity, though it is to be understood that any number of clips 256 of a leaflet removal device 254 is contemplated. While an exemplary leaflet removal device 254shaving first 272 and second 270 cages that include string 276 of a type similar to that described above with respect to Figs. 17A-17B, is illustrated in Figs. 21A-21D, it is to understood that this is shown by way of illustration and not limitation, and that the cages 270, 272 of a leaflet removal device 254 described below with respect to Figs. 21A-21D can include any other type of outer 270 and inner 272 cages, such as cages that include a mesh 274, a frame, and the like.

[0289] Fig. 21 A shows the leaflet removal device 254 in an open configuration, advanced in a distal direction, with the free edge 36 of the target host leaflet 32 initially inserted between 32 clip arms 258, 260 and the cages 270, 272, such that as the leaflet removal device 254 is further advanced, the first clip arm 258 and at least a portion of the first cage 270 are disposed between the host leaflet 32 and the frame 16, while the second clip arm 260 and at least a portion of the second cage 272 are disposed at an opposite side of the host leaflet 32, radially inwards relative to the inner surface 42 of the host leaflet 32.

[0290] Figs. 21B shows the leaflet removal device 254 at the end of its axial travel path, still in the open configuration, with at least one of the clip arms 258, 260 axially aligned with, or in close proximity to, the cusp end portion 34 of the host leaflet 32. As further shown in Fig. 21B, in some examples, the upper U-shaped portions of the clip 256 can optionally be disposed around portions of the host leaflets 32 at or in close proximity to the commissures 40.

[0291] Fig. 21C shows a subsequent step that includes moving the leaflet removal device 254 to the closed configuration, by approximating the clip arms 258, 260 towards each other. In some examples, cutting of the host leaflets 32 can take place simultaneously with the closing operation. In some examples, cutting of the host leaflets 32 can occur after the closing operation.

[0292] In some examples, the second cage 272 can optionally be relatively loose or relaxed either prior to, during, and / or after cutting of the host leaflet 32. Fig. 21D shows a leaflet removal device 254 with the clip arms 258, 260 closed over the host leaflet 32, wherein the second cage 272 is loose enough to allow the host leaflet 32 to radially move inside of it towards and away the remaining host leaflet 32. When the second cage 272 includes a series of strings 276, as shown in Fig. 2 ID, the strings 276 can optionally be loose enough to extend and / or at least partially fold radially inwards, as illustrated. When the second cage 272 is made of a mesh 274, the mesh 274 can optionally be flexible and loose enough to allow similar freedom of movement of the host leaflet 32.

[0293] Keeping the second cages 272 loosened allows the corresponding host leaflets 32 to transition between their closed and open states, optionally reaching full coaptation in their closed state, while still held inside the corresponding clips 256. This can advantageously allow the host valvular structure 30 to maintain control of blood flow therethrough, prior to and / or during implantation of the new replacement valve 100.

[0294] In some examples, such as after implantation of the replacement valve 100 inside the frame 16, the second cage 272 can optionally be tensioned to approach the host leaflet 32 prior to and / or during retraction of the host leaflets 32 from the frame 16. In some examples, the proximal end portion of the second cage 272 can optionally be coupled to an axially movable component (not shown) of the delivery apparatus 202 that can be distally advanced, relative to the second clip arm 260, to loosen the second cage 272, and can be proximally pulled, relative to the second clip arm 260, to tension the second cage 272.

[0295] In some examples, the first cage 270 can optionally remain taut at all times, as illustrated for example in Fig. 2 ID. In some examples, the first cage 270 can optionally be loose, in a similar manner to that described and illustrated with respect to the second cage 272of Fig. 21D, in a manner that can allow full opening of the leaflet 32 against the frame 16 in the open state. In some examples, the proximal end portion of the first cage 270 can optionally be coupled to an axially movable component (not shown) of the delivery apparatus 202 that can be distally advanced, relative to the first clip arm 258, to loosen the first cage 270, and can be proximally pulled, relative to the first clip arm 258, to tension the first cage 270. In some examples, the proximal end portions of both cages 270, 272 can optionally be coupled to the same axially movable component (not shown) of the delivery apparatus 202 that can be distally advanced, relative to the clip arm 258, 260, to simultaneously loosen both cages 270, 272, and can be proximally pulled, relative to the clip arm 258, 260, to simultaneously tension both cages 270, 272.

[0296] Fig. 22 shows an exemplary leaflet removal device 2541. The leaflet removal device 2541is an exemplary implementation of leaflet removal device 254, and thus can include any of the features described above for leaflet removal device 254, except that the leaflet removal device 2541further includes one or more pull wires 284 attached to at least one of the second clip arm 260 and / or first clip arm 258. A single clip 2561is illustrated in Fig. 22 for simplicity, though it is to be understood that any number of clips 2561of a leaflet removal device 2541is contemplated. While an exemplary leaflet removal device 2541having inner 272 and outer 270 cages that include string 276 is illustrated in Fig. 22, it is to understood that this is shown by way of illustration and not limitation, and that the cages 270, 272 of a leaflet removal device 2541described herein can include any other type of outer 270 and inner 272 cages, such as cages that include a mesh 274, a frame, and the like.

[0297] In the example illustrated in Fig. 22, a plurality of pull wires 284 are shown to extend proximally from the second clip arm 260, such as by being coupled to the distal (e.g., cuspshaped) of the second clip arm 260. The clip arms 258, 260 can optionally be biased towards each other to the closed configuration, as long as not external force is applied thereto to separate them from each other. The pull wires 284 can optionally extend into the handle of the delivery apparatus 202, or can optionally be coupled to an axially movable component (not shown) that can be controlled by the handle, such that when the pull wires are proximally pulled (or tensioned), they can pull the second clip arm 260 away from the first clip arm 258. In such examples, when reclosure is desired, the tension applied to the pull wires 284 can optionally be released, allowing them to loosen such that the second clip arm 260 can return to its biased state, moving closer to the first clip arm 258. In this manner, the leaflet removal device 2541can be controllably moved between the closed and open configurations.

[0298] While a plurality of pull wires 284 are illustrated in Fig. 22, it is to be understood that in some examples, a single pull wire 284 can be coupled to the clip arm. While pull wires 284 are shown to be coupled to the second clip arms 260 in Fig. 22, it is to be understood that in some examples, one or more pull wires 284 can optionally be coupled to the first clip arm 258, and can be similarly pulled or tensioned to distance the first clip arm 258 from the second clip arm 260, and loosened to allow the first clip arm 258 to move closer to the second clip arm 260. In some examples, one or more wires can optionally be coupled to a single one of the first clip arm 258 or the second clip arm 260 of a respective clip 2561. In some examples, pull wires 284 can optionally be coupled to both clip arms 258, 260.

[0299] In some examples, the leaflet removal device 254 comprises a plurality of clips 256, which can optionally match the number of host leaflets 32 of a host prosthetic valve 10, such that all of the host leaflets 32 of the host prosthetic valve 10 can be similarly cut and removed from the frame 16. In some examples, the leaflet removal device 254 can optionally include a single clip 256, which can be utilized to excise a single one of the host leaflets 32, and can be repeatedly used to perform the same procedure to excise the other host leaflet 32 of the host prosthetic valve 10.

[0300] In some examples, the releasable coupling arms 224 of any replacement valve 100 disclosed herein, including replacement valves 100 used in combination with delivery apparatus 202aor delivery apparatus 202f, can be optionally implemented in a manner that is similar to that described above for coupling extension 264 of a leaflet removal device 254. In such examples, the releasable coupling arms 224 can optionally be part of the frame 106, and include axial struts (similar to axial struts 266) extending proximally from the apex regions 114 (for example, instead of the coupling extensions 146 illustrated in Fig. 8), each terminating with a head portion that can be similar to any example described above for head portion 268. An axially movable retaining member, similar to any example of retaining member 280 described above, can optionally reside inside the delivery shaft, and include recessed portions (similar to recessed portion 282) in which the head portions of the releasable coupling arms are situated. Release of such a replacement valve 100 from the delivery apparatus 202 can be accomplished by exposing the retaining member and the head portions engaged therewith, from the delivery shaft 220, allowing the head portions of the axial struts to extend radially away and out of the retaining member.

[0301] Figs. 23A-23E show cross-sectional views of various exemplary leaflet removal devices 254 illustrated along a region of the host leaflet 30 that can be, for example, representative of a cusp end portion 34 of the leaflet 32, wherein at least one of the clip arms258, 260 includes a cutting edge that can be utilized for cutting the host leaflet 32. An first clip arm 258 defines a first end 286 oriented towards the proximal direction at least along the distal cusp portions of the first clip arm 258, a second end 287 oriented towards the distal direction at least along the distal cusp portions of the first clip arm 258, an inner side 288 facing a central axis that can be defined by the leaflet removal device 254 (which can coincide with the axial central axis Ca of the host prosthetic valve 10 when the leaflet removal device 254 is deployed therein), and an outer side 289 opposite to the inner side 288, which can optionally face the frame 16 of the host prosthetic valve 10 when the leaflet removal device 254 is deployed therein.

[0302] An second clip arm 260 defines a first end 292 oriented towards the proximal direction at least along the distal cusp portions of the second clip arm 260, a second end 293 oriented towards the distal direction at least along the distal cusp portions of the second clip arm 260, an inner side 294 facing a central axis that can be defined by the leaflet removal device 254 (which can coincide with the axial central axis Ca of the host prosthetic valve 10 when the leaflet removal device 254 is deployed therein), and an outer side 295 opposite to the inner side 294, which can optionally face the frame 16 of the host prosthetic valve 10 when the leaflet removal device 254 is deployed therein.

[0303] In some examples, the first clip arm 258 of leaflet removal device 254 is configured to cut through tissue, such as through leaflets of a valve in which the replacement valve 100 is to be implanted. In some examples, the first clip arm 258 of leaflet removal device 254 is configured to cut through leaflets 32 of a host valvular structure 30 of a host prosthetic valve 10. In some examples, the first clip arm 258 of leaflet removal device 254 is configured to cut through leaflets 32 of a host valvular structure 30 of a host prosthetic valve 10 along their cusp end portions 34. In some examples, the first clip arm 258 of leaflet removal device 254 is further configured to cut through commissures 40 of a host prosthetic valve 10.

[0304] In some examples, the second clip arm 260 of leaflet removal device 254 is configured to cut through tissue, such as through leaflets of a valve in which the replacement valve 100 is to be implanted. In some examples, the second clip arm 260 of leaflet removal device 254 is configured to cut through leaflets 32 of a host valvular structure 30 of a host prosthetic valve 10. In some examples, the second clip arm 260 of leaflet removal device 254 is configured to cut through leaflets 32 of a host valvular structure 30 of a host prosthetic valve 10 along their cusp end portions 34. In some examples, the second clip arm 260 of leaflet removal device 254 is further configured to cut through commissures 40 of a host prosthetic valve 10.

[0305] In some examples, the second end 287 of the first clip arm 258 comprises a cutting edge configured to cut through tissue, such as through leaflets of a valve in which the replacement valve 100 is to be implanted. In some examples, the second end 287 of the first clip arm 258 comprises a cutting edge configured to cut through leaflets 32 of a host valvular structure 30 of a host prosthetic valve 10. In some examples, the second end 287 of the first clip arm 258 comprises a cutting edge configured to cut through leaflets 32 of a host valvular structure 30 of a host prosthetic valve 10 along their cusp end portions 34. In some examples, the second end 287 of the first clip arm 258 comprises a cutting edge configured to cut through commissures 40 of a host prosthetic valve 10.

[0306] In some examples, the inner side 288 of the first clip arm 258 comprises a cutting edge configured to cut through tissue, such as through leaflets of a valve in which the replacement valve 100 is to be implanted. In some examples, the inner side 288 of the first clip arm 258 comprises a cutting edge configured to cut through leaflets 32 of a host valvular structure 30 of a host prosthetic valve 10. In some examples, the inner side 288 of the first clip arm 258 comprises a cutting edge configured to cut through leaflets 32 of a host valvular structure 30 of a host prosthetic valve 10 along their cusp end portions 34. In some examples, the inner side 288 of the first clip arm 258 comprises a cutting edge configured to cut through commissures 40 of a host prosthetic valve 10.

[0307] In some examples, the first end 292 of the second clip arm 260 comprises a cutting edge configured to cut through tissue, such as through leaflets of a valve in which the replacement valve 100 is to be implanted. In some examples, the first end 292 of the second clip arm 260 comprises a cutting edge configured to cut through leaflets 32 of a host valvular structure 30 of a host prosthetic valve 10. In some examples, first end 292 of the second clip arm 260 comprises a cutting edge configured to cut through leaflets 32 of a host valvular structure 30 of a host prosthetic valve 10 along their cusp end portions 34. In some examples, the first end 292 of the second clip arm 260 comprises a cutting edge configured to cut through commissures 40 of a host prosthetic valve 10.

[0308] In some examples, the outer side 295 of the second clip arm 260 comprises a cutting edge configured to cut through tissue, such as through leaflets of a valve in which the replacement valve 100 is to be implanted. In some examples, the outer side 295 of the second clip arm 260 comprises a cutting edge configured to cut through leaflets 32 of a host valvular structure 30 of a host prosthetic valve 10. In some examples, the outer side 295 of the second clip arm 260 comprises a cutting edge configured to cut through leaflets 32 of a host valvular structure 30 of a host prosthetic valve 10 along their cusp end portions 34. In some examples,the outer side 295 of the second clip arm 260 comprises a cutting edge configured to cut through commissures 40 of a host prosthetic valve 10.

[0309] Fig. 23A shows an exemplary leaflet removal device 254J. The leaflet removal device 254' is an exemplary implementation of leaflet removal device 254, and thus can include any of the features described above for leaflet removal device 254, except that the second end 287 of the first clip arm 258Jcomprises a sharp edge or a blade 290 serving as the cutting edge, which can optionally be formed as a single or double beveled cutting edge 126. The first clip arm 258' and the second clip arm 260' can be radially aligned with each other in the closed configuration. Fig. 23A shows a portion of the host leaflet 32 disposed between the first clip arm 258Jand second clip arm 260' in the closed configuration, such that when the clip 256' is distally pushed in this state, the sharp edge 290 axially cuts through the leaflet material.

[0310] Fig. 23B shows an exemplary leaflet removal device 254k, which can be similar to the leaflet removal device 254J, with the second end 287 of the first clip arm 258kcomprising a sharp edge or a blade 290 serving as the cutting edge, except that the first clip arm 258kand the second clip arm 260kcan be axially aligned with each other in the closed configuration. Fig. 23B shows a portion of the host leaflet 32 disposed between the first clip arm 258kand second clip arm 260kin the closed configuration, wherein, similar to leaflet removal device 254', when the clip 256kis distally pushed in this state, the sharp edge 290 axially cuts through the leaflet material.

[0311] Fig. 23C shows an exemplary leaflet removal device 2541, which can be similar to the leaflet removal device 254k, with the first clip arm 2581and the second clip arm 2601shown axially aligned with each other in the closed configuration, except that the outer side 295 of the second clip arm 2601comprises a sharp edge or a blade 296 serving as the cutting edge. Fig. 23C shows a portion of the host leaflet 32 disposed between the first clip arm 2581and second clip arm 2601in a partially closed configuration, wherein the first clip arm 2581and the second clip arm 2601are configured to completely close against each other at a sufficient force that forces the sharp edge 296 to radially cut through the leaflet material as the clip arms move to the closed configuration.

[0312] Fig. 23D shows an exemplary leaflet removal device 254m. The leaflet removal device 254mis an exemplary implementation of leaflet removal device 254, and thus can include any of the features described above for leaflet removal device 254, except that the second end 287 of the first clip arm 258mcomprises an electrically conductive surface 291 configured to cut tissue and / or other soft components of the host prosthetic valve 10 contacted thereby, by application of electrical energy (e.g., RF energy). The first clip arm 258mand the second cliparm 260mcan optionally be radially aligned with each other in the closed configuration. In some examples, the first clip arm 258mfurther includes an electrically insulating layer 298 covering at least a portion of the first clip arm 258mwhile the electrically conductive surface 291 remains a non- insulated portion of the first clip arm 258m. In some examples, the first end 286 and at least a portion of the inner side 288 and the outer side 289 of the first clip arm 258mare covered by an insulating layer 298, while at least a portion of the second end second end 287, and optionally the entirety of second end 287, can remain exposed.

[0313] Fig. 23D shows a portion of the host leaflet 32 disposed between the first clip arm 258mand second clip arm 260min the closed configuration, such that when the electrical energy (e.g., RF energy) is supplied to the first clip arm 258m, optionally while the clip 256mis distally pushed in this state, the leaflet material contacted by the electrically conductive surface 291 is cut thereby.

[0314] Fig. 23E shows an exemplary leaflet removal device 254n. The leaflet removal device 254" is an exemplary implementation of leaflet removal device 254, and thus can include any of the features described above for leaflet removal device 254, except that the inner side 288 of the first clip arm 258ncomprises an electrically conductive surface 291, and the outer side 295 of the second clip arm 260" comprises an electrically conductive surface 297, each electrically conductive surface 291, 297 configured to cut tissue and / or other soft components of the host prosthetic valve 10 contacted thereby, by application of electrical energy (e.g., RF energy). The first clip arm 258nand the second clip arm 260ncan optionally be axially aligned with each other in the closed configuration.

[0315] In some examples, the first clip arm 258" further includes an electrically insulating layer 298 covering at least a portion of the first clip arm 258nwhile the electrically conductive surface 291 remains a non-insulated portion of the first clip arm 258n. In some examples, the outer side 289 and at least a portion of the first end 286 and the second end 287 of the first clip arm 258nare covered by an insulating layer 298, while at least a portion of the inner side 288, and optionally the entirety of inner side 288, can optionally remain exposed.

[0316] In some examples, the second clip arm 260nfurther includes an electrically insulating layer 298 covering at least a portion of the second clip arm 260nwhile the electrically conductive surface 297 remains a non-insulated portion of the second clip arm 260n. In some examples, the inner side 294 and at least a portion of the first end 292 and the second end 293 of the second clip arm 26011are covered by an insulating layer 298, while at least a portion of the outer side 295, and optionally the entirety of outer side 295, can remain exposed.

[0317] Fig. 23E shows a portion of the host leaflet 32 disposed between the second clip arm 260nand first clip arm 258nin a partially closed configuration, wherein the second clip arm 260nand the first clip arm 258nare configured to forcibly close against the leaflets, striving to approximate each other at a sufficient force that that maintains contact with the surfaces of the leaflet 32, such that when the electrical energy (e.g., RF energy) is supplied to the first clip arm 258mand the second clip arms 260m, the leaflet material contacted by the electrically conductive surfaces 291, 297 is cut thereby.

[0318] It is to be understood that other arrangements and configuration of cutting edges of a leaflet removal device 254 are contemplated. In some examples, a leaflet removal device 254 with clip arms 258, 260 which are radially aligned with each other in the closed configuration, as shown for example in Fig. 23 A, can optionally have a first end 292 of the second clip arm 260 comprising a sharp edge or a blade, instead of or in addition to a sharp edge or blade 290 of the first clip arm 258. In some examples, a leaflet removal device 254 with clip arms 258, 260 which are axially aligned with each other in the closed configuration, as shown for example in Fig. 23C, can optionally have inner side 288 of the first clip arm 258 comprising a sharp edge or a blade, instead of or in addition to a sharp edge or blade 296 of the second clip arm 260.

[0319] When a cutting edge of a leaflet removal device 254 comprises an electrically conductive surface, the electrically conductive surface can be supplied with a level of current and / or radio frequency energy to be applied by the electrically conductive surface to the host leaflet material to bum, vaporize, lacerate, slice, tear, cut, or otherwise separate the host leaflet.

[0320] In some examples, the any of the clip arms 258, 260 can optionally be electrically connected, by one or more components of the delivery apparatus 202f, to a power source (not shown) that can be activated to provide electrical energy, such as radiofrequency (RF) energy, to the clip arms 258 and / or 260. In some examples, the power source can be configured to provide other forms of energy (for example, microwave, light, ultrasonic, etc.) to any of the clip arms 258, 260. In some examples, a conduction path can optionally extend from a power source (which can be external to the patient’s body), towards an along the coupling extensions 264. In such examples, both coupling extensions 264 and any of the clip arms 258, 260 can optionally comprise electrically conductive material, such as metals.

[0321] In some examples, the power source is included in the handle of the delivery apparatus 202f. In some examples, the power source is external to the handle of the delivery apparatus 202f. In some examples, the handle includes a knob configured to activate or deactivate thepower source. In some examples, one or more cutting edges of the leaflet removal device 254 can optionally include both a sharp edge and an electrically conductive surface 128.

[0322] In some examples, a clip 256 of a leaflet removal device 254 can optionally include a movable cutting member (not shown). For example, a movable cutting member can optionally be in the form of a sharp blade, a string or a wire, extending between the outer 158 and inner 260 clip arms at one end, such as in proximity to a proximal joint 262 at one end of the arms 258, 260, and when a host leaflet 32 is positioned therebetween, the cutting member can be slid along the arms 258, 260, cutting the host leaflet 32 as it moves from one side of the arms 258, 260 to the other, such as from a position in close proximity to one proximal joint 262 towards the other proximal joint 262 by which the same arms 258, 260 are coupled. When implemented as a string or wire, the string or wire can optionally be thin enough to facilitate cutting of the leaflet material. In some examples, a movable cutting member can optionally include an electrically conductive wire, configured to deliver electric energy (e.g., RF energy) to facilitate cutting through the leaflet material.

[0323] In some examples, a delivery assembly 200 can optionally include a replacement valve 100 having a cutting edge along the first end 118 of its support frame 106, used in combination with a delivery apparatus 202 equipped with a leaflet removal device 254 that does not necessarily include a cutting edge along any of the outer 258 or inner 260 clip arms. For example, a leaflet removal device 254 devoid of a cutting edge can optionally be deployed and utilized to clamp host leaflet 32 between its clamping arms 258, 260 in a manner that can be similar to any example described above with respect to a leaflet removal device 254 of delivery apparatus 202f, mutatis mutandis. A replacement valve 100 equipped with a cutting edge can optionally be deployed out of the delivery shaft 220 and advanced distally between the host leaflets 32 and the frame 16 of the host prosthetic valve 10 in a manner that can be similar to any example described above with respect to a replacement valve 100 of delivery apparatus 202a, mutatis mutandis.

[0324] Deployment and / or advancement of the prosthetic valve 100 to place the cusp portions 108 at or in close proximity to the cusp end portions 34 of the host leaflets 32 can be performed prior to, simultaneously with, or after deployment of the leaflet removal device 254 and clamping of the host leaflets 32 inside the respective clips 256. When the host leaflets 32 are clamped by the leaflet removal device 254, the replacement valve 100 can optionally be utilized to cut the host leaflets 32 so as to separate them from the frame 16 of the host prosthetic valve 10, in a manner that can be similar to any example described above with respect to a replacement valve 100 of delivery apparatus 202a, mutatis mutandis. As the host leaflets 32 areseparated from the frame 16, the cut portions of the host leaflets 32 remain clamped by the clamping arms 258, 260, retained between the inner 272 and outer 270 cages, preventing them from being released to the blood stream. The replacement valve 100 can be then released from the delivery apparatus 202, and the delivery apparatus 202 can be optionally retrieved from the patient's body along with the cut portions of the host leaflets 32 retained by the leaflet removal device 254, leaving the replacement valve 100 mounted inside the frame 16 of the host prosthetic valve 10.

[0325] While various examples of delivery assemblies 200 are described and illustrated herein for cutting leaflet 32 of a previously implanted host prosthetic valve 10, and implantation of a guest replacement valve 100 inside the host prosthetic valve 10, it is to be understood that this is not meant to be limiting, and that delivery assemblies 200 disclosed herein can be used in combination with other types of existing valves. For example, any delivery assembly 200 disclosed herein can be utilized in a similar manner to cut native leaflets 64 of a native heart valve 60, and to implant a replacement valve 100 inside the native heart valve 60, such as against its annulus 62.

[0326] Similarly, delivery assembly 200 disclosed herein can be optionally utilized in a similar manner to cut leaflets 132 of a previously implanted replacement valve 100a, and to implant a new replacement valve 100b therein. For example, a first replacement valve 100a can be implanted inside a host prosthetic valve 10 after cutting and removing the leaflets 32 of the host prosthetic valve 10. If another interventional procedure is required after a period of several years, such as due to malfunctioning of the valvular structure 130a of the first replacement valve 100a, a delivery assembly 200 can be similarly utilized to cut the leaflets 132a of the first replacement valve 100a, and implant a second replacement valve 100b in a similar manner. This procedure can be repeated as many times as required during the lifetime of a patient in need thereof.

[0327] Any of the valves, assemblies, etc. disclosed herein can 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 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 Technology

[0328] Some examples of above-described technology are enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example takenin 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.

[0329] Example 1. A replacement valve comprising: a self-expandable support frame comprising: a plurality of cusp portions; and a plurality of commissure support portions, each comprising a pair of support struts joined by an apex region, wherein the support struts continuously extend from the cusp portions; and a valvular structure coupled to the support frame and comprising a plurality of leaflets configured to regulate flow through the replacement valve; wherein a first end of the support frame comprises a cutting edge configured to cut through host leaflets of an existing heart valve; and wherein the first end of the frame is oriented in a distal direction at least along part of the cusp portions.

[0330] Example 2. The replacement valve of any example herein, particularly of example 1, wherein the first end of the support frame is oriented in the distal direction along the apex regions.

[0331] Example 3. The replacement valve of any example herein, particularly of example 1 or 2, wherein the first end of the support frame along one of the pair of support struts of any of the commissure support portions is facing the first end of the support struts along the other one of the pair of support stmts of the same commissure support portion.

[0332] Example 4. The replacement valve of any example herein, particularly of any one of examples 1 to 3, wherein the cutting edge comprises a sharp edge.

[0333] Example 5. The replacement valve of any example herein, particularly of any one of examples 1 to 3, wherein the cutting edge comprises an electrically conductive surface configured to conduct electric energy for severing the leaflets of the existing heart valve when contacted thereby.

[0334] Example 6. The replacement valve of any example herein, particularly of example 5, wherein the electric energy comprises radiofrequency energy.

[0335] Example 7. The replacement valve of any example herein, particularly of example 5 or 6, further comprising an electrically insulating layer covering at least a portion of the support frame, excluding the electrically conductive surface.

[0336] Example 8. The replacement valve of any example herein, particularly of any one of examples 1 to 7, wherein the existing heart valve is a host prosthetic valve that includes a frame and the host leaflets mounted inside the frame of the host prosthetic valve.

[0337] Example 9. The replacement valve of any example herein, particularly of example 8, wherein the host leaflets are coupled to the frame of the host prosthetic valve along cusp endportions of the host leaflets, and wherein the cutting edge of the support frame of the replacement valve is configured to cut through the cusp end portions of the host leaflets.

[0338] Example 10. The replacement valve of any example herein, particularly of example 8 or 9, wherein commissure attachment portions of adjacent host leaflets form commissures that are coupled to the frame of the host prosthetic valve, and wherein the cutting edge of the support frame of the replacement valve is configured to cut through the commissures of the host prosthetic valve.

[0339] Example 11 . The replacement valve of any example herein, particularly of any one of examples 8 to 10, wherein the cutting edge of the support frame of the replacement valve is configured to separate the host leaflets from the frame of the host prosthetic valve.

[0340] Example 12. The replacement valve of any example herein, particularly of any one of examples 8 to 11, wherein the support frame of the replacement valve is configured to selfexpand against the frame of the host prosthetic valve.

[0341] Example 13. The replacement valve of any example herein, particularly of any one of examples 1 to 12, wherein the plurality of leaflets of the valvular structure comprises three leaflets.

[0342] Example 14. The replacement valve of any example herein, particularly of example 13, wherein the plurality of cusp portions comprises three cusp portions, and wherein the plurality of commissure support portions comprises three commissure attachment portions.

[0343] Example 15. The replacement valve of any example herein, particularly of any one of examples 1 to 14, wherein each leaflet of the valvular structure comprises a cusp end portion coupled to a corresponding one of the plurality of the cusp portions of the support frame.

[0344] Example 16. The replacement valve of any example herein, particularly of any one of examples 1 to 15, wherein each leaflet of the valvular structure comprises a pair of oppositely- directed commissure attachment portions, and wherein the commissure attachment portions of adjacent leaflets are attached to the commissure support portions of the support frame, thus forming commissures of the replacement valve.

[0345] Example 17. The replacement valve of any example herein, particularly of any one of examples 1 to 16, wherein the support frame has a rectangular cross-section defining a cross- sectional height and a thickness.

[0346] Example 18. The replacement valve of any example herein, particularly of example 17, wherein the cross-sectional height of the support frame is greater than its thickness.

[0347] Example 19. The replacement valve of any example herein, particularly of example 17 or 18, wherein the cross-sectional height of the support frame is at least five times greater than its thickness.

[0348] Example 20. The replacement valve of any example herein, particularly of any one of examples 17 to 19, wherein the cross-sectional height of the support frame is at least ten times as great as its thickness.

[0349] Example 21. The replacement valve of any example herein, particularly of any one of examples 17 to 20, wherein the cross-sectional height of the support frame is equal to or greater than 1 mm.

[0350] Example 22. The replacement valve of any example herein, particularly of any one of examples 17 to 21, wherein the cross-sectional height of the support frame is equal to or greater than 1.5 mm.

[0351] Example 23. The replacement valve of any example herein, particularly of any one of examples 17 to 22, wherein the cross-sectional height of the support frame is equal to or greater than 2 mm.

[0352] Example 24. The replacement valve of any example herein, particularly of any one of examples 17 to 23, wherein the support frame comprises a plurality of apertures extending through its thickness.

[0353] Example 25. The replacement valve of any example herein, particularly of example 24, wherein the leaflets are coupled to the support frame by one or more sutures extending through the apertures of the support frame.

[0354] Example 26. The replacement valve of any example herein, particularly of any one of examples 1 to 16, wherein the support frame has a circular cross-section.

[0355] Example 27. The replacement valve of any example herein, particularly of any one of examples 1 to 26, wherein the support frame further comprises a plurality of coupling extensions extending from the apex regions, configured to releasably couple the replacement valve to a delivery apparatus.

[0356] Example 28. The replacement valve of any example herein, particularly of example 27, wherein each coupling extension comprises an opening configured to allow passage of a retaining wire of the delivery apparatus therethrough.

[0357] Example 29. The replacement valve of any example herein, particularly of example 27, wherein each coupling extension comprises an axial strut terminating at a head portion, wherein the head portion is configured to reside inside a recessed portion of a retaining member of the delivery apparatus.

[0358] Example 30. The replacement valve of any example herein, particularly of any one of examples 1 to 26, wherein the support frame comprises a shape memory material.

[0359] Example 31. The replacement valve of any example herein, particularly of example 30, wherein the shape memory material comprises Nitinol.

[0360] Example 32. A delivery assembly comprising: a replacement valve comprising: a selfexpandable support frame comprising a cutting edge along a first end of the support frame; and a valvular structure coupled to the support frame and comprising a plurality of leaflets configured to regulate flow through the replacement valve; and a delivery apparatus comprising: a delivery shaft configured to retain the replacement valve in a compressed configuration when the replacement valve is inside the delivery shaft; a retrieval device movable between a compacted configuration and a deployed configuration; wherein the cutting edge is configured to cut through host leaflet of an existing heart valve; and wherein the retrieval device is axially movable relative to the replacement valve, and is configured to move from the compacted configuration to the deployed configuration at a position distal to the replacement valve, when the replacement valve is deployed out of the delivery shaft.

[0361] Example 33. The assembly of any example herein, particularly of example 32, wherein the delivery apparatus further comprises an inner shaft axially movable through and relative to the delivery shaft.

[0362] Example 34. The assembly of any example herein, particularly of example 33, wherein the delivery apparatus further comprises a gripping shaft axially movable through and relative to the inner shaft, wherein the retrieval device is attached to gripping shaft.

[0363] Example 35. The assembly of any example herein, particularly of example 34, wherein the inner shaft is configured to retain the retrieval device in the compacted configuration when the retrieval device is inside the inner shaft, and wherein the gripping shaft is configured to expose the retrieval device out of a distal end portion of the inner shaft to allow the retrieval device to move to its deployed configuration.

[0364] Example 36. The assembly of any example herein, particularly of any one of examples 32 to 35, wherein the retrieval device is self-expandable.

[0365] Example 37. The assembly of any example herein, particularly of example 36, wherein the retrieval device comprises a shape memory material.

[0366] Example 38. The assembly of any example herein, particularly of example 37, wherein the shape memory material comprises Nitinol.

[0367] Example 39. The assembly of any example herein, particularly of any one of examples 32 to 38, wherein the retrieval device comprises a mesh configured to prevent cut portions of the host leaflet from passing upstream therethrough.

[0368] Example 40. The assembly of any example herein, particularly of any one of examples 32 to 38, wherein the retrieval device comprises a frame configured to prevent cut portions of the host leaflet from passing upstream therethrough.

[0369] Example 41. The assembly of any example herein, particularly of any one of examples 32 to 40, wherein the delivery apparatus further comprises a filter configured to transition from a compacted configuration to a deployed configuration thereof at a position proximal to the replacement valve, when the replacement valve is deployed out of the delivery shaft.

[0370] Example 42. The assembly of any example herein, particularly of any one of examples 32 to 41, wherein the delivery apparatus further comprises an outer shaft disposed around the delivery shaft, wherein the delivery shaft is axially movable relative to the outer shaft.

[0371] Example 43. The assembly of any example herein, particularly of any one of examples 32 to 42, further comprising one or more releasable coupling arms configured to releasably couple the replacement valve to the delivery apparatus.

[0372] Example 44. The assembly of any example herein, particularly of any one of examples 32 to 42, wherein the support frame comprises a plurality of cusp portions and a plurality of commissure support portions.

[0373] Example 45. The assembly of any example herein, particularly of example 44, wherein the first end of the frame is oriented in a distal direction at least along part of the cusp portions.

[0374] Example 46. The assembly of any example herein, particularly of example 44 or 45, wherein each commissure support portion comprises a pair of support struts joined by an apex region, wherein the support struts continuously extend from the cusp portions.

[0375] Example 47. The assembly of any example herein, particularly of example 46, wherein the first end of the support frame along one of the pair of support struts of any of the commissure support portions is facing the first end of the support struts along the other one of the pair of support struts of the same commissure support portion.

[0376] Example 48. The assembly of any example herein, particularly of example 46 or 47, wherein the support frame further comprises a plurality of coupling extensions extending from the apex regions.

[0377] Example 49. The assembly of any example herein, particularly of example 48, wherein the delivery apparatus further comprises a plurality of prongs, wherein each prong comprisesan opening, and wherein the coupling extensions are configured to be inserted into the openings of the prongs.

[0378] Example 50. The assembly of any example herein, particularly of example 49, wherein the delivery apparatus further comprises a plurality of retaining wires configured to be inserted into openings of the coupling extensions.

[0379] Example 51. The assembly of any example herein, particularly of example 48, wherein the delivery apparatus further comprises a retaining member axially movable relative to the delivery shaft.

[0380] Example 52. The assembly of any example herein, particularly of example 51, wherein the coupling extensions comprise axial struts terminating at head portions, wherein the head portions are configured to be retained inside recessed portions of the retaining member when the retaining member is positioned inside the delivery shaft, and to extend away from the recessed portions when the retaining member is moved distally to and out of the delivery shaft.

[0381] Example 53. The assembly of any example herein, particularly of any one of examples 32 to 52, wherein the cutting edge comprises a sharp edge.

[0382] Example 54. The assembly of any example herein, particularly of any one of examples 32 to 52, wherein the cutting edge comprises an electrically conductive surface configured to conduct electric energy for severing the leaflets of the existing heart valve when contacted thereby.

[0383] Example 55. The assembly of any example herein, particularly of example 54, wherein the electric energy comprises radiofrequency energy.

[0384] Example 56. The assembly of any example herein, particularly of example 54 or 55, wherein the replacement valve further comprises an electrically insulating layer covering at least a portion of the support frame, excluding the electrically conductive surface.

[0385] Example 57. The assembly of any example herein, particularly of any one of examples 32 to 56, wherein the existing heart valve is a host prosthetic valve that includes a frame and the host leaflets mounted inside the frame of the host prosthetic valve.

[0386] Example 58. The assembly of any example herein, particularly of example 57, wherein the cutting edge of the support frame of the replacement valve is configured to separate the host leaflets from the frame of the host prosthetic valve.

[0387] Example 59. The assembly of any example herein, particularly of example 57 or 58, wherein the support frame of the replacement valve is configured to self-expand against the frame of the host prosthetic valve.

[0388] Example 60. The assembly of any example herein, particularly of any one of examples 32 to 59, wherein the support frame has a rectangular cross-section defining a cross-sectional height and a thickness.

[0389] Example 61. The assembly of any example herein, particularly of example 60, wherein the cross-sectional height of the support frame is at least five times greater than its thickness.

[0390] Example 62. The assembly of any example herein, particularly of example 60 or 61, wherein the cross-sectional height of the support frame is equal to or greater than 1.5 mm.

[0391] Example 63. The assembly of any example herein, particularly of any one of examples 60 to 62, wherein the support frame comprises a plurality of apertures extending through its thickness.

[0392] Example 64. The assembly of any example herein, particularly of example 63, wherein the leaflets are coupled to the support frame by one or more sutures extending through the apertures of the support frame.

[0393] Example 65. A method comprising: advancing a delivery assembly to a host prosthetic valve, the delivery assembly comprising a delivery apparatus and a replacement valve maintained in a compressed configuration thereof inside a delivery shaft of the delivery apparatus, the replacement valve comprising a support frame having a cutting edge, the host prosthetic valve comprising a frame and a plurality of host leaflets mounted inside the frame; and deploying the replacement valve out of the delivery shaft at a position proximal to the host leaflets; deploying a retrieval device of the delivery apparatus at a position distal to the host leaflets; cutting the host leaflets by advancing the replacement valve towards and against the host leaflets; collecting cut portions of the host leaflet with the retrieval device by proximally retracting the retrieval device; and retrieving the delivery apparatus along with the cut portions of the host leaflets, wherein the replacement valve remains expanded against the frame of the host prosthetic valve during the retrieval; wherein the replacement valve comprises a valvular structure coupled to the support frame and comprising a plurality of leaflets configured to regulate flow through the replacement valve.

[0394] Example 66. The method of any example herein, particularly of example 65, wherein the deploying the replacement valve comprises allowing the support frame to self-expand when exposed out of the delivery shaft.

[0395] Example 67. The method of any example herein, particularly of example 65 or 66, wherein the deploying the replacement valve comprises maintaining the replacement valve coupled to the delivery apparatus by a plurality of releasable coupling arms.

[0396] Example 68. The method of any example herein, particularly of example 65 or 66, wherein the cutting the host leaflets comprises maintaining the replacement valve coupled to the delivery apparatus by a plurality of releasable coupling arms.

[0397] Example 69. The method of any example herein, particularly of example 68, further comprising, prior to the retrieving the delivery apparatus, decoupling the replacement valve from the delivery apparatus by releasing the releasable coupling arms.

[0398] Example 70. The method of any example herein, particularly of any one of examples 65 to 69, further comprising, prior to the cutting the host leaflets, advancing the retrieval device, in a compacted state thereof, through the replacement valve and the host prosthetic valve, and moving the retrieval device to a deployed configuration distal to the host leaflets.

[0399] Example 71. The method of any example herein, particularly of any one of examples 65 to 70, further comprising, prior to the cutting the host leaflets, deploying a filter at a position proximal to the host prosthetic valve.

[0400] Example 72. The method of any example herein, particularly of any one of examples 65 to 71 , wherein the cutting the host leaflets comprises cutting cusp end portions of the host leaflets by cusp portions of the support frame pushed there-against.

[0401] Example 73. The method of any example herein, particularly of any one of examples 65 to 72, wherein the cutting the host leaflets comprises commissures of the host prosthetic valve by commissure support portions of the support frame pushed there-against.

[0402] Example 74. The method of any example herein, particularly of any one of examples 65 to 73, wherein the cutting edge comprises a sharp edge, and wherein the cutting the host leaflets comprises distally pushing the sharp edge at a force sufficient to cut through regions of the host leaflets contacted thereby.

[0403] Example 75. The method of any example herein, particularly of any one of examples 65 to 73, wherein the cutting edge comprises an electrically conductive surface, and wherein the cutting the host leaflets comprises conducting electric energy, via the delivery assembly, to the electrically conductive surface.

[0404] Example 76. The method of any example herein, particularly of example 75, wherein the conducting electric energy comprises conducting radiofrequency energy.

[0405] Example 77. The method of any example herein, particularly of example 75 or 76, wherein the cutting the host leaflets comprises distally pushing the support frame simultaneous with the conducting the electric energy to the electrically conductive surface.

[0406] Example 78. A delivery assembly comprising: a replacement valve comprising: a selfexpandable support frame; and a valvular structure coupled to the support frame andcomprising a plurality of leaflets configured to regulate flow through the replacement valve; and a delivery apparatus comprising: a delivery shaft configured to retain the replacement valve in a compressed configuration when the replacement valve is inside the delivery shaft; an inner shaft axially movable through and relative to the delivery shaft; a leaflet removal device comprising at least one clip, the clip comprising: a first clip arm; a second clip arm; a first cage coupled to the first clip arm and extending proximally therefrom; a second cage coupled to the second clip arm and extending proximally therefrom; wherein the leaflet removal device is movable between an open configuration when positioned inside the inner shaft and a closed configuration when exposed out of the inner shaft; wherein a radial distance between the first clip arm and the second clip arm is greater in the open configuration than in the closed configuration; and wherein at least one of the first clip arm and / or the second clip arm comprises a cutting edge configured to cut through host leaflets of an existing heart valve.

[0407] Example 79. The assembly of any example herein, particularly of example 78, wherein the first clip arm and the second clip arm are joined to each other at proximal joints.

[0408] Example 80. The assembly of any example herein, particularly of example 79, wherein the first clip arm and the second clip arm are pivotably movable relative to each other about the proximal joints.

[0409] Example 81. The assembly of any example herein, particularly of example 79 or 80, wherein the leaflet removal device further comprises one or more coupling extensions extending from the proximal joints into the inner shaft.

[0410] Example 82. The assembly of any example herein, particularly of any one of examples 78 to 81, wherein the first clip arm and the second clip arm are configured to close against one of the host leaflets in a manner that prevent the host leaflet from slipping away from the clip in the closed configuration.

[0411] Example 83. The assembly of any example herein, particularly of any one of examples 78 to 82, wherein, when one of the host leaflets is disposed inside the clip in the closed configuration, the first cage and the second cage are configured to prevent the corresponding host leaflet from passing therethrough.

[0412] Example 84. The assembly of any example herein, particularly of any one of examples 78 to 83, wherein each of the first cage and the second cage comprises a mesh.

[0413] Example 85. The assembly of any example herein, particularly of any one of examples 78 to 83, wherein each of the first cage and the second cage comprises a frame.

[0414] Example 86. The assembly of any example herein, particularly of any one of examples 78 to 83, wherein each of the first cage and the second cage comprises a plurality of strings.

[0415] Example 87. The assembly of any example herein, particularly of any one of examples 78 to 86, wherein the radial distance between the first clip arm and the second clip arm in the open configuration is configured to allow passage of a corresponding one of the host leaflets therebetween.

[0416] Example 88. The assembly of any example herein, particularly of any one of examples 78 to 87, wherein the second cage is configured to be loose enough when a corresponding one of the host leaflets is retained inside the clip, so as to allow the corresponding host leaflet to move towards and away from the remaining host leaflets to allow continued functioning of the host leaflets with respect to regulating flow of blood through the existing heart valve.

[0417] Example 89. The assembly of any example herein, particularly of any one of examples 78 to 88, wherein the first clip arm and the second clip arm are biased towards each other to the closed configuration in a free state thereof.

[0418] Example 90. The assembly of any example herein, particularly of example 89, wherein the leaflet removal device further comprises one or more pull wires coupled to the second clip arm and extending proximally therefrom, wherein proximally pulling the pull wires is configured to move the second clip arm away from the first clip arm, and wherein releasing the pull wires is configured to allow the second clip arm to return to a position closer to the first clip arm.

[0419] Example 91. The assembly of any example herein, particularly of any one of examples 78 to 90, wherein the first clip arm and the second clip arm are radially aligned with each other in the closed configuration.

[0420] Example 92. The assembly of any example herein, particularly of any one of examples 78 to 90, wherein the first clip arm and the second clip arm are axially aligned with each other in the closed configuration.

[0421] Example 93. The assembly of any example herein, particularly of any one of examples 78 to 92, wherein the at least one cutting edge is comprised along a second end of the first clip arm, oriented in a distal direction along at least a distal-most portion of the first clip arm.

[0422] Example 94. The assembly of any example herein, particularly of any one of examples 78 to 92, wherein the at least one cutting edge is comprised along an inner side of the first clip arm, oriented radially inwards.

[0423] Example 95. The assembly of any example herein, particularly of any one of examples 78 to 94, wherein the at least one cutting edge is comprised along an outer side of the second clip arm, oriented radially outwards.

[0424] Example 96. The assembly of any example herein, particularly of any one of examples 78 to 95, wherein the at least one cutting edge comprises a sharp edge.

[0425] Example 97. The assembly of any example herein, particularly of any one of examples 78 to 95, wherein the at least one cutting edge comprises an electrically conductive surface configured to conduct electric energy for severing the leaflets of the existing heart valve when contacted thereby.

[0426] Example 98. The assembly of any example herein, particularly of example 97, wherein the electric energy comprises radiofrequency energy.

[0427] Example 99. The assembly of any example herein, particularly of example 97 or 98, wherein the clip further comprises an electrically insulating layer covering at least a portion of at least one of the first clip arms and / or the second clip arm, excluding the electrically conductive surface.

[0428] Example 100. The assembly of any example herein, particularly of any one of examples 78 to 99, wherein the delivery apparatus further comprises a filter configured to transition from a compacted configuration to a deployed configuration thereof at a position proximal to the replacement valve, when the replacement valve is deployed out of the delivery shaft.

[0429] Example 101. The assembly of any example herein, particularly of any one of examples 78 to 100, wherein the delivery apparatus further comprises an outer shaft disposed around the delivery shaft, wherein the delivery shaft is axially movable relative to the outer shaft.

[0430] Example 102. The assembly of any example herein, particularly of any one of examples 78 to 101, further comprising one or more releasable coupling arms configured to releasably couple the replacement valve to the delivery apparatus.

[0431] Example 103. The assembly of any example herein, particularly of any one of examples 78 to 103, wherein the support frame comprises a plurality of cusp portions and a plurality of commissure support portions.

[0432] Example 104. The assembly of any example herein, particularly of example 103, wherein each commissure support portion comprises a pair of support struts joined by an apex region, wherein the support struts continuously extend from the cusp portions.

[0433] Example 105. The assembly of any example herein, particularly of example 104, wherein the support frame further comprises a plurality of coupling extensions extending from the apex regions.

[0434] Example 106. The assembly of any example herein, particularly of example 105, wherein the delivery apparatus further comprises a plurality of prongs, wherein each prongcomprises an opening, and wherein the coupling extensions are configured to be inserted into the openings of the prongs.

[0435] Example 107. The assembly of any example herein, particularly of example 106, wherein the delivery apparatus further comprises a plurality of retaining wires configured to be inserted into openings of the coupling extensions.

[0436] Example 108. The assembly of any example herein, particularly of example 105, wherein the delivery apparatus further comprises a retaining member axially movable relative to the delivery shaft.

[0437] Example 109. The assembly of any example herein, particularly of example 108, wherein the coupling extensions comprise axial struts terminating at head portions, wherein the head portions are configured to be retained inside recessed portions of the retaining member when the retaining member is positioned inside the delivery shaft, and to extend away from the recessed portions when the retaining member is moved distally to and out of the delivery shaft.

[0438] Example 110. The assembly of any example herein, particularly of any one of examples 78 to 109, wherein the existing heart valve is a host prosthetic valve that includes a frame and the host leaflets mounted inside the frame of the host prosthetic valve.

[0439] Example 111. The assembly of any example herein, particularly of example 110, wherein the at least one cutting edge of the leaflet removal device is configured to separate the host leaflets from the frame of the host prosthetic valve.

[0440] Example 112. The assembly of any example herein, particularly of example 110 or 111, wherein the support frame of the replacement valve is configured to self-expand against the frame of the host prosthetic valve.

[0441] Example 113. The assembly of any example herein, particularly of any one of examples 78 to 112, wherein the support frame has a rectangular cross-section defining a cross-sectional height and a thickness.

[0442] Example 114. The assembly of any example herein, particularly of example 113, wherein the cross-sectional height of the support frame is at least five times greater than its thickness.

[0443] Example 115. The assembly of any example herein, particularly of example 113 or 114, wherein the cross-sectional height of the support frame is equal to or greater than 1.5 mm.

[0444] Example 116. The assembly of any example herein, particularly of any one of examples 113 to 115, wherein the support frame comprises a plurality of apertures extending through its thickness.

[0445] Example 117. The assembly of any example herein, particularly of example 116, wherein the leaflets are coupled to the support frame by one or more sutures extending through the apertures of the support frame.

[0446] Example 118. The assembly of any one of claims 78 to 117, wherein the at least one clip comprises a plurality of clips.

[0447] Example 119. The assembly of any example herein, particularly of example 118, wherein the plurality of clips comprises three clips.

[0448] Example 120. A method comprising: advancing a delivery assembly comprising a delivery apparatus and a replacement valve maintained in a compressed configuration thereof inside a delivery shaft of the delivery apparatus, to a host prosthetic valve comprising a frame and a plurality of host leaflets mounted inside the frame; and deploying a leaflet removal device of the delivery apparatus at a position proximal to the host leaflets; advancing at least one clip of the leaflet removal device, in an open configuration of the leaflet removal device, towards and around a corresponding one of the host leaflets, such that a first clip arm of the clip and an first cage extending proximally therefrom is positioned between the corresponding host leaflet and the frame of the host prosthetic valve, and such that a second clip arm of the clip and a second cage extending proximally therefrom are disposed radially inwards to the corresponding host leaflet; closing the second clip arm and the first clip arm against the corresponding host leaflet; cutting the corresponding host leaflet by at least one cutting edge of at least one of the first clip arm and / or the second clip arm; and removing a cut portion of the corresponding host leaflet from the host prosthetic valve by proximally retracting the clip in which it is retained.

[0449] Example 121. The method of any example herein, particularly of example 120, wherein the deploying the leaflet removal device comprises allowing the leaflet removal device to selfexpand when exposed out of an inner shaft of the delivery apparatus.

[0450] Example 122. The method of any example herein, particularly of example 121, wherein the inner shaft is axially movable through and relative to the delivery shaft.

[0451] Example 123. The method of any example herein, particularly of any one of examples 120 to 122, wherein the deploying the leaflet removal device comprises pivotably moving the second clip arm and first clip arms away from each other to a radial distance therebetween sufficient to allow insertion of the corresponding host leaflet therebetween.

[0452] Example 124. The method of any example herein, particularly of example 123, wherein the pivotably moving the second clip arm and first clip arms away from each other comprises proximally pulling one or more pull wires coupled to the second clip arm.

[0453] Example 125. The method of any example herein, particularly of example 124, wherein the closing the second clip arm and the first clip arm comprises releasing the one or more pull wires.

[0454] Example 126. The method of any example herein, particularly of any one of examples 120 to 125, wherein the closing the second clip arm and the first clip arm comprises maintaining the second cage loose enough to allow the corresponding host leaflet to move towards and away from the remaining host leaflets to allow continued functioning of the host leaflets with respect to regulating flow of blood through the host prosthetic valve.

[0455] Example 127 The method of any example herein, particularly of any one of examples 120 to 126, wherein the closing the second clip arm and the first clip arm comprises preventing the corresponding host leaflet from slipping away from the clip.

[0456] Example 128. The method of any example herein, particularly of any one of examples 120 to 127, wherein the closing the second clip arm and the first clip arm comprises preventing the corresponding host leaflet from passing through the second cage or the first cage.

[0457] Example 129. The method of any example herein, particularly of any one of examples 120 to 128, wherein each of the first cage and the second cage comprises a mesh.

[0458] Example 130. The method of any example herein, particularly of any one of examples 120 to 128, wherein each of the first cage and the second cage comprises a frame.

[0459] Example 131. The method of any example herein, particularly of any one of examples 120 to 128, wherein each of the first cage and the second cage comprises a plurality of strings.

[0460] Example 132. The method of any example herein, particularly of any one of examples 120 to 131, wherein the closing the second clip arm and the first clip arm comprises radially aligning the second clip arm and the first clip arm.

[0461] Example 133. The method of any example herein, particularly of any one of examples 120 to 131, wherein the closing the second clip arm and the first clip arm comprises axially aligning the second clip arm and the first clip arm.

[0462] Example 134. The method of any example herein, particularly of any one of examples 120 to 133, wherein the at least one cutting edge is comprised along an inner side of the first clip arm, oriented radially inwards.

[0463] Example 135. The method of any example herein, particularly of any one of examples 120 to 134, wherein the at least one cutting edge is comprised along an outer side of the second clip arm, oriented radially outwards.

[0464] Example 136. The method of any example herein, particularly of example 134 or 135, wherein the closing the second clip arm and the first clip arm comprises the cutting the corresponding host leaflet.

[0465] Example 137. The method of any example herein, particularly of any one of examples 120 to 133, wherein the at least one cutting edge is comprised along a second end of the first clip arm, oriented in a distal direction along at least a distal-most portion of the first clip arm.

[0466] Example 138. The method of any example herein, particularly of example 137, wherein the cutting the corresponding host leaflet comprises distally pushing the cutting edge at a force sufficient to cut through regions of the host leaflet contacted thereby.

[0467] Example 139. The method of any example herein, particularly of any one of examples 120 to 138, wherein the at least one cutting edge comprises a sharp edge.

[0468] Example 140. The method of any example herein, particularly of any one of examples 120 to 138, wherein the at least one cutting edge comprises an electrically conductive surface, and wherein the cutting the corresponding host leaflet comprises conducting electric energy, via the delivery assembly, to the electrically conductive surface.

[0469] Example 141. The method of any example herein, particularly of example 140, wherein the conducting electric energy comprises conducting radiofrequency energy.

[0470] Example 142. The method of any example herein, particularly of any one of examples 120 to 141, further comprising, prior to the cutting the corresponding host leaflet, deploying a filter at a position proximal to the host prosthetic valve.

[0471] Example 143. The method of any example herein, particularly of any one of examples 120 to 142, wherein the cutting the corresponding host leaflet comprises cutting all of the host leaflets.

[0472] Example 144. The method of any example herein, particularly of example 143, wherein the leaflet removal device comprises a single clip, and wherein the cutting all of the host leaflets comprises repeating the advancing, the closing, the cutting and the removing for each one of the host leaflets.

[0473] Example 145. The method of any example herein, particularly of example 143, wherein the leaflet removal device comprises a plurality of clips matching in number the plurality of host leaflets, and wherein the cutting all of the host leaflets comprises simultaneously cutting the plurality of host leaflets by the corresponding plurality of clamp sections, and wherein the removing the corresponding host leaflet comprises removing cut portions of all of the host leaflets from the frame of the host prosthetic valve.

[0474] Example 146. The method of any example herein, particularly of any one of examples 143 to 144, further comprising deploying the replacement valve out of the delivery shaft at a position proximal to the host leaflets.

[0475] Example 147. The method of any example herein, particularly of example 146, further comprising expanding the replacement valve against the frame of the host prosthetic valve.

[0476] Example 148. The method of any example herein, particularly of example 147, further comprising, after the expanding and after the removing, retrieving the delivery apparatus along with cut portions of the host leaflets, wherein the replacement valve comprises a support frame and a valvular structure coupled to the support frame and comprising a plurality of leaflets configured to regulate flow through the replacement valve.

[0477] Example 149. The method of any example herein, particularly of example 148, wherein the deploying the replacement valve comprises allowing the support frame to self-expand when exposed out of the delivery shaft.

[0478] Example 150. The method of any example herein, particularly of example 148 or 149, wherein the deploying the replacement valve comprises maintaining the replacement valve coupled to the delivery apparatus by a plurality of releasable coupling arms.

[0479] Example 151. The method of any example herein, particularly of example 148 or 149, wherein the expanding the replacement valve against the frame of the host prosthetic valve comprises maintaining the replacement valve coupled to the delivery apparatus by a plurality of releasable coupling arms.

[0480] 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.

[0481] 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 replacement valve comprising: a self-expandable support frame comprising: a plurality of cusp portions; and a plurality of commissure support portions, each comprising a pair of support struts joined by an apex region, wherein the support struts continuously extend from the cusp portions; and a valvular structure coupled to the support frame and comprising a plurality of leaflets configured to regulate flow through the replacement valve; wherein a first end of the support frame comprises a cutting edge configured to cut through host leaflets of an existing heart valve; and wherein the first end of the frame is oriented in a distal direction at least along part of the cusp portions.

2. The replacement valve of claim 1, wherein the first end of the support frame is oriented in the distal direction along the apex regions.

3. The replacement valve of claim 1 or 2, wherein the first end of the support frame along one of the pair of support struts of any of the commissure support portions is facing the first end of the support struts along the other one of the pair of support struts of the same commissure support portion.

4. The replacement valve of any one of claims 1 to 3, wherein the cutting edge comprises a sharp edge.

5. The replacement valve of any one of claims 1 to 3, wherein the cutting edge comprises an electrically conductive surface configured to conduct electric energy for severing the leaflets of the existing heart valve when contacted thereby.

6. The replacement valve of claim 5, further comprising an electrically insulating layer covering at least a portion of the support frame, excluding the electrically conductive surface.

7. A delivery assembly comprising: a replacement valve comprising: a self-expandable support frame comprising a cutting edge along a first end of the support frame; and a valvular structure coupled to the support frame and comprising a plurality of leaflets configured to regulate flow through the replacement valve; and a delivery apparatus comprising:a delivery shaft configured to retain the replacement valve in a compressed configuration when the replacement valve is inside the delivery shaft; a retrieval device movable between a compacted configuration and a deployed configuration; wherein the cutting edge is configured to cut through host leaflet of an existing heart valve; and wherein the retrieval device is axially movable relative to the replacement valve, and is configured to move from the compacted configuration to the deployed configuration at a position distal to the replacement valve, when the replacement valve is deployed out of the delivery shaft.

8. The assembly of claim 7, wherein the retrieval device is self-expandable.

9. The assembly of any one of claims 7 to 8, wherein the retrieval device comprises a mesh configured to prevent cut portions of the host leaflet from passing upstream therethrough.

10. The assembly of any one of claims 7 to 9, wherein the delivery apparatus further comprises a filter configured to transition from a compacted configuration to a deployed configuration thereof at a position proximal to the replacement valve, when the replacement valve is deployed out of the delivery shaft.

11. The assembly of any one of claims 7 to 10, further comprising one or more releasable coupling arms configured to releasably couple the replacement valve to the delivery apparatus.

12. The assembly of any one of claims 7 to 10, wherein the support frame comprises a plurality of cusp portions and a plurality of commissure support portions.

13. The assembly of claim 12, wherein the first end of the frame is oriented in a distal direction at least along part of the cusp portions.

14. The assembly of any one of claims 7 to 13, wherein the cutting edge comprises a sharp edge.

15. The assembly of any one of claims 7 to 13, wherein the cutting edge comprises an electrically conductive surface configured to conduct electric energy for severing the leaflets of the existing heart valve when contacted thereby.

16. A method comprising: advancing a delivery assembly to a host prosthetic valve, the delivery assembly comprising a delivery apparatus and a replacement valve maintained in a compressed configuration thereof inside a delivery shaft of the delivery apparatus, the replacement valve comprising a support frame having a cuttingedge, the host prosthetic valve comprising a frame and a plurality of host leaflets mounted inside the frame; and deploying the replacement valve out of the delivery shaft at a position proximal to the host leaflets; deploying a retrieval device of the delivery apparatus at a position distal to the host leaflets; cutting the host leaflets by advancing the replacement valve towards and against the host leaflets; collecting cut portions of the host leaflet with the retrieval device by proximally retracting the retrieval device; and retrieving the delivery apparatus along with the cut portions of the host leaflets, wherein the replacement valve remains expanded against the frame of the host prosthetic valve during the retrieval; wherein the replacement valve comprises a valvular structure coupled to the support frame and comprising a plurality of leaflets configured to regulate flow through the replacement valve.

17. The method of claim 16, wherein the deploying the replacement valve comprises allowing the support frame to self-expand when exposed out of the delivery shaft.

18. The method of claim 16 or 17, wherein the cutting the host leaflets comprises maintaining the replacement valve coupled to the delivery apparatus by a plurality of releasable coupling arms.

19. The method of claim 18, further comprising, prior to the retrieving the delivery apparatus, decoupling the replacement valve from the delivery apparatus by releasing the releasable coupling arms.

20. The method of any one of claims 16 to 19, further comprising, prior to the cutting the host leaflets, advancing the retrieval device, in a compacted state thereof, through the replacement valve and the host prosthetic valve, and moving the retrieval device to a deployed configuration distal to the host leaflets.

21. The method of any one of claims 16 to 20, further comprising, prior to the cutting the host leaflets, deploying a filter at a position proximal to the host prosthetic valve.

22. The method of any one of claims 16 to 21 , wherein the cutting the host leaflets comprises cutting cusp end portions of the host leaflets by cusp portions of the support frame pushed there- against.

23. The method of any one of claims 16 to 22, wherein the cutting edge comprises a sharp edge, and wherein the cutting the host leaflets comprises distally pushing the sharp edge at a force sufficient to cut through regions of the host leaflets contacted thereby.

24. The method of any one of claims 16 to 23, wherein the cutting edge comprises an electrically conductive surface, and wherein the cutting the host leaflets comprises conducting electric energy, via the delivery assembly, to the electrically conductive surface.

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