Guidewire locking devices

Abstract

A delivery apparatus disclosed herein can include a delivery shaft (210) and a wire (230). The wire includes at least one wire portion extending through the wall of the delivery shaft and out of an opening of a channel formed in the wall of the delivery shaft, and a loop (236) extending from the opening. The loop is configured to allow passage of a guidewire (250) extending through a lumen of the delivery shaft therethrough. The wire is configured to move between a loose state, in which the loop is sized to allow axial movement of the guidewire through the loop, and a tensioned state, wherein the loop is tightened around the wire in a manner that prevents axial movement of the guidewire relative to the delivery shaft.

Description

GUIDEWIRE LOCKING DEVICESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 662,053, filed June 20, 2024, which is incorporated by reference herein.FIELD

[0002] The present disclosure relates to devices configured to lock the axial position of a guidewire during replacement of shafts or tools thereover.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.SUMMARY

[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 replacement of shafts or tools extendable over a guidewire to perform different procedural steps at the target site of treatment. However, retrieval of an existing shaft or tool can apply forces on a guidewire over which it extends, which can accidentally dislodge the guidewire from its position at the target site of treatment.

[0007] In one of its basic configurations, a delivery apparatus comprises a wire comprising at least one wire portion extending through and axially movable relative to at least one channel extending through a delivery shaft wall of a delivery shaft, and a loop of the wire extending from an opening of the at least one channel. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0008] In some examples, the delivery shaft wall can surround a delivery shaft lumen optionally configured to allow extension of a guidewire therethrough.

[0009] In some examples, the delivery shaft wall can terminate at a distal end of the delivery shaft.

[0010] In some examples, the loop can be optionally configured to allow passage of the guidewire therethrough.

[0011] In some examples, the wire can be optionally configured to move between a loose state and a tensioned state.

[0012] In some examples, in the loose state, the loop can optionally be sized to allow axial movement of the guidewire through the loop.

[0013] In some examples, in the tensioned state, the loop can optionally be tightened around the wire.

[0014] In some examples, in the tensioned state, the loop can optionally be tightened around the wire in a manner that prevents axial movement of the guidewire relative to the delivery shaft.

[0015] In some examples, the wire can optionally be configured to move from the loose state to the tensioned state upon proximal pulling of the at least one wire portion.

[0016] In some examples, the loop can optionally be oriented at an angle relative to the at least one wire portion.

[0017] In some examples, the loop can optionally extend towards a central longitudinal axis of the delivery shaft.

[0018] In some examples, when the wire is in the loose state, the loop can optionally extend past a central longitudinal axis of the delivery shaft.

[0019] In some examples, when the wire is in the loose state, the loop can optionally extend past a centra] longitudinal axis of the delivery shaft.

[0020] In some examples, when the wire is in the loose state, the loop can optionally be sized to allow axial movement of an inner shaft extendable over the guidewire, through the delivery shaft lumen and through the loop.

[0021] In some examples, the at least one wire portion can optionally comprise a first wire portion and a second wire portion, and the at least one channel can optionally comprise a first channel terminating at a first opening, and a second channel terminating at a second opening.

[0022] In some examples, an arc-distance between the first opening and the second opening can optionally be less than 30% of the perimeter of the delivery shaft.

[0023] In some examples, the at least one wire portion can optionally comprise a single wire portion, and the loop can optionally be affixed to the delivery shaft wall at an affixation point.

[0024] In some examples, an arc-distance between the opening of the channel and the affixation point can optionally be less than 30% of the perimeter of the delivery shaft.

[0025] In some examples, the at least one opening can optionally be formed at the distal end of the delivery shaft.

[0026] In some examples, the at least one opening can optionally be proximal to the distal end of the delivery shaft.

[0027] In some examples, the loop can optionally extend into the delivery shaft lumen.

[0028] In one of its basic configurations, a method comprises advancing a delivery shaft of a delivery apparatus, over a guidewire, towards a target site of treatment, wherein the guidewire extends through a loop of a wire of the delivery apparatus. 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.

[0029] In some examples, when advancing the delivery shaft, the wire can optionally be maintained is a loose state.

[0030] In some examples, the method can further comprise advancing an inner shaft, over the guidewire, through the delivery shaft and the loop.

[0031] In some examples, the method further comprises locking the axial position of the guidewire by moving the wire from the loose state to a tensioned state thereof.

[0032] In some examples, the method can further comprise retracting the inner shaft out of the delivery shaft.

[0033] In some examples, the locking the axial position of the guidewire can optionally be by moving the wire from the loose state to a tensioned state thereof.

[0034] In some examples, the method can optionally further comprise, prior to the locking the axial position of the guidewire, axially positioning a distal end of the inner shaft proximal to the loop.

[0035] In some examples, the moving the wire from the loose state to a tensioned state can optionally comprise tightening the loop around the guidewire.

[0036] In some examples, the moving the wire from the loose state to a tensioned state can optionally comprise pressing the guidewire against an inner surface of the delivery shaft.

[0037] In some examples, the method can optionally further comprise, before the locking the axial position of the guidewire, forming a pilot puncture in a leaflet at the target site of treatment, and extending the guide wire through the leaflet opening.

[0038] In some examples, the forming the pilot puncture can optionally further comprise advancing an anchor device through the inner shaft toward the leaflet.

[0039] In some examples, the forming the pilot puncture can optionally further comprise, after the advancing the anchor device, anchoring an anchor head of the anchor device to the leaflet.

[0040] In some examples, the forming the pilot puncture can optionally further comprise, after the anchoring the anchor head, advancing a needle head of a needle extending over the guidewire through the anchor device, against the leaflet.

[0041] In some examples, the method can optionally further comprise, after the forming the pilot puncture, releasing the anchor head from the leaflet.

[0042] In some examples, the method can optionally further comprise, after the forming the pilot puncture and before the locking the axial position of the guidewire, positioning the anchor head and the needle head proximal to the loop.

[0043] In one of its basic configurations, a delivery apparatus comprises a delivery shaft comprising a shaft wall defining a lumen, and a first channel extending through and along theshaft wall, and further comprises a wire extending through the first channel, the wire forming an adjustable loop over at least a portion of the lumen of the delivery 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.

[0044] In some examples, the fist channel can optionally comprise a first distal opening.

[0045] In some examples, the wire can optionally extend through the first distal opening.

[0046] In some examples, the adjustable loop can optionally be configured to move between a loose state and a tensioned state, wherein the adjustable loop is sized to allow axial movement of a delivery device through the adjustable loop when in the loose state, and wherein the adjustable loop is tightened around the delivery device in a manner that prevents axial movement of the delivery device through the adjustable loop when in the tensioned state.

[0047] In some examples, the delivery shaft can optionally comprise a second channel extending through and along the shaft wall and comprising a second distal opening, and the wire can optionally extend through the second channel and through the second distal opening.

[0048] The aspects of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.BRIEF DESCRIPTION OF THE FIGURES

[0049] 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:

[0050] Fig. 1 is a sectional view of an aortic root.

[0051] 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.

[0052] Fig. 3 shows a valve-in- valve implantation within the native aortic valve of Fig. 1, according to an example.

[0053] Fig. 4 illustrates an exemplary tissue delivery apparatus that includes a wire movable between loose and tensioned states thereof.

[0054] Figs. 5A and 5B shows a portion of an exemplary delivery apparatus corresponding to region 5 of Fig. 4, with the wire illustrated in a loose state and a tensioned state, respectively.

[0055] Fig. 6 shows a tissue modification system that includes a perforation apparatus extendable through the delivery apparatus of Fig. 4.

[0056] Figs. 7-8 illustrate some steps in an exemplary method for utilizing the perforation apparatus of Fig. 6 for forming a pilot puncture in a target tissue.

[0057] Fig. 9 shows an exemplary dilation apparatus extendable through the delivery apparatus of Fig. 4.

[0058] Figs. 10-11 illustrate some steps in an exemplary method for utilizing the dilation apparatus of Fig. 8 for forming a leaflet opening.

[0059] Fig. 12 shows a guest prosthetic valve positioned, in a radially compressed configuration thereof, inside a leaflet opening.

[0060] Fig. 13 shows a portion of an exemplary delivery apparatus corresponding to region 5 of Fig. 4, with the loop extending on one end from an opening of a channel, and affixed at an opposite affixation point to the wall of the delivery shaft.

[0061] Fig. 14 shows a portion of an exemplary delivery apparatus corresponding to region 14 of Fig. 4, with the loop extending into the delivery shaft lumen at a position proximal to the distal end of the delivery shaft.DETAILED DESCRIPTION

[0062] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present, or problems be solved. The technologies from any example can be combined with thetechnologies described in any one or more of the other examples. In view of the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology.

[0063] 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.

[0064] 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.

[0065] 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”.

[0066] Directions and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as “inner”, “outer”, “upper”, “lower”, “inside”, “outside”, “top”, “bottom”, “interior”, “exterior”, “left”, right”, and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an “upper” part can become a “lower” part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] 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 aspecific 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.

[0073] 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.

[0074] 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.

[0075] 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.

[0076] 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 the 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 beenfully 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.).

[0077] 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.

[0078] 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 expanded state. Thus, a plurality of partially expanded states may relate to any expansion diameter between radially compressed or crimped state, and maximally expanded state. A prosthetic valve of the current disclosure (for example, prosthetic valve 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.

[0079] It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses. Balloon expandable valves generally involve a procedure of inflating a balloon within a prosthetic valve, thereby expanding the prosthetic valve within the desired implantation site. Once the valve is sufficiently expanded, the balloon is deflated and retrieved along with a delivery apparatus (not shown). Self-expandable valves include a frame that is shape-set to automatically expand as soon an outer retaining shaft or capsule (not shown) is withdrawn proximally relative to the prosthetic valve. Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion. The mechanical actuation mechanism usually includes a plurality of expansion and locking assemblies (such as the prosthetic valves described in U.S. Patent No. 10,603,165, International Application No. PCT / US 2021 / 052745 and U.S. Provisional Application Nos. 63 / 85,947 and 63 / 209904, each of which is incorporated herein by reference in its entirety), releasably coupled to respective actuation assemblies of a delivery apparatus, controlled via a handle (not shown) for actuating the expansion and locking assemblies to expand the prosthetic valve to a desired diameter. The expansion and locking assemblies may optionally lock the valve' s diameter to prevent undesired recompression thereof, and disconnection of the actuation assemblies from the expansion and locking assemblies, to enable retrieval of the delivery apparatus once the prosthetic valve is properly positioned at the desired site of implantation.

[0080] 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.

[0081] 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.

[0082] The term “inflow”, as used herein, refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve 100.

[0083] 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.

[0084] 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.

[0085] The terms “longitudinal” and “axial”, as used herein, refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0086] The prosthetic valve 100 comprises an annular frame 102 movable between a radially compressed configuration and a radially expanded configuration, and a valvular structure 1 13 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.

[0087] 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.

[0088] 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, lasercutting, electroforming, and / or physical vapor deposition, while retaining the ability to collapse / expand radially in the absence of hinges and like.

[0089] A valvular structure 113 of the prosthetic valve 100 can include a plurality of prosthetic valve leaflets 114 (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 1 14. 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.

[0090] 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.

[0091] 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 previously 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.

[0092] 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.

[0093] The cells 110, defined by interconnected struts 108, define cell openings 112. While some of the cell openings 1 12 can be covered by the inner skirt and / or the outer skirt, at least a portion of the cell opening 112 can remain uncovered, such as cell openings 112 which are closer to the outflow end 106 of the prosthetic valve.

[0094] 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.

[0095] 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.

[0096] 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 valve 20. 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 balloonexpandable guest valve 100b can be implanted inside a previously implanted mechanically expandable or self-expandable host valve 100a.

[0097] 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.

[0098] 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.

[0099] 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.

[0100] 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 prostheticheart 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.

[0101] 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.

[0102] 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 40 for a native aortic valve 20, or a prosthetic valve commissure 116 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.

[0103] Fig. 4 illustrates an exemplary delivery apparatus 202 that can be used to deliver a prosthetic device or tool to a target site of treatment in a patient’s body. The delivery apparatus 202 comprises a delivery shaft 210 distally extending from a handle 204. The delivery shaft 210 is configured to be advanced towards the target site over a guidewire 250.

[0104] The handle 204 can be maneuvered to control the delivery shaft 210. In some examples, the handle 204 includes one or more actuators, such as knobs 206, configured to control various components of the delivery apparatus 202 or components extending therethrough. While the handle 204 is illustrated in Fig. 4 two include two rotatable knobs 206a and 206b, it is to be understood that any other number of knobs is contemplated, such as a single knob or more than two knobs, and that knobs or other types of actuators can be implemented in any suitable manner, such as rotatable knobs, sliding knobs, click buttons, and the like.

[0105] In some examples, the delivery shaft 210 can be optionally implemented as a steerable catheter. In some examples, the handle 204 can optionally include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery shaft 210. In the illustrated example, the handle 204 can optionally include an adjustment member, such as a rotatable knob 206, which in turn is operatively coupled to the proximal end portion of a pull wire (not shown). The pull wire can optionally extend distally from the handle 204 through the delivery shaft 210 and has a distal end portion affixed to the delivery shaft 210 at or near the distal end 216 of the delivery shaft 210. Rotating such a knob 206 can optionally increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery shaft 210. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein.

[0106] In some examples, the handle 204 can optionally include a shaft securement knob, such as a second knob 206b illustrated in Fig. 4, configured to restrain movement of a shaft that can optionally extend through the handle 204 and a lumen 212 of the delivery shaft 210, relative to the delivery shaft 210.

[0107] As mentioned above, the delivery shaft 210 can be advanced over a guidewire 250 through the patient's vasculature towards the target site of treatment. One or more inner shafts and / or prosthetic devices can extend towards the target site of treatment through the delivery shaft lumen 212, over the guidewire 250. Such inner shaft or prosthetic device or tool can be delivered to the target site of treatment either along with the delivery shaft 210, such as by residing inside the delivery shaft lumen 212 such that both shafts can be simultaneously advanced through the patient's vasculature, or separately, such as by being inserted into the delivery shaft lumen 212 and advanced distally over the guidewire 250 after the delivery shaft 210 has already been advanced and has its distal end 216 positioned next to the target site of treatment.

[0108] In some cases, a procedure of treatment can involve replacement of shafts and / or prosthetic devices or tools used in combination with the delivery shaft 210. For example, a first shaft and / or prosthetic device or tool extending through the delivery shaft lumen 212 over guidewire 250 can be retrieved from the patient's body while the delivery shaft 210 and guidewire 250 remain in position, allowing a different shaft and / or prosthetic device or tool to be subsequently advanced through the delivery shaft lumen 212 and over the guidewire 250, towards the target site of treatment. In some cases, it may be desirable to maintain the axial position of a distal end portion 252 of the guidewire 250 during such exchange of shaft and / or prosthetic devices or tools. Frictional forces applied to the guide wire 250 during retraction ofan existing inner shaft and / or prosthetic device or tool, as well as forces applied to the guidewire 250 during advancement of a new inner shaft and / or prosthetic device or tool thereover, can cause inadvertent axial displacement of the guidewire 250. Disclosed herein are retainment mechanisms configured to retain the axial position of a guidewire 250 during retraction and / or advancement of shafts or devices through a delivery shaft, relying on wires 230 that define a loop 236 through which the guidewire 250 can extend.

[0109] In some examples, a delivery apparatus 202 further comprises a wire 230 extending distally from the handle 204. The wire 230 comprises at least one wire portion 234 (indicated, for example, in Fig. 13), and defines a loop 236 at a distal end of the wire 230. In some examples, the wire 230 can be also referred to as a retainment wire. The wire 230 is configured to move between a loose state, in which the loop 236 is relatively loose and defines an opening larger enough to allow advancement of an inner shaft and / or prosthetic device or tool therethrough, and a tensioned state, in which a proximal end 232 of the wire 230 can be optionally pulled so as to constrict the loop 236. Figs. 5A and 5B show an enlarged view of a distal portion of an exemplary delivery apparatus 202 (corresponding to region 5 indicated in Fig. 4, for example) in loose and tensioned states, respectively, of the wire 230.

[0110] Various exemplary implementations for apparatuses (e.g., delivery apparatus 202), devices, and / or components thereof can be referred to, throughout the specification, with superscripts, for ease of explanation of features that refer to such exemplary implementations. It is to be understood, however, that any reference to structural or functional features of any apparatus, device or component, without a superscript, refers to these features being commonly shared by all specific exemplary implementations that can be also indicated by superscripts. In contrast, features emphasized with respect to an exemplary implementation of any apparatus, device or component, referred to with a superscript, may be optionally shared by some but not necessarily all other exemplary implementations. For example, a delivery apparatus 202a, illustrated in Figs. 4-5B, is an exemplary implementation of delivery apparatus 202, and thus can include any of the features described for delivery apparatus 202 throughout the current disclosure, except that the wire 230aof delivery apparatus 202“ includes two wire portions 234a, 234b extending towards and out of the distal end 216 of the delivery shaft 210, such that the loop 236 is positioned at or distal to the distal end 216 of the delivery shaft 210.

[0111] In some examples, the at least one wire portion 234 extends through the wall 214 of the delivery shaft 210. In some examples, at least one channel 218 (indicated, for example, in Fig. 13) can extend through delivery shaft wall 214, the channel 218 terminating at a corresponding opening 220. The wire portion 234 extends through, and is axially movable relative to, thecorresponding channel 218, and exits through the respective opening 220 therefrom. A wire portion 234 can be optionally defined as the portion of the wire 230 extending through the channel 218, such as between the wire proximal end 232 and the loop 236. The loop 236 can be optionally defined as a portion of the wire 230 disposed out of the channel(s) 218, such as by being the portion of the wire 230 distal to the opening(s) 220.

[0112] In the example illustrated in Figs. 5A-5B for wire 230a, a first wire portion 234a and a second wire portion 234b can extend through a first channel 218a and a second channel 218b, respectively. The first channel 218a terminates at a first opening 220a, and the second channel 218b terminates at a second opening 220b. In some examples, the first channel 218a and the second channel 218b can axially extend in parallel to each other. In some examples, the opening(s) 220 can be axially oriented, such as by being formed at the distal end 216 of the delivery shaft 210 and oriented in a distal direction, as shown for example in Figs. 4-5B.

[0113] In some examples, the first and second channels 218a, 218b through which the first and second wire portions 234a, 234b extend, can be relatively close to each other along the circumference of the delivery shaft 210. For example, the arc-distance between the first and second channels 218a, 218b, and / or between the first and second openings 220a, 220b, can optionally be less than 30% of the perimeter of the delivery shaft 210, less than 20% of the perimeter of the delivery shaft 210, or less than 10% of the perimeter of the delivery shaft 210. In this manner, the openings 220 can be close enough to each other such that the loop 236 extends from one side of the delivery shaft wall 214.

[0114] In some examples, the loop 236 can be radially oriented at an angle relative to the wire portion(s) 234. Any reference to an orientation of the loops 236 refers to the orientation of a plane that can be defined by the loop 236, and / or to orientation of a trajectory extending from the beginning of the loop at the opening 220 (for example, the openings 220a, 220b), to an opposite head 238 of the loop. In some examples, the loop 236 extends from the opening 220 (for example, the openings 220a, 220b), optionally at an angle, towards a central longitudinal axis CA of the delivery shaft 210, and optionally towards an opposite side of the delivery shaft wall 214 or an imaginary axial extension thereof.

[0115] As shown in Figs. 5A-5B, the loop 236 can optionally be distal to the distal end 216 of the delivery shaft 210, such that a central opening defined by the loop, for example in a loose state of the wire 230, generally faces, and can be optionally distal to, the delivery shaft lumen 212. In some examples, the loop 236 can be oriented radially inwards (e.g., towards the central longitudinal axis CA of the delivery shaft 210) at an angle of at least 30° relative to the wire portion(s) 234. In some examples, the loop 236 can be oriented radially inwards at an angle ofat least 45° relative to the wire portion(s) 234. In some examples, the loop 236 can be oriented radially inwards at an angle of at least 60° relative to the wire portion(s) 234. In some examples, the loop 236 can be oriented radially inwards at right angle relative to the wire portion(s) 234.

[0116] As shown in Fig. 5A, when the wire 230 is in its loose state, the loop is large enough to allow axial movement of the guidewire 250 therethrough. While only a guidewire 250 is illustrated in Fig. 5 A to extend through the loop 236, it is to be understood that in the loose state, the loop 236 can be sized to allow axial movement therethrough not only of the guide wire 250, but any inner shaft or prosthetic device or tool configured to extend, over the guidewire 250, through the delivery shaft lumen 212.

[0117] In some examples, a projection of the loop 236 (or an imaginary line extending from an opening 220 to the head 238 of the loop 236) on a plane orthogonal to the central longitudinal axis CA of the delivery shaft 210 (e.g., a plane along which a diameter of the delivery shaft lumen 212 is defined), in the loose state, is greater than the radius of the delivery shaft lumen 212. In some examples, a projection of the loop 236 on a plane orthogonal to the central longitudinal axis CA, in the loose state, is greater than 75% of the diameter of the delivery shaft lumen 212. In some examples, a projection of the loop 236 on a plane orthogonal to the central longitudinal axis CA, in the loose state, is greater than 80% of the diameter of the delivery shaft lumen 212. In some examples, a projection of the loop 236 on a plane orthogonal to the central longitudinal axis CA, in the loose state, is greater than 90% of the diameter of the delivery shaft lumen 212. In some examples, a projection of the loop 236 on a plane orthogonal to the central longitudinal axis CA, in the loose state, is substantially equal the diameter of the delivery shaft lumen 212. In some examples, the loop 236 extends, in the loose state, past the central longitudinal axis CA. In some examples, the loop 236 does not necessarily define a circular perimeter in a free state thereof, but may assume an elliptic or other shape. It is to be understood that any reference herein to a diameter of the loop 236, when the loop is not necessarily circular, refers to an equivalent diameter of the loop when formed to have an equivalent circular shape having the same perimeter as in the loop's non-circular shape.

[0118] When the loop 236 extends distally from the distal end 216 of the delivery shaft 210, it is not necessarily bound by the delivery shaft wall 214, in which case a projection of the loop 236 on a plane orthogonal to the central longitudinal axis of the delivery shaft, in the loose state, can optionally be even greater than the diameter of the delivery shaft lumen 212.

[0119] Movement of the wire 230 from the loose state to the tensioned state can be facilitated by proximally pulling the wire portion(s) 234. For example, the wire proximal end(s) 232 can optionally extend into the handle 204 and be coupled to a mechanism controllable by anactuator, such as a first knob 206a, such that rotation of the knob 206a can cause the mechanism (not shown) to proximally pull the wire proximal end(s) 232 and the wire portion(s) 234 therewith.

[0120] For example, when a wire 230aincludes two wire portions 234, both the first and second wire portions 234a, 234b can be optionally pulled simultaneously in the proximal direction 80, thereby reducing the size of the loop 236 extending out of the openings 220a, 220b. This can be also accomplished by proximally pulling on one of the two wire portions, while the other wire portion can remain axially affixed in position.

[0121] As the loop 236 is constricted, it radially pulls the guidewire 250 therewith towards the delivery shaft wall 214, such as towards the side of the wall 214 that includes the openings 220, as shown for example in Fig. 5B. The wire 230 is continuously pulled until the guidewire 250 is press-locked against delivery shaft wall 214 at a force sufficient to prohibit unintentional axial movement of the guidewire 250 relative to the delivery shaft 210. The wire 230 can remain locked in the tensioned state during retraction of an existing inner shaft and / or prosthetic device or tool, and / or during advancement of a new inner shaft and / or prosthetic device or tool.

[0122] When release of the guidewire 250 is desired, optionally when a new inner shaft and / or prosthetic device or tool is advanced towards the loop 236, the wire 230 can be moved back to the loose state, optionally by allowing the wire portion(s) 234 to passively or actively move in a distal direction, such that the loop 236 can re-expand by enlargement of the loop's perimeter, as shown for example in Fig. 5 A.

[0123] In some examples, the delivery apparatus 202 can be part of a tissue modification system 200. Fig. 6 shows an exemplary tissue modification system 200 that includes the delivery apparatus 202 and a perforation apparatus 300 that can optionally extend through the handle 204 and delivery shaft 210. The perforation apparatus 300 includes an inner shaft 308 attached to a handle 302 of apparatus 300 and extending distally therefrom. The inner shaft 308 defines an inner shaft lumen 310 (indicated, for example, in Figs. 7-8) and has an inner shaft distal end 312 which can optionally be, in some examples, an atraumatic distal end 312, such as by being rounded and / or being curved radially inwards, or otherwise formed to include an outer surface tapering in the distal direction.

[0124] The perforation apparatus 300 further includes a hollow needle 318 and an anchor device 334 through which the needle 318 can extend. The needle 318 comprises a needle head 322 and a needle shaft 328 extending proximally from the needle head 322, collectively defining a needle lumen 320 (indicated, for example, in Fig. 7) through which a guidewire 250can optionally extend. The needle head 322 is configured to pierce a target tissue, such as a host leaflet 10 of a host valvular structure 12, to form a pilot puncture 50 in the host leaflet 10. The needle head 322 can optionally define an angled surface 324 terminating at a sharp needle tip 326 configured to facilitate piercing the host leaflet 10 when the needle 318 is pressed thereagainst.

[0125] The anchor device 334 of apparatus 300 includes a helical anchor head 338 which is attached, directly or via one or more intermediate components, to a distal end portion of an anchor shaft 344. The anchor head 338 defines an anchor channel 336 and has a sharp anchor tip 340 configured to allow it to engage and penetrate a target tissue, such as a host leaflet 10 of a host valvular structure. Optionally, the helical anchor head 338 can be used in combination with the needle 318 which can extend through the anchor channel 336 towards and through a host leaflet 10, for modifying the host leaflet 10. The anchor shaft 344 can optionally extend through the inner shaft lumen 212. Optionally, the inner shaft 308 and the anchor shaft 344 can be configured to be axially movable relative to each other. For example, a distally oriented movement of the anchor shaft 344 relative to the inner shaft 308 can optionally expose the anchor head 338 from the inner shaft 308.

[0126] 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 inner 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 inner shaft, to the inner shaft being movable in the proximal or distal direction relative to the anchor shaft, or both.

[0127] The anchor shaft 344 can optionally be a torque shaft, configured to be movable rotatably relative to a central axis thereof and / or rotatable relative to another shaft of the apparatus 300, such as relative to the inner shaft 308. The anchor head 338 is affixed, directly or via one or more intermediate components, to the anchor shaft 344, such that rotation of the anchor shaft 344 effects rotation of the anchor head 338 therewith. The anchor shaft 344 defines an anchor shaft lumen 346 (indicated, for example, in Fig. 7) which is in fluid communications with the anchor channel 336. In some examples, at least a portion of the anchor shaft 344 is formed as a hypotube, configured to increase flexibility thereof. In some examples, at least a portion of the anchor shaft 344 comprises a helical hollow strand (HHS) tube.

[0128] The proximal ends of the inner shaft 308, the anchor shaft 344 and the needle shaft 328 extend into and are coupled to the handle 302 of apparatus 300. During delivery through the patient's vasculature, the handle 302 can be maneuvered by an operator (for example, a clinician or a surgeon) to control movement of components of the apparatus 300, such as the anchor shaft 344 and the needle shaft 328.

[0129] In some examples, an anchor head 338 can optionally be a tube-cut anchor head. Manufacturing of a tube-cut anchor head 338 can employ any suitable cutting method, such as, but not limited to, laser cutting, water-jet cutting, plasma cutting, and the like. The anchor head 338 can optionally define one or more helical turns 342 continuously extending between a proximal end of the anchor head 338 and the anchor tip 340. In some examples, the anchor head 338 can optionally be formed from a rounded wire shaped to form the helical turns 342. Sharpening the anchor tip 340 can employ grinding or any other suitable sharpening method.

[0130] The handle 302 includes first handle portion 304 and a second handle portion 306 which are separable from each other. A first knob 314a (which may be referred to as an engagement knob) of the handle 302 can be optionally configured to control a lock and release mechanism that can either maintain the two handle portions 304 and 306 coupled to each other, or to release one from the other so as to allow separation between the first handle portion 304 and the second handle portion 306.

[0131] The second handle portion 306 can include a second knob 314b (which may be referred to as an anchor control knob), configured to control rotational movement of the anchor device 334, and a third knob 314c (which may be referred to as a needle control knob) configured to control axial movement of the needle 318, wherein proximal portions of the anchor shaft 344 and the needle shaft 328 can be coupled to the second handle portion 306, such as to mechanisms of the second handle portion 306 controllable by the knobs 314b, 314c. The inner shaft 308 is attached to the first handle portion 304, while the anchor device 334 and needle 318 can extend through the first handle portion 304 to connect with the second handle portion 306, without being attached to the first handle portion 304 itself. Thus, when the first knob 314a is actuated (e.g., rotated) to allow separation between the handle portions 304 and 306, the anchor device 334 and the needle 318 can be removed, along with the second handle portion 306, from the first handle portion 304.

[0132] The handle 204 of delivery apparatus 202 can optionally include a rear port 208 through which various shafts, wires (e.g., guidewire 250), prosthetic devices and / or tools, can be extended into the handle 204 and through the delivery shaft lumen 212. The delivery shaft 210 can be advanced towards the valvular structure 12 over the guidewire 250, and the inner shaft308 can be optionally passed, along with the anchor device 334 and needle 318, through the delivery shaft 210, over a guidewire 250, towards the host leaflet 10. The wire 230 is maintained in a loose state during these stages, such that the loop 236 is large enough to allow the guidewire 250 to freely extend therethrough during advancement of the delivery shaft 210 towards the target site of treatment, and is also large enough to allow extension and axial movement of components of the perforation apparatus 300, such as inner shaft 308, anchor device 334 and needle 318, through the loop 236.

[0133] In some examples, the delivery shaft 210 can he optionally advanced through the patient's vasculature without the perforation apparatus 300, taking advantage of an optional steerability of the delivery shaft 210 to navigate it during delivery, after which the inner shaft 308 can optionally be inserted through the rear port 208 of the handle 204 and advanced through the delivery shaft 210.

[0134] Figs. 7-8 illustrate some steps in an exemplary method for utilizing a perforation apparatus 300, extendable through a delivery shaft 210 of a system 200, for forming a pilot puncture 50 in a target tissue. An exemplary implementation of the method is illustrated in Figs. 7-8, as well as follow up steps for forming a tissue opening illustrated in Figs. 10-12, with respect to forming a leaflet opening inside a host leaflet, which can optionally be performed prior to implanting a guest prosthetic valve inside the host valvular structure. The perforation apparatus 300 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.

[0135] The distal end portion of the perforation apparatus 300, which can optionally include the atraumatic inner shaft distal end 312, is configured to be advanced towards the host leaflet 10, optionally through a pre-inserted delivery shaft 210. Positioning the inner shaft distal end 312 relative to the host leaflet 10 may comprise advancing the inner shaft 308 toward the leaflet over the guidewire 250. The needle 318 can optionally be configured to accommodate the guidewire 250 that can extend through the needle lumen 320.

[0136] During delivery, the anchor head 338 can optionally be retained inside inner shaft lumen 310, such that the anchor tip 340 is at or proximal to the inner shaft distal end 312. This position conceals the sharp tip 340 of the anchor head 338 from the surrounding anatomy, to protect the anatomical structures, as well as the delivery shaft 210 through which it can optionally be advanced, from being engaged or punctured by the anchor tip 340 during advancement towards the site of treatment. The needle head 322 can optionally be similarly retained inside the anchor device 334, such that the needle tip 326 is at or proximal to the anchor tip 340. This position conceals the sharp tip 326 of the needle head 322 from thesurrounding anatomy and / or delivery shaft 210, to similarly protect them from being engaged or punctured by the needle-sharp tip 326 during advancement towards the site of treatment.

[0137] The anchor head 338 can be approximated to the host leaflet 10, and the anchor control knob 314b can optionally be then rotated in a rotational direction that causes the anchor head 338 to engage and penetrate the host leaflet 10, thereby securing the anchor head 338 to host leaflet 10 as shown in Fig. 7. The tissue material of host leaflet 10 can be retained between successive helical turns 342 of the anchor head 338. In some examples, the inner shaft distal end 312 can optionally be in contact with, and / or slightly pushed against, the host leaflet 10, prior to rotating the anchor head 338 to screw it into the host leaflet 10, which can stretch and / or flatten the host leaflet 10 to some extent along a plane perpendicular to the axial direction of anchor device 334 and needle 318 advancement, which can increase stability of the leaflet for improved engagement with the anchor head 338 at it is being screwed thereinto.

[0138] Following engagement of the anchor head 338 with the host leaflet 10, the needle control knob 314c can optionally be rotated in a rotational direction that facilitates distal advancement of the needle 318, causing the needle head 322 to puncture the host leaflet 10 to form a pilot puncture 50 within host leaflet 10, as shown in Fig. 7.

[0139] An attempt to pass a needle 318 through a relatively thin and movable tissue component, such as a leaflet, in the absence of an anchor, might push the leaflet to some extent prior to eventually penetrating therethrough, which, even if achieving the goal of eventually puncturing the leaflet, might result in a wrong or somewhat offset position of the puncture hole due to this undesired relative movement. Advantageously, the anchor head 338 captures the host leaflet 10 and stabilizes it during formation of a pilot puncture 50 by a needle 318 being pushed against and through the host leaflet 10.

[0140] Once the needle head 322 is positioned, at least partially, past the host leaflet 10, the guidewire 250 is advanced through the needle lumen 320 to terminate with a distal end portion 252 thereof at a position distal to the pilot puncture 50 of host leaflet 10, as shown in Fig. 7.

[0141] Subsequent to forming the pilot puncture 50 and advancing the guidewire 250 to extend therethrough, the needle 318 can be optionally retracted by rotating the needle control knob 314c in a counter rotational direction configured to facilitate proximal movement of the needle shaft 328. The anchor control knob 314b can be similarly rotated in a counter rotational direction, opposite to the rotational direction used for securing it to the leaflet 10, so as to release the anchor head 338 from the host leaflet 10, which can optionally be similarly retracted by being then axially pulled away from the host leaflet 10, as shown in Fig. 8, while leaving the guidewire 250 extending through the pilot puncture 50.

[0142] It is to be understood that the order of procedural steps described above with respect to Figs. 7-8 is merely described by way of example only, and that reverse rotation of the anchor head 338 to release it from the host leaflet 10 and retract it can optionally be performed prior to needle 318 retraction. In some examples, counter-rotation of the anchor control knob 314b to release the anchor head 338 from the host leaflet 10 can optionally be performed prior to counter rotation of the needle control knob 330 to retract the needle 318, and axial retraction of the anchor head 338 can optionally be performed simultaneously with, or subsequent to, needle 318 retraction.

[0143] In some examples, the guidewire 250 can optionally be advanced simultaneously with advancement of the needle 318 during formation of the pilot puncture 50. In some examples, the guidewire 250 can optionally be advanced to terminate distal to the host leaflet 10 after formation of the pilot puncture 50 by the needle 318. In some examples, the guidewire 250 can optionally be advanced through pilot puncture 50 to terminate distal to the host leaflet 10 after retrieval of the needle 318, optionally prior to release of the anchor head 338 from the host leaflet 10.

[0144] In some examples, advancement of the guidewire 250 to position the guidewire distal end portion 252 distal to the pilot puncture 50 can optionally be performed subsequent to counter-rotation of the anchor control knob 314b to release the anchor head 338 from the host leaflet 10 and / or axial retraction of the anchor head 338, while the needle 318 is still positioned inside of pilot puncture 50, after which the needle 318 can optionally be retracted. In some examples, advancement of the guidewire 250 to position the guidewire distal end portion 252 distal to the pilot puncture 50 can optionally be performed after needle 318 retraction while the anchor head 338 is still engaged with the host leaflet 10, after which the anchor head 338 can optionally be released and retracted.

[0145] In some examples, a tissue modification system 200 can optionally further include a dilation apparatus 350, having an expansion member 368 configured to transition between a compacted state and an expanded state thereof. In some examples, the expansion member comprises a hole-dilating balloon 368 mounted on a balloon catheter 362, as shown for example in Fig. 9.

[0146] After formation of the pilot puncture 50, the second handle portion 306 can optionally be released and separated from the first handle portion 304. Optionally, the second handle portion 306, to which the anchor device 334 and the needle 318 are attached, can be then retracted, pulling the anchor device 334 and the needle 318 through the delivery shaft lumen 212 and out of the patient's body, while leaving the delivery shaft 210 and the inner shaft 308extending therethrough in position, with the guidewire 250 extending through the lumens 310, 212 of the inner and delivery shafts 308, 210, and through the pilot puncture 50, as shown in Fig- 8.

[0147] Thereafter, the balloon catheter 362 of dilation apparatus 350 can optionally be inserted into the inner shaft 308 through the first handle portion 304, over the guidewire 250. Optionally, the balloon catheter 362 can be then advanced through the inner shaft lumen 310, over the guidewire 250, towards the host leaflet 10, as shown for example in Fig. 10.

[0148] In the absence of a guidewire locking mechanism, retrieval of the needle 318 and anchor device 334 can apply frictional forces against guidewire 250 that can cause accidental displacement of the guidewire 250 out of the pilot puncture 50 formed in the host leaflet 10. If the guidewire 250 is pulled out of the leaflet 10, it may be difficult or even impossible to properly navigate the balloon catheter 362 into the pilot puncture 50. Thus, a wire 230 extending through the delivery shaft wall 214 and forming a loop 236 through which the guidewire 250 extends, can be optionally moved to the tensioned state, such as by pulling its wire portion(s) 234, so as to constrict the loop 236 around the guidewire 250 and lock the guidewire 250 in position, thereby advantageously allowing retrieval of the needle 318 and anchor device 334 without posing a risk of displacing the guidewire 250.

[0149] In some examples, moving the wire 230 to the tensioned state is performed after all components of the perforation apparatus 300 are positioned proximal to the loop 236, such that only the guidewire 250 extends through the loop 236 itself. For example, the needle tip 326, the anchor tip 340, and / or the inner shaft distal end 312, can be positioned proximal to the loop 236 and / or proximal to the opening(s) 220 from which the wire 230 extends to form the loop 236, after which the wire 230 can be moved to the tensioned state, constricting the loop 236 so as to lock the guidewire 250 in position and prevent it from slipping out of the host leaflet 10.

[0150] After locking the guidewire 250 by moving the wire 230 to the tensioned state, the needle 318 and anchor device 334 can be further proximally pulled until they are fully retrieved from the patient's body, while the inner shaft 308 can optionally remain in position, extending through the delivery shaft lumen 212, wherein the inner shaft distal end 312 can remain proximal to the loop 236 and / or proximal to the opening(s) 220.

[0151] In some examples, the wire 230 can optionally remain in the tensioned state during insertion of the balloon catheter 362 thereover into the inner shaft lumen 310. In some examples, the wire 230 can optionally remain in the tensioned state during partial advancement of the balloon catheter 362 thereover. Prior to approximation of the distal end portion of dilation apparatus 350 to the loop 236, the wire 230 is moved back into the loose state, sufficientlyenlarging the perimeter of the loop 236 to release the guidewire 250 and allow the distal end portion of the dilation apparatus 350, including balloon catheter 362 and hole-dilating balloon 368, to be axially passed over the guidewire 250, through the loop 236, towards and into the pilot puncture 50 of the leaflet 10.

[0152] As mentioned above, movement of the wire 230 from the tensioned state to the loose state can be either passive, for example when the wire 230 is biased, optionally by a biasing member (not shown), to the loose state, and / or actively, for example by actuating a mechanism configured to actively push the wire portion(s) 234 in a distal direction through the channel(s) 218.

[0153] The hole-dilating balloon 368 is configured to transition between a radially deflated state, shown for example in Fig. 10, and a radially inflated state, shown for example in Fig. 11. The hole-dilating balloon 368 is configured to be positioned inside the pilot puncture 50, and expand the pilot puncture to form a tissue opening, such as a leaflet opening 52, as shown in Fig. 11.

[0154] The balloon catheter 362 can define a balloon catheter lumen 364 (indicated, for example, in Fig. 11), through which the guide wire 250, and one or more additional shafts of the dilation apparatus 350, can optionally extend. The balloon catheter 362 can extend from a balloon catheter adaptor 372 that includes a first adaptor port 374a configured to receive guide wire 250 therethrough, and a second adaptor port 374b configured to be fluidly connectable to a fluid source (not shown) for inflating the hole-dilating balloon 368. 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 368. The inflation fluid source is in fluid communication with the balloon catheter lumen 364, such that fluid from the fluid source can flow through the balloon catheter lumen 364 into hole-dilating balloon 368 to inflate it.

[0155] In some examples, an inflatable balloon 368 of dilation apparatus 350, utilized as a hole-dilating balloon, can be different from a typical balloon used for expanding balloonexpandable 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 overexpansion) the diameter of the native annulus in which the valve is deployed, the maximum diameter of a hole-dilating balloon 368 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 torn by a hole-dilating balloon 368).

[0156] 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 368 can be inflated is equal to or less than 12 mm. In some examples, the maximum diameter to which the hole-dilating balloon 368 can be inflated is equal to or less than 10 mm. Nevertheless, as mentioned above, in some examples a holedilating balloon 368 can be configured to tear a host leaflet 10, in which case the maximum diameter to which the hole-dilating balloon 368 can be greater than 12 mm., such as in a range of 20-25 mm.

[0157] In some examples, a dilation apparatus 350 can further include a dilator 352 that can be conical or frustoconical in shape, and include a dilator tapering portion 356 terminating at a dilator distal end 354, and a dilator proximal portion 358 that can be coupled to a dilator shaft 370 (indicated, for example, in Fig. 11) that extends proximally therefrom. A dilator lumen 360 (indicated, for example, in Fig. 10) continuously extends through the dilator shaft 370 and the dilator 352, open ended at the dilator distal end 354. Attachment of the dilator shaft 370 to the dilator proximal portion 358 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 370 can extend through the entire length of the dilator 352, such that a distal end of the dilator shaft 370 is aligned with the dilator distal end 354. In some examples (not illustrated), the dilator shaft 370 is coupled to one or more components, such as collars or other connectors, which are in turn attached to the dilator 352.

[0158] In some examples, the hole-dilating balloon 368 is coupled to a distal end portion of the balloon catheter 362 at its proximal end, while the balloon's distal end can be coupled, directly or indirectly, to another component of the dilation apparatus 350, such as the dilator 352 or dilator shaft 370. In the examples illustrated in Figs. 9-11, the hole-dilating balloon 368 is shown to be coupled to the dilator proximal portion 358. The dilator proximal portion 358 can optionally include an outer step configured to accommodate the distal end of the holedilating balloon 368, such that the outer surface of the hole-dilating balloon 368 can be flush or otherwise relatively continuous with the outer surface of the dilator 352.

[0159] In some examples, such as when the hole-dilating balloon 368 is attached at both ends thereof to the dilator 352 and balloon catheter 362, both the dilator 352 with dilator shaft 370 and the balloon catheter 362 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, axial movement of the balloon catheter362 can cause the dilator shaft 370 to move therewith, or axial movement of one of the dilator shaft 370 or dilator 352 can cause the balloon catheter 362 to move therewith.

[0160] The dilator shaft 370 can extend through the balloon catheter lumen 364, and may be sized such that an annular space is formed within balloon catheter lumen 364 between an inner surface of the balloon catheter 362 and an outer surface of the dilator shaft 370 along the length of balloon catheter 362. This annular space is in fluid communication with one or more inflation openings 366 exposed to an internal cavity of the hole-dilating balloon 368, which can be in fluid communication, via adaptor port 374h of balloon catheter adaptor 372, with a fluid source (for example, a syringe or a pump) that can inject inflation fluid (for example, saline) into the hole-dilating balloon 368, so as to inflate the balloon 368, for example during formation of a leaflet opening 52. The pressure of the inflation fluid within hole-dilating balloon 368 may provide the force that allows it to dilate a leaflet opening 52. Further, the balloon catheter lumen 364 may be configured to withdraw fluid from the balloon 368 through the inflation opening(s) 366 (indicated, for example, in Fig. 11), to deflate the balloon 368.

[0161] Figs. 10-11 illustrate some steps in an exemplary method for utilizing a dilation apparatus 350 for forming an opening by dilating a previously formed puncture in a target tissue, such as a host leaflet 10. As mentioned above, subsequent to forming the pilot puncture 50 and after retraction of the anchor device 334 and needle 318, the hole-dilating balloon 368, carried over the balloon catheter 362, can be advanced towards the host leaflet 10 according to any of the methods described above, including utilization of the wire 230 to lock the guidewire 250 in position during retraction of the needle 318 and anchor device 334, and moving the wire 230 to the loose state prior to extending and of the dilator 352, the balloon catheter 362, and hole-dilating balloon 368, through the loop 236.

[0162] In some examples, when the dilation apparatus 350 further includes a dilator 352 as also shown in the example illustrated in Fig. 9, the dilator 352 can be advanced, optionally along with the balloon catheter 362 and hole-dilating balloon 368, towards the host leaflet 10. When included in dilation apparatus 350, the dilator 352 can be inserted into the pilot puncture 50 to expand the pilot puncture 50, as shown in Fig. 10. As the dilator 352 is inserted into the host leaflet 10, the inherent resiliency of the leaflet 10 may urge the leaflet 10 radially inwardly against the dilator 352. The dilator 352 can have sufficient stiffness to facilitate advancement thereof through the leaflet 10, wherein the gradually tapering shape of the dilator 352 facilitates expanding the pilot puncture 50 to a greater diameter.

[0163] In a subsequent step of the method, the hole-dilating balloon 368 may be inserted within the pilot puncture 50, such as by further advancement of the dilator 352 with dilator shaft 370and / or balloon catheter 362. With the hole-dilating balloon 368 received within the pilot puncture 50, inflating the hole-dilating balloon 368 to transition it from a radially deflated state (Fig. 10) to a radially inflated state (Fig. 11) can expand the pilot 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 368 is inflated to form the leaflet opening 52 as shown in Fig. 11, the hole-dilating balloon 368 is deflated, optionally allowing for insertion of a guest prosthetic valve inside the leaflet opening 52.

[0164] In some examples, inflating the hole-dilating balloon 368 within the host leaflet 10 serves to increase a diameter of the pilot puncture 50 such that the resulting leaflet opening 52 is a hole with an increased diameter relative to the pilot puncture 50. In some examples in which the leaflet opening 52 is a hole, the leaflet opening 52 may be a substantially circular hole. In some examples, the leaflet opening 52 may be non-circular (for example, elliptical or asymmetric). In such examples, the diameter of the leaflet opening 52 may refer to any suitable dimension of the leaflet opening 52, such as a minimum diameter of the leaflet opening 52, a maximum diameter of the leaflet opening 52, and / or an average diameter of the leaflet opening 52.

[0165] In some examples, inflating the hole-dilating balloon 368 within the host leaflet 10 may cause the host leaflet 10 to rip and / or tear such that the leaflet opening 52 is not a bounded hole. Stated differently, in such examples, the leaflet opening 52 may be formed by a tear that extends from the pilot puncture 50 fully to the free edge of the host leaflet 10 (the coaptation edge of the leaflet).

[0166] While a dilation apparatus 350 that includes a hole-dilating balloon 368 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 member 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 instead of a valve-expanding balloon.

[0167] In some examples, retraction of the hole-dilating balloon 368, after deflation thereof, is performed while the guidewire 250 is kept in position, extending through the leaflet opening 52. Subsequent to deflation of the hole-dilating balloon 368 (or recompressing of any other type of an expansion member) 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.

[0168] In the absence of a guidewire locking mechanism, retrieval of the balloon catheter 362 can apply frictional forces against guidewire 250 that can cause accidental displacement of the guidewire 250 out of the leaflet opening 52 formed in the host leaflet 10. If the guidewire 250 is pulled out of the leaflet 10, it may be difficult or even impossible to properly navigate the replacement valve delivery assembly 380 carrying the guest prosthetic valve 100 into the leaflet opening 52. Thus, a wire 230 extending through the delivery shaft wall 214 and forming a loop 236 through which the guidewire 250 extends, can be optionally moved to the tensioned state, such as by pulling its wire portion(s) 234, so as to constrict the loop 236 around the guidewire 250 and lock the guidewire 250 in position, thereby advantageously allowing retrieval of the balloon catheter 362 of dilation apparatus 350 without posing a risk of displacing the guidewire 250.

[0169] In some examples, moving the wire 230 to the tensioned state is performed after the distal end of the dilation apparatus 350 is positioned proximal to the loop 236, such that only the guidewire 250 extends through the loop 236 itself. For example, the dilator distal end 354 can be positioned proximal to the loop 236 and / or proximal to the opening(s) 220 from which the wire 230 extends to form the loop 236, after which the wire 230 can be moved to the tensioned state, constricting the loop 236 so as to lock the guidewire 250 in position and prevent it from slipping out of the host leaflet 10. If the inner shaft 308 is extended through the loop 236 during formation of the leaflet opening 52, the inner shaft distal end 312 can be also positioned proximal to the loop 236 and / or proximal to the opening(s) 220 prior to constricting the loop 236 around the guidewire 250.

[0170] After locking the guidewire 250 by moving the wire 230 to the tensioned state, the dilation apparatus 350 can be further proximally pulled until it is fully retrieved from the patient’s body. In some examples, the inner shaft 308 can optionally be also retrieved from the patient’s body, either prior to, after, or simultaneously with the retrieval of the dilation apparatus 350.

[0171] In some examples, the wire 230 can optionally remain in the tensioned state during insertion of a valve delivery assembly 380 thereover into the delivery shaft lumen 212. In some examples, the wire 230 can optionally remain in the tensioned state during partial advancement of a balloon catheter 382 thereover of the valve delivery assembly 380 (indicated, for example, in Fig. 12). Prior to approximation of a distal end portion of valve delivery assembly 380 to the loop 236, the wire 230 is moved back into the loose state, sufficiently enlarging the perimeter of the loop 236 to release the guidewire 250 and allow the distal end portion of the valve delivery assembly 380, including balloon catheter 382 and a valve-expanding balloon 384(indicated, for example, in Fig. 12), to be axially passed over the guidewire 250, through the loop 236, towards and into the leaflet opening 52.

[0172] Fig. 12 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 380 that can be advanced towards the host leaflet 10 over the guidewire 250, optionally through the delivery shaft lumen 212.

[0173] In some examples, the guest prosthetic valve is a balloon expandable valve, and the replacement valve delivery assembly 380 comprises a balloon catheter 382 carrying a valveexpanding balloon 384. In contrast to some examples of a hole-dilating balloon 368 described above, such as a hole-dilating balloon 368 configured to form a leaflet opening 52 without tearing the host leaflet, the maximum diameter to which a valve-expanding balloon 384 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.

[0174] While a replacement valve delivery assembly 380 equipped with a valve-expanding balloon 384 at a distal end portion of a balloon catheter 382 is illustrated in Fig. 12, it is to be understood that this is shown by way of illustration and not limitation, and that a replacement valve delivery assembly 380 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.

[0175] As shown in Fig. 12, 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 384 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.

[0176] In some examples, the guest prosthetic valve can be a mechanically-expandable prosthetic valve and radial expansion thereof can be achieved by actuating a mechanicalactuator 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.

[0177] While a tissue modification system 200 is described above for use in a method for modifying a host leaflet 10 by forming a leaflet opening prior to implantation a guest prosthetic valve 100 inside a host valvular structure 12, it is to be understood that the tissue modification system 200 can be used to modify other tissues, such as by forming a puncture or opening in any target tissue.

[0178] While a delivery apparatus 202 that includes a wire 230 configured to lock and release a guidewire 250 is described above as part of a tissue modification system 200, it is to be understood that this is not meant to be limiting, and that any exemplary delivery apparatus 202 disclosed herein may be used in combination with any other shaft, catheter, apparatus or assembly extendable through the delivery shaft 210, for use in a procedure that can be applicable to the aortic valve or to other areas of the body.

[0179] In some examples, the wire 230 can be comprised in the perforation apparatus 300. For example, the inner shaft 308 of perforation apparatus 300 can be referred to as the delivery catheter that includes the one or more channels 218 described above, and the handle 302 of the perforation apparatus 300 can include an actuator, such as a knob 314, that can be rotated in one direction to move the wire 230 to the tensioned state, constricting the loop 236 to lock a guidewire 250 extending through the shaft's lumen 310, and rotated in an opposite direction to move the wire 230 to the loose state, allowing movement of the guidewire 250 through the loop 236. Any example of a wire 230 implemented as part of a delivery apparatus 202, can be applied to a wire 230 similarly implemented as part of a perforation apparatus 300, mutatis mutandis.

[0180] Fig. 13 show an enlarged perspective view of a distal portion (corresponding to region 5 of Fig. 4, for example) of an exemplary delivery apparatus 202b. Delivery apparatus 202bis an exemplary implementation of delivery apparatus 202, and thus includes all of the features described for delivery apparatus 202 throughout the current disclosure, except that the wire 230bof delivery apparatus 202bincludes a single wire portion 234 extending distally from a wire proximal end 232 situated in the handle 204, through a channel 218 formed in the wall 214 of delivery shaft 210b, towards and out an opening 220. The portion of the wire 230bthatextends out of the opening 220 forms a loop 236 which is affixed, at an affixation point 222 on the opposite end of the loop 236 (e.g., opposite to the position of the opening 220), to the delivery shaft 210b, such as optionally to the delivery shaft wall 214. For example, the opening 220 can be formed, as shown in Fig. 13, at the distal end 216 of the delivery shaft 210b, and the affixation point 222 can be positioned at the distal end 216 next to the opening 220, wherein the arc-distance between the opening 220 and the affixation point 222 can be generally similar to any example described above for an arc-distance between two openings 220 of delivery apparatus 202a, mutatis mutandis.

[0181] The wire 230bcan be affixed to delivery shaft 210bat affixation point 222 by any suitable manner, such as by welding, gluing, embedding or over-molding, and the like. Moving the wire 230bof delivery apparatus 202bto the tensioned state can be accomplished by proximally pulling the wire proximal end 232 of the wire portion 234 through the channel 218, which serve to constrict the loop 236.

[0182] Fig. 14 show an enlarged perspective view of a portion that is closer to the handle 204, corresponding for example to region 14 of Fig. 4, of an exemplary delivery apparatus 202c. Delivery apparatus 202cis an exemplary implementation of delivery apparatus 202, and thus includes all of the features described for delivery apparatus 202 throughout the current disclosure, except that the loop 236 of wire 230 of delivery apparatus 202bextends into the lumen 212 of delivery shaft 210cat a position that is proximal to the distal end 216 of delivery shaft 210c.

[0183] A cutout through the wall 214 of delivery shaft 210cis shown for illustrative purpose only, to expose the wire portion(s) 234 extending through the delivery shaft wall 214. In some examples, the opening(s) 220 of delivery apparatus 202care formed proximal to the distal end 216 of delivery shaft 210c, and are oriented towards the delivery shaft lumen 212. In some examples, the opening(s) 220 and the loop 236 extending therefrom can optionally be closer to the handle 204 than to the distal end 216 of the delivery shaft 210c. Though the guidewire 250 can extend through the lumen 212 of delivery shaft 210c, past the loop 236, such that the guidewire distal end portion 252 can be positioned distal to the distal end 216 of the delivery shaft 210c, moving the wire 230 to the tensioned state can constrict the loop 236 and cause it to press the portion of the guidewire 250 extending therethrough against the inner surface of the delivery shaft wall 214 in the same manner to any example described above, resulting in a similar position locking of the guidewire 250 to prevent undesirable displacement of its distal end portion 252.

[0184] It is to be understood that the wire 230 of delivery apparatus 202cis shown in Fig. 14 to include two wire portions 234a, 234b extending through two channels 218a, 218b by way of illustration and not limitation, and that in some examples, a wire 230 of delivery apparatus 202ccan include a single wire portion 234 extending through a corresponding channel 218 formed in a delivery shaft 210cand terminating with an opening 220 proximal to the distal end 216 of the delivery shaft 210c, with the loop 236 affixed to the delivery shaft wall at an affixation point 222, in a similar manner to that described above for an exemplary delivery apparatus 202bwith respect to Fig. 1 , mutatis mutandis.

[0185] 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

[0186] 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.

[0187] Example 1. A delivery apparatus comprising: a delivery shaft comprising: a delivery shaft lumen configured to allow extension of a guidewire therethrough; a delivery shaft wall surrounding the delivery shaft lumen and terminating at a distal end of the delivery shaft; and at least one channel extending through the delivery shaft wall and terminating at a corresponding opening of the channel; and a wire comprising: at least one wire portion extending through the at least one channel towards the opening, wherein the at least one wire portion is axially movable relative to the delivery shaft; and a loop extending from the opening, configured to allow passage of the guidewire therethrough; wherein the wire is configured to move between a loose state, in which the loop is sized to allow axial movement of the guidewire through the loop, and a tensioned state, wherein the loop is tightened around the wire in a manner that prevents axial movement of the guidewire relative to the delivery shaft.

[0188] Example 2. The apparatus of any example herein, particularly of claim 1, wherein the wire is configured to move from the loose state to the tensioned state upon proximal pulling of the at least one wire portion.

[0189] Example 3. The apparatus of any example herein, particularly of any one of examples 1-2, wherein the loop is oriented at an angle relative to the at least one wire portion.

[0190] Example 4. The apparatus of any example herein, particularly of any one of examples 1-3, wherein the loop extends towards a central longitudinal axis of the delivery shaft.

[0191] Example 5. The apparatus of any example herein, particularly of any one of examples 1-3, wherein, when the wire is in the loose state, the loop extends past a central longitudinal axis of the delivery shaft.

[0192] Example 6. The apparatus of any example herein, particularly of any one of examples 1-5, wherein, when the wire is in the tensioned state, the loop is configured to press the guidewire against the delivery shaft wall.

[0193] Example 7. The apparatus of any example herein, particularly of any one of examples 1-6, wherein, when the wire is in the loose state, the loop is sized to allow axial movement of an inner shaft extendable over the guidewire, through the delivery shaft lumen and through the loop.

[0194] Example 8. The apparatus of any example herein, particularly of any one of examples 1-7, wherein the loop defines a diameter that is greater in the loose state than in the tensioned state.

[0195] Example 9. The apparatus of any example herein, particularly of claim 8, wherein the diameter of the loop in the loose state is greater than 75% of a diameter of the delivery shaft lumen.

[0196] Example 10. The apparatus of any example herein, particularly of claim 8, wherein the diameter of the loop in the loose state is greater than 90% of a diameter of the delivery shaft lumen.

[0197] Example 11. The apparatus of any example herein, particularly of any one of examples 1-10, wherein the at least one wire portion comprises a first wire portion and a second wire portion, and wherein the at least one channel comprises a first channel terminating at a first opening, and a second channel terminating at a second opening.

[0198] Example 12. The apparatus of any example herein, particularly of claim 11, wherein an arc-distance between the first opening and the second opening is less than 30% of the perimeter of the delivery shaft.

[0199] Example 13. The apparatus of any example herein, particularly of claim 11, wherein an arc-distance between the first opening and the second opening is less than 20% of the perimeter of the delivery shaft.

[0200] Example 14. The apparatus of any example herein, particularly of claim 11, wherein an arc-distance between the first opening and the second opening is less than 10% of the perimeter of the delivery shaft.

[0201] Example 15. The apparatus of any example herein, particularly of any one of examples 1-14, wherein the wire is configured to move from the loose state to the tensioned state upon simultaneous pulling of the first and second wire portions.

[0202] Example 16. The apparatus of any example herein, particularly of any one of examples 1 -14, wherein the wire is configured to move from the loose state to the tensioned state upon pulling of the first wire portion, while maintaining the second wire portion axially immovable.

[0203] Example 17. The apparatus of any example herein, particularly of any one of examples 1-10, wherein the at least one wire portion comprises a single wire portion, and wherein the loop is affixed to the delivery shaft wall at an affixation point.

[0204] Example 18. The apparatus of any example herein, particularly of claim 17, wherein an arc-distance between the opening of the channel and the affixation point is less than 30% of the perimeter of the delivery shaft.

[0205] Example 19. The apparatus of any example herein, particularly of claim 17, wherein an arc-distance between the opening of the channel and the affixation point is less than 20% of the perimeter of the delivery shaft.

[0206] Example 20. The apparatus of any example herein, particularly of claim 17, wherein an arc-distance between the opening of the channel and the affixation point is less than 10% of the perimeter of the delivery shaft.

[0207] Example 21. The apparatus of any example herein, particularly of any one of examples 1-20, wherein the at least one opening is formed at the distal end of the delivery shaft.

[0208] Example 22. The apparatus of any example herein, particularly of claim 21, wherein the loop is distal to the distal end of the delivery shaft.

[0209] Example 23. The apparatus of any example herein, particularly of any one of examples 1-20, wherein the at least one opening is proximal to the distal end of the delivery shaft.

[0210] Example 24. The apparatus of any example herein, particularly of claim 23, wherein the at least one opening is oriented towards the delivery shaft lumen.

[0211] Example 25. The apparatus of any example herein, particularly of any one of examples 23-24, wherein the loop extends into the delivery shaft lumen.

[0212] Example 26. The apparatus of any example herein, particularly of any one of examples 1-25, wherein the delivery shaft is a steerable shaft.

[0213] Example 27. The apparatus of any example herein, particularly of any one of examples 1-26, further comprising a handle from which the delivery shaft distally extends.

[0214] Example 28. The apparatus of any example herein, particularly of claim 27, wherein the wire comprises at least one wire proximal end extending into the handle.

[0215] Example 29. The apparatus of any example herein, particularly of claim 28, wherein the handle comprises a knob configured to control axial movement of the at least one wire proximal end.

[0216] Example 30. A method comprising: advancing a delivery shaft of a delivery apparatus, over a guidewire, towards a target site of treatment, wherein the guidewire extends through a loop of a wire of the delivery apparatus, and wherein the wire is maintained is a loose state; advancing an inner shaft, over the guidewire, through the delivery shaft and the loop; locking the axial position of the guidewire by moving the wire from the loose state to a tensioned state thereof; and retracting the inner shaft out of the delivery shaft.

[0217] Example 31. The method of any example herein, particularly of claim 30, further comprising, prior to the locking the axial position of the guidewire, axially positioning a distal end of the inner shaft proximal to the loop.

[0218] Example 32. The method of any example herein, particularly of any one of examples 30-31, wherein the wire further comprises at least one wire portion axially extending through at least one channel formed in a wall of the delivery shaft, towards an opening of the channel, and wherein the loop extends out of the opening.

[0219] Example 33. The method of any example herein, particularly of claim 32, wherein the moving the wire from the loose state to a tensioned state comprises proximally pulling the at least one wire portion.

[0220] Example 34. The method of any example herein, particularly of any one of examples 32-33, wherein the at least one wire portion comprises a single wire portion, and wherein the loop is affixed to the delivery shaft wall at an affixation point.

[0221] Example 35. The method of any example herein, particularly of claim 32, wherein the at least one wire portion comprises a first wire portion and a second wire portion, and wherein the at least one channel comprises a first channel and a second channel.

[0222] Example 36. The method of any example herein, particularly of claim 35, wherein the moving the wire from the loose state to a tensioned state comprises simultaneously pulling the first wire portion and the second wire portion.

[0223] Example 37. The method of any example herein, particularly of any one of examples 30-36, wherein the loop extends from a distal end of the delivery shaft.

[0224] Example 38. The method of any example herein, particularly of any one of examples 30-36, wherein the loop is proximal to a distal end of the delivery shaft.

[0225] Example 39. The method of any example herein, particularly of any one of examples 30-38, wherein the moving the wire from the loose state to a tensioned state comprises constriction the loop.

[0226] Example 40. The method of any example herein, particularly of any one of examples 30-39, wherein the moving the wire from the loose state to a tensioned state comprises tightening the loop around the guidewire.

[0227] Example 41. The method of any example herein, particularly of any one of examples 30-39, wherein the moving the wire from the loose state to a tensioned state comprises pressing the guidewire against an inner surface of the delivery shaft.

[0228] Example 42. The method of any example herein, particularly of any one of examples 30-41, further comprising, before the locking the axial position of the guidewire, forming a pilot puncture in a leaflet at the target site of treatment, and extending the guidewire through the leaflet opening.

[0229] Example 43. The method of any example herein, particularly of claim 42, wherein the forming the pilot puncture comprises advancing an anchor device through the inner shaft toward the leaflet.

[0230] Example 44. The method of any example herein, particularly of claim 43, wherein the forming the pilot puncture further comprising, after the advancing the anchor device, anchoring an anchor head of the anchor device to the leaflet.

[0231] Example 45. The method of any example herein, particularly of claim 44, wherein the forming the pilot puncture further comprising, after the anchoring the anchor head, advancing a needle head of a needle extending over the guidewire through the anchor device, against the leaflet.

[0232] Example 46. The method of claim 45, wherein the needle head comprises an angled surface and terminates at a needle tip.

[0233] Example 47. The method of any example herein, particularly of claim 46, wherein the forming the pilot puncture comprises piercing the target tissue by the needle tip.

[0234] Example 48. The method of any example herein, particularly of any one of examples 45-47, further comprising, after the forming the pilot puncture, releasing the anchor head from the leaflet.

[0235] Example 49. The method of any example herein, particularly of any one of examples 45-48, further comprising, after the forming the pilot puncture and before the locking the axialposition of the guidewire, positioning the anchor head and the needle head proximal to the loop.

[0236] Example 50. The method of any example herein, particularly of claim 49, further comprising, after the locking the axial position of the guidewire, retrieving the anchor device and the needle.

[0237] Example 51. The method of any example herein, particularly of claim 50, further comprising, after the retrieving the anchor device and the needle, distally advancing a dilation apparatus over the guidewire.

[0238] Example 52. The method of any example herein, particularly of claim 51, wherein the distally advancing the dilation apparatus comprises passing the dilation apparatus through the loop.

[0239] Example 53. The method of any example herein, particularly of claim 52, further comprising, prior to passing the dilation apparatus through the loop, releasing the guidewire by moving the wire from the tensioned state to the loose state.

[0240] Example 54. The method of any example herein, particularly of claim 53, wherein the dilation apparatus comprises an expansion member configured to transition between a compacted state and an expanded state thereof.

[0241] Example 55. The method of any example herein, particularly of claim 54, wherein the dilation apparatus further comprises a dilator distal to the expansion member, and a dilator shaft attached to the dilator and extending proximally therefrom.

[0242] Example 56. The method of any example herein, particularly of claim 55, wherein the dilator comprises a tapering portion.

[0243] Example 57. The method of any example herein, particularly of claim 56, further comprising, after the passing the dilation apparatus through the loop, passing the dilator through the pilot puncture, thereby expanding the pilot puncture.

[0244] Example 58. The method of any example herein, particularly of any one of examples 54-57, further comprising, after the passing the dilation apparatus through the loop, positioning the expansion member, in its compacted state, within the pilot puncture.

[0245] Example 59. The method of any example herein, particularly of claim 58, further comprising, after the positioning the expansion member inside the pilot puncture, expanding the expansion member inside the pilot puncture to dilate the pilot puncture and form a leaflet opening within the leaflet.

[0246] Example 60. The method of any example herein, particularly of claim 59, further comprising, after the expanding the expansion member, compressing the expansion member.

[0247] Example 61. A delivery apparatus comprising: a delivery shaft comprising: a shaft wall defining a lumen; and a first channel extending through and along the shaft wall and comprising a first distal opening; and a wire extending through the first channel and through the first distal opening, the wire forming an adjustable loop over at least a portion of the lumen of the delivery shaft.

[0248] Example 62. The delivery apparatus of any example herein, particularly of claim 61, wherein the adjustable loop is configured to move between a loose state and a tensioned state, wherein the adjustable loop is sized to allow axial movement of a delivery device through the adjustable loop when in the loose state, and wherein the adjustable loop is tightened around the delivery device in a manner that prevents axial movement of the delivery device through the adjustable loop when in the tensioned state.

[0249] Example 63. The delivery apparatus of any example herein, particularly of any one of examples 61-62, wherein the delivery shaft comprises a second channel extending through and along the shaft wall and comprising a second distal opening, and wherein the wire extends through the second channel and through the second distal opening.

[0250] Example 64. The delivery apparatus of any example herein, particularly of any one of examples 61-63, wherein a first end of the wire and a second end of the wire are attached to a delivery handle proximally attached to the delivery shaft, wherein the delivery handle comprises a mechanism configured to pull and the wire and create tension in the wire.

[0251] Example 65. The delivery apparatus of any example herein, particularly of any one of examples 61-62, wherein a first end of the wire is affixed to a portion of the delivery shaft, and a second end of the wire is attached to a delivery handle proximally attached to the delivery shaft, wherein the delivery handle comprises a mechanism configured to pull and the wire and create tension in the wire.

[0252] Example 66. The delivery apparatus of any example herein, particularly of claim 65, wherein the first end of the wire is attached proximate to the distal end of the delivery shaft.

[0253] Example 67. The delivery apparatus of any example herein, particularly of any one of examples 61-66, wherein the adjustable loop is positioned distal to the distal end of the delivery shaft.

[0254] Example 68. The delivery apparatus of any example herein, particularly of any one of examples 61-66, wherein the adjustable loop is positioned proximal to the distal end of the delivery shaft and within the lumen of the delivery shaft.

[0255] 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.

[0256] In view of the many possible examples to which the principles of the disclosure may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope. Rather, the scope is defined by the following claims. We therefore claim all that comes within the scope and spirit of these claims.

Claims

WE CLAIM:

1. A delivery apparatus comprising: a delivery shaft comprising: a delivery shaft lumen configured to allow extension of a guidewire therethrough; a delivery shaft wall surrounding the delivery shaft lumen and terminating at a distal end of the delivery shaft; and at least one channel extending through the delivery shaft wall and terminating at a corresponding opening of the channel; and a wire comprising: at least one wire portion extending through the at least one channel towards the opening, wherein the at least one wire portion is axially movable relative to the delivery shaft; and a loop extending from the opening, configured to allow passage of the guidewire therethrough; wherein the wire is configured to move between a loose state, in which the loop is sized to allow axial movement of the guidewire through the loop, and a tensioned state, wherein the loop is tightened around the wire in a manner that prevents axial movement of the guidewire relative to the delivery shaft.

2. The apparatus of claim 1, wherein the wire is configured to move from the loose state to the tensioned state upon proximal pulling of the at least one wire portion.

3. The apparatus of any one of claims 1-2, wherein the loop is oriented at an angle relative to the at least one wire portion.

4. The apparatus of any one of claims 1-3, wherein the loop extends towards a central longitudinal axis of the delivery shaft.

5. The apparatus of any one of claims 1-3, wherein, when the wire is in the loose state, the loop extends past a central longitudinal axis of the delivery shaft.

6. The apparatus of any one of claims 1-5, wherein, when the wire is in the tensioned state, the loop is configured to press the guidewire against the delivery shaft wall.

7. The apparatus of any one of claims 1-6, wherein, when the wire is in the loose state, the loop is sized to allow axial movement of an inner shaft extendable over the guidewire, through the delivery shaft lumen and through the loop.

8. The apparatus of any one of claims 1-7, wherein the at least one wire portion comprises a first wire portion and a second wire portion, and wherein the at least one channelcomprises a first channel terminating at a first opening, and a second channel terminating at a second opening.

9. The apparatus of claim 8, wherein an arc-distance between the first opening and the second opening is less than 30% of the perimeter of the delivery shaft.

10. The apparatus of any one of claims 1-9, wherein the at least one wire portion comprises a single wire portion, and wherein the loop is affixed to the delivery shaft wall at an affixation point.1 1 . The apparatus of claim 10, wherein an arc-distance between the opening of the channel and the affixation point is less than 30% of the perimeter of the delivery shaft.

12. The apparatus of any one of claims 1-11, wherein the at least one opening is formed at the distal end of the delivery shaft.

13. The apparatus of any one of claims 1-11, wherein the at least one opening is proximal to the distal end of the delivery shaft.

14. The apparatus of claim 13, wherein the loop extends into the delivery shaft lumen.

15. A method comprising : advancing a delivery shaft of a delivery apparatus, over a guidewire, towards a target site of treatment, wherein the guidewire extends through a loop of a wire of the delivery apparatus, and wherein the wire is maintained is a loose state; advancing an inner shaft, over the guidewire, through the delivery shaft and the loop; locking the axial position of the guidewire by moving the wire from the loose state to a tensioned state thereof; and retracting the inner shaft out of the delivery shaft.

16. The method of claim 15, further comprising, prior to the locking the axial position of the guidewire, axially positioning a distal end of the inner shaft proximal to the loop.

17. The method of any one of claims 15-16, wherein the moving the wire from the loose state to a tensioned state comprises tightening the loop around the guidewire.

18. The method of any one of claims 15-16, wherein the moving the wire from the loose state to a tensioned state comprises pressing the guidewire against an inner surface of the delivery shaft.

19. The method of any one of claims 15-18, further comprising, before the locking the axial position of the guidewire, forming a pilot puncture in a leaflet at the target site of treatment, and extending the guidewire through the leaflet opening.

20. The method of claim 19, wherein the forming the pilot puncture comprises advancing an anchor device through the inner shaft toward the leaflet.

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