Delivery apparatus with atraumatic flexible members

Abstract

The present disclosure relates to an outer shafts with flexible atraumatic members at distal portions thereof. In an example, a delivery apparatus comprises an outer shaft and a plurality of atraumatic flexible members disposed around a circumference of a distal portion of the outer shaft, each of the atraumatic flexible members includes an extension extending along at least part of, and affixed to, the distal portion of the outer shaft, an atraumatic tip positioned distal to the distal end of the outer shaft, and optionally a bendable portion extending between the extension and the atraumatic tip. The atraumatic flexible members are configured to move between a first configuration and a second configuration, such that the atraumatic tips are positioned, in the second configuration, radially outwards relative to their radial position in the first configuration.

Description

Attorney Docket No: THVDL-23864WO01DELIVERY APPARATUS WITH ATRAUMATIC FLEXIBLE MEMBERSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 681,681, filed August 9, 2024, which is incorporated by reference herein.FIELD

[0002] The present disclosure relates to devices configured to form an opening in the target tissue, which can be a leaflet of an 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. The term “host valve” is also used herein to refer to the native aortic valve in a native TAVR procedure.Attorney Docket No: THVDL-23864WO01SUMMARY

[0006] A treatment procedure at a target site in a patient’s body, such as modification of a leaflet of an existing valvular structure prior to implantation of a new prosthetic valve, as can be the case for example in ViV procedures, may require advancement of an apparatus that includes an outer shaft and a primary extendable device extendable therethrough, such as an anchor device having a helical anchor head, terminating at a sharp distal tip. The anchor device can be retained inside of the lumen of the outer shaft, exposing a distal end of the outer shaft in a manner that can pose a risk of contacting and potentially scraping against outer walls, such as anatomical arterial walls of the patient's vasculature, during advancement towards the target site of treatment.

[0007] In one of its basic configurations, a delivery apparatus comprises an outer shaft, a primary extendable device extendable through the outer shaft, and a plurality of atraumatic flexible members disposed around a circumference of the outer shaft. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0008] In some examples, each of the atraumatic flexible members can comprise an extension, optionally extending along at least part of the outer shaft.

[0009] In some examples, each of the atraumatic flexible members can comprise an atraumatic tip positioned distal to the outer shaft.

[0010] In some examples, the atraumatic flexible members can be configured to move between a first configuration and a second configuration, such that the atraumatic tips are positioned, in the second configuration, radially outwards relative to their radial position in the first configuration.

[0011] In some examples, the outer shaft can optionally comprise an outer shaft lumen defining a central longitudinal axis.

[0012] In some examples, the outer shaft can comprise a distal portion terminating at a distal end.

[0013] In some examples, the primary extendable device can optionally comprise a distal portion terminating at a distal end.

[0014] In some examples, the flexible members can optionally be disposed around a circumference of the distal portion of the outer shaft.Attorney Docket No: THVDL-23864WO01

[0015] In some examples, the extensions can optionally be affixed to the outer shaft.

[0016] In some examples, the extensions can optionally be affixed to the distal portion of the outer shaft.

[0017] In some examples, the atraumatic tip can optionally be positioned distal to the distal end of the outer shaft.

[0018] In some examples, the atraumatic tip can optionally be positioned distal to the distal end of the outer shaft.

[0019] In some examples, the atraumatic tip can optionally be positioned distal to the distal end of the outer shaft.

[0020] In some examples, the primary extendable device can optionally be axially movable relative to the outer shaft.

[0021] In some examples, the atraumatic flexible members can be configured to move to the second configuration when the distal end of the primary extendable device is distally advanced out of the outer shaft.

[0022] In some examples, when the atraumatic flexible members are in the second configuration, the distal end of the primary extendable device can optionally be distal to the distal end of the outer shaft.

[0023] In some examples, movement of the atraumatic flexible members from the first configuration to the second configuration can optionally comprise moving the atraumatic tips radially away from the central longitudinal axis.

[0024] In some examples, the bendable portions can optionally comprise a flexible material configured to flex in a radial direction.

[0025] In some examples, movement of the atraumatic flexible members from the first configuration to the second configuration can optionally comprise bending the bendable portions radially outwards.

[0026] In some examples, the atraumatic tips can optionally extend radially outwards, in the first configuration, past an outer surface of the distal portion of the outer shaft.

[0027] In some examples, the first curved surface portion can optionally be further oriented radially outwards.

[0028] In some examples, the second curved surface portion can optionally be further oriented radially inwards.

[0029] In some examples, the second curved surface portion can optionally be opposite to the first curved surface portion.

[0030] In some examples, each atraumatic tip can optionally comprise a bead.Attorney Docket No: THVDL-23864WO01

[0031] In some examples, the extension and the bendable portion can optionally be integrally formed.

[0032] In some examples, the bendable portions can optionally be configured to radially bias the atraumatic tips.

[0033] In some examples, the bendable portions can optionally be configured to bias the atraumatic tips radially inwards.

[0034] In some examples, the bendable portions can optionally comprise a shape-memory material.

[0035] In some examples, the shape-memory material can optionally comprise Nitinol.

[0036] In some examples, the atraumatic tip and the bendable portion can optionally be integrally formed.

[0037] In some examples, the distal end of the primary extendable device can optionally comprise a sharp tip.

[0038] In some examples, the primary extendable device can optionally comprise an anchor device, wherein the distal portion of the primary extendable device comprises an anchor head, and wherein the distal end of the primary extendable device comprises an anchor tip.

[0039] In some examples, the anchor device can optionally further comprise an anchor shaft proximally extending from the anchor head.

[0040] In some examples, an outer diameter of the anchor device can optionally be greater than an outer diameter of the anchor shaft.

[0041] In some examples, when the anchor tip is distal to the distal end of the outer shaft, and a proximal end of the anchor head is proximal to the distal end of the outer shaft, the atraumatic flexible members can optionally be in the second configuration.

[0042] In one of its basic configurations, a method comprises advancing a delivery apparatus, over a guidewire, towards a target site of treatment, wherein the delivery apparatus comprises an outer shaft and a plurality of atraumatic flexible members comprising a plurality of atraumatic tips disposed distal to the outer shaft. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.Attorney Docket No: THVDL-23864WO01

[0043] In some examples, the method further comprises moving the atraumatic flexible members from a first configuration to a second configuration in which the atraumatic tips are positioned radially outwards relative to their radial position in the first configuration.

[0044] In some examples, the plurality of flexible members can optionally be affixed to the outer shaft.

[0045] In some examples, the plurality of flexible members can optionally be affixed to a distal portion of the outer shaft.

[0046] In some examples, the atraumatic tips can optionally be disposed distal to a distal end of the outer shaft.

[0047] In some examples, the atraumatic flexible members can optionally be moved from a first configuration to a second configuration by distally advancing a distal portion of a primary extendable device through the distal end of the outer shaft.

[0048] In some examples, each of the atraumatic flexible members can optionally comprise an extension extending along at least part of, and affixed to, the distal portion of the outer shaft.

[0049] In some examples, each of the atraumatic flexible members can optionally further comprise a bendable portion extending between the extension and the atraumatic tip.

[0050] In some examples, the advancing the delivery apparatus can optionally comprise maintaining a distal end of the primary extendable device at or proximal to the distal end of the outer shaft.

[0051] In some examples, the advancing the delivery apparatus can optionally comprise maintaining the atraumatic flexible members in the first configuration.

[0052] In some examples, the plurality of the atraumatic flexible members can optionally be disposed around a circumference of the distal end of the outer shaft.

[0053] In some examples, the plurality of the atraumatic flexible members can optionally be biased radially inwards.

[0054] In some examples, the primary extendable device can optionally comprise an anchor device, and the distal portion of the primary extendable device can optionally comprise an anchor head terminating at a sharp anchor tip.

[0055] 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 theAttorney Docket No: THVDL-23864WO01 invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.BRIEF DESCRIPTION OF THE FIGURES

[0056] 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:

[0057] Fig. 1 is a sectional view of an aortic root.

[0058] Fig. 2 shows a cross-sectional view of a prosthetic heart valve implanted in the native aortic valve of within the aortic root of Fig. 1 , according to an example.

[0059] Fig. 3 shows a valve-in- valve implantation within the native aortic valve of Fig. 1, according to an example.

[0060] Figs. 4A and 4B show a perspective sectional view and a cross-sectional side view, respectively, of an exemplary delivery apparatus devoid of atraumatic flexible members.

[0061] Fig. 5 shows a perspective sectional view of an exemplary delivery apparatus equipped with atraumatic flexible members.

[0062] Fig. 6A shows the delivery apparatus of Fig. 5 in a first configuration of the atraumatic flexible members.

[0063] Fig. 6B shows the delivery apparatus of Figs. 5 in a second configuration of the atraumatic flexible members.

[0064] Fig. 6C shows the delivery apparatus of Fig. 5 in a third configuration of the atraumatic flexible members.

[0065] Figs. 7A-7E illustrate some steps in an exemplary method for utilizing the delivery apparatus of Figs. 5-6C for forming a leaflet opening.

[0066] Fig. 8 shows a guest prosthetic valve positioned, in a radially compressed configuration thereof, inside a leaflet opening.DETAILED DESCRIPTION

[0067] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, andAttorney Docket No: THVDL-23864WO01 systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present, or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology.

[0068] 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.

[0069] 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.

[0070] 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”.

[0071] 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, toAttorney Docket No: THVDL-23864WO01 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.

[0072] 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.

[0073] 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.

[0074] 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 an apparatus disclosed herein or a shaft thereof does not require the component to be aligned with a center of the shaft; rather, the component can extend substantially along a direction parallel to a central axis of the apparatus or a shaft thereof.

[0075] 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.Attorney Docket No: THVDL-23864WO01

[0076] 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.

[0077] As used herein, terms such as “first”, “second”, and the like are intended to serve as respective labels of distinct components, steps, etc. and are not intended to connote or imply a specific sequence or priority. For example, unless otherwise stated, a step of performing a second action and / or of forming a second component may be performed prior to a step of performing a first action and / or of forming a first component.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] Described herein are devices and methods for implanting prosthetic valves and modifying leaflets of an existing valvular structure in a patient’s heart. Prior to or during implantation of the prosthetic heart valve within the existing valvular structure, each device, such as a delivery apparatus that can optionally carry a prosthetic valve, can be provided in theAttorney Docket No: THVDL-23864WO01 ascending aorta of a patient and can be used to pierce, lacerate, slice, tear, cut or otherwise modify a leaflet or commissure of the existing valvular structure. In some examples, the existing valvular structure can be a native aortic valve (for example, normal or abnormal, such as bicuspid aortic valve (BAV)) or a prosthetic valve previously implanted in the native aortic valve. The modification can avoid, or at least reduce the likelihood of, issues that leaflets of the existing valvular structure might otherwise cause once the prosthetic heart valve has been fully installed, for example, obstruction of blood flow to the coronary arteries, improper mounting due to a non-circular valve cross-section, and / or restricted access to the coronary arteries if subsequent intervention is required. While described with respect to aortic valve, it should be understood that the disclosed examples can be adapted to deliver devices that can modify existing valvular structure, and in some implementations, implant prosthetic devices, to and / or in any of the native annuluses of the heart (for example, the aortic, pulmonary, mitral, and tricuspid annuluses), and can be used with any of various delivery approaches (for example, retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0082] Fig. 1 illustrates an anatomy of the aortic root 22, which is positioned between the left ventricle 32 and the ascending aorta 26. The aortic root 22 includes a native aortic valve 20 having a native valvular structure 29 comprising a plurality of native leaflets 30. Normally, the native aortic valve 20 has three leaflets (only two leaflets are visible in the simplified illustration of Fig. 1), but aortic valves with fewer than three leaflets are possible. The leaflets 30 are supported at native commissures by the aortic annulus 24, which is a ring of fibrous tissue at the transition point between the left ventricle 32 and the aortic root 22. The leaflets 30 can cycle between open and closed positions (the closed position is shown in Fig. 1) to regulate flow of blood from the left ventricle 32 to the ascending aorta 26. Branching off the aortic root 22 are the coronary arteries 34, 36. The coronary artery ostia 42, 44 are the openings that connect the aortic root 22 to the coronary arteries 34, 36.

[0083] Fig. 2 shows an exemplary prosthetic valve 100 that can be implanted in a native heart valve, such as the native aortic valve 20 of Fig. 1. 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 expandedAttorney Docket No: THVDL-23864WO01 state. Thus, a plurality of partially expanded states may relate to any expansion diameter between radially compressed or crimped state, and maximally expanded state. A prosthetic valve of the current disclosure (for example, prosthetic valve 100) 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.

[0084] It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses. Balloon expandable valves generally involve a procedure of inflating a balloon within a prosthetic valve, thereby expanding the prosthetic valve within the desired implantation site. Once the valve is sufficiently expanded, the balloon is deflated and retrieved along with a delivery apparatus (not shown). Self-expandable valves include a frame that is shape-set to automatically expand as soon an outer retaining shaft or capsule (not shown) is withdrawn proximally relative to the prosthetic valve. Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion. The mechanical actuation mechanism usually includes a plurality of expansion and locking assemblies (such as the prosthetic valves described in U.S. Patent No. 10,603, 165, International Application No. PCT / US2021 / 052745 and U.S. Provisional Application Nos. 63 / 85,947 and 63 / 209904, each of which is incorporated herein by reference in its entirety), releasably coupled to respective actuation assemblies of a delivery apparatus, controlled via a handle (not shown) for actuating the expansion and locking assemblies to expand the prosthetic valve to a desired diameter. The expansion and locking assemblies may optionally lock the valve' s diameter to prevent undesired recompression thereof, and disconnection of the actuation assemblies from the expansion and locking assemblies, to enable retrieval of the delivery apparatus once the prosthetic valve is properly positioned at the desired site of implantation.

[0085] Fig. 2 shows an example of a prosthetic valve 100, which can be a balloon expandable valve or any other type of valve, illustrated in an expanded state. The prosthetic valve 100 can comprise an outflow end 106 and an inflow end 104. In some instances, the outflow end 106 is the proximal end of the prosthetic valve 100, and the inflow end 104 is the distal end of the prosthetic valve 100. Alternatively, depending for example on the delivery approach of the valve, the outflow end can be the distal end of the prosthetic valve, and the inflow end can be the proximal end of the prosthetic valve.

[0086] The term “outflow”, as used herein, refers to a region of the prosthetic valve through which the blood flows through and out of the prosthetic valve 100.

[0087] The term “inflow”, as used herein, refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve 100.Attorney Docket No: THVDL-23864WO01

[0088] 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, the lower end of the prosthetic valve is its inflow end and the upper end of the prosthetic valve is its outflow end.

[0089] 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.

[0090] The terms “longitudinal” and “axial”, as used herein, refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0091] The prosthetic valve 100 comprises an annular frame 102 movable between a radially compressed configuration and a radially expanded configuration, and a valvular structure 113 that comprises prosthetic valve leaflets 114 mounted within the frame 102. The frame 102 can be made of various suitable materials, including plastically-deformable materials such as, but not limited to, stainless steel, a nickel-based alloy (for example, a nickel-cobalt-chromium alloy such as MP35N alloy), polymers, or combinations thereof. When constructed of a plastically- deformable materials, the frame 102 can 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. Alternatively or additionally, the frame 102 can be made of shape-memory materials such as, but not limited to, nickel-titanium alloy (for example, Nitinol). When constructed of a shape-memory material, the frame 102 can be crimped to a radially compressed state and restrained in the compressed state by insertion into a shaft or equivalent mechanism of a delivery apparatus.

[0092] In the example illustrated in Fig. 2, the frame 102 is an annular, stent- like structure comprising a plurality of intersecting struts 108. 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 108 may be any elongated member or portion of the frame 102. The frame 102 can include a plurality of strut rungs that can collectively define one or more rows of cells 110. The frame 102 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 104 to the outflow end 106 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.Attorney Docket No: THVDL-23864WO01

[0093] The struts 108 can include a plurality of angled struts and vertical or axial struts. At least some of the struts 108 can be pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame 102 can be formed from a single piece of material, such as a metal tube, via various processes such as, but not limited to, laser cutting, electroforming, and / or physical vapor deposition, while retaining the ability to collapse / expand radially in the absence of hinges and like.

[0094] A valvular structure 113 of the prosthetic valve 100 can include a plurality of prosthetic valve leaflets 1 14 (for example, three leaflets), positioned at least partially within the frame 102, and configured to regulate flow of blood through the prosthetic valve 100 from the inflow end 104 to the outflow end 106. While three leaflets 114 arranged to collapse in a tricuspid arrangement, are shown in the example illustrated in Fig. 2, it will be clear that a prosthetic valve 100 can include any other number of leaflets 114. Adjacent leaflets 1 14 can be arranged together to form prosthetic valve commissures 116 that are coupled (directly or indirectly) to respective portions of the frame 102, thereby securing at least a portion of the valvular structure 113 to the frame 102. The prosthetic valve leaflets 114 can be made from, in whole or part, biological material (for example, pericardium), bio-compatible synthetic materials, or other such materials. Further details regarding transcatheter prosthetic valves, including the manner in which leaflets 114 can be coupled to the frame 102 of the prosthetic valve 100, 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.

[0095] In some examples, the prosthetic valve 100 can comprise at least one skirt or sealing member. For example, the prosthetic valve 100 can include an inner skirt (not shown in Fig. 2), which can be secured to the inner surface of the frame 102. Such an inner skirt can be configured to function, for example, as a sealing member to prevent or decrease perivalvular leakage. An inner skirt can further function as an anchoring region for leaflets 114 to the frame 102, and / or function to protect the leaflets 114 against damage which may be caused by contact with the frame 102, for example during valve crimping or during working cycles of the prosthetic valve 100. An inner skirt can be disposed around and attached to the inner surface of frame 102, while the leaflets can be sutured to the inner skirt along a scalloped line (not shown). An inner skirt can be coupled to the frame 102 via sutures or another form of coupler.

[0096] The prosthetic valve 100 can comprise, in some examples, an outer skirt 118 mounted on the outer surface of frame 102 (as shown in Fig. 2), configured to function, for example, as a sealing member retained between the frame 102 and the surrounding tissue of the native annulus against which the prosthetic valve is mounted, or against an inner side of a previouslyAttorney Docket No: THVDL-23864WO01 implanted valve in the case of ViV procedures (described further below), thereby reducing risk of paravalvular leakage (PVL) past the prosthetic valve 100. The outer skirt 118 can be coupled to the frame 102 via sutures or another form of coupler.

[0097] Any of the inner skirt and / or outer skirt can be made of various suitable biocompatible materials, such as, but not limited to, various synthetic materials (for example, PET) or natural tissue (for example pericardial tissue). In some cases, the inner skirt can be formed of a single sheet of material that extends continuously around the inner surface of frame 102. In some cases, the outer skirt 118 can be formed of a single sheet of material that extends continuously around the outer surface of frame 102.

[0098] The cells 110, defined by interconnected struts 108, define cell openings 112. While some of the cell openings 112 can be covered by the inner skirt and / or the outer skirt, at least a portion of the cell opening 1 12 can remain uncovered, such as cell openings 112 which are closer to the outflow end 106 of the prosthetic valve.

[0099] Fig. 2 illustrates a hypothetical coronary artery obstruction that could occur in some cases from implantation of a prosthetic valve 100 within the native aortic valve 20. In this example, the prosthetic valve 100 is the guest valve or new valve, and the native aortic valve 20 is the host valve or old valve.

[0100] During implantation of the prosthetic valve 100, the prosthetic valve 100 is positioned within a central region defined between the native leaflets 30, which are also the host leaflets 10 for the example illustrated in Fig. 2. The prosthetic valve 100 is then radially expanded against the host leaflets 10. As illustrated, the host leaflets 10 form a tube around the frame 102 of the prosthetic valve 100 after the prosthetic valve 100 is radially expanded to the working diameter. As further illustrated, expansion of the prosthetic valve 100 displaces the host leaflets 10 outwards towards the coronary ostia 42, 44 such that the host leaflets 10 contact a portion of the aortic root 22 surrounding the coronary ostia 42, 44, causing coronary artery obstruction.

[0101] 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. 3 illustrates an exemplary hypothetical coronary artery obstruction that could occur in some cases from implantation of a prosthetic valve 100b within a previously implanted prosthetic valve 100a (for example, after a ViV procedure). In this example, the prosthetic valve 100b is the guest valve or new valve, and the prosthetic valve 100a is the host valve or old valve. In this example, the prosthetic valve 100a was previously implanted within the orifice of the native aortic valveAttorney Docket No: THVDL-23864WO0120. Each of the prosthetic valves 100a, 100b can have the general structure of the prosthetic valve 100 described with reference to Fig. 2, though in some examples, each of the prosthetic valves 100a, 100b can be a different type of prosthetic valve. For example, a balloon expandable guest valve 100b can be implanted inside a previously implanted mechanically expandable or self-expandable host valve 100a.

[0102] During implantation of the prosthetic valve 100b, the prosthetic valve 100b is positioned within a central region defined between the leaflets 114a of the prosthetic valve 100a, which now take the role of host leaflet 10. The prosthetic valve 100b is then radially expanded against the host leaflets 10 (i.e., against the prosthetic valve leaflets 114c). As illustrated, the radial expansion of the prosthetic valve 100a results in outward displacement of the host leaflets 10. As further illustrated, the host leaflets 10 are displaced such that the host leaflets 10 contact the aortic root 22 at positions superior to the coronary artery ostia 42, 44, causing coronary artery ostia obstruction. Alternatively, the guest prosthetic valve 100b can displace the host leaflets 114a outwardly against the frame 102a of the host valve 100a, thereby blocking the flow of blood through the frame 102a to the coronary ostia 42, 44.

[0103] In some patient anatomies (for example, when the outflow end 106 of the prosthetic valve 100 is at the STJ level 28 and the diameter of the prosthetic valve 100 is similar to the STJ diameter such that the frame 102 touches or is very close to the aortic wall 38 at the STJ level 28), the host leaflets 10 may compromise the ability for future access into the coronary arteries 34, 36 or perfusion through the frame 102 to the coronary arteries 34, 36 during the diastole phase of the cardiac cycle. Similar problems may occur in some patient anatomies either when a guest prosthetic valve 100b is percutaneously expanded within a previously implanted host prosthetic valve 100a, or when a prosthetic valve 100 is percutaneously expanded within a native valve, displacing the native leaflets 30 outward toward the coronary ostia 42, 44.

[0104] The risk illustrated in Fig. 3 may be higher when the host valve is a bioprosthetic valve without a frame or when the leaflets of the host valve are external to a frame. Risk of coronary artery ostia obstruction can increase in a cramped aortic root or when the coronary artery ostium sits low. In the examples illustrated in Figs. 2-3, the host leaflets 10 are shown obstructing both coronary artery ostia 42, 44. In some cases, only one host leaflet 10 may obstruct a respective coronary artery ostium. For example, the risk of obstructing the left coronary ostium 42 tends to be greater than obstructing the right coronary ostium 44 because the left coronary ostium 42 typically sits lower than the right coronary ostium 44.Attorney Docket No: THVDL-23864WO01

[0105] The term “host valve” as used herein refers to a native heart valve in which a prosthetic valve is implanted or a previously implanted prosthetic valve in which a new prosthetic valve is implanted. Moreover, in any of the examples disclosed herein, when the host valve is a previously implanted prosthetic valve, the host valve can be a surgically implanted prosthetic heart valve (known as a “surgical valve”) or a transcatheter heart valve. The term “guest valve”, as used herein, refers to a prosthetic valve implanted in a host valve, which can be either a native heart valve or a previously implanted prosthetic valve. Similarly, the term “host leaflets 10”, as used herein, refers to native leaflets 30 of a native valve in which a new guest prosthetic valve 100 is implanted, or to prosthetic valve leaflets 114a of a previously implanted host valve 100a in which a new guest prosthetic valve 100b is implanted.

[0106] When a guest prosthetic valve 100 is deployed inside a host valvular structure 12, it displaces the host leaflets 10 of the host valve radially outwards, towards and against a host interior surface, which can be the interior surface of the aortic wall 38 if the host valve is the native valve, or an interior surface of the frame 102a of a previously implanted prosthetic valve 100a serving as the host valve.

[0107] To avoid obstruction of blood flow to the coronary arteries 34, 36, the valvular structure 12 of the existing host valve (whether a native aortic valve or a previously implanted prosthetic valve) can be modified by components of a delivery apparatus prior to or during implantation of a new prosthetic valve within the existing valvular structure 12. In some examples, the host valvular structure 12 is modified by piercing, lacerating, tearing, slicing, and / or cutting one or more host leaflets 10 (for example, a free end of the host leaflet 10 or a commissure of adjacent host leaflets 10, which can be a native commissure for a native aortic valve 20, or a prosthetic valve commissure for a previously implanted host prosthetic valve 100) using the delivery apparatus. The modification thus disrupts the impermeable tubular structure that would otherwise be formed by the existing host leaflets 10, thereby allowing blood to flow to the coronary arteries 34, 36.

[0108] Figs. 4A and 4B show a perspective sectional view and a cross-sectional side view, respectively, of an exemplary delivery apparatus 200' that includes an outer shaft 208 defining an outer shaft lumen 210 and terminating at a distal end 214. One or more components or tools extendable through the outer shaft 208 can be maintained inside of the outer shaft 208, such as by terminating at or proximal to the outer shaft distal end 214, in a manner that exposes the inner surface (facing the central longitudinal axis CA of the outer shaft 208) during advancement of the outer shaft 208 through the patient's vasculature, towards a target site of treatment.Attorney Docket No: THVDL-23864WO01

[0109] In some examples, the delivery apparatus 200' can be used to deliver components or tools for modification of a target tissue, such as a host leaflet of a host valvular structure. In some examples, the delivery apparatus 200' can be used to deliver an anchor device 229 extendable through the outer shaft lumen 210, and a hollow needle 270 extendable through the anchor device 229. In some examples, an anchor device 229 and a hollow needle 270 are separate components insertable into, and extendable through, the outer shaft lumen 210 of the delivery apparatus 200'. In some examples, the delivery apparatus 200' comprises the anchor device 229 and the hollow needle 270.

[0110] The anchor device 229 includes a helical anchor head 250 which is attached, directly or via one or more intermediate components, to a distal portion of an anchor shaft 230. The anchor head 250 defines an anchor channel 252 and has a sharp anchor tip 254 configured to allow it to engage and penetrate a target tissue, such as a host leaflet 10 of a host valvular structure. The helical anchor head 250 can be optionally used in combination with a perforation member such as needle 270 that can extend through the anchor channel 252 towards a target tissue, such as a host leaflet 10, for modifying the host leaflet 10. Optionally, the outer shaft 208 and the anchor shaft 230 can be configured to be axially movable relative to each other. For example, a distally oriented movement of the anchor shaft 230 relative to the outer shaft 208 can optionally expose the anchor head 250 from the outer shaft 208.

[0111] It is to be understood that any reference throughout the specification and the claims, to two components which are axially movable relative to each other, is not limited to both of the components being able to axially move relative to the other when the other component is maintained axially immovable, but rather to either one of the components being axially movable relative to the other component, or both being axially movable relative to each other. For example, a reference to an anchor shaft and an outer shaft being axially movable with respect to each other can refer either to the anchor shaft being movable in the proximal or distal direction relative to the outer shaft, to the outer shaft being movable in the proximal or distal direction relative to the anchor shaft, or both.

[0112] In some examples, the anchor shaft 230 can optionally be a torque-transferring shaft, configured to be movable rotatably relative to the central longitudinal axis CA and / or relative to another shaft of the apparatus 200', such as relative to the outer shaft 208. The anchor head 250 is affixed, directly or via one or more intermediate components, to the anchor shaft 230, such that rotation of the anchor shaft 230 effects rotation of the anchor head 250 therewith.

[0113] In some examples, a helical anchor head 250 can be a tube-cut anchor head. Manufacturing of a tube-cut helical anchor head 250 can employ any suitable cutting method,Attorney Docket No: THVDL-23864WO01 such as, but not limited to, laser cutting, water-jet cutting, plasma cutting, and the like. The helical anchor head 250 can optionally include at least one helical slot 260 extending distally from a proximal end 266 of the anchor head 250, and defining one or more helical turns 256 continuously extending between the anchor proximal end 266 and the sharp anchor tip 254. In some examples, the anchor head 250 can optionally be formed from a rounded wire shaped to form the helical turns 256. Sharpening the anchor tip 254 can employ grinding or any other suitable sharpening method.

[0114] In some examples, the anchor head 250 can be maintained inside the outer shaft lumen 210, axially positioning the sharp anchor tip 254 at or proximal to the outer shaft distal end 214, to conceal the sharp anchor tip 254 of the anchor head 250 from the surrounding anatomy during delivery, thereby mitigating the risk of the sharp anchor tip 254 contacting and / or damaging any anatomical structure prior to reaching the site of treatment. In such examples, the diameter of outer shaft lumen 210, at least along the outer shaft distal end 214, is greater than an outer diameter of the anchor head 250.

[0115] The anchor shaft 230 defines an anchor shaft lumen 232 which is in fluid communication with the anchor channel 252. In some examples, at least a portion of the anchor shaft 230 is formed as a hypotube, configured to increase flexibility thereof. In some examples, at least a portion of the anchor shaft 230 comprises a helical hollow strand (HHS) tube.

[0116] It is to be understood that a reference to a helical anchor head 250 attached to an anchor shaft 230 can refer either to a helical anchor head 250 provided as a separate component coupled, directly or indirectly, to a distal end of an anchor shaft 230, or to a unitary component wherein the helical anchor head 250 is integrally formed with the anchor shaft 230. An exemplary anchor head 250 is shown in Figs. 4A-4B as a separate, optionally tube-cut anchor, coupled to a distal end of an anchor shaft 230. In some examples, the anchor proximal end 266 can provide a rigid structure by which a separately formed anchor head 250 can be solidly coupled to the anchor shaft 230, such as by welding, gluing, press-fitting, or any other suitable form of coupling.

[0117] While separately formed anchor head 250 and anchor shaft 230 coupled to each other are illustrated in Figs. 4A-4B and described above, a unitary component formed from a single tube that includes an anchor shaft 230 and a helical anchor head 250 integrally formed from a single tube can be similarly utilized in any exemplary apparatus 200' or 200 disclosed herein.

[0118] The needle 270 comprises a needle head 274 and a needle shaft 271 extending proximally from the needle head 274, collectively defining a needle lumen 272. The needle head 274 is configured to pierce a target tissue, such as a host leaflet 10 of a host valvularAttorney Docket No: THVDL-23864WO01 structure 12, to form a pilot puncture 50 in the host leaflet 10. The needle head 274 can optionally define an angled surface 276 terminating at a sharp needle tip 278 configured to facilitate piercing of a target tissue, such as the host leaflet 10, when the needle 270 is pressed thereagainst. In some examples, at least a portion of the needle shaft 271 is formed as a hypotube, configured to increase flexibility thereof.

[0119] The apparatus 200’ can optionally further include an expansion member configured to transition between a compacted state and an expanded state thereof. In some examples, the expansion member comprises a hole-dilating balloon 296 mounted on a balloon catheter 290.

[0120] The hole-dilating balloon 296 is configured to transition between a radially deflated state (shown for example in Fig. 7D) and a radially inflated state (shown for example in Fig. 7E). The hole-dilating balloon 296 can be configured to be positioned inside a pilot puncture 50 (as shown in Fig. 7D) formed, for example, by a needle 270, and expand the pilot puncture to form a tissue opening, such as a leaflet opening 52 (shown, for example, in Fig. 7E).

[0121] The balloon catheter 290 can define a balloon catheter lumen 292, through which a guidewire 80 (indicated, for example, in Fig. 7D), as well as one or more additional shafts, can optionally extend. The balloon catheter 290 is fluidly connectable, at a proximal portion thereof, to a fluid source (not shown) for inflating the hole-dilating balloon 296. The fluid source comprises an inflation fluid. The term “inflation fluid”, as used herein, means a fluid (for example, saline, though other liquids or gas can be used) used for inflating the hole-dilating balloon 296. The inflation fluid source is in fluid communication with the balloon catheter lumen 292, such that fluid from the fluid source can flow through the balloon catheter lumen 292 into hole-dilating balloon 296 to inflate it.

[0122] In some examples, an inflatable balloon 296, utilized as a hole-dilating balloon, can be different from a typical balloon used for expanding balloon-expandable prosthetic valves or stents, in that while a typical valve-expanding balloon is inflatable to a diameter that can allow expansion of a prosthetic valve to a functional diameter thereof, which can be similar to, or greater than (for example, in the case of valve over-expansion) the diameter of the native annulus in which the valve is deployed, the maximum diameter of a hole-dilating balloon 296 can be significantly smaller, configured to increase the size of a pilot puncture 50 to form a larger leaflet opening 52, optionally without tearing the host leaflet 10 (though in some examples, the host leaflet 10 may be still tom by a hole-dilating balloon 296).

[0123] In some examples, such as when dilation of a pilot puncture 50 is desired to form a larger leaflet opening 52, without necessarily tearing the leaflet 10, the maximum diameter to which the hole-dilating balloon 296 can be inflated is equal to or less than 12 mm. In someAttorney Docket No: THVDL-23864WO01 examples, the maximum diameter to which the hole-dilating balloon 296 can be inflated is equal to or less than 10 mm. Nevertheless, as mentioned above, in some examples a holedilating balloon 296 can be configured to tear a host leaflet 10, in which case the maximum diameter to which the hole-dilating balloon 296 can be inflated can be greater than 12 mm., such as within the range of 20 to 25 mm.

[0124] In some examples, a dilator 280 can be further provided distal to the hole-dilating balloon 296. Dilator 280 can be conical or frustoconical in shape, and include a dilator tapering portion 284 terminating at a dilator distal end 282, and a dilator proximal portion 286 that can be coupled to a dilator shaft 298 that extends proximally therefrom. A dilator lumen 288 continuously extends through the dilator shaft 298 and the dilator 280, open ended at the dilator distal end 282. Attachment of the dilator shaft 298 to the dilator proximal portion 286 can be achieved by a variety of methods, such as overmolding, radio-frequency welding, through an adhesive, and / or a combination thereof. In some examples (not illustrated), the dilator shaft 298 can extend through the entire length of the dilator 280, such that a distal end of the dilator shaft 298 is aligned with the dilator distal end 282. In some examples (not illustrated), the dilator shaft 298 is coupled to one or more components, such as collars or other connectors, which are in turn attached to the dilator 280.

[0125] In some examples, the hole-dilating balloon 296 is coupled to a distal end portion of the balloon catheter 290 at its proximal end, while the balloon’s distal end can be coupled, directly or indirectly, to a portion of another component, such as the dilator 280 or dilator shaft 298. In the examples illustrated in Figs. 4A-4B, the hole-dilating balloon 296 is shown to be coupled to the dilator proximal portion 286. The dilator proximal portion 286 can optionally include an outer step configured to accommodate the distal end of the balloon 296, such that the outer surface of the balloon 296 can be flush or otherwise relatively continuous with the outer surface of the dilator 280.

[0126] The outer shaft 208, balloon catheter 290, and / or dilator shaft 298, can be configured to be axially movable relative to each other. For example, a proximally oriented movement of the outer shaft 208 relative to the balloon catheter 290, or a distally oriented movement of the balloon catheter 290 relative to the outer shaft 208, can expose the balloon 296 from the outer shaft 208. Similarly, a proximally oriented movement of the dilator 280 relative to the outer shaft 208, or a distally oriented movement of the outer shaft 208 relative to the dilator 280, can expose the dilator 280 and axially translate it in a desired direction.

[0127] In some examples, such as when the hole-dilating balloon 296 is attached at both ends thereof to the dilator 280 and balloon catheter 290, both the dilator 280 with dilator shaft 298Attorney Docket No: THVDL-23864WO01 and the balloon catheter 290 can be configured to move simultaneously in the axial direction, without necessarily being axially movable relative to each other, or while axial movement of one relative to the other is limited. In such examples, an apparatus 200' can be designed such that axial movement of the balloon catheter 290 causes the dilator shaft 298 to move therewith, or such that axial movement of one of the dilator shaft 298 or dilator 280 causes the balloon catheter 290 to move therewith.

[0128] In some examples, a needle 270 of an apparatus 200' comprising a hole-dilating balloon 296, can extend through the dilator lumen 288, and configured to be axially movable in the distal and proximal direction relative to any of the dilator shaft 298, the balloon catheter 290, and / or the anchor shaft 230.

[0129] The dilator shaft 298 can extend through the balloon catheter lumen 292, and may be sized to such that an annular space is formed within balloon catheter lumen 292 between an inner surface of the balloon catheter 290 and an outer surface of the dilator shaft 298 along the length of balloon catheter 290. This annular space is in fluid communication with one or more balloon catheter inflation openings 294 exposed to an internal cavity of the balloon 296, which can be in fluid communication with a fluid source (for example, a syringe or a pump) that can inject inflation fluid (for example, saline) into the balloon 296, so as to inflate the hole-dilating balloon 296, for example during formation of a leaflet opening 52 as will be described below. The pressure of the inflation fluid within hole-dilating balloon 296 may provide the force that allows it to dilate a leaflet opening 52. Further, the balloon catheter lumen 292 may be configured to withdraw fluid from the balloon 296 through the balloon catheter inflation opening(s) 294, to deflate the balloon 296.

[0130] In some examples, a capsule 212 can be attached to the outer shaft 208, or be integrally formed with the outer shaft 208 along a proximal portion thereof. Figs. 4A-4B show an exemplary capsule 212 attached to the outer shaft 208, wherein the distal end 214 of the outer shaft can be defined by the distal end of the capsule. In some examples, the capsule 212 defines a capsule proximal step 216, defined at a transition from a first diameter of the outer shaft lumen 210 along the length of the outer shaft 208, to a greater diameter extending distally from the capsule proximal step 216 along the remainder of the capsule 212.

[0131] The diameter of the outer shaft lumen 210 along the length of the outer shaft 208 extending proximally from the capsule proximal step 216 can be greater than the outer diameter of the anchor shaft 230, but less than the outer diameter of the helical anchor head 250, while the inner diameter of the capsule 212 along the portion distal to the capsule proximal step 216 can be greater than the diameter of the helical anchor head 250. The length of the portion ofAttorney Docket No: THVDL-23864WO01 the capsule extending distally from the capsule proximal step 216 to the distal end 214 can be greater than a length of the anchor head 250. In this manner, the anchor head 250 can be retained inside the capsule 212 in a manner that conceals its sharp tip 254 to prevent it from contacting and possibly damaging the surrounding anatomical structures, during delivery towards the site of treatment (such as toward host valvular structure 12), or during retraction from the patient’s body. The anchor device 229 can be proximally pulled relative to the outer shaft 208 until a proximally-facing surface 263 of the anchor proximal end 266 hits against capsule proximal step 216, thereby concealing the helical anchor head 250 inside the capsule 212 as shown in Figs. 4A-4B.

[0132] While an outer shaft 208 equipped with a capsule 212 shaped and sized to accommodate a helical anchor head 250 in a concealed state therein, is illustrated in Figs. 8A-8B as part of an exemplary apparatus 200', it is to be understood that this arrangement is merely optional, and that an outer shaft 208 of an apparatus 200 does not necessarily need to include such a capsule. For example, the outer shaft 208 and / or a lumen 210 thereof can be uniform along the length of the outer shaft 208, optionally sized to accommodate the anchor head 250 inside the outer shaft lumen 210 when desired, such as during delivery of the apparatus 200' towards a target site of treatment.

[0133] In some examples, the apparatus 200' can optionally further comprise a delivery shaft 218 disposed between the anchor device 229 and the balloon catheter 290. The delivery shaft 218 extends through the anchor shaft lumen 232, and defines a delivery shaft lumen 220 through which the balloon 296 and balloon catheter 290 can extend. The delivery shaft 218 includes a distal portion 222 which can have, in some examples, an atraumatic end 224, such as by being rounded and / or being curved radially inwards, or otherwise formed to include an outer surface tapering in the distal direction. The delivery shaft distal portion 222 can be formed as an integral distal portion of the delivery shaft 218, or as a separate component attached to the delivery shaft 218. The delivery shaft 218 can be axially movable in the proximal and distal directions, relative to the anchor device 229 and / or the balloon catheter 290.

[0134] In some examples, at least a portion of the delivery shaft 218 is formed as a hypotube, configured to increase flexibility thereof. The delivery shaft 218 can optionally include a plurality of circumferential bands 268 arranged between circumferential slits 267, with axially extending connecting portions connecting adjacent bands 268. Two adjacent circumferential bands 268 can be connected by a plurality of angularly spaced connecting portions. In such arrangements, the delivery shaft 218 exhibits sufficient flexibility to allow it to flex as it is pushed through a tortuous pathway without kinking or buckling, and / or to bend when anotherAttorney Docket No: THVDL-23864WO01 component of the apparatus 200 is implemented as a steerable catheter that can be actively articulated to orient the apparatus 200 in a desired direction.

[0135] While a specific pattern is illustrated in Fig. 4A, which can be a laser cut pattern, it is to be understood that the pattern of bands 268 and slits 267 and / or the width of the bands 268 and / or slits 267 can vary along the length of the delivery shaft 218 in order to vary stiffness of the delivery shaft 218 along its length. For example, the width of the bands 268 can decrease from the proximal end to the distal end of the delivery shaft 218 to provide greater stiffness near the proximal end and greater flexibility near the distal end of the delivery shaft 218. Any of the anchor shaft 230 and / or needle shaft 271 can optionally includes similarly characterized slits and bands, arranged in any suitable arrangement.

[0136] When a balloon catheter 290 carrying an inflatable hole-dilating balloon 296 extends through the anchor shaft 230, it may be important to protect the hole-dilating balloon 296 from being accidentally contacted by the sharp anchor tip 254. Thus, a delivery shaft 218 that can be disposed between the helical anchor head 250 and the hole-dilating balloon 296 can advantageously protect the hole-dilating balloon 296 from being punctured by the anchor’s sharp tip 254.

[0137] Conventional delivery systems are typically advanced through the patient's vascular path while another component is positioned at, or extendable distally from, the distal end of the outer shaft, such that the distal end of the outer shaft (which can be also referred to as a delivery catheter) is not exposed at its inner surface. For example, another shaft of prosthetic device can be disposed inside an outer shaft at the axial position of its distal end, dimensioned to reach the inner surface or form a relatively small and insignificant radial gap that does not pose a risk of skiving the surrounding anatomical walls. In some examples, delivery systems can include a nosecone distally tapering from the distal end of the outer shaft.

[0138] In contrast, the delivery apparatus 200’ shown in Figs. 4A-4B includes an anchor head 250 having a sharp anchor tip 254 that needs to be concealed inside of the outer shaft 208 during delivery, and without a nosecone or any other component extending radially towards the inner surface 217 of a distal portion 211 of the outer shaft 208, in order to enable extension of the anchor head 250 towards a target tissue (e.g., host leaflet 10) upon reaching the target site of treatment. This means that a relatively thin- walled distal portion 211 of the outer shaft 208 of apparatus 200', defined between an outer surface 215 and an inner surface 217 thereof, remains exposed, posing a risk of contacting and scraping tissue material of the surrounding anatomy as the apparatus 200’ is distally pushed, during delivery, through the patient's vasculature.Attorney Docket No: THVDL-23864WO01

[0139] Fig. 5 shows a perspective sectional view of an exemplary delivery apparatus 200. Delivery apparatus 200 can be structurally and functionally similar to any of the examples described above with respect to delivery apparatus 200', expect that delivery apparatus 200 further comprises a plurality of atraumatic flexible members 240 coupled to the distal portion 211 of the outer shaft 208, and configured to prevent the distal end 214 of the outer shaft 208 from being directly contacted by anatomical walls of a patient's vasculature, such as during advancement of the delivery apparatus 200 towards a target site of treatment.

[0140] Any reference to a distal portion 21 1 of an outer shaft 208 of apparatus 200' or 200, as disclosed herein, refers to a portion proximally extending to some extent from the distal end 214, and can optionally be defined either as a distal part of a capsule 212 for implementation of an apparatus 200' or 200 equipped with a capsule, or a distal part of a uniform-diameter outer shaft 208 for implementations that do not include a separate capsule.

[0141] An atraumatic flexible member 240 can optionally include an atraumatic tip (or protector) 246 and an extension 242 proximally extending from the atraumatic tip 246. In some examples, a bendable portion 244 is defined between the extension 242 and the atraumatic tip 246. The extension 242 serves as a portion of the atraumatic flexible member 240 configured to anchor the atraumatic flexible member 240 to the distal portion 211 of the outer shaft 208. In some examples, the extension 242 can extend along at least a portion of the distal portion 211, and can be affixed to the distal portion 211. For example, the extension 242 can be an axially elongated member (e.g., elongated wire) of the atraumatic flexible member 240, optionally embedded inside the distal portion 211 of the outer shaft 208. In some examples, attachment of the atraumatic flexible member 240 to the outer shaft 208 can be achieved by overmolding the distal portion 211 of the outer shaft 208 over extensions 242.

[0142] In some examples, the bendable portions 244 extend out of the distal end 214 of outer shaft 208. For example, the bendable portion 244 can distally extend out of distal end 214, and terminate with corresponding beads 246.

[0143] An atraumatic tip 246 defines at least a first curved surface portion 248 oriented in a distal direction. In some examples, the first curved surface portion 248 is a curved surface oriented both in the distal direction and radially outwards from the central longitudinal axis CA. In some examples, the atraumatic tip 246 further defines a second curved surface portion 249 oriented in a proximal direction. In some examples, the second curved surface portion 249 is generally opposite to the first curved surface portion 248. In some examples, the second curved surface portion 249 is a curved surface oriented both in the proximal direction and radially inwards, towards the central longitudinal axis CA.Attorney Docket No: THVDL-23864WO01

[0144] In some examples, an atraumatic tip 246 comprises a bead having spherical, ovoid, or semi-spherical shape. When the atraumatic tip 246 is implemented as a bead 246, the first curved surface portion 248 and the second curved surface portion 249 can be continuous portions of a generally spherical outer surface of the bead 246.

[0145] It is to be understood that spherical (or bead-like) atraumatic tips 246 are illustrated in Figs. 5-7E and described herein with respect to Figs. 5-7E by way of example only, and that any reference to beads 246 herein similarly refers to any implementation of atraumatic tips 246 which can be otherwise- shaped to have non-spherical configuration, for example, but defining a first curved surface portion 248 and in some example, an optional second curved surface portion 249.

[0146] In some examples, the bendable portion 244 is a flexible portion of the atraumatic flexible member 240, configured to allow for radial movement of the bead 246 towards and away from the central longitudinal axis CA of the outer shaft 208.

[0147] In some examples, the bendable portion 244 is further configured to function as a biasing portion of the atraumatic flexible member 240, configured to bias the bead 246 to a free state of the atraumatic flexible member 240, defined as the state of the atraumatic flexible member 240 when not subjected to forces configured to push the bead 246 radially inwards or outwards. In some examples, the bendable portion 244 comprises a shape-memory material, such as Nitinol, which can be optionally shape set to bias the bead 246 to the free state, optionally biasing the bead 246 radially inwards.

[0148] In some examples, the bendable portion 244 is an integral portion of the extension 242, such that the entire extension can comprise a shape memory material (e.g., Nitinol), wherein only the bendable portion can be optionally shape-set. In some examples, the extension, bendable portion 244, and bead 246, are integrally formed, collectively defining a unitary component.

[0149] In some examples, the extension 242 can be defined as the portion of the atraumatic flexible member 240 which is embedded in the distal portion 211 of the outer shaft 208, while the bendable portion 244 and the bead 246 extend out of the distal portion 211. In some examples, the extension 242 is longer than the bendable portion 244. The extension 242 can be relatively elongated to improve securement to the distal portion 211 of the outer shaft 208. The bendable portion 244 can be significantly shorter, having a length sufficient to allow it to radially bend so as to allow radial movement of the bead 246 towards and away from the central axis CA, yet not too long so as to keep the bead 246 in close proximity to the distal end 214 of the outer shaft 208.Attorney Docket No: THVDL-23864WO01

[0150] A delivery apparatus 200 can generally include a primary extendable device configured to extend through, and is axially movable relative to, the outer shaft, such that a distal end of the primary extendable device can be either distal to the distal end 214 of the outer shaft, or positioned inside the outer shaft lumen 210, such as by being axially aligned with, or positioned proximal to, the distal end 214 of the outer shaft 208. A delivery apparatus 200 can optionally further comprise one or more secondary extendable devices configured to extend through, and axially movable relative to, the primary extendable device. When several devices are extendable through the outer shaft, such as a primary extendable device and one or more secondary extendable devices, the primary extendable device will define the largest outer diameter, thereby being also the closest to the inner surface 217 of the outer shaft 208.

[0151] In the example illustrated in Fig. 5, the primary extendable device is the anchor device 229, and the distal end of the primary extendable device is the anchor tip 254. Any of the components or shafts extendable through the anchor shaft lumen 232 can be considered as secondary extendable devices. For example, any of the delivery shaft 218, dilator 280, balloon catheter 290, and / or needle 270, can be termed to serve as optional secondary extendable devices which are extendable through the anchor device.

[0152] The atraumatic flexible members 240 are movable between a first configuration and a second configuration. Optional additional configurations of the atraumatic flexible members 240, such as a third configuration, are also contemplated. Figs. 6A-6C illustrate different configuration of the atraumatic flexible members 240 corresponding to optional states of the apparatus 200 of Fig. 5.

[0153] Fig. 6A shows a first configuration of the atraumatic flexible members 240, achieved when the distal end of the primary extendable device is at or proximal to the distal end 214 of the outer shaft. Stated differently, the atraumatic flexible members 240 are in the first configuration when the distal end of the primary extendable device (e.g., the anchor tip 254 of the anchor device 229) is maintained inside the outer shaft lumen 210. This state of the apparatus 200 can be assumed, for example, during advancement of the apparatus 200 through a patient’s vasculature towards the target site of treatment, wherein the anchor head 250 is concealed inside the outer shaft lumen 210 such that the anchor tip 254 does not extend past the distal end 214 of the outer shaft 208, in a manner somewhat similar to that illustrated for the relative positions of the anchor head 250 and the outer shaft 208 in Fig. 5, for example. In some examples, the anchor tip 254 is axially aligned with, or is proximal to, the distal end 214 of the outer shaft 208 during delivery.Attorney Docket No: THVDL-23864WO01

[0154] While an optional dilator 280 is shown to at least partially extend distally past the distal end 214 of the outer shaft 208 in Figs. 6A-6C, it is to be understood that this is shown by way of illustration and not limitation, and that other positions of an optional dilator 280 are contemplated. Moreover, in some examples, a delivery apparatus 200 can be devoid of a dilator or hole-dilating balloon.

[0155] While a distal portion 222 of an optional delivery shaft 218 is shown to be axially aligned with, or even at least partially extend distally from, the distal end 214 of the outer shaft 208 in Fig. 6A, it is to he understood that this is shown by way of illustration and not limitation, and that other positions of the delivery shaft 218 are contemplated. Moreover, in some examples, a delivery apparatus 200 can be devoid of the delivery shaft 218.

[0156] The atraumatic flexible members are shown in Fig. 6A to extend, in the first configuration, distally from the distal portion 211 of the outer shaft 208, such that the beads 246, positioned in front (e.g., distal to) the distal end 214, sufficiently conceal the distal end 214 so as to prevent the distal end 214 from being able to directly contact surfaces surrounding the distal portion 211, such as anatomical surfaces of blood vessels and / or an inner surface of an introducer sheath that can be used to deliver the apparatus 200 into and through the patient's body.

[0157] In some examples, the atraumatic flexible members 240 are in their free state in the first configuration. In some examples, the atraumatic flexible members 240 are biased radially inwards in the first configuration. In some examples, the bendable portions 244 are linear or straight (e.g., parallel to the central axis CA) in the first configuration. In some examples, the bendable portions 244 are inwardly bent (e.g., towards the central axis CA) in the first configuration.

[0158] In some examples, a secondary extendable device of the apparatus 200 can extend past the distal end 214 of the outer shaft 208 while the distal end of the primary extendable device is proximal to the distal end 214, such that a gap is formed at the distal end 214 between the inner surface 217 of the distal portion 211 and the secondary extendable device. In some examples, the atraumatic flexible members 240 are positioned, in the first configuration, in front of (e.g., distal to) such a gap, and can optionally conceal at least 50% of the area of the gap-

[0159] In some examples, a secondary extendable device in the form of the delivery shaft 218 extends through the distal end 214, such that the delivery shaft distal end 224 can be optionally positioned at or distal to the distal end 214, while the anchor tip 254 remains proximal to the distal end 214, as illustrated in Fig. 6A. A gap formed at the distal end 214 between the deliveryAttorney Docket No: THVDL-23864WO01 shaft 218 (such as its distal portion 222 as illustrated in Fig. 6A, or any other portion of delivery shaft 218) and the inner surface 217 of the outer shaft 208, and the beads 246 are shown to circumscribe and optionally abut or contact the delivery shaft 218, in front of this gap. In some examples, the bendable portions 244 can be configured to bias the beads 246 radially inwards in the first configuration, against a secondary extendable device, such as the delivery shaft 218.

[0160] In some examples, a secondary extendable device in the form of the dilator 280 extends through the distal end 214, such that the dilator distal end 282 can be optionally positioned distal to the distal end 214, while the anchor tip 254 remains proximal to the distal end 214. The dilator 280 can be exposed, at the axial position of the distal end 214, to the distal end 214, without being covered at this position by another secondary extendable device. For example, the apparatus 200 can be devoid of a delivery shaft 218, or a delivery shaft 218 of the apparatus 200 can terminate proximal to the distal end 214, forming a gap at the distal end 214 between the dilator 280 (such as its tapering portion 284) and the inner surface 217 of the outer shaft 208, wherein the beads 246 can circumscribe and optionally abut or contact the dilator 280, in front of such a gap. In some examples, the bendable portions 244 can be configured to bias the beads 246 radially inwards in the first configuration, against a secondary extendable device, such as the dilator 280.

[0161] In some examples, when the atraumatic flexible members 240 are in the first configuration, the beads 246 are configured to extend radially outwards past the outer surface 215 of the distal portion 211, and to extend radially inwards past the inner surface 217 of the distal portion 211 of the outer shaft 208. In some examples, when the atraumatic flexible members 240 are in the first configuration, the beads 246 are configured to extend radially inwards past an outer surface of the primary extendable device, such as past an outer surface 258 of the anchor head 250.

[0162] Fig. 6B shows a second configuration of the atraumatic flexible members 240, achieved when the distal end of the primary extendable device is distal to the distal end 214 of the outer shaft. Stated differently, the atraumatic flexible members 240 are in the second configuration when a distal portion of the primary extendable device (e.g., an anchor head 250 of the anchor device 229) extends at least partially through the distal end 214 of the outer shaft 208, such that a distal end of the primary extendable device (e.g., anchor tip 254) is distal to the distal end 214 of the outer shaft 208. This state of the apparatus 200 can be assumed, for example, during advancement of the primary extendable device (e.g., anchor device 229) out of the outer shaft 208, optionally when positioned at or proximate to the target site of treatment (e.g., host leaflet 10 of host valvular structure 12).Attorney Docket No: THVDL-23864WO01

[0163] When the atraumatic tips 246 extend radially inwards, in the first configuration, past the outer surface 258 of the anchor head 250, advancement of the anchor head 250 through and out of the outer shaft 208 will cause the anchor head 250 to contact and push against the atraumatic tips 246. In some examples, the atraumatic tips 246 can slide over the distal end of the anchor head 250 when the anchor head 250 is pushed against the beads 246. Optionally, curved surfaces of some exemplary atraumatic tips 246 can facilitate such sliding motion, though it is understood that some exemplary tips 246 can be otherwise shaped while still being able to slide over a primary extendable device pushed there-against. Moreover, since the bendable portions 244 are flexible, they can be forced to flex radially outwards by the anchor head 250, enabling the atraumatic tips 246 (which can be spherical or otherwise shaped) to be pushed radially outwards to allow undisturbed axial advancement of the anchor head 250 past the atraumatic tips 246, as shown in Fig. 6B.

[0164] Thus, in the second configuration of the atraumatic flexible members 240, the atraumatic tips 246 are positioned radially farther from the central longitudinal axis CA, relative to their positions in the first configuration.

[0165] In some examples, the outer diameter of a distal portion of the primary extendable device can be larger than the remainder of the primary extendable device. For example, the anchor device 229 is shown in Fig. 5 to include an anchor head defining an outer diameter greater than that of the anchor shaft 230. In such examples, the second configuration can be achieved when the larger-diameter distal-portion of the primary extendable device, such as the anchor head 250, is axially aligned with the distal end 214 of the outer shaft 208, but did not fully extend out of the outer shaft 208 yet, as shown in Fig. 6B for example.

[0166] While the first curved surface portions 248 of atraumatic tips 246, such as beads 246, are generally oriented towards the surrounding walls, such as anatomical walls of blood vessels to protect them from being directly engaged by the distal end 214 of outer shaft 208, the second curved surface portions 249 can optionally serve a different purpose, such as being configured to be engaged by a distal end of the anchor head 250, such that when the anchor head 250 (or a distal portion of a different primary extendable device) is advanced out of the outer shaft lumen 210, it can slide along the second curved surface portions 249 to easily push the atraumatic tips 246 (e.g., beads 246) radially outwards.

[0167] An optional third configuration of the atraumatic flexible members 240 can be achieved once the anchor head 250 is fully extended out of the outer shaft lumen 210 (e.g., such that the anchor proximal end 266 is distal to the distal end 214 of the outer shaft 208), and the anchor shaft 230 extends through the distal end 214, as shown in Fig. 6C. Since the anchor shaft 230Attorney Docket No: THVDL-23864WO01 is shown to define a smaller outer diameter, the beads 246 can optionally be biased radially inwards so as to contact or abut the anchor shaft 230. Thus, in an optional third configuration of the atraumatic flexible members 240, the beads 246 are positioned radially closer the central longitudinal axis CA, relative to their positions in the second configuration. In this manner, the beads 246 can at least partially conceal an optional gap that can be formed between the anchor shaft 230 and the distal end 214 of the outer shaft 208. The radial position of the beads 246 in the third configuration can be either similar to, or different from, their radial position in the first configuration.

[0168] Figs. 7A-7E illustrate some steps in an exemplary method for utilizing a delivery apparatus 200 for forming a tissue opening 52 in a target tissue. An exemplary implementation of the method is illustrated in Figs. 7A-7E with respect to forming a leaflet opening 52 inside a host leaflet, which can optionally be performed prior to implanting a guest prosthetic valve inside the host valvular structure. The delivery apparatus 200 can optionally be used to perforate a host leaflet 10, such as a native leaflet 30 or a prosthetic valve leaflet 114 of a previously implanted prosthetic valve.

[0169] The distal portion 211 of the apparatus 200 is configured to be inserted into a patient’s vasculature, such as within an ascending aorta, and to be advanced towards the host leaflet 10. Positioning the distal end 214 of the outer shaft 208 relative to the host leaflet 10, may comprise advancing the outer shaft 208 toward the leaflet over the guidewire 80.

[0170] When an apparatus 200 includes an additional lacerating member optionally extendable through a dilator lumen 288, such as a needle 270, the needle lumen 272 can be configured to accommodate a guidewire 80 that can extend through the needle lumen 272. In such examples, the guidewire 80 can be inserted into the patient’s vasculature, and then the needle 270 and / or other shafts or tubes of the apparatus 200 may be advanced toward the host leaflet 10 over the guidewire 80.

[0171] During delivery, the distal portion of the primary extendable device of apparatus 200, such as the anchor head 250, is retained inside the outer shaft lumen 210 such that the sharp anchor tip 254 is at or proximal to the distal end 214 of the outer shaft 208, as illustrated in Fig. 7A. As explained above, this position conceals the sharp tip of the anchor head 250 from the surrounding anatomy, to protect the anatomical structures from being engaged or punctured by the sharp anchor tip 254 during advancement towards the site of treatment. When used in combination with a needle 270, the needle head 274 can be optionally retained inside the dilator lumen 288, such that the sharp needle tip 278 is at or proximal to the dilator distal end 282, as also illustrated in Fig. 7A. This position conceals the sharp tip of the needle 270 from theAttorney Docket No: THVDL-23864WO01 surrounding anatomy, to similarly protect the anatomical structures from being engaged or punctured by the sharp needle tip 278 during advancement towards the site of treatment.

[0172] The delivery shaft 218 can be mostly or entirely retained inside the outer shaft 208, for example such that the delivery shaft distal portion 222 is retained inside the outer shaft lumen 210, optionally with the delivery shaft end 224 positioned distally to the sharp anchor tip 254 as shown in Fig. 7A.

[0173] As further shown in Fig. 7A, the atraumatic flexible members 240 are maintained in the first configuration during delivery towards the target site of treatment, such as host valvular structure 12, protecting the surrounding anatomical walls from being directly contacted and / or scraped by the distal end 214 of the outer shaft 208 during advancement thereof.

[0174] Prior, or simultaneously with, advancement of the helical anchor head 250 towards the host leaflet 10, optionally exposing it out of the outer shaft lumen 210 (e.g., out of an optional capsule 212), the delivery shaft 218 can be distally advanced, relative to the balloon catheter 290, closer to, and optionally up to contact or close proximity with, the host leaflet 10, as shown in Fig. 7B.

[0175] The anchor device 229 can be axially translated in a distal direction, subsequent to or simultaneously with advancement of the delivery shaft 218, for example to expose the anchor head 250 out of the outer shaft lumen 210 (e.g., out of an optional capsule 212) and position the anchor tip 254 in closer proximity to the host leaflet 10.

[0176] As shown in Fig. 7B, when the anchor head 250 begins to extend through the distal end 214 of the outer shaft 208, the atraumatic flexible members 240 are moved from the first configuration to the second configuration, outwardly bending the bendable portions 244 to displace the beads 246 radially outwards, as described above with respect to Fig. 6B for example. Further advancement of the anchor device such that the anchor shaft 230, optionally having a smaller outer diameter than that of the anchor head 250, extends through the distal end 214 of the outer shaft 208, can allow the atraumatic flexible members 240 to move to the third configuration, displacing the beads radially inwards against the anchor shaft 230 as shown in Fig. 7C, in a similar manner to that described above with respect to Fig. 6C for example.

[0177] The anchor shaft 230 is then rotated in a first rotation direction around the central axis CA, rotating the helical anchor head 250 therewith, causing it to engage and penetrate the host leaflet 10, thereby securing the helical anchor head 250 to host leaflet 10 as shown in Fig. 7C. The tissue material of host leaflet 10 can be retained within helical slot 260, between successive helical turns 256 of the anchor head 250.Attorney Docket No: THVDL-23864WO01

[0178] For optional instances in which a delivery shaft 218 is distally advanced up to contact with the host leaflet 10 prior to anchoring of the anchor head 250 into the leaflet 10, as illustrated in Figs. 7B-7C, the delivery shaft 218 can apply a limited extent of a distally oriented push-force against the host leaflet 10, during extension of the anchor head 250 distally and rotatably into the host leaflet 10 to anchor against the host leaflet 10. The delivery shaft 218, in such examples, can provide an internal support structure over which the anchor head 250 can be advanced and anchored into the leaflet 10, in a manner that increases stability of the leaflet for improved engagement with the helical anchor head 250 as it is being screwed thereinto.

[0179] A perforating member, such as a needle 270, can be then distally advanced to puncture the host leaflet 10 to form a pilot puncture 50 within host leaflet 10 as also shown in Fig. 7C, for example when the needle head 274 is axially translated relative to anchor device 229 and / or dilator 280, wherein the helical anchor head 250 serves to capture and stabilize the host leaflet 10 during formation of a pilot puncture 50 by the needle 270.

[0180] Once the needle head 274 is positioned, at least partially, past the host leaflet 10, the guidewire 80 can be optionally advanced through the needle lumen 272 to terminate with guidewire tip 82 at a position distal to the pilot puncture 50 of host leaflet 10.

[0181] Subsequent to forming the pilot puncture 50 and optionally advancing the guidewire 80, the dilator 280 can be inserted into the pilot puncture 50 to expand the pilot puncture 50. As the dilator 280 is inserted into the host leaflet 10, the inherent resiliency of the leaflet 10 may urge the leaflet 10 radially inwardly against the dilator 280. Advantageously, keeping the helical anchor head 250 engaged with the host leaflet 10, while the dilator 280 is passed through the anchor channel 252, provides adequate counter force that facilitates passage of the dilator 280 through the pilot puncture 50, wherein the gradually tapering shape of the dilator 280 can expand the pilot puncture 50 to a greater diameter.

[0182] The needle head 274 can be re-concealed within dilator lumen 288, such as due to advancement of dilator 280 in a distal direction over the needle head 274, and / or retraction of needle 270 such that the sharp needle tip 278 is at or proximal to the dilator distal end 282, to avoid damage that may be caused to internal anatomical structures of the patient’ s body due to accidental contact with the sharp needle tip 278.

[0183] In some examples, the guidewire 80 can be advanced simultaneously with advancement of the needle 270 during formation of the pilot puncture 50. In some examples, the guidewire 80 can be advanced to terminate distal to the host leaflet 10 after formation of the pilot puncture 50 by the needle 270. In some examples, the guidewire 80 can be advanced to terminate distalAttorney Docket No: THVDL-23864WO01 to the host leaflet 10 prior to advancement of the dilator 280 through the pilot puncture 50. In some examples, the guidewire 80 can be advanced simultaneously with advancement of the dilator 280 into and through the pilot puncture 50 after formation of the pilot puncture 50 by the needle 270.

[0184] In some examples, the needle 270 can be retracted back into dilator lumen 288 prior to advancement of the dilator 280 into pilot puncture 50, in which case the dilator 280 can be guided through the pilot puncture 50 of host leaflet 10 over a guide wire 80 distally advanced into and through pilot puncture 50, optionally prior to retraction of the needle 270.

[0185] Prior to advancement of the balloon catheter 290 to position the hole-dilating balloon 296 inside the pilot puncture 50, the anchor shaft can be rotated in the second rotational direction, so as to release the helical anchor head 250 from the host leaflet 10, which can be then retracted back into the capsule 212 by being axially pulled away from the host leaflet 10. Advantageously, the delivery shaft 218 protects the hole-dilating balloon 296 from being contacted by the sharp anchor tip 254 during retraction of the helical anchor head 250.

[0186] After proximally pulling the helical anchor head 250 to a position proximal to the holedilating balloon 296, optionally inside the outer shaft lumen 210 (e.g., out of an optional capsule 212), such that it no longer poses a risk of engaging with the balloon 296, the delivery shaft 218 is proximally pulled relative to the balloon catheter 290, so as to expose the holedilating balloon 296 as shown in Fig. 7D.

[0187] The anchor head 250 can be optionally re-inserted into the outer shaft lumen 210, as shown in Fig. 7D, during retraction from the host leaflet 10. As the anchor head 250 is proximally passed through the distal end 214 of the outer shaft 208, the beads 246 can be optionally pushed thereby radially outwards, moving the atraumatic flexible members 240 back to the second configuration. When the anchor head 250 is fully retracted back into the outer shaft lumen 210, such that the anchor tip 254 is at or proximal to the distal end 214, the beads 246 can optionally move radially inwards, moving the atraumatic flexible members 240 back to the first configuration, wherein the beads 246 can be optionally pressed against or otherwise biased towards a secondary extendable device that can extend through the distal end 214, such as a delivery shaft 218 or a balloon catheter 290 (as shown, for example, in Fig. 7D).

[0188] In a subsequent step of the method, as shown in Fig. 7D, the hole-dilating balloon 296 may be inserted within the pilot puncture 50, such as by further advancement of the dilator 280 with dilator shaft 298 and / or balloon catheter 290. With the hole-dilating balloon 296 received within the pilot puncture 50, inflating the hole-dilating balloon 296 to transition it from a radially deflated state (Fig. 7D) to a radially inflated state (Fig. 7E) can expand the pilotAttorney Docket No: THVDL-23864WO01 puncture 50 to form a leaflet opening 52 that is sized to receive the prosthetic valve 100 in the radially compressed or crimped configuration. After the hole-dilating balloon 296 is inflated to form the leaflet opening 52 as shown in Fig. 7E, the balloon 296 is deflated, optionally allowing for insertion of a guest prosthetic valve inside the leaflet opening 52.

[0189] While an exemplary apparatus 200 is described above and illustrated in Figs. 5-7E to include the balloon catheter 290 and hole-dilating balloon 296, it is to be understood that a delivery apparatus 200 disclosed herein can be provided without the balloon catheter 290 and hole-dilating balloon 296. For example, a delivery apparatus 200 can include an expansion member, such as a hole-dilating balloon 296 mounted on a balloon catheter 290, provided as a separate apparatus or sub-assembly that can be advanced over the guidewire 80 towards the pilot puncture 50 formed in host leaflet 10.

[0190] While a hole-dilating balloon 296 is described above and illustrated for expanding a pilot puncture 50 to form a leaflet opening 52, it is to be understood that other types of expansion members can be used instead of a balloon in any of the methods and / or systems described herein. For example, U.S. Provisional Application No. 63 / 335,739, which is incorporated herein by reference in its entirety, describes an expandable frame that can be used as an expansion member 296 instead of a hole-dilating balloon.

[0191] An exemplary apparatus 200 disclosed herein may be configured to form the leaflet opening 52 in any of a variety of host valvular structures 12. In the example of Figs. 7A-7E, the host valvular structure 12 can be the valvular structure 113 of a previously implanted prosthetic valve, such as the prosthetic valve 100a of Fig. 3. In such examples, using an apparatus 200 as described herein to form the leaflet opening 52 in a previously implanted prosthetic valve may be followed by steps for implanting a guest prosthetic valve 100b within the previously implanted prosthetic valve 100a (for example, via a ViV procedure).

[0192] Similarly, the host valvular structure 12 can be a valvular structure 29 of a native heart valve, such as the native aortic valve 20 shown in Figs. 2A-2B. In such examples, the apparatus 200 can be configured to puncture a native leaflet 30 of the native aortic valve 20. In some examples, the host valvular structure and / or the native valve may refer to another valve of a patient’s heart, such as a mitral valve, a pulmonary valve, or a tricuspid valve.

[0193] While illustrated and described above with respect to forming a leaflet opening 52 within a host leaflet 10, it is to be understood that an exemplary apparatus 200 disclosed herein may be configured to form a tissue opening through other tissues in a patient’s body. For example, prosthetic devices can be delivered to the left atrium or the left ventricle in a transseptal approach, wherein an apparatus 200 is passed through the vena cava, into the rightAttorney Docket No: THVDL-23864WO01 atrium, and through the interatrial septum tissue. Such delivery approaches require puncturing the interatrial septum. Thus, in some examples, an apparatus 200 may be utilized to form an opening through the interatrial septum, for example at the site of the fossa ovalis, which is a region of the septum containing tissue of lesser thickness than is typical of the rest of the septum. Thus, any example of an apparatus 200 described herein can be utilized in a manner similar to that described with respect to Figs. 7A-7E, or modifications thereof, to form a tissue opening, equivalent to leaflet opening 52 described with respect to Figs. 7A-7E, in a target tissue, equivalent to a host leaflet 10 described with respect to Figs. 7A-7E.

[0194] In some examples, some or all of the components of any exemplary apparatus 200 described herein can be part of a delivery assembly that includes a delivery apparatus carrying a prosthetic valve (examples not shown explicitly). Similarly, an apparatus 200 according to any example of the current disclosure, can be used for implantation of other prosthetic devices aside from prosthetic valves, such as stents or grafts.

[0195] A delivery apparatus 200 can be part of an assembly utilized, for example, to deliver a prosthetic aortic valve for mounting against the native aortic annulus or against a prosthetic valve previously implanted in a native aortic valve, to deliver a prosthetic mitral valve for mounting against the native mitral annulus or against a prosthetic valve previously implanted in a native mitral valve, or to deliver a prosthetic valve for mounting against any other native annulus or against a prosthetic valve previously implanted in any other native valve.

[0196] In some examples, after forming the leaflet opening 52, and optionally after deflating the hole-dilating balloon 296, a guest prosthetic valve 100 can be positioned in the valvular structure 12 in a compressed state thereof, and expanded therein to implant the guest prosthetic valve 100 inside the host valvular structure.

[0197] In some examples, retraction of the expansion member, such as a hole-dilation balloon 296, after deflation thereof, can be performed while the guidewire 80 may be kept in position, extending through the leaflet opening 52. Subsequent to recompressing the expansion member 296 inside the leaflet opening 52 and retracting it away from the host leaflet 10, the method can further include steps of positioning a guest prosthetic valve 100 inside the leaflet opening 52.

[0198] Fig. 8 shows a guest prosthetic valve 100 positioned, in a radially compressed configuration thereof, inside the leaflet opening 52. The guest prosthetic valve 100 can be mounted on a replacement valve delivery assembly 302 that can be advanced towards the host leaflet 10 over the guidewire 80.Attorney Docket No: THVDL-23864WO01

[0199] In some examples, the guest prosthetic valve is a balloon expandable valve, and the replacement valve delivery assembly 302 comprises a balloon catheter 304 carrying a valveexpanding balloon 306. In contrast to some examples of a hole-dilating balloon 296 described above, such as a hole-dilating balloon 296 configured to form a leaflet opening 52 without tearing the host leaflet, the maximum diameter to which a valve-expanding balloon 306 can be inflated can optionally be, in some examples, greater than 18 mm., greater than 20 mm., greater than 23 mm., greater than 26 mm., and / or greater than 29 mm.

[0200] While a replacement valve delivery assembly 302 equipped with a valve-expanding balloon 306 at a distal end portion of a balloon catheter 304 is illustrated in Fig. 8, it is to be understood that this is shown by way of illustration and not limitation, and that a replacement valve delivery assembly 302 can include other shafts and / or mechanisms, for example when utilized to advance and expand other types of replacement prosthetic valves, such as selfexpandable prosthetic valves or mechanically expandable prosthetic valves.

[0201] As shown in Fig. 8, the guest prosthetic valve 100 is placed in the leaflet opening 52 in its radially compressed configuration, optionally positioned over a deflated valve-expanding balloon 306 in the case of a balloon-expandable prosthetic valve. With the prosthetic valve 100 received within the leaflet opening 52, radially expanding the guest prosthetic valve 100 can serve to increase a size of the leaflet opening 52 and / or to tear the leaflet. As a result, radially expanding the guest prosthetic valve 100 can serve to modify the host leaflet 10 such that the leaflet does not obstruct a cell opening 112 in a frame 102 of the guest prosthetic valve 100 or at least increases the area of the host valve and the guest valve that is not covered or obstructed by the modified host leaflet to permit access and sufficient perfusion to the adjacent coronary artery. For example, radially expanding the guest prosthetic valve within the leaflet opening 52 can operate to push a portion of the leaflet extending radially exterior of the guest prosthetic valve below an upper edge of an outer skirt of the guest prosthetic valve 100 and / or away from one or more cell openings 112 of the guest prosthetic valve 100.

[0202] In some examples, the guest prosthetic valve can be a mechanically-expandable prosthetic valve and radial expansion thereof can be achieved by actuating a mechanical actuator of the guest prosthetic valve to mechanically expand a frame of the guest prosthetic valve. In some examples, the guest prosthetic valve can be a self-expandable prosthetic valve that can be retained during delivery toward the host valvular structure in a capsule or other restraint disposed therearound, and valve expansion can be achieved by removing the capsule or other restraint from the guest prosthetic valve to allow it to radially self-expand within the host valvular structure.Attorney Docket No: THVDL-23864WO01

[0203] Any of the systems, devices, apparatus, 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

[0204] 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 taken in combination and, optionally, in combination with one or more features of one or more examples below are examples also falling within the disclosure of this application.

[0205] Example 1. A delivery apparatus comprising: an outer shaft comprising: an outer shaft lumen defining a central longitudinal axis; and a distal portion terminating at a distal end; a primary extendable device extendable through the outer shaft, the primary extendable device comprising a distal portion terminating at a distal end; and a plurality of atraumatic flexible members disposed around a circumference of the distal portion of the outer shaft, each of the atraumatic flexible members comprising: an extension extending along at least part of, and affixed to, the distal portion of the outer shaft; an atraumatic tip positioned distal to the distal end of the outer shaft, the atraumatic tip defining a first curved surface portion oriented in a distal direction; and a bendable portion extending between the extension and the atraumatic tip; wherein the atraumatic flexible members are configured to move between a first configuration and a second configuration, such that the atraumatic tips are positioned, in the second configuration, radially outwards relative to their radial position in the first configuration.

[0206] Example 2. The apparatus of any example herein, particularly of example 1, wherein the primary extendable device is axially movable relative to the outer shaft.

[0207] Example 3. The apparatus of any example herein, particularly of any one of examples 1-2, wherein the atraumatic flexible members are configured to be maintained in the first configuration when the distal end of the primary extendable device is at or proximal to the distal end of the outer shaft.

[0208] Example 4. The apparatus of any example herein, particularly of example 3, wherein the atraumatic flexible members are configured to move to the second configuration when the distal end of the primary extendable device is distally advanced out of the outer shaft.Attorney Docket No: THVDL-23864WO01

[0209] Example 5. The apparatus of any example herein, particularly of any one of examples 1-4, wherein, when the atraumatic flexible members are in the second configuration, the distal end of the primary extendable device is distal to the distal end of the outer shaft.

[0210] T Example 6. he apparatus of any example herein, particularly of any one of examples 1-5, wherein movement of the atraumatic flexible members from the first configuration to the second configuration comprises moving the atraumatic tips radially away from the central longitudinal axis.

[0211] Example 7. The apparatus of any example herein, particularly of any one of examples 1-6, wherein the bendable portions comprise a flexible material configured to flex in a radial direction.

[0212] Example 8. The apparatus of any example herein, particularly of any one of examples 1-7, wherein movement of the atraumatic flexible members from the first configuration to the second configuration comprises bending the bendable portions radially outwards.

[0213] Example 9. The apparatus of any example herein, particularly of any one of examples 1-8, wherein a push force applied by the distal portion of the primary extendable device is configured to move the atraumatic flexible members from the first configuration to the second configuration.

[0214] Example 10. The apparatus of any example herein, particularly of any one of examples 1-9, wherein the atraumatic tips extend radially outwards, in the first configuration, past an outer surface of the distal portion of the outer shaft.

[0215] Example 11. The apparatus of any example herein, particularly of any one of examples 1-10, wherein the atraumatic tips extend radially inwards, in the first configuration, past an inner surface of the distal portion of the outer shaft.

[0216] Example 12. The apparatus of any example herein, particularly of any one of examples 1-11, wherein the first curved surface portion is further oriented radially outwards.

[0217] Example 13. The apparatus of any example herein, particularly of any one of examples 1-12, wherein each atraumatic tip further comprises a second curved surface portion, oriented in a proximal direction.

[0218] Example 14. The apparatus of any example herein, particularly of example 13, wherein the second curved surface portion is further oriented radially inwards.

[0219] Example 15. The apparatus of any example herein, particularly of any one of examples 13-14, wherein the second curved surface portion is opposite to the first curved surface portion.

[0220] Example 16. The apparatus of any example herein, particularly of any one of examples 1-15, wherein each atraumatic tip comprises a bead.Attorney Docket No: THVDL-23864WO01

[0221] Example 17. The apparatus of any example herein, particularly of any one of examples 1-16, wherein each atraumatic tip is spherical.

[0222] Example 18. The apparatus of any example herein, particularly of any one of examples 13-15, wherein the first curved surface portion and the second curved surface portion are continuous portions of a spherical outer surface of the atraumatic tip.

[0223] Example 19. The apparatus of any example herein, particularly of any one of examples 1-18, wherein the extension and the bendable portion are integrally formed.

[0224] Example 20. The apparatus of any example herein, particularly of any one of examples 1-19, wherein the bendable portions are configured to radially bias the atraumatic tips.

[0225] Example 21. The apparatus of any example herein, particularly of example 20, wherein the bendable portions are configured to bias the atraumatic tips radially inwards.

[0226] Example 22. The apparatus of any example herein, particularly of any one of examples 1-19, wherein the bendable portions comprise a shape- memory material.

[0227] Example 23. The apparatus of any example herein, particularly of example 22, wherein the shape-memory material comprises Nitinol.

[0228] Example 24. The apparatus of any example herein, particularly of any one of examples 1-23, wherein the atraumatic tip and the bendable portion are integrally formed.

[0229] Example 25. The apparatus of any example herein, particularly of any one of examples 1-24, wherein the distal end of the primary extendable device comprises a sharp tip.

[0230] Example 26. The apparatus of any example herein, particularly of any one of examples 1-25, wherein the primary extendable device comprises an anchor device, wherein the distal portion of the primary extendable device comprises an anchor head, and wherein the distal end of the primary extendable device comprises an anchor tip.

[0231] Example 27. The apparatus of any example herein, particularly of example 26, wherein the anchor device further comprises an anchor shaft proximally extending from the anchor head.

[0232] Example 28. The apparatus of any example herein, particularly of example 27, wherein an outer diameter of the anchor device is greater than an outer diameter of the anchor shaft.

[0233] Example 29. The apparatus of any example herein, particularly of example 28, wherein, when the anchor tip is distal to the distal end of the outer shaft, and a proximal end of the anchor head is proximal to the distal end of the outer shaft, the atraumatic flexible members are in the second configuration.

[0234] Example 30. The apparatus of any example herein, particularly of example 29, wherein the atraumatic flexible members are further configured to move from the second configurationAttorney Docket No: THVDL-23864WO01 to a third configuration, such that the atraumatic tips are positioned, in the third configuration, radially inwards relative to their radial position in the second configuration.

[0235] Example 31. The apparatus of any example herein, particularly of example 30, wherein, when the proximal end of the anchor head is distal to the distal end of the outer shaft, the atraumatic flexible members are in the second configuration.

[0236] Example 32. The apparatus of any example herein, particularly of any one of examples 1-31, further comprising one or more secondary extendable devices extendable through the primary extendable device.

[0237] Example 33. The apparatus of any example herein, particularly of any one of examples 26-31, further comprising a needle extending through, and axially movable relative to, the anchor device.

[0238] Example 34. The apparatus of any example herein, particularly of example 33, wherein the needle further comprises a needle head terminating at a needle tip.

[0239] Example 35. The apparatus of any example herein, particularly of any one of examples 33-34, further comprising an expansion member movable between a compacted state and an expanded state.

[0240] Example 36. The apparatus of any example herein, particularly of example 35, wherein the anchor device and the expansion member are axially movable relative to each other.

[0241] Example 37. The apparatus of any example herein, particularly of any one of examples 35-36, wherein the expansion member is a balloon mounted on a balloon catheter, wherein the compacted state of the expansion member is a deflated state of the balloon, and wherein the expanded state of the expansion member is an inflated state of the balloon.

[0242] Example 38. The apparatus of any example herein, particularly of example 37, further comprising a dilator attached to a dilator shaft extending proximally therefrom through the balloon catheter.

[0243] Example 39. The apparatus of any example herein, particularly of example 38, wherein the dilator comprises a dilator tapering portion.

[0244] Example 40. The apparatus of any example herein, particularly of any one of examples 38-39, wherein the needle extends through a dilator lumen collectively defined by the dilator and the dilator shaft.

[0245] Example 41. The apparatus of any example herein, particularly of any one of examples 37-40, wherein the balloon catheter is extendable through the anchor device.Attorney Docket No: THVDL-23864WO01

[0246] Example 42. The apparatus of any example herein, particularly of any one of examples 37-41, further comprising a delivery shaft disposed between the anchor device and the balloon catheter.

[0247] Example 43. The apparatus of any example herein, particularly of example 42, wherein the anchor device and the delivery shaft are axially movable relative to each other.

[0248] Example 44. A method comprising: advancing a delivery apparatus, over a guidewire, towards a target site of treatment, wherein the delivery apparatus comprises an outer shaft and a plurality of atraumatic flexible members affixed to a distal portion of the outer shaft and comprising a plurality of atraumatic tips disposed distal to a distal end of the outer shaft; and moving the atraumatic flexible members from a first configuration to a second configuration in which the atraumatic tips are positioned radially outwards relative to their radial position in the first configuration, by distally advancing a distal portion of a primary extendable device through the distal end of the outer shaft.

[0249] Example 45. The method of any example herein, particularly of example 44, wherein each of the atraumatic flexible members comprises an extension extending along at least part of, and affixed to, the distal portion of the outer shaft.

[0250] Example 46. The method of any example herein, particularly of example 45, wherein each of the atraumatic flexible members further comprises a bendable portion extending between the extension and the atraumatic tip.

[0251] Example 47. The method of any example herein, particularly of any one of examples 44-46, wherein each of the atraumatic tips defines a first curved surface portion oriented in a distal direction.

[0252] Example 48. The method of any example herein, particularly of any one of examples 44-47, wherein the advancing the delivery apparatus comprises maintaining a distal end of the primary extendable device at or proximal to the distal end of the outer shaft.

[0253] Example 49. The method of any example herein, particularly of any one of examples 44-48, wherein the advancing the delivery apparatus comprises maintaining the atraumatic flexible members in the first configuration.

[0254] Example 50. The method of any example herein, particularly of any one of examples 44-49, wherein the plurality of the atraumatic flexible members are disposed around a circumference of the distal end of the outer shaft.

[0255] Example 51. The method of any example herein, particularly of any one of examples 44-50, wherein the plurality of the atraumatic flexible members are biased radially inwards.Attorney Docket No: THVDL-23864WO01

[0256] Example 52. The method of any example herein, particularly of any one of examples 44-51 , wherein the primary extendable device comprises an anchor device, and wherein the distal portion of the primary extendable device comprises an anchor head terminating at a sharp anchor tip.

[0257] Example 53. The method of any example herein, particularly of example 52, further comprising forming a pilot puncture in a leaflet at the target site of treatment.

[0258] Example 54. The method of any example herein, particularly of example 53, further comprising, after the moving the atraumatic flexible members to the second configuration, further advancing the anchor head towards the leaflet.

[0259] Example 55. The method of any example herein, particularly of example 54, wherein the forming the pilot puncture further comprises, after the advancing the anchor device, anchoring the anchor head to the leaflet.

[0260] Example 56. The method of any example herein, particularly of example 55, wherein the forming the pilot puncture further comprises, after the anchoring the anchor head to the leaflet, distally advancing a needle head of a needle relative to the anchor device.

[0261] Example 57. The method of any example herein, particularly of example 56, wherein the forming the pilot puncture further comprises piercing the leaflet by a needle tip of the needle head.

[0262] Example 58. The method of any example herein, particularly of example 57, further comprising, after the forming the pilot puncture, positioning a balloon, in a deflated state thereof, inside the pilot puncture.

[0263] Example 59. The method of any example herein, particularly of example 58, further comprising, after the forming the pilot puncture, retracting the needle from the leaflet.

[0264] Example 60. The method of any example herein, particularly of any one of examples 58-59, further comprising, after the forming the pilot puncture, releasing the anchor head from the leaflet and retracting it from the leaflet.

[0265] Example 61. The method of any example herein, particularly of any one of examples 60, further comprising, after the positioning the balloon inside the pilot puncture, advancing the delivery shaft towards the leaflet, forming a leaflet opening by inflating the balloon.

[0266] Example 62. The method of any example herein, particularly of example 61, wherein the delivery apparatus further comprises a delivery shaft disposed between the anchor device and the balloon.Attorney Docket No: THVDL-23864WO01

[0267] Example 63. The method of any example herein, particularly of example 62, further comprising, before the positioning the balloon inside the pilot puncture, advancing the delivery shaft towards the leaflet.

[0268] Example 64. The method of any example herein, particularly of example 63, further comprising, before the inflating the balloon, retracting the delivery shaft from around the balloon.

[0269] Example 65. The method of any example herein, particularly of any one of examples 61-64, further comprising, after the forming the leaflet opening, deflating the balloon.

[0270] 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.

[0271] 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

Attorney Docket No: THVDL-23864WO01WE CLAIM:

1. A delivery apparatus comprising: an outer shaft comprising: an outer shaft lumen defining a central longitudinal axis; and a distal portion terminating at a distal end; a primary extendable device extendable through the outer shaft, the primary extendable device comprising a distal portion terminating at a distal end; and a plurality of atraumatic flexible members disposed around a circumference of the distal portion of the outer shaft, each of the atraumatic flexible members comprising: an extension extending along at least part of, and affixed to, the distal portion of the outer shaft; an atraumatic tip positioned distal to the distal end of the outer shaft, the atraumatic tip defining a first curved surface portion oriented in a distal direction; and a bendable portion extending between the extension and the atraumatic tip; wherein the atraumatic flexible members are configured to move between a first configuration and a second configuration, such that the atraumatic tips are positioned, in the second configuration, radially outwards relative to their radial position in the first configuration.

2. The apparatus of claim 1, wherein the primary extendable device is axially movable relative to the outer shaft.

3. The apparatus of any one of claims 1-2, wherein the atraumatic flexible members are configured to be maintained in the first configuration when the distal end of the primary extendable device is at or proximal to the distal end of the outer shaft, and are configured to move to the second configuration when the distal end of the primary extendable device is distally advanced out of the outer shaft.

4. The apparatus of any one of claims 1-3, wherein, when the atraumatic flexible members are in the second configuration, the distal end of the primary extendable device is distal to the distal end of the outer shaft.

5. The apparatus of any one of claims 1-4, wherein movement of the atraumatic flexible members from the first configuration to the second configuration comprises moving the atraumatic tips radially away from the central longitudinal axis.Attorney Docket No: THVDL-23864WO016. The apparatus of any one of claims 1-5, wherein the bendable portions comprise a flexible material configured to flex in a radial direction.

7. The apparatus of any one of claims 1-6, wherein movement of the atraumatic flexible members from the first configuration to the second configuration comprises bending the bendable portions radially outwards.

8. The apparatus of any one of claims 1-7, wherein the atraumatic tips extend radially outwards, in the first configuration, past an outer surface of the distal portion of the outer shaft.

9. The apparatus of any one of claims 1-8, wherein the first curved surface portion is further oriented radially outwards.

10. The apparatus of any one of claims 1-9, wherein the extension and the bendable portion are integrally formed.

11. The apparatus of any one of claims 1-10, wherein the bendable portions are configured to radially bias the atraumatic tips.

12. The apparatus of claim 11, wherein the bendable portions are configured to bias the atraumatic tips radially inwards.

13. The apparatus of any one of claims 1-10, wherein the bendable portions comprise a shape-memory material.

14. A method comprising: advancing a delivery apparatus, over a guide wire, towards a target site of treatment, wherein the delivery apparatus comprises an outer shaft and a plurality of atraumatic flexible members affixed to a distal portion of the outer shaft and comprising a plurality of atraumatic tips disposed distal to a distal end of the outer shaft; and moving the atraumatic flexible members from a first configuration to a second configuration in which the atraumatic tips are positioned radially outwards relative to their radial position in the first configuration, by distally advancing a distal portion of a primary extendable device through the distal end of the outer shaft.

15. The method of claim 14, wherein each of the atraumatic flexible members comprises an extension extending along at least part of, and affixed to, the distal portion of the outer shaft.Attorney Docket No: THVDL-23864WO0116. The method of any one of claims 14-15, wherein the advancing the delivery apparatus comprises maintaining a distal end of the primary extendable device at or proximal to the distal end of the outer shaft.

17. The method of any one of claims 14-16, wherein the advancing the delivery apparatus comprises maintaining the atraumatic flexible members in the first configuration.

18. The method of any one of claims 14-17, wherein the plurality of the atraumatic flexible members are disposed around a circumference of the distal end of the outer shaft.

19. The method of any one of claims 14-18, wherein the plurality of the atraumatic flexible members are biased radially inwards.

20. The method of any one of claims 14-19, wherein the primary extendable device comprises an anchor device, and wherein the distal portion of the primary extendable device comprises an anchor head terminating at a sharp anchor tip.

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