Prosthetic valves and delivery assemblies therefor

Abstract

The present disclosure relates to prosthetic valves and delivery assemblies therefor. In an example, a prosthetic valve comprises an annular frame movable between a radially compressed state and a radially expanded state, the frame comprising an outflow cell row and a plurality of subsequent cell rows distal to the outflow cells row. The outflow cell row comprises a plurality of first outflow cells and a plurality of second outflow cells which are wider than the first outflow cells, wherein each second outflow cells spans a width of two cells of the subsequent cell rows.

Description

Attorney Docket No: THVVA-23974WO01PROSTHETIC VALVES AND DELIVERY ASSEMBLIES THEREFORCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 681,362, filed August 9, 2024, which is incorporated by reference herein.FIELD

[0002] The present disclosure relates to implantable, radially expandable prosthetic devices, such as prosthetic valves, and delivery assemblies therefor.BACKGROUND

[0003] Native heart valves, such as the aortic, pulmonary and mitral valves, function to assure adequate directional flow from and to the heart, and between the heart's chambers, to supply blood to the whole cardiovascular system. Various valvular diseases can render the valves ineffective and require replacement with artificial valves. Surgical procedures can be performed to repair or replace a heart valve. Surgeries are prone to an abundance of clinical complications, hence alternative less invasive techniques of delivering a prosthetic heart valve over a catheter and implanting it over the native malfunctioning valve, have been developed over the years.

[0004] Different types of prosthetic heart valves are known to date, including balloon expandable valve, self-expandable valves and mechanically-expandable valves. Different methods of delivery and implantation are also known, and may vary according to the site of implantation and the type of prosthetic valve. One exemplary technique includes utilization of a delivery assembly for delivering a prosthetic valve in a crimped state, from an incision which can be located at the patient's femoral or iliac artery, towards the native malfunctioning valve. Once the prosthetic valve is properly positioned at the desired site of implantation, it can be expanded against the surrounding anatomy, such as an annulus of a native valve, and the delivery assembly can be retrieved thereafter.SUMMARY

[0005] Described herein are prosthetic valves, and delivery assemblies comprising such prosthetic valves mounted on a delivery apparatus.

[0006] In one of its basic configurations, a delivery assembly comprises a prosthetic valve comprising an annular frame movable between a radially compressed state and a radiallyAttorney Docket No: THVVA-23974WO01 expanded state, wherein the frame comprises an outflow eyelet extending from an outflow end of the frame, and an inflow eyelet extending from an inflow end of the frame. 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.

[0007] In some examples, the frame comprises an outflow cell row comprising a plurality of outflow cells.

[0008] In some examples, the frame further comprises a plurality of subsequent cell rows distal to the outflow cell row, each subsequent cell row comprising a plurality of subsequent cells;

[0009] In some examples, the frame further comprises an inflow cell row distal to the plurality of subsequent cell rows, the inflow cell row comprising a plurality of inflow cells.

[0010] In some examples, the outflow eyelet extends from one of the first outflow cells.

[0011] In some examples, the inflow eyelet extends from one of the inflow cells.

[0012] In some examples, the frame an outflow rung comprising a plurality of outflow angled struts.

[0013] In some examples, the frame further comprises a plurality of subsequent rungs distal to the outflow rung, each of the subsequent rungs comprising a plurality of subsequent angled struts.

[0014] In some examples, the frame further comprises an inflow rung distal to the plurality of subsequent rungs and comprising a plurality of inflow angled struts.

[0015] In some examples, the frame further comprises a plurality of axially extending struts that extend between the outflow rung and a proximal-most subsequent rung of the plurality of subsequent rungs.

[0016] In some examples, the outflow eyelet extends distally from the outflow end.

[0017] In some examples, the inflow eyelet extends proximally from the inflow end.

[0018] In some examples, the outflow eyelet extends into the corresponding outflow cell.

[0019] In some examples, the inflow eyelet extends into the corresponding inflow cell.

[0020] In some examples, the inflow eyelet and the outflow eyelet are circumferentially aligned with each other.

[0021] In some examples, the prosthetic valve further comprises a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.Attorney Docket No: THVVA-23974WO01

[0022] In some examples, each leaflet extends between a cusp edge and a free edge thereof.

[0023] In some examples, the outflow eyelet extends proximally from the outflow end.

[0024] In some examples, the inflow eyelet extends distally from the inflow end.

[0025] In some examples, the inflow eyelet is bent radially inwards.

[0026] In some examples, the inflow eyelet is bent radially inwards relative to a plane defined by the corresponding inflow cell.

[0027] In some examples, the outflow eyelet is bent radially inwards relative to a plane defined by the corresponding outflow cell.

[0028] In some examples, the inflow eyelet and the outflow eyelet are circumferentially aligned with each other.

[0029] In some examples, the outflow eyelet is one of a plurality of outflow eyelets.

[0030] In some examples, the inflow eyelet is one of a plurality of inflow eyelets.

[0031] In some examples, the plurality of outflow cells comprises a plurality of first outflow cells and a plurality of second outflow cells which are wider than the first outflow cells.

[0032] In some examples, each second outflow cell spans a width of two subsequent cells of a proximal-most cell row of the plurality of subsequent cell rows.

[0033] In some examples, each first outflow cell has a width equal to that of a subsequent cell of the proximal-most subsequent cell row.

[0034] In some examples, the proximal-most subsequent cell row comprises fifteen subsequent cells.

[0035] In some examples, the outflow cell row comprises three first outflow cells and six second outflow cells.

[0036] In some examples, the plurality of outflow angled struts comprises a plurality of first outflow angled struts and a plurality second outflow angled struts which are longer than the first outflow angled struts.

[0037] In some examples, the outflow eyelet is connected to, and extends from, a junction connecting a pair of the first outflow angled struts.

[0038] In some examples, each pair of second outflow angled struts defines an outflow apex at an outflow end of the frame.

[0039] In some examples, the proximal-most subsequent rung further defines a plurality of free apices which are circumferentially aligned with the outflow apices.

[0040] In some examples, each first outflow cell is defined by two of the first outflow angled struts, two of the axially extending struts, and two of the subsequent angled struts of the proximal-most subsequent rung.Attorney Docket No: THVVA-23974WO01

[0041] In some examples, each second outflow cell is defined by two of the second outflow angled struts, two of the axially extending struts, and four of the subsequent angled struts of the proximal-most subsequent rung.

[0042] In some examples, the delivery assembly further comprises a delivery apparatus comprising a balloon catheter and an inflatable balloon mounted on the balloon catheter.

[0043] In some examples, the prosthetic valve is disposed around the balloon.

[0044] In some examples, the delivery apparatus comprises a first adjustment string extending through the outflow eyelet and terminating at a first loop disposed radially outwards to the prosthetic valve.

[0045] In some examples, the delivery apparatus comprises a second adjustment string extending through the inflow eyelet and terminating at a second loop disposed radially outwards to the prosthetic valve.

[0046] In some examples, the delivery apparatus comprises a locking wire extending through the first loop and the second loop.

[0047] In some examples, the locking wire is axially slidable through and relative to the first loop and the second loop.

[0048] In some examples, the locking wire is configured to limit axial displacement of the prosthetic valve when it extends through the first loop and the second loop.

[0049] In some examples, the locking wire is configured to prevent the first loop from slipping out of the outflow eyelet when it extends through the first loop.

[0050] In some examples, the locking wire is configured to prevent the second loop from slipping out of the inflow eyelet when it extends through the second loop.

[0051] In some examples, when the locking wire is pulled out of the first loop and the second loop, the first adjustment string is configured to slide out of the outflow eyelet, and the second adjustment string is configured to slide out of the inflow eyelet, upon expansion of the prosthetic valve.

[0052] In some examples, the first adjustment string extending radially inwards through the outflow eyelet, across a junction connecting the outflow eyelet to the outflow cell, and radially outwards through the outflow cell, terminating at a first loop disposed radially outwards to the prosthetic valve.

[0053] In some examples, the free edges of the leaflets are distal to the outflow end of the frame.

[0054] In some examples, the free edges of the leaflets are distal to the outflow eyelet.Attorney Docket No: THVVA-23974WO01

[0055] In some examples, a portion of the first adjustment wire which is positioned radially inwards to the frame, is axially offset from the free edge of the leaflet which is circumferentially aligned therewith.

[0056] In some examples, the delivery apparatus further comprises an outer shaft disposed around, and axially movable relative to, the balloon catheter.

[0057] In some examples, the delivery apparatus further comprises a handle from which the balloon catheter distally extends.

[0058] In some examples, the first adjustment string extends distally from the handle.

[0059] In some examples, the second adjustment string extends distally from the handle to a position distal to the prosthetic valve, then bending backwards and extending proximally towards the inflow eyelet.

[0060] In some examples, each of the first adjustment string and the second adjustment string is configured to be independently tensioned or released.

[0061] In some examples, the first adjustment string axially extends between the balloon catheter and the outer shaft.

[0062] In some examples, the delivery apparatus further comprises a nosecone positioned distal to the balloon.

[0063] In some examples, the delivery apparatus further comprises a nosecone shaft extending proximally from the nosecone.

[0064] In some examples, the second adjustment string extends through the nosecone shaft.

[0065] In some examples, the nosecone comprises a side opening defining the position distal to the prosthetic valve through which the second adjustment string extends.

[0066] In some examples, when the locking wire extends through the first loop and the second loop, tensioning the first adjustment string and releasing the second adjustment string is configured to move the prosthetic valve in the proximal direction.

[0067] In some examples, when the locking wire extends through the first loop and the second loop, tensioning the second adjustment string and releasing the first adjustment string is configured to move the prosthetic valve in the distal direction.

[0068] In some examples, when the locking wire extends through the first loop and the second loop, simultaneously tensioning the first adjustment string and the second adjustment string is configured to axially lock the prosthetic valve in position.

[0069] 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 orAttorney Docket No: THVVA-23974WO01 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

[0070] 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:

[0071] Fig. 1A is a perspective view of an exemplary prosthetic valve.

[0072] Fig. IB is a side view of an annular frame of the prosthetic valve of Fig. 1A.

[0073] Fig. 2 shows an exemplary delivery assembly comprising a delivery apparatus carrying a prosthetic valve.

[0074] Fig. 3 is a cross-sectional view of a multi-way hub of an exemplary delivery apparatus.

[0075] Fig. 4 is a cross-sectional view of a distal portion of an exemplary delivery apparatus.

[0076] Figs. 5 A-5D shows stages in an exemplary method for deployment of a prosthetic valve utilizing a delivery assembly that includes an axial securement mechanism.

[0077] Fig. 6 is a perspective view of an exemplary frame that includes eyelets extending into the corresponding cells.

[0078] Fig. 7 is a perspective view of an exemplary frame that includes inwardly bent eyelets.

[0079] Fig. 8 shows an exemplary delivery assembly that includes adjustment string extending radially outwards through the corresponding eyelets.

[0080] Fig. 9 shows an exemplary delivery assembly that includes adjustment string extending radially inwards through the corresponding eyelets.

[0081] Fig. 10 shows an exemplary delivery apparatus that includes independently controllable adjustment strings.

[0082] Fig. 11 shows an enlarged view of a distal end portion of the delivery apparatus of Fig. 10.

[0083] Fig. 12 is a flattened view of a part of an exemplary frame that includes two types of outflow cells.Attorney Docket No: THVVA-23974WO01DETAILED DESCRIPTION

[0084] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present, or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology.

[0085] 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.

[0086] 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.

[0087] 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.”Attorney Docket No: THVVA-23974WO01

[0088] 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.

[0089] The term "plurality” or "plural” when used together with an element means two or more of the element. Directions and other relative references (e.g., 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.

[0090] The term "proximal,” as used herein, generally refers to a position, direction, or portion of any device or a component of a device, which is closer to a user of a delivery apparatus that can be used to implant the device in the patient and farther away from the implantation site. 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 device. The term "distal,” as used herein, generally refers to a position, direction, or portion of any device or a component of a device, which is further away from the user and closer to the implantation site. 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.

[0091] 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.

[0092] Figs. 1 A and IB show perspective views of an example of a prosthetic valve 100, with and without soft components (such as a skirt and a valvular structure), respectively. Fig. 2Attorney Docket No: THVVA-23974WO01 shows a perspective view of an exemplary delivery assembly 200. The delivery assembly 200 can include the prosthetic valve 100 and a delivery apparatus 202. The prosthetic valve 100 can be on or releasably coupled to the delivery apparatus 202.

[0093] 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 valves can be crimped on or retained by an implant delivery apparatus 202 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.

[0094] A prosthetic valve 100 of the current disclosure may include any prosthetic valve configured to be mounted within the native aortic valve, the native mitral valve, the native pulmonary valve, and the native tricuspid valve.

[0095] It is to be 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. Self-expandable valves include a frame that is shape-set to automatically expand as soon an outer retaining shaft or capsule (not shown) is withdrawn proximally relative to the prosthetic valve. Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion. The mechanical actuation mechanism usually includes a plurality of expansion and locking assemblies (such as the prosthetic valves described in U.S. Patent No. 10,603,165, International Application No. PCT / US2021 / 052745, and U.S. Provisional Application Nos. 63 / 085,947 and 63 / 209904, each of which is incorporated herein by reference in its entirety), releasably coupled to respective actuation assemblies of a delivery apparatus, controlled via a handle (not shown) for actuating the expansion and locking assemblies to expand the prosthetic valve to a desired diameter. The expansion and locking assemblies may optionally lock the valve's diameter to prevent undesired recompression thereof, and disconnection of the actuation assemblies from the expansion and locking assemblies, to enable retrieval of the delivery apparatus once the prosthetic valve is properly positioned at the desired site of implantation.Attorney Docket No: THVVA-23974WO01

[0096] A catheter deliverable prosthetic valve 100 can be delivered to the site of implantation via the delivery assembly carrying the valve 100 in a radially compressed or crimped state, toward the target site, to be mounted against the native anatomy, by expanding the prosthetic valve 100. Balloon expandable valves 100 generally involve a procedure of inflating a balloon 240 within a prosthetic valve 100, thereby expanding the prosthetic valve 100 within the desired implantation site. Once the valve is sufficiently expanded, the balloon 240 is deflated and retrieved along with the delivery apparatus 202. The delivery assembly 200 can be utilized, for example, to deliver a prosthetic aortic valve for mounting against the aortic annulus, to deliver a prosthetic mitral valve for mounting against the mitral annulus, or to deliver a prosthetic valve for mounting against any other native annulus.

[0097] The term "plurality", as used herein, means more than one.

[0098] The prosthetic valve 100 comprises an inflow end 104 and an outflow end 106. In some instances, the inflow end 104 is the distal end of the prosthetic valve 100, and the outflow end 106 is the proximal end of the prosthetic valve 100. Alternatively, depending for example on the delivery approach of the valve, the inflow end can be the proximal end of the prosthetic valve, and the outflow end can be the distal end of the prosthetic valve.

[0099] 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.

[0100] The term "inflow", as used herein, refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve 100.

[0101] 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.

[0102] The terms "longitudinal” and "axial,” as used herein, refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0103] The valve 100 comprises an annular frame 102 movable between a radially compressed state and a radially expanded state, and a valvular structure 170 mounted within the frame 102. The frame 102 can be made of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol). When constructed of a plastically- expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state on a balloon catheter 214, and then expanded inside a patient by an inflatable balloon 240. When constructed of a self-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state byAttorney Docket No: THVVA-23974WO01 insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0104] Suitable plastically-expandable materials that can optionally be used to form the frames disclosed herein (e.g., the frame 102) include metal alloys, polymers, or combinations thereof. Example metal alloys can optionally comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 102 comprises stainless steel. In some examples, the frame 102 comprises cobalt-chromium. In some examples, the frame 102 comprises nickel-cobalt-chromium. In some examples, the frame 102 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS technologies), which is equivalent to UNS R3OO35 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0105] In the example illustrated in Figs. 1A-1B, the frame 102 is an annular, stent-like structure comprising a plurality of intersecting struts 108. In this application, the term "strut" 108 encompasses vertical struts, angled or curved struts, support posts, commissure windows, 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 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.

[0106] Figs. 1 A-1B show an exemplary prosthetic valve 100 that can be representative of, but is not limited to, a balloon expandable prosthetic valve. The interconnected struts 108 comprise a plurality of angled struts 110 arranged in a plurality of circumferentially extending rungs 112 of angled struts, with the strut rungs 112 being arrayed along the length of the frame 102 between the outflow end 106 and the inflow end 104. Struts 108 of the frame 102 can optionally further include a plurality of axially extending struts 114. The term "axially extending strut" refers to a strut or a component of the frame 102 that generally extends in an axial direction, while the term "angled strut" generally refers to a strut that can extend at an angle relative to an axial line intersecting therewith along a plane defined by the frame 102. It is to be understood that the term "angled strut" encompasses both linear angled struts and curved struts.

[0107] Two or more struts 108 can intersect at junctions 124, which can be equally or unequally spaced apart from each other. The struts 108 may be pivotable or bendable relativeAttorney Docket No: THVVA-23974WO01 to each other, so as to permit frame expansion or compression. For example, the frame 102 can be formed from a single piece of material, such as a metal tube, via various processes such as, but not limited to, laser cutting, electroforming, and / or physical vapor deposition, while retaining the ability to collapse / expand radially in the absence of hinges and like.

[0108] In some examples, the frame 102 further comprises a plurality of outflow apices 122 at the outflow end 106 of the frame, and a plurality of inflow apices 120 at the inflow end 104 of the frame. A plurality of intermediate junctions 124 are disposed between the inflow end 104 and outflow end 106.

[0109] The frame 102 of a prosthetic valve 100 comprises an inflow rung 1121 of inflow angled struts 1101 at the inflow end 104 of the frame, an outflow rung 1120 of outflow angled struts 110O at the outflow end 106 of the frame, and a plurality of subsequent rungs 112S arranged between the inflow rung 1121 and the outflow rung 1120, each comprising a plurality of subsequent angled struts 110S.

[0110] The frame 102 further comprises an inflow cell row 1181 comprising a plurality of inflow cells 1161 at the inflow end 104 of the frame 102, an outflow cell row 1180 of outflow cells 1160 at the outflow end 106 of the frame 102, and optionally one or more subsequent cell rows 118S arranged between the inflow cell row 1181 and the outflow cell row 1180, each comprising a plurality of subsequent cells 116S.

[0111] An exemplary frame 102 illustrated in Figs. 1A-1B is shown to include a first subsequent rung 112S1 proximal to the inflow rung 1121 and comprising subsequent angled struts 1 10S1, a second subsequent rung 112S2 proximal to the first subsequent rung 112S1 and comprising subsequent angled struts 110S2, a third subsequent rung 112S3 proximal to the second subsequent rung 112S2 and comprising subsequent angled struts 11 OS 3, a fourth subsequent rung 112S4 proximal to the third subsequent rung 112S3 and comprising subsequent angled struts 110S4, and an outflow rung 1120 proximal to the fourth subsequent rung 112S4 and comprising outflow angled struts 110O.

[0112] Similarly, the frame 102 is shown to include a first subsequent cell row 118S 1 proximal to the inflow cell row 1181 and comprising first subsequent cells 116S1, a second subsequent cell row 118S2 proximal to the first subsequent cell row 118S1 and comprising second subsequent cells 116S2, a third subsequent cell row 118S3 proximal to the second subsequent cell row 118S2 and comprising third subsequent cells 116S3, and an outflow cell row 1180 proximal to the third subsequent cell row 118S3 and comprising outflow cells 1160.Attorney Docket No: THVVA-23974WO01

[0113] A frame 102 of a prosthetic valve 100 can optionally include a plurality of axially extending struts 114 vertically extending between the outflow rung 1120 of angled struts 110O, and the fourth or proximal-most subsequent rung 1 12S4 of angled struts 110S4.

[0114] The upper end portions of the outflow angled struts 110O of the outflow rung 1120 can form outflow apices 122 at or proximate to the outflow end 106, and end portions of the inflow angled struts 1101 of the inflow rung 1121 can form inflow apices 120 at the inflow end 104. The outflow angled struts 110O of the outflow rung 1120 are further connected to axially extending struts 1 14 at lower junctions 124 which are distal to the outflow apices 122, such that the outflow angled struts 110O circumferentially extend in a zig-zagged formation between the outflow apices 122 and the lower junctions 124 of the outflow rung 1120. The struts of each of the inflow rung 1121 and the subsequent rungs 112S can also extend circumferentially in a zig-zagged formation as illustrated.

[0115] The valvular structure 170 can include a plurality of leaflets 172 (e.g., 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 172 arranged to collapse in a tricuspid arrangement, are shown in the example illustrated in Fig. 1 A, it will be clear that a prosthetic valve 100 can include any other number of leaflets 172. Adjacent leaflets 172 can be optionally arranged together to form commissures 186 that are coupled (directly or indirectly) to respective portions of the frame 102, thereby securing at least a portion of the valvular structure 170 to the frame 102. In some examples, the valvular structure 170 can be formed as a unitary component having dedicated regions thereof defining integrally formed leaflets 172 that can be continuously interconnected at commissure attachment regions which can be, in turn, secured to the frame 102 to form commissures 186.

[0116] In some examples, the plurality of leaflets 172 can be integrally formed as regions of a one-piece valvular structure 170, meaning that all of the leaflets 172 are continuous with each other without the need to otherwise couple them to each other (such as by suturing, adhering, and the like) to form the valvular structure 170. In some examples, the plurality of leaflets 172 can be formed and provided as separate components, which can be in turn joined to each other and / or to the frame 102 (e.g., by suturing) to form the valvular structure 170. Each leaflet 172 can optionally include a pair of opposite commissure attachment portions in the form of tabs 184 between their cusp line 176 and the free edge 178. Tabs 184 of adjacent leaflets can be joined to form commissures 186 secured to the frame 102.Attorney Docket No: THVVA-23974WO01

[0117] The leaflets 172 can be made from, in whole or part, biological material (e.g., pericardium), bio-compatible synthetic materials, or other such materials. Further details regarding transcatheter prosthetic valves, including the manner in which the valvular structure 170 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.

[0118] In some examples, the axially extending struts 114 comprise a plurality of axial struts 136 and a plurality of commissure support members 138. The axially extending struts 1 14, including axially extending struts 136 and commissure support members 138, can be parallel to each other and / or to a central longitudinal axis Ca of the prosthetic valve 100.

[0119] A commissure support member 138 can be an axially extending strut which is configured to support a commissure 186 attachable or attached thereto, and may optionally include a geometry or features configured to facilitate attachment of the commissure 186 thereto, such as grooves, protrusions, holes, window openings, and the like. An axial strut 136 can be an axially extending strut which is configured to remain unattached to the valvular structure 170. That is to say, an axial strut 136 is not configured to mount a commissure, and may be devoid of geometrical or other features included in a commissure support member 138 for that end.

[0120] In some examples, a commissure support member 138 can include at least one recess 140 formed over at least one side of the commissure support member 138. In some examples, a commissure support member 138 can have wavy or otherwise-shaped edges that define a plurality of recesses 140 on both sides of the commissure support member 138, as shown, for example, in Fig. IB. Tabs 184 of adjacent leaflets 172 can be sutured to each other to form a commissure 186, wherein the suture can be passed through or along the recesses 140 to improve securement and prevent the knot of the commissure 186 from axially sliding along the commissure support member 138.

[0121] The prosthetic valve 100 can further comprise at least one skirt or sealing member. In some examples, a prosthetic valve can include a skirt 130 having a base layer 132 secured to an inner surface 128 of the frame 102, and can optionally include a plurality of protruding extensions 1 4 extending radially outwards from the base layer 132 and through corresponding cells 116 and / or opening defined between angled struts 110 of the frame, the skirt 130 configured to function, for example, as a sealing member to prevent or decrease perivalvular leakage. In some examples, skirt 130 can be provided as a separate component that can further function as an anchoring region for the leaflets 172 to the frame 102, and / or function to protectAttorney Docket No: THVVA-23974WO01 at least some portions of the leaflets 172 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.

[0122] In some examples, outwardly protruding extensions 134 of the skirt 130 protrude radially away from the frame's outer surface 127, configure to function, for example, as sealing members extending between the frame 102 and the surrounding tissue of the native annulus against which the prosthetic valve is mounted, thereby reducing risk of paravalvular leakage (PVL) past the prosthetic valve 100.

[0123] Each cell row 118 of the frame 102 comprises a plurality of cells 116 extending circumferentially such that each cell 116 is directly coupled to two circumferentially adjacent cells 116 on both sides thereof within the same cell row 118. The term "cell", as used herein, refers to a closed cell, having an enclosed perimeter defined by at least four struts 108.

[0124] In some examples, the outflow cells 1160 are coupled to adjacent outflow cells 1160 within the outflow cell row 1180 via axially extending struts 114. The outflow cells 1160 of the exemplary valve 100 shown in Figs. 1A-1B can be generally hexagonal, each outflow cell 1160 defined between two outflow angled struts HOO of the outflow rung 1120, two fourth subsequent angled struts 110S4 of the fourth subsequent rung 112S4, and two axially extending struts 114 extending between the outflow rung 1120 and the fourth subsequent rung 112S4.

[0125] Cells 1161 and 116S of the inflow cell row 1181 and subsequent cell rows 118S can be generally diamond-shaped cells. For example, the frame 102 illustrated in Figs. 1A-1B is shown to include inflow cells 1161 defined by two inflow struts 1101 and two first subsequent angled struts 110S 1 , first subsequent cells 116S1 defined by two first subsequent angled struts 1 IOS 1 and two second subsequent angled struts 110S2, second subsequent cells 116S2 defined by two second subsequent angled struts 110S2 and two third subsequent angled struts 110S 3, and third subsequent cells 116S3 defined by two third subsequent angled struts 110S3 and two fourth subsequent angled struts 110S4.

[0126] In some examples, the outflow cells 1160 of the prosthetic valve 100 can have a height (measured in the axial direction) which is greater than the height of cells 116S, 1161 of the subsequent and / or inflow cell rows 118S, 1181, due to the axially extending struts 114 interconnecting the outflow rung 1120 and the fourth subsequent rung 112S4.

[0127] While all cells 116 of the inflow cell row 1181 and the subsequent cell rows 118S are shown in the example illustrated in Figs. 1A-1B to have substantially the same size and shape, it is to be understood that in some examples, cells 116 of the inflow cell row 1181 and the subsequent cell rows 118S, as well as outflow cells 1160, can have different sizes and shapes.Attorney Docket No: THVVA-23974WO01

[0128] Each leaflet 172 includes a leaflet belly 174 which is the movable and unattached part of the leaflet, defined between a lower cusp line 176 and an upper free edge 178 of the leaflet 172. In some examples, leaflet bellies 174 described herein can have a three-dimensional and concave shape, thereby resulting in increased mobility of the leaflet when the prosthetic valve is implanted in a patient. As a result, the efficiency of the prosthetic valve including the valvular structure can be improved.

[0129] Fig. 2 illustrates a delivery assembly 200 that includes a delivery apparatus 202, optionally adapted to deliver a prosthetic device, which can he the prosthetic valve 100 described above with respect to Figs. 1A-1B. Figs. 3 and 4 are cross-sectional views of a proximal portion and a distal portion, respectively, of the delivery apparatus 202. The delivery apparatus 202 includes a handle 204 and a balloon catheter 214 having an inflatable balloon 240 mounted on its distal end. A balloon expandable prosthetic device, such as balloon expandable prosthetic valve 100, can be carried in a crimped state over the balloon catheter 214.

[0130] In some examples, a delivery apparatus 202 further comprises an outer sheath 208. Optionally, an outer sheath 208 of a delivery apparatus 202 can concentrically extend over the balloon catheter 214.

[0131] The outer sheath 208 and the balloon catheter 214 can be configured to be axially movable relative to each other. For example, a proximally oriented movement of the outer sheath 208 relative to the balloon catheter 214, or a distally oriented movement of the balloon catheter 214 relative to the outer sheath 208, can expose the prosthetic valve 100 from the outer sheath 208.

[0132] A delivery apparatus 202 can further include a nosecone 226 to facilitate advancement of the delivery apparatus 202 through the patient’s vasculature to the site of treatment. A nosecone shaft 222 (shown, for example, in Fig. 4) can extend proximally from the nosecone 226 through a lumen 216 of the balloon catheter 214. The nosecone 226 can be conical or frustoconical in shape, and can include a nosecone tapering outer surface 234 terminating at a nosecone distal end 228, and a nosecone proximal end portion 230 that can be coupled to the nosecone shaft 222 extending proximally therefrom. Attachment of the nosecone shaft 222 to the nosecone proximal end portion 230 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 nosecone shaft 222 can extend through the entire length of the nosecone 226, such that a distal end of the nosecone shaft 222 is aligned with the nosecone distal end 228. In some examples (not illustrated), the nosecone shaft 222 is coupled to one orAttorney Docket No: THVVA-23974WO01 more components, such as collars or other connectors, which are in turn attached to the nosecone 226.

[0133] In Fig. 2, a prosthetic valve 100 is mounted on the balloon 240 and is shown in a crimped state, providing prosthetic valve 100 with a reduced diameter for delivery to the heart via the patient’s vasculature.

[0134] The proximal ends of the balloon catheter 214, the outer sheath 208, and / or the nosecone shaft 222, can be coupled to the handle 204. During delivery, the handle 204 can be maneuvered by an operator (e.g., a clinician or a surgeon) to axially advance or retract components of the delivery apparatus 202, such as the nosecone shaft 222, the outer sheath 208, and / or the balloon catheter 214, through the patient’s vasculature and / or along the target site of implantation, as well as to inflate the balloon 240 mounted on the balloon catheter 214, for example to expand a prosthetic valve 100 mounted on the balloon 240, and to deflate the balloon 240 and retract the delivery apparatus 202, for example once the prosthetic valve 100 is mounted in the implantation site.

[0135] The handle 204 can include knobs 206 or other actuation members operable by an operator to manipulate different components of the delivery apparatus. In some examples, the handle 204 can include an adjustment member such as the illustrated rotatable knob 206a, configured to adjust the axial position of the outer sheath 208.

[0136] In some examples, the handle 204 can include a steering mechanism configured to adjust the curvature of a distal end portion of the delivery apparatus 202. In some examples, the delivery apparatus can further comprise a steering shaft 256 that can be disposed around the balloon catheter 214, optionally extending through a lumen 210 of the outer sheath 208. A steering shaft 256 can be controllably manipulated to bend along a distal end portion thereof, so as to facilitate advancement of the delivery apparatus 202 through curved portions of the patient's vasculature.

[0137] In the illustrated example, the handle 204 includes an adjustment member, such as the illustrated rotatable knob 206b, which in turn can be operatively coupled to the proximal end portion of a pull wire (not shown). The pull wire can extend distally from the handle 204 through the steering shaft 256 and has a distal end portion affixed to the steering shaft 256 at or near the distal end of the steering shaft 256. Rotating the knob 206b can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 202. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Pat. No. 9,339,384, which is incorporated by reference herein.Attorney Docket No: THVVA-23974WO01

[0138] In some examples, the outer sheath 208 can be a steerable sheath, thereby obviating the need to include and separately control a separate steering shaft.

[0139] A prosthetic valve 100 can be carried by the delivery apparatus 202 during delivery in a crimped state, and expanded, for example by balloon inflation, to secure it in a native heart valve annulus (such as an aortic annulus) or against a previously implanted prosthetic valve (for example, during valve-in-valve implantation procedures).

[0140] The balloon 240 can be secured to balloon catheter 214 at the balloon’s proximal end, and to either the balloon catheter 214, the nosecone shaft 222, or the nosecone 226, at its distal end. In some examples, the balloon 240 is secured to a distal end portion of the balloon catheter 214 at its proximal end, while the balloon’s distal end can be coupled, directly or indirectly, to another component of the delivery apparatus 202, such as the nosecone 226 or nosecone shaft 222.

[0141] In some examples, the distal end of the balloon 240 is coupled, directly or indirectly, to the nosecone proximal end portion 230. In the example illustrated in Fig. 4, the balloon 240 is shown to be coupled to a cylindrical nosecone connector 258 attached to the nosecone proximal end portion 230, wherein the nosecone connector 258 can have a smaller diameter than that of the nosecone proximal end portion 230. In some examples, the outer sheath 208 can include a sheath distal portion 212 configured to slidably cover the balloon 240 and the prosthetic valve 100 during delivery. When the sheath distal portion 212 covers the balloon 240 and prosthetic valve 100, it can restrain the prosthetic valve 100 to limit expansion thereof during delivery.

[0142] In some examples, the nosecone proximal end portion 230 can optionally include an outer annular step 229 configured to accommodate the sheath distal end portion 212, as illustrated for example in Fig. 4. The annular step 229 can serve as a stopper that limits axial advancement of the outer sheath 208, and can be sized such that the outer surface of the sheath distal portion 212 is flush with the outer surface of the nosecone 226 when the distal end of the sheath distal end portion 212 is seated in the annular step 229.

[0143] After reaching the site of implantation, the balloon 240 and prosthetic valve 100 crimped thereover, can be exposed out of the outer sheath 208, such as by proximally pulling the outer sheath 208 relative to the balloon 240 and balloon catheter 214, thereby allowing inflation of the balloon 240 and expansion of the prosthetic valve 100.

[0144] In some examples, the distal end portion of the balloon catheter 214 can include an outer annular step configured to accommodate the proximal end of the balloon 240, such that the outer surface of the balloon 240 can be flush or otherwise relatively continuous with the outer surface of the balloon catheter 214.Attorney Docket No: THVVA-23974WO01

[0145] In some examples, such as when the balloon 240 is attached at both ends thereof to the nosecone 226 and balloon catheter 214, both the nosecone 226 with nosecone shaft 222 and the balloon catheter 214 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, the delivery apparatus 202 can be designed such that axial movement of the balloon catheter 214 causes the nosecone shaft 222 to move therewith, or such that axial movement of the nosecone shaft 222 causes the balloon catheter 214 to move therewith.

[0146] Balloon 240 is configured to transition between a deflated state, shown for example in Figs. 2 and 5 A, and an inflated state, shown for example in Fig. 5B. When reaching the site of implantation, the deflated balloon 240, carrying crimped prosthetic valve 100 thereover, can be advanced to the target site to expand the prosthetic valve. Once the prosthetic valve 100 is expanded to its functional diameter within a native annulus or within a previously implanted prosthetic valve, the balloon 240 can be deflated, and the delivery apparatus 202 can be retrieved from the patient’s body.

[0147] As indicated in Figs. 5A-5B for example, balloon 240 comprises a balloon proximal section 246, a balloon distal section 248, and a balloon intermediate section 250 extending therebetween. The balloon proximal section 246 extends from a proximal end of the balloon 240, at which it can be attached to the balloon catheter 214, to the balloon intermediate section 250, and can include a portion configured to assume a proximally-tapering configuration in the inflated state of the balloon 240. The balloon distal section 248 extends from the balloon intermediate section 250 to a distal end of the balloon 240, at which it can be attached to the nosecone 226 (or any other distal component of the delivery apparatus 202), and can include a portion configured to assume a distally-tapering configuration in the inflated state of the balloon 240. When a prosthetic valve 100 is mounted on balloon 240, it may be disposed around the balloon intermediate section 250, while the balloon proximal section 246 and balloon distal section 248 can remain uncovered by prosthetic valve 100.

[0148] As shown, for example, in Fig. 3, the balloon catheter 214 can define a balloon catheter lumen 216 through which a guide wire (not shown) and one or more additional shafts of the delivery apparatus 202 can extend. The balloon catheter 214 can extend through the handle 204 and be fluidly connectable to a fluid source for inflating the balloon 240.

[0149] In some examples, as further shown in Figs. 2-3, the balloon catheter 214 can distally extend from a multi-way hub 252 which can be disposed proximally to the handle 204. In some examples, the multi-way hub 252 can be connected to a rear portion of the handle 204. In someAttorney Docket No: THVVA-23974WO01 examples, the handle 204 can include an adjustment member such as the illustrated rotatable knob 206c, configured to adjust the axial position of the multi-way hub 252 and / or the balloon catheter 214 attached thereto.

[0150] The multi-way hub 252 includes a first port 254a configured to receive a guidewire therethrough, and a second port 254b configured to receive fluid from a fluid source comprising inflation fluid. The term “inflation fluid,” as used herein, means a fluid (e.g., saline, though other liquids or gas can be used) used for inflating the balloon 240. The inflation fluid source (not shown) is in fluid communication with the balloon catheter lumen 216 via second port 254b, such that fluid from the fluid source can flow through the balloon catheter lumen 216 into balloon 240 to inflate it.

[0151] As further shown, for example, in Figs. 3-4, the nosecone shaft 222 and the nosecone 226 collectively define a guidewire passage lumen 236 extending along the entire length of the nosecone shaft 222 and nosecone 226, and continuous with the first port 254a, through which the guidewire can pass, such that the entire delivery apparatus 202 can be advanced toward the treatment region over the guidewire. The outer diameter of the nosecone shaft 222 can be sized such that an annular space is formed within balloon catheter lumen 216 between balloon catheter wall 220 and the nosecone shaft 222 along the length of balloon catheter 214. This annular space can be in fluid communication with one or more inflation openings 218 exposed to an internal cavity 244 of the balloon 240, which can be in fluid communication with a fluid source (e.g., a syringe or a pump) that can inject an inflation fluid (e.g., saline) into balloon cavity 244. In this way, inflation fluid from the fluid source can flow through the balloon catheter lumen 216 into balloon cavity 244 via inflation opening(s) 218 to inflate the balloon 240, and optionally expand and deploy a prosthetic valve 100 when such a device is disposed thereon.

[0152] For example, the pressure of the fluid within balloon 240 may provide the force that allows the intermediate section 250 of balloon 240 to dilate the prosthetic valve 100. Further, the balloon catheter lumen 216 may be configured to withdraw fluid from the balloon cavity 244 through the opening(s) 218 to deflate the balloon 240. Thus, the balloon catheter lumen 216 may be utilized to inflate the balloon 240 to transition the balloon 240 to the inflated or deployed state, and may be utilized to deflate the balloon 240 to transition the balloon 240 to the deflated or undeployed state.

[0153] Nosecone shaft 222, balloon catheter 214, outer sheath 208, and / or the steering shaft 256, can be formed from, or include, any of various suitable materials, such as Nylon, PTFE, braided stainless steel wires, or a polyether block amide (commercially available as Pebax®).Attorney Docket No: THVVA-23974WO01In some examples, balloon catheter 214 and / or optional outer sheath 208 have longitudinal sections formed from, or including, different materials, in order to vary the flexibility of the shafts along their lengths. In some examples, nosecone shaft 222 has an inner liner or layer formed of Teflon® to minimize sliding friction with a guidewire. Balloon 240 includes a balloon wall 242 surrounding and defining the balloon cavity 244 (indicated, for example, in Fig. 4), which may be made of one polymer, or use several layers or a mix of different polymers. Polymers such as Nylon, PEBAX, PET, parylene and / or polyurethane may be used to make the balloon wall 242.

[0154] In some examples, any delivery assembly of the current disclosure can be packaged in a sterile package that can be supplied to end users for storage and eventual use. In some examples, the leaflets of the prosthetic valve (typically made from bovine pericardium tissue or other natural or synthetic tissues) are treated during the manufacturing process so that they are completely or substantially dehydrated and can be stored in a partially or fully crimped state without a hydrating fluid. In this manner, the package containing the delivery assembly can be free of any liquid. Methods for treating tissue leaflets for dry storage are disclosed in U.S. Pat. Nos. 8,007,992 and 8,357,387, both of which documents are incorporated herein by reference.

[0155] In some cases, a balloon 240 may be non-uniformly expanded during inflation thereof. For example, when the inflation openings 218 are exposed to a proximal end of the balloon cavity 244, the balloon proximal section 246 can expand faster, while the balloon intermediate section 250 still remains in a compacted configuration with the prosthetic valve 100 crimped thereover. This can cause the prosthetic valve 100 to axially slip, for example in the distal direction, affecting the subsequent expansion profile of the valve itself.

[0156] Figs. 5 A-5D shows stages in an exemplary method for deployment of a prosthetic valve 100 utilizing a delivery assembly 200 that includes an axial securement mechanism. In some examples, the delivery apparatus 202 comprises a locking wire 260 that can be utilized for locking the axial position of the prosthetic valve 100 over the balloon 240, as will be described in greater detail below. In some examples, the multi-way hub 252 can include a third port 254c (see Fig. 4) through which the locking wire 260 can extend distally, towards the prosthetic valve 100 crimped around the balloon 240.

[0157] The delivery apparatus 202 can further comprise, in some examples, a first adjustment string 264 having a first loop 266, and a second adjustment string 268 having a second loop 270, wherein the locking wire 260 can be configured to slide through, such as into and out of, the first and second loops 266, 270.Attorney Docket No: THVVA-23974WO01

[0158] In some examples, the prosthetic valve 100 can comprise eyelets 126 (see Figs. 1A- 1B), configure to serve as support members the prosthetic valve 100, through which the first and second adjustment strings 264, 268 can extend. For example, the frame 102 can comprise one or more outflow eyelets 1260 at the outflow end 106, through which a first adjustment string 264 can extend, and one or more inflow eyelets 1261 at the inflow end 104, through which a second adjustment string 268 can extend. In some examples, the eyelets 126 can be formed as closed rings, as illustrated in Figs. 1A- 1B. In some examples, an eyelet 126 can be in the form of arc-shaped structure which is opened to the cell 1 16 from which it extends (embodiment not shown).

[0159] Various exemplary implementations for delivery assembly 200, delivery apparatus 202, prosthetic valve 100 and / or components thereof can be referred to, throughout the specification, with superscripts, for ease of explanation of features that refer to such exemplary implementations. It is to be understood, however, that any reference to structural or functional features of any device, apparatus or component, without a superscript, refers to these features being commonly shared by all specific exemplary implementations that can be also indicated by superscripts. In contrast, features emphasized with respect to an exemplary implementation of any device, apparatus or component, referred to with a superscript, may be optionally shared by some but not necessarily all other exemplary implementations. For example, a prosthetic valve 100a, illustrated in Fig. 1A, is an exemplary implementation of a prosthetic valve 100, and thus can include any of the features described for a prosthetic valve 100 throughout the current disclosure, except that outflow and inflow eyelets 1260, 1261 of the prosthetic valve 100aextends axially past that outflow and inflow apices 122, 120, respectively, and may be generally co-planar with the plane defined by the cells 116 they extend for.

[0160] As shown in Figs. 5A-5B, during delivery and initial deployment of the prosthetic valve 100, the first adjustment string 264 extends through the outflow eyelet 1260 such that the first loop 266 can be disposed radially outwards from, and optionally distally to, the outflow eyelet 1260. The second adjustment string 268 similarly extends through the inflow eyelet 1261 such that the second loop 270 can be disposed radially outwards from, and optionally proximally to, the inflow eyelet 1261.

[0161] The locking wire 260 can move between a locked position and an unlocked position. In the locked position, as shown in Fig. 5A for example, the locking wire 260 extends through the first loop 266 and the second loop 270, and can be axially locked in position, having its distal end optionally releasably coupled to a component of the delivery apparatus 202. For example, the nosecone 226 can optionally define a wire passage channel 225 extending distally from theAttorney Docket No: THVVA-23974WO01 proximal end of the nosecone 226, into which the distal end portion 262 of the locking wire 260 can extend in the locked position, as shown in Fig. 4.

[0162] In some examples, the locking wire 260 can extend distally from the handle 204 through the sheath lumen 210, such as through a space defined between the outer sheath 208 and the balloon catheter 214. In some examples, the locking wire 260 can axially extend through a dedicated lumen or channel that can be formed in the outer sheath 208 or the balloon catheter 214. In some examples, the outer sheath 208 can be a multi-lumen sheath (example not shown) that includes a first or primary sheath lumen 210 through which the balloon catheter 214 extends, and a second lumen through which the locking wire 260 can extend, wherein the wire is configured to exit the second lumen at a position proximal to the first loop 266. In some examples, the balloon catheter 214 can be a multi-lumen catheter (example not shown) that includes a first or primary balloon catheter lumen 216 which is in fluid communication with the balloon cavity 244, and a second lumen through which the locking wire 260 can extend, wherein the second lumen can be radially outwards from the first lumen 216.

[0163] In some examples, the locking wire 260 can be made of or include polymeric materials or metals. For example, the locking wire 260 can be optionally made of 304 or 316 stainless steel alloy, and have a diameter of about 0.5 mm, suitable to withstand axial forces applied thereto when distally pushed, for example, through the loops 266, 270. In some examples, the locking wire 260 can be coated by PTFE or other suitable material configured to reduce friction against other components of the delivery assembly 200.

[0164] Figs. 5A-5D illustrate an exemplary delivery apparatus 202b, which is 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 first adjustment string 264 and the second adjustment string 268 of delivery apparatus 202bare affixed, at ends thereof opposite to the first loop 266 and the second loop 270, respectively, to components of the delivery apparatus 202b, such as by bonding, binding, and the like. For example, the first adjustment string 264 of delivery apparatus 202bis shown to be affixed, at its proximal end, to the balloon catheter 214 (for example, to balloon catheter wall 220), and the second adjustment string 268 of delivery apparatus 202bis shown to be affixed, at its distal end, to the nosecone 226. In some examples, the first adjustment string 264 can be attached to a shaft disposed between the balloon catheter 214 and the outer sheath 208, such as to a steering shaft 256. In some examples, the second adjustment string 268 can be attached to any of the nosecone proximal end portion 230, the nosecone connector 258, or a distal portion of the balloon 240.Attorney Docket No: THVVA-23974WO01

[0165] The first adjustment string 264 and the second adjustment string 268 can be optionally, but not necessarily, circumferentially aligned with each other. While a single first loop 266 and a single second loop 270 are illustrated, it is to be understood that the first adjustment string 264 can include more than one first loop 266, and that the second adjustment string 268 can include more than one second loop 270. While a single first adjustment string 264 and a single second adjustment string 268 are illustrated, it is to be understood that more than a delivery apparatus 202 can include, in some examples, a plurality of first adjustment strings 264 and / or a plurality of second adjustment strings 268, when a plurality of first or second adjustment strings are provided, they can be circumferentially spaced from each other around the central longitudinal axis Ca.

[0166] While a single locking wire 260 is illustrated, it is to be understood that in some examples, a plurality of locking wires 260 can be provided. If the number of locking wires 260 is less than the number of the first adjustment strings 264 or the number of second adjustment strings 268, a single locking wire 260 can be passed through several first loops 266 and / or several second loops 270. When a plurality of locking wires 260 are provided, they can be either independently controlled by the handle 204, or they can be linked together to move in unison between the locked and unlocked positions.

[0167] During delivery to the site of implantation, the outer sheath 208 can cover the prosthetic valve 100, having its distal end portion 212 extending distally to the prosthetic valve 100 and / or the balloon 240, such as by being received in the annular step 229 at the nosecone proximal end portion 230, as shown in Fig. 4. This position of the outer sheath 208 serves to restrain the prosthetic valve 100 in its lumen 210, limiting undesired partial or full premature expansion thereof.

[0168] Upon reaching the target site of implantation, the prosthetic valve 100 and balloon 240 can be exposed out of the outer sheath 208, as shown in Fig. 5A, optionally by proximally pulling the outer sheath 208 relative to the balloon 240 and balloon catheter 214. In the locked configuration of the delivery assembly 200 shown in Fig. 5A, the first and second adjustment strings 264, 268 extend through the corresponding outflow and inflow eyelets 1260, 1261, and the locking wire 260 is in a locking position, extending through both first and second loops 266, 270, optionally extending into a wire passage channel 225 as shown in Fig. 4. This prevents the first and second loops 266, 270 from slipping out of the outflow and inflow eyelets 1260, 1261, respectively, to restrain axial displacement of the prosthetic valve 100 over the balloon 240.Attorney Docket No: THVVA-23974WO01

[0169] In some examples, the proximal end of the locking wire 260 can be attached to an operating member 274, as shown in Fig. 3, which in turn can be optionally detachably coupled to the third port 254c of the multi-way hub 252. Upon detachment of the operating member 274 from the multi-way hub 252, it can serve as an operating handle to control axial movement of the locking wire 260. When no axial movement of the locking wire 260 is required, the operating member 274 can be attached to the multi-way hub 252, for example by threaded engagement with the third port 254c.

[0170] When the locking wire 260 is moved to the unlocked position, such as by proximally pulling it out of the first and second loops 266, 270, as shown in Fig. 5C, the balloon 240 is free to inflate so as to expand the prosthetic valve 100 disposed thereover, in which case the first and second adjustment strings 264, 268 are allowed to freely slip out of the outflow and inflow eyelets 1260, 1261 during valve expansion. The balloon can be then deflated, as shown in Fig. 5D, and the delivery apparatus 202 can be retrieved from the patient's body, leaving the prosthetic valve 100 implanted in the patient's body.

[0171] An exemplary prosthetic valve 100athat includes outflow and inflow eyelets 1260, 1261 axially past the outflow and inflow apices 122, 120, respectively, may result in a relatively elongated valve, having a maximum frame length defined between the free edges of the outflow eyelets 1260 and the inflow eyelets 1261. Longer valves can lead to conduction disturbances due to the risk of the distal-most portion of the valve, such as the inflow eyelets 1261, contacting the septal conductive pathways, or have the proximal portion, such as the outflow eyelets 1260, positioned high enough (for example, above the STJ level) so as to interfere with coronary flow and access.

[0172] Fig. 6 shows a portion of a frame 102cof an exemplary prosthetic valve 100c. Frame 102cis an exemplary implementation of a frame 102, and thus can include any of the features described for a frame 102 throughout the current disclosure, except that the frame 102cincludes eyelets 126 extending axially into the corresponding cells 116 they are attached to. The outflow eyelet 126cO of frame 102cis shown to extend distally from the corresponding outflow apex 122, into the outflow cell 1160, and the inflow eyelet 126CI is shown to extend proximally from the corresponding inflow apex 120, into the inflow cell 1161. In this manner, the maximum frame length of the frame 102ccan be defined between the inflow apices 120 and the outflow apices 122, without having eyelets 126 that extend past apices 120, 122, resulting in a relatively shorter valve.

[0173] A potential risk introduced by exposed eyelets 126 of a prosthetic valve, such as eyelets 126 which are generally co-planar with the cells 116 they extend from in the case of exemplaryAttorney Docket No: THVVA-23974WO01 prosthetic valve 100a, relates to inflow eyelets 1261 that may contact an inner wall of another component of the delivery apparatus 202, such as an inner wall of a catheter or sheath in which the prosthetic valve 100 may reside during passage of the delivery assembly 200 through the patient's vasculature. For example, an introducer sheath (not shown) can be arranged within a patient's blood vessel, extending along a portion of a length of the patient's blood vessel, en route to the target site of implantation. The introducer sheath can assume a curved profile throughout its length in the patient's body, including multiple curves or bends having different angles that are oriented at different directions, based on an architecture of the patient’s vasculature. The delivery apparatus 202 can then be inserted into the introducer sheath and routed through it toward the target site of implantation. In some examples, the prosthetic valve 100 is not necessarily covered by an outer sheath 208 or a sheath distal portion 212 thereof while advanced through the patient's vasculature.

[0174] When passing through a curved region of the introducer sheath, the inflow end 104 of the prosthetic valve 100, including exposed inflow eyelets 1261, can come into contact with the inner wall of the sheath. Direct contact between the inflow eyelets 1261 and the sheath may cause degradation of the sheath. Furthermore, if the inflow eyelets 1261 are pressed against the inner wall of the sheath with a great enough force at specific angles, the eyelets 126 may puncture the inner wall of the sheath. In some cases, contact of the relatively stiff eyelets 1261 with the softer (or less stiff) introducer sheath may result in increased friction between the inflow eyelets 1261 and the inner wall of the sheath, thereby resulting in adherence between the eyelets and the sheath (making it more difficult to advance the valve through the sheath to the target implantation site) and potential damage to the sheath. Additionally, due to a relatively small contact area of the inflow eyelets 1261 against the sheath, the sheath may become degraded or damaged during contact with the inflow eyelets 1261.

[0175] While described with respect to an introducer sheath, it is to be understood that exposed inflow eyelets 1261 contacting an inner wall of any other shaft or catheter surrounding the prosthetic valve 100 during delivery, such as the outer sheath 208, may be subjected to similar risks. Further, in some cases, eyelets 126 of the frame 102 may come into contact with the native anatomy of the patient, either along the delivery route to or at the target implantation site.

[0176] Fig. 7 shows a portion of a frame 102dof an exemplary prosthetic valve 100d. Frame 102dis an exemplary implementation of a frame 102, and thus can include any of the features described for a frame 102 throughout the current disclosure, except that at least one, some, or all of the eyelets 126 are bent radially inwards relative to the plane defined by the cell(s) 116Attorney Docket No: THVVA-23974WO01 they extend from. Line Tc indicated in Fig. 7 is tangent to the frame 102 and can extend between the inflow end 104 and the outflow end 106. Line TA indicated in Fig. 7 is tangent to an eyelet 126. A non-zero angle a is defined between the tangent line TA of the eyelet 126 and the tangent line Tc of the frame 102, such that the eyelet 126 is bent radially inwards, towards the central longitudinal axis Ca of the frame. In some examples, the angle a is greater than 5 degrees. In some examples, the angle a is greater than 10 degrees. In some examples, the angle a is greater than 20 degrees. In some examples, the angle a is greater than 30 degrees.

[0177] In some examples, the prosthetic valve 100dcan be configured to expand to a substantially cylindrical configuration, such that the line TA tangent to the frame 102dis parallel to the central longitudinal axis Ca. Thus, a line Tc tangent to an eyelet 126 can define an angle a relative to the central longitudinal axis Ca or any line parallel thereto.

[0178] While a frame tangent line TA is shown to extend linearly along the height or length of the frame 102, between its inflow end 104 and outflow end 106, in some examples, a line tangent to an outflow portion of the valve, such as to outflow cell(s) 1160, can be oriented at a different direction relative to a line tangent to an inflow portion of the valve, such as to inflow cell(s) 1161. For example, a frame 102 can assume, in some cases, a barrel-shaped configuration, an hourglass-shaped configuration, a Y-shaped configuration, and the like, in its expanded state. Thus, a line tangent to an outflow eyelet 1260 can be optionally angled relative to a line tangent to the corresponding outflow cell 1160, and a line tangent to an inflow eyelet 1261 can be optionally angled relative to a line tangent to the corresponding inflow cell 1161.

[0179] While both the inflow eyelet 1261 and the outflow eyelet 1260 are shown in Fig. 7 to be inwardly angled, it is to be understood that in some examples, only the inflow eyelet(s) 1261 can be angled, and / or only the outflow eyelet(s) can be angled. Moreover, while both the inflow eyelet 1261 and the outflow eyelet 1260 are shown in Fig. 7 to be similarly angled at the same angle a radially inwards, it is to be understood that each of the inflow eyelet(s) 1261 and / or the outflow eyelet(s) can be angled at a different angle. For example, inflow eyelet(s) 1261 can be angled radially inwards at a first non-zero angle al, and outflow eyelet(s) 1260 can be angled radially inwards at a second non-zero angle a2.

[0180] Fig. 8 shows exemplary threading paths of the adjustment string(s) 264 and / or 268 through the corresponding eyelet(s) 126. The first adjustment string 264 can be threaded radially outwards through the outflow eyelet 1260, such as by extending the first adjustment string 264 from the balloon catheter 214 towards an inner side of the frame 102, such as inwardly to the inner surface 128 of the frame 102, and passing it radially outwards throughAttorney Docket No: THVVA-23974WO01 the outflow eyelet 1260 to position the first loop 266 radially outwards to the outer surface 127 of the frame 102.

[0181] In some cases, the portion of the first adjustment string 264 can include a slack of material disposed on the inner side of the frame 102, which can optionally extend toward and contact a leaflet 172 of the valve 100. This can potentially abrade or otherwise damage the leaflet 172, either when the leaflets 172 are pressed against the string 264 during crimping, and / or due to relative movement between the string 264 and the leaflet during delivery or deployment of the valve.

[0182] Fig. 9 shows a distal portion of an exemplary delivery assembly 200e. Delivery assembly 200eis an exemplary implementation of delivery assembly 200, and thus can include any of the features described for a delivery assembly 200 throughout the current disclosure, except that the threading path of the first adjustment string 264 includes threading it radially inwards through the outflow eyelet 1260. This threading path includes extending the first adjustment string 264 from the balloon catheter 214 towards an outer side of the outflow eyelet 1260, such as outwardly to the outer surface 127 of the frame 102, and passing it radially inwards through the outflow eyelet 1260. The first adjustment string 264 is then extended distally, along the inner side of the frame 102, across the junction connecting the outflow eyelet 1260 to the corresponding outflow cell 1160, and is then extended radially outward, through the outflow cell 1160, to position the first loop 266 radially outwards to the outer surface 127 of the frame 102.

[0183] The valvular structure 170 of prosthetic valve 100 can be assembled such that the free edges 178 of the leaflet 172 are sufficiently distal to the outflow end 106, including being axially offset from the junction(s) defined between the outflow eyelet(s) 1260 and the outflow cell(s) 1160 connected thereto, so as to axially offset the first adjustment string 264 from the leaflet 172 to mitigate risk associated to otherwise optional contact therebetween.

[0184] In some examples, the threading path of the second adjustment string 268 of exemplary delivery assembly 200ecan be similar, such as by extending the second adjustment string 268 radially inwards through the inflow eyelet 1261, then along the junction defined between the inflow eyelet 1261 and the corresponding inflow cell 1161, and radially outwards through the inflow cell 1 161 so as to position the second loop 270 radially outwards to the outer surface 127 of the frame 102. However, while both adjustment string 264, 268 are shown in Fig. 9 to extend radially inwards through corresponding eyelets 1260, 1261, it is to be understood that in some examples, the second adjustment string 268 can follow a different threading path than the first adjustment string 264.Attorney Docket No: THVVA-23974WO01

[0185] For example, while the first adjustment string 264 can be threaded in the manner described herein with respect to Fig. 9, the second adjustment string 268 of a delivery assembly 200ecan be optionally threaded in a manner similar to that illustrated in Fig. 8, such as by extending the second adjustment string 268 from the nosecone 226 (or any other component of the delivery apparatus 202 distal to the inflow end 104 of the valve 100) towards an inner side of the frame 102, such as inwardly to the inner surface 128 of the frame 102, and passing it radially outwards through the inflow eyelet 1261 to position the second loop 270 radially outwards to the outer surface 127 of the frame 102.

[0186] As mentioned herein with respect, for example, delivery apparatus 202a, any of the first adjustment string 264 and the second adjustment string 268 can be affixed at ends thereof opposite to the loops 266, 270, to components of the delivery apparatus, such as the balloon catheter 214, the nosecone 226, and the like. When adjustment strings 264 and 268 are long enough to sufficiently distance their loops 266, 270 away from the eyelets 126, the crimped prosthetic valve 100 may have room to slide back and forth over the balloon 240.

[0187] Fig. 10 shows a distal portion of a delivery assembly 200 that includes an exemplary delivery apparatus 202f. Fig. 11 shows an enlarged view of a distal end portion of the delivery apparatus 202* of Fig. 10, with some components thereof, such as the balloon 240 and / or optional nosecone connector 258 removed from view for illustrative purpose. Delivery apparatus 202fis an exemplary implementation of delivery apparatus 202, and thus can include any of the features described for a delivery apparatus 202 throughout the current disclosure, except that the first adjustment string 264fand the second adjustment string 268fof delivery apparatus 202fare independently controllably movable in the axial direction.

[0188] The first adjustment string 264fcan distally extend from the handle 204 towards the prosthetic valve 100, and extend through the outflow eyelet 1260 to position the first loop 266 radially outwards to the prosthetic valve 100. The second adjustment string 268fcan distally extend from the handle 204 towards a position that is distal to the prosthetic valve 100, and then fold backwards in the proximal direction so as to extend through the inflow eyelet 1261, thereby positioning the second loop 270 radially outwards to the prosthetic valve 100. Each of the first adjustment string 264fand the second adjustment string 268fcan be controllably pulled, at a proximal end thereof (not shown), in a proximal direction, or released. For example, the handle 204 of delivery apparatus 202fcan include one or more tensioning mechanism(s) (not shown), optionally controllable by a user of the handle 204 by one or more dedicated knob(s) 206, which can either proximally pull any of the adjustment strings 264, 268, or release pullingAttorney Docket No: THVVA-23974WO01 force therefrom in a manner that can optionally allow them to be passively displaced from position.

[0189] In some examples, the first adjustment string 264fcan axially extend through the sheath lumen 210, such as through a space between the balloon catheter 214 and the outer sheath 208. In some examples, the outer sheath 208 can be a multi-lumen catheter that includes a first lumen through which the balloon catheter 214 can extend, and a second lumen through which the first adjustment string 264fcan extend. Optionally, a third lumen can be provided, through which the locking wire 260 can extend.

[0190] In some examples, the second adjustment string 268fcan axially extend through an inner shaft of the delivery apparatus 202fthat extends to a position distal to the prosthetic valve 100, such as the nosecone shaft 222f. In some examples, the nosecone shaft 222fcan be a multilumen shaft that includes a first lumen serving as the guidewire passage lumen 236, and a second lumen through which the second adjustment string 268fcan extend. An exit point 232 through which the second adjustment string 268fcan extend outwards and then loop backwards, such as towards and through the inflow eyelet 1261, can be positioned distal to the prosthetic valve 100 and / or distal to the balloon 240.

[0191] As shown in Fig. 11, an exemplary nosecone 226fcan optionally include a side opening 232, such as at the nosecone proximal end portion 230, which is exposed to the channel or lumen through which the second adjustment string 268f, such that the second adjustment string 268fcan extend distally from the handle 204, optionally through the nosecone shaft 222f, towards and out of the side opening 232 of nosecone 226f, and then bend backwards to extend proximally towards the inflow eyelet 1261.

[0192] It is to be understood that a side opening 232 at the nosecone proximal end portion 230 is shown in Fig. 11 by way of illustration and not limitation, and that a side opening 232 can be formed at other component of the delivery apparatus 202f, such as, but not limited to, the nosecone connector 258. Moreover, it is to be understood that a side opening 232 is merely optional, and that in some examples, the second adjustment string 268fcan bend over itself at a position distal to the prosthetic valve 100 and / or balloon 240 in any suitable manner. Furthermore, it is to be understood that extension of the second adjustment string 268fis shown in Fig. 11 by way of illustration and not limitation, and that extension of the second adjustment string 268fto a position distal to the inflow eyelet 1261 can be accomplished by any other suitable manner. For example, the second adjustment string 268fcan extend through a dedicated tube or shaft extending either through the balloon 240, such as side-by-side with the nosecone shaft 222, or between the balloon 240 and the prosthetic valve 100.Attorney Docket No: THVVA-23974WO01

[0193] When adjustment of the axial position of the prosthetic valve 100 over the balloon 240 is required, at least one of the adjustment strings 264for 268fcan be tensioned, depending on the desired direction of displacement of the prosthetic valve 100. For example, when proximal repositioning of the prosthetic valve 100 is desired, the first adjustment string 264fcan be tensioned, meaning that a pull force is applied to a proximal end thereof, while the second adjustment string 268fcan be released, such that no tension is applied thereto, or its proximal end can be proximally pulled by a pulling force that is smaller than that applied to the first adjustment strings 264f. This will cause the first loop 266 to be proximally pulled against the outflow eyelet 1260. The locking wire 260, extending through the first loop 266, will prevent the first loop 266 from slipping out of the outflow eyelet 1260, such that when proximally pulled, the first loop 266 will proximally drag the outflow eyelet 1260, and therefor move the entire prosthetic valve 100 therewith, in the proximal direction. Since the second adjustment string 268fis in a released state, it can passively move or otherwise allow axial proximal movement of the prosthetic valve 100 dragged by the first loop 266.

[0194] When distal repositioning of the prosthetic valve 100 is desired, the second adjustment string 268fcan be tensioned, meaning that a pull force is applied to a proximal end thereof, while the first adjustment string 264fcan be released, such that no tension is applied thereto, or its proximal end can be proximally pulled by a pulling force that is smaller than that applied to the second adjustment strings 268f. This will cause the second loop 270 to be distally pulled against the inflow eyelet 1261. The locking wire 260, extending through the second loop 270, will prevent the second loop 270 from slipping out of the inflow eyelet 1261, such that when the portion of the second adjustment string 268fextending through the nosecone shaft 222fis proximally pulled, the portion of the second adjustment string 268fextending out of the side opening 232 and through the inflow eyelet 1261 will be distally pulled, causing the second loop 270 to distally drag the inflow eyelet 1261, and therefor move the entire prosthetic valve 100 therewith, in the distal direction. Since the first adjustment string 264fis in a released state, it can passively move or otherwise allow axial distal movement of the prosthetic valve 100 dragged by the second loop 270.

[0195] In some examples, such as when the prosthetic valve 100 is tightly compressed around the balloon 240, the balloon 240 can be partially inflated to expand the prosthetic valve 100 to a diameter that is slightly larger than the crimped diameter, after which the balloon 240 can be deflated, thereby allowing for easier axial movement of the prosthetic valve 100 relative to the balloon 240.Attorney Docket No: THVVA-23974WO01

[0196] When axial position locking of the prosthetic valve 100 over the balloon 240 is desired, such as during delivery towards the site of implantation, tension can be simultaneously applied to both the first adjustment string 264fand the second adjustment string 268f. Prior to inflation of the balloon 240 to expand the prosthetic valve 100, both the first adjustment string 264fand the second adjustment string 268fcan be released.

[0197] Some prosthetic valves may have an overall axial length, in their expanded state, that can place the outflow cell row 1180 at the level of the coronary ostia. For example, such valves 100 can be designed to have their outflow apices 122 and / or outflow eyelets 1260 contacting or being placed in the vicinity of the sinuses or the Sinotubular Junction (STJ) when expanded at the site of implantation. In some instances, a patient may require implantation of a coronary stent of other procedure that requires access to a coronary artery after prosthetic valve implantation. For such instances, a physician may need to access the coronary artery through the opening defined by an outflow cell 1160 of the outflow cell row 1180 facing the coronary ostium. While the outflow cells 1160 of the outflow cell row 1180 of the prosthetic valve 100aillustrated, for example, in Figs. 1A-1B, may have a height (measured in the axial direction) which is greater than the height of subsequent cell rows 118S and / or inflow cell row 1181, due to the axially extending struts 1 14 interconnecting the outflow rung 1120 and the proximal- most subsequent rung 112S (which is the fourth subsequent rung 112S4 in the example illustrated in Figs. 1A-1B), their width (measured in the circumferential direction, such as between two immediately adjacent axially extending struts 114) is identical to the width of all other cells 116. Since the number of cells can be chosen to be relatively large to provide sufficient radial force during expansion against the native annulus, this may result in a cell width that can compromise the ability for future access into the coronary arteries or perfusion through the frame 102 to the coronary arteries during the diastolic phase of the cardiac cycle.

[0198] Fig. 12 shows one third of a frame 102gan exemplary prosthetic valve 1008. Frame 102gis an exemplary implementation of a frame 102, and thus can include any of the features described for a frame 102 throughout the current disclosure, except that the outflow cell row 118sO of exemplary frame 102gincludes two types of cells, namely first outflow cells 11601 and second outflow cells 11602 which are wider than the first outflow cells 11601. The outflow rung 1 12g0 of exemplary frame 1028can further include two types of outflow angled struts, namely first outflow angled struts 11001 and second outflow angled struts 11002 which are longer than the first outflow angled struts 11001.

[0199] Taking advantage of the fact that increased radial force during valve expansion is required primarily at the region of the native annulus, corresponding to the region of the frameAttorney Docket No: THVVA-23974WO01 that include the subsequent cell rows 118S, the outflow cell row 118g0 of frame 102gcan include second outflow cells 11602 which are wider than cells 116 of the other cell rows. The width of the second outflow cells 11602 can be configured to be larger than the outer diameter of a selected coronary catheter (e.g., a 6 Fr coronary catheter).

[0200] In some examples, each second outflow cell 11602 can span a width of two subsequent cells 116S of a proximal-most subsequent cell row 118S. In some examples, all subsequent cells 116S, and optionally inflow cells 1161 as well, can have the same width, such that the second outflow cell 1 1602 can span a width of two subsequent cells 1 16S of any of the subsequent cell rows 118S, and / or two inflow cells 1161 of the inflow cell row 1181.

[0201] In some examples, each first outflow cell 11601 can have the same width as that of a subsequent cell 116S of the proximal-most subsequent cell row 118S, such as the third subsequent cell row 118S3 in the example illustrated in Fig. 12. In some examples, each first outflow cell 11601 can have the same width as that of a subsequent cell 116S of any of the subsequent cell rows 118S, and / or an inflow cell 1161 of the inflow cell row 1181. In some examples, each second outflow cell 11602 can be two times wider than any first outflow cell 11601.

[0202] In some examples, pairs of second outflow angled struts 11002 can define the outflow apices 122 of the frame 102s. In some examples, outflow eyelets 1260 can extend from junctions defined by pairs of first outflow angled stmts 11002. In some examples, the proximal-most subsequent rung 112S, such as the fourth rung 112S4 in the example illustrated in Fig. 12, can further define a plurality of free apices 142 which are circumferentially aligned with outflow apices 122. Free apices 142 are defined as apices of the proximal-most subsequent rung 112S which are not attached to any other stmts 108 other than the subsequent angled stmts 1 IOS of the proximal-most subsequent mng 112S. The remainder of the upper junctions of the proximal-most subsequent mng 112S, which are not free apices 142, can be further connected to axially extending stmts 114 extending proximally therefrom.

[0203] While the proximal-most subsequent cell row 118S in the example illustrated in Fig. 12 is the third subsequent cell row 118S3, and the proximal-most subsequent mng 112S is shown to be the fourth subsequent mng 112S4, it is to be understood that a frame 102scan include more or less than three subsequent cells rows 118S between the inflow cell row 1 181 and the outflow cell row 118g0, defining an appropriate number of subsequent mngs 112S.

[0204] A first outflow cell 11601 can be defined between two first outflow angled stmts 11001, two subsequent angled stmts 1 IOS of the proximal-most subsequent rung 112S, and two axially extending stmts 114 extending between the outflow mng 112g0 and the proximal-Attorney Docket No: THVVA-23974WO01 most subsequent rung 112S. A second outflow cell 11602 can be defined between two second outflow angled struts 11002, four subsequent angled struts 110S of the proximal-most subsequent rung 112S, and two axially extending struts 114 extending between the outflow rung 112g0 and the proximal-most subsequent rung 1 12S.

[0205] In some examples, each cell row 118 of exemplary frame 102gcan include an uneven number of cells 116. In some examples, the outflow cell row 118s0 includes a total of nine outflow cells 1160 that comprise three first outflow cells 11601 and six second outflow cells 1 1602, while any subsequent cell row 118S, and optionally the inflow cell row 1 181 as well, can include fifteen cells 116. In some examples, the outflow eyelets 1260 and the inflow eyelets 1261 are circumferentially aligned with each other.Some Examples of the Disclosed Implementations

[0206] Some examples of above-described implementations are enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more examples below are examples also falling within the disclosure of this application.

[0207] Example 1. A delivery assembly comprising: a prosthetic valve comprising: an annular frame movable between a radially compressed state and a radially expanded state, wherein the frame comprises: an outflow eyelet extending distally from an outflow end of the frame; and an inflow eyelet extending proximally from an inflow end of the frame.

[0208] Example 2. The delivery assembly of any example herein, particularly of example 1, wherein the inflow eyelet and the outflow eyelet are circumferentially aligned with each other.

[0209] Example 3. The delivery assembly of any example herein, particularly of example 1 or 2, wherein the inflow eyelet and the outflow eyelet are axially oriented towards each other.

[0210] Example 4. The delivery assembly of any example herein, particularly of any one of examples 1 to 3, wherein the outflow eyelet is one of a plurality of outflow eyelets, and wherein the inflow eyelet is one of a plurality of inflow eyelets.

[0211] Example 5. The delivery assembly of any example herein, particularly of any one of examples 1 to 4, wherein the outflow eyelet extends into an outflow cell of the frame, and wherein the inflow eyelet extends into an inflow cell of the frame.

[0212] Example 6. The delivery assembly of any example herein, particularly of any one of examples 1 to 5, wherein the frame further defines a plurality of outflow apices at the outflow end, and a plurality of inflow apices at the inflow end.Attorney Docket No: THVVA-23974WO01

[0213] Example 7. The delivery assembly of any example herein, particularly of example 6, wherein the outflow eyelet extends distally from one of the plurality of outflow apices, and wherein the inflow eyelet extends proximally from one of the plurality of inflow apices.

[0214] Example 8. The delivery assembly of any example herein, particularly of example 6 or 7, wherein all outflow apices are axially aligned with each other.

[0215] Example 9. The delivery assembly of any example herein, particularly of any one of examples 6 to 8, wherein all inflow apices are axially aligned with each other.

[0216] Example 10. The delivery assembly of any example herein, particularly of any one of examples 1 to 9, wherein the prosthetic valve further comprises a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.

[0217] Example 11. The delivery assembly of any example herein, particularly of any one of examples 1 to 10, wherein the prosthetic valve further comprises a skirt coupled to the frame.

[0218] Example 12. The delivery assembly of any example herein, particularly of example 11, wherein the skirt comprises a base layer disposed around an inner surface of the frame, and a plurality of protruding cells attached to the skirt and extending radially outwards through the frame.

[0219] Example 13. The delivery assembly of any example herein, particularly of any one of examples 1 to 12, further comprising a delivery apparatus comprising: a balloon catheter; an inflatable balloon mounted on the balloon catheter, wherein the prosthetic valve is disposed around the balloon; a first adjustment string extending through the outflow eyelet and terminating at a first loop disposed radially outwards to the prosthetic valve; a second adjustment string extending through the inflow eyelet and terminating at a second loop disposed radially outwards to the prosthetic valve; and a locking wire extending through the first loop and the second loop; wherein the locking wire is axially slidable through and relative to the first loop and the second loop.

[0220] Example 14. The delivery assembly of any example herein, particularly of example 13, wherein the locking wire is configured to limit axial displacement of the prosthetic valve when it extends through the first loop and the second loop.

[0221] Example 15. The delivery assembly of any example herein, particularly of example 13 or 14, wherein the locking wire is configured to prevent the first loop from slipping out of the outflow eyelet when it extends through the first loop.Attorney Docket No: THVVA-23974WO01

[0222] Example 16. The delivery assembly of any example herein, particularly of any one of examples 12 to 15, wherein the locking wire is configured to prevent the second loop from slipping out of the inflow eyelet when it extends through the second loop.

[0223] Example 17. The delivery assembly of any example herein, particularly of any one of examples 12 to 16, wherein, when the locking wire is pulled out of the first loop and the second loop, the first adjustment string is configured to slide out of the outflow eyelet, and the second adjustment string is configured to slide out of the inflow eyelet, upon expansion of the prosthetic valve.

[0224] Example 18. The delivery assembly of any example herein, particularly of any one of examples 1 to 17, wherein the outflow eyelet and the inflow eyelet are integrally formed with the frame.

[0225] Example 19. The delivery assembly of any example herein, particularly of any one of examples 1 to 18, wherein the frame comprises a plastically deformable material.

[0226] Example 20. A delivery assembly comprising: a prosthetic valve comprising: an annular frame movable between a radially compressed state and a radially expanded state, wherein the frame comprises: an outflow eyelet extending from an outflow end of the frame; and an inflow eyelet extending from an inflow end of the frame; wherein the inflow eyelet is bent radially inwards.

[0227] Example 21. The delivery assembly of any example herein, particularly of example 20, wherein the inflow eyelet is bent radially inwards relative to a plane defined by an inflow cell of the frame, from which the inflow eyelet extends.

[0228] Example 22. The delivery assembly of any example herein, particularly of example 20, wherein a line tangent to the inflow eyelet defines a non-zero angle relative to a line tangent to the frame between the inflow end and the outflow end.

[0229] Example 23. The delivery assembly of any example herein, particularly of example 20, wherein a line tangent to the inflow eyelet defines a non-zero angle relative to a line tangent to an inflow cell of the frame from which the inflow eyelet extends.

[0230] Example 24. The delivery assembly of any example herein, particularly of example 22 or 23, wherein the non-zero angle is greater than 5 degrees.

[0231] Example 25. The delivery assembly of any example herein, particularly of example 22 or 23, wherein the non-zero angle is greater than 10 degrees.

[0232] Example 26. The delivery assembly of any example herein, particularly of example 22 or 23, wherein the non-zero angle is greater than 20 degrees.Attorney Docket No: THVVA-23974WO01

[0233] Example 27. The delivery assembly of any example herein, particularly of example 22 or 23, wherein the non-zero angle is greater than 30 degrees.

[0234] Example 28. The delivery assembly of any example herein, particularly of any one of examples 20 to 27, wherein the outflow eyelet is bent radially inwards.

[0235] Example 29. The delivery assembly of any example herein, particularly of any one of examples 20 to 28, wherein the outflow eyelet is bent radially inwards relative to a plane defined by an outflow cell of the frame, from which the inflow eyelet extends.

[0236] Example 30. The delivery assembly of any example herein, particularly of any one of examples 22 to 27, wherein the non-zero angle is a first non-zero angle, and wherein a line tangent to the outflow eyelet defines a second non-zero angle relative to a line tangent to an outflow cell of the frame, from which the inflow eyelet extends.

[0237] Example 31. The delivery assembly of any example herein, particularly of example 30, wherein the first non-zero angle is equal to the second non-zero angle.

[0238] Example 32. The delivery assembly of any example herein, particularly of any one of examples 20 to 31, wherein the inflow eyelet and the outflow eyelet are circumferentially aligned with each other.

[0239] Example 33. The delivery assembly of any example herein, particularly of any one of examples 20 to 32, wherein the outflow eyelet is one of a plurality of outflow eyelets, and wherein the inflow eyelet is one of a plurality of inflow eyelets.

[0240] Example 34. The delivery assembly of any example herein, particularly of any one of examples 20 to 33, wherein the prosthetic valve further comprises a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.

[0241] Example 35. The delivery assembly of any example herein, particularly of any one of examples 20 to 34, wherein the prosthetic valve further comprises a skirt coupled to the frame.

[0242] Example 36. The delivery assembly of any example herein, particularly of example 35, wherein the skirt comprises a base layer disposed around an inner surface of the frame, and a plurality of protruding cells attached to the skirt and extending radially outwards through the frame.

[0243] Example 37. The delivery assembly of any example herein, particularly of any one of examples 20 to 36, wherein the outflow eyelet and the inflow eyelet are integrally formed with the frame.

[0244] Example 38. The delivery assembly of any example herein, particularly of any one of examples 20 to 37, wherein the frame comprises a plastically deformable material.Attorney Docket No: THVVA-23974WO01

[0245] Example 39. The delivery assembly of any example herein, particularly of any one of examples 20 to 38, further comprising a delivery apparatus comprising: a balloon catheter; an inflatable balloon mounted on the balloon catheter, wherein the prosthetic valve is disposed around the balloon; a first adjustment string extending through the outflow eyelet and terminating at a first loop disposed radially outwards to the prosthetic valve; a second adjustment string extending through the inflow eyelet and terminating at a second loop disposed radially outwards to the prosthetic valve; and a locking wire extending through the first loop and the second loop; wherein the locking wire is axially slidable through and relative to the first loop and the second loop.

[0246] Example 40. The delivery assembly of any example herein, particularly of example 39, wherein the locking wire is configured to limit axial displacement of the prosthetic valve when it extends through the first loop and the second loop.

[0247] Example 41. The delivery assembly of any example herein, particularly of example 39 or 40, wherein the locking wire is configured to prevent the first loop from slipping out of the outflow eyelet when it extends through the first loop.

[0248] Example 42. The delivery assembly of any example herein, particularly of any one of examples 39 to 41, wherein the locking wire is configured to prevent the second loop from slipping out of the inflow eyelet when it extends through the second loop.

[0249] Example 43. The delivery assembly of any example herein, particularly of any one of examples 39 to 42, wherein, when the locking wire is pulled out of the first loop and the second loop, the first adjustment string is configured to slide out of the outflow eyelet, and the second adjustment string is configured to slide out of the inflow eyelet, upon expansion of the prosthetic valve.

[0250] Example 44. A delivery assembly comprising: a prosthetic valve comprising: an annular frame movable between a radially compressed state and a radially expanded state, wherein the frame comprises: an outflow eyelet extending from an outflow cell of the frame; and an inflow eyelet extending from an inflow cell of the frame; and a delivery apparatus comprising: a balloon catheter; an inflatable balloon mounted on the balloon catheter, wherein the prosthetic valve is disposed around the balloon; a first adjustment string extending radially inwards through the outflow eyelet, across a junction connecting the outflow eyelet to the outflow cell, and radially outwards through the outflow cell, terminating at a first loop disposed radially outwards to the prosthetic valve; a second adjustment string extending through the inflow eyelet and terminating at a second loop disposed radially outwards to the prostheticAttorney Docket No: THVVA-23974WO01 valve; and a locking wire extending through the first loop and the second loop; wherein the locking wire is axially slidable through and relative to the first loop and the second loop.

[0251] Example 45. The delivery assembly of any example herein, particularly of example 44, wherein the prosthetic valve further comprises a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.

[0252] Example 46. The delivery assembly of any example herein, particularly of example 45, wherein each leaflet extends between a cusp edge and a free edge thereof, and wherein the free edges of the leaflets are distal to an outflow end of the frame.

[0253] Example 47. The delivery assembly of any example herein, particularly of example 46, wherein the free edges of the leaflets are distal to the outflow eyelet.

[0254] Example 48. The delivery assembly of any example herein, particularly of example 46 or 47, wherein a portion of the first adjustment wire which is positioned radially inwards to the frame, is axially offset from the free edge of the leaflet which is circumferentially aligned therewith.

[0255] Example 49. The delivery assembly of any example herein, particularly of any one of examples 44 to 48, wherein the prosthetic valve further comprises a skirt coupled to the frame.

[0256] Example 50. The delivery assembly of any example herein, particularly of example 49, wherein the skirt comprises a base layer disposed around an inner surface of the frame, and a plurality of protruding cells attached to the skirt and extending radially outwards through the frame.

[0257] Example 51. The delivery assembly of any example herein, particularly of any one of examples 44 to 50, wherein the second adjustment string extends radially outwards through the inflow eyelet.

[0258] Example 52. The delivery assembly of any example herein, particularly of any one of examples 44 to 50, wherein the second adjustment string extends radially inwards through the inflow eyelet, across a junction connecting the inflow eyelet to the inflow cell, and radially outwards through the inflow cell.

[0259] Example 53. The delivery assembly of any example herein, particularly of any one of examples 44 to 52, wherein the delivery apparatus further comprises an outer shaft disposed around, and axially movable relative to, the balloon catheter.

[0260] Example 54. The delivery assembly of any example herein, particularly of any one of examples 44 to 53, wherein the inflow eyelet is bent radially inwards.

[0261] Example 55. The delivery assembly of any example herein, particularly of any one of examples 44 to 54, wherein the outflow eyelet is bent radially inwards.Attorney Docket No: THVVA-23974WO01

[0262] Example 56. The delivery assembly of any example herein, particularly of any one of examples 44 to 55, wherein the inflow eyelet and the outflow eyelet are circumferentially aligned with each other.

[0263] Example 57. The delivery assembly of any example herein, particularly of any one of examples 44 to 56, wherein the outflow eyelet is one of a plurality of outflow eyelets, and wherein the inflow eyelet is one of a plurality of inflow eyelets.

[0264] Example 58. The delivery assembly of any example herein, particularly of any one of examples 44 to 57, wherein the outflow eyelet and the inflow eyelet are integrally formed with the frame.

[0265] Example 59. The delivery assembly of any example herein, particularly of any one of examples 44 to 58, wherein the frame comprises a plastically deformable material.

[0266] Example 60. The delivery assembly of any example herein, particularly of any one of examples 44 to 59, wherein the locking wire is configured to limit axial displacement of the prosthetic valve when it extends through the first loop and the second loop.

[0267] Example 61. The delivery assembly of any example herein, particularly of any one of examples 44 to 60, wherein the locking wire is configured to prevent the first loop from slipping out of the outflow eyelet when it extends through the first loop.

[0268] Example 62. The delivery assembly of any example herein, particularly of any one of examples 44 to 61, wherein the locking wire is configured to prevent the second loop from slipping out of the inflow eyelet when it extends through the second loop.

[0269] Example 63. The delivery assembly of any example herein, particularly of any one of examples 44 to 62, wherein, when the locking wire is pulled out of the first loop and the second loop, the first adjustment string is configured to slide out of the outflow eyelet, and the second adjustment string is configured to slide out of the inflow eyelet, upon expansion of the prosthetic valve.

[0270] Example 64. A delivery assembly comprising: a prosthetic valve comprising: an annular frame movable between a radially compressed state and a radially expanded state, wherein the frame comprises: an outflow eyelet extending from an outflow cell of the frame; and an inflow eyelet extending from an inflow cell of the frame; and a delivery apparatus comprising: a handle; a balloon catheter extending distally from the handle; an inflatable balloon mounted on the balloon catheter, wherein the prosthetic valve is disposed around the balloon; a first adjustment string extending distally from the handle, through the outflow eyelet, and terminating at a first loop disposed radially outwards to the prosthetic valve; a second adjustment string extending distally from the handle to a position distal to the prosthetic valve,Attorney Docket No: THVVA-23974WO01 then bending backwards and extending proximally towards the prosthetic valve, through the inflow eyelet, and terminating at a second loop disposed radially outwards to the prosthetic valve; and a locking wire extending through the first loop and the second loop; wherein the locking wire is axially slidable through and relative to the first loop and the second loop; and wherein each of the first adjustment string and the second adjustment string is configured to be independently tensioned or released.

[0271] Example 65. The delivery assembly of any example herein, particularly of example 64, wherein the delivery apparatus further comprises an outer shaft disposed around the balloon catheter.

[0272] Example 66. The delivery assembly of any example herein, particularly of example 65, wherein the first adjustment string axially extends between the balloon catheter and the outer shaft.

[0273] Example 67. The delivery assembly of any example herein, particularly of any one of examples 64 to 66, wherein the delivery apparatus further comprises a nosecone positioned distal to the balloon.

[0274] Example 68. The delivery assembly of any example herein, particularly of any one of examples 64 to 67, wherein the delivery apparatus further comprises a nosecone shaft extending proximally from the nosecone.

[0275] Example 69. The delivery assembly of any example herein, particularly of example 68, wherein the nosecone and the nosecone shaft collectively define a guidewire passage lumen.

[0276] Example 70. The delivery assembly of any example herein, particularly of example 68 or 69, wherein the nosecone shaft extends through the balloon catheter and the balloon.

[0277] Example 71. The delivery assembly of any example herein, particularly of any one of examples 68 to 70, wherein the second adjustment string extends through the nosecone shaft.

[0278] Example 72. The delivery assembly of any example herein, particularly of example 71, wherein the nosecone comprises a side opening defining the position distal to the prosthetic valve through which the second adjustment string extends.

[0279] Example 73. The delivery assembly of any example herein, particularly of any one of examples 64 to 72, wherein the locking wire is configured to limit axial displacement of the prosthetic valve when it extends through the first loop and the second loop.

[0280] Example 74. The delivery assembly of any example herein, particularly of any one of examples 64 to 73, wherein the locking wire is configured to prevent the first loop from slipping out of the outflow eyelet when it extends through the first loop, and to prevent the second loop from slipping out of the inflow eyelet when it extends through the second loop.Attorney Docket No: THVVA-23974WO01

[0281] Example 75. The delivery assembly of any example herein, particularly of example 74, wherein, when the locking wire extends through the first loop and the second loop, tensioning the first adjustment string and releasing the second adjustment string is configured to move the prosthetic valve in the proximal direction.

[0282] Example 76. The delivery assembly of any example herein, particularly of example 74 of 75, wherein, when the locking wire extends through the first loop and the second loop, tensioning the second adjustment string and releasing the first adjustment string is configured to move the prosthetic valve in the distal direction.

[0283] Example 77. The delivery assembly of any example herein, particularly of any one of examples 74 to 76, wherein, when the locking wire extends through the first loop and the second loop, simultaneously tensioning the first adjustment string and the second adjustment string is configured to axially lock the prosthetic valve in position.

[0284] Example 78. The delivery assembly of any example herein, particularly of any one of examples 74 to 77, wherein, when the first adjustment string and the second adjustment string are released and the locking wire is pulled out of the first loop and the second loop, the first adjustment string is configured to slide out of the outflow eyelet, and the second adjustment string is configured to slide out of the inflow eyelet, upon expansion of the prosthetic valve.

[0285] Example 79. The delivery assembly of any example herein, particularly of any one of examples 64 to 78, wherein the prosthetic valve further comprises a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.

[0286] Example 80. The delivery assembly of any example herein, particularly of any one of examples 64 to 79, wherein the prosthetic valve further comprises a skirt coupled to the frame.

[0287] Example 81. The delivery assembly of any example herein, particularly of example 80, wherein the skirt comprises a base layer disposed around an inner surface of the frame, and a plurality of protruding cells attached to the skirt and extending radially outwards through the frame.

[0288] Example 82. The delivery assembly of any example herein, particularly of any one of examples 64 to 81, wherein the outflow eyelet is bent radially inwards.

[0289] Example 83. The delivery assembly of any example herein, particularly of any one of examples 64 to 82, wherein the inflow eyelet and the outflow eyelet are circumferentially aligned with each other.Attorney Docket No: THVVA-23974WO01

[0290] Example 84. The delivery assembly of any example herein, particularly of any one of examples 64 to 83, wherein the outflow eyelet is one of a plurality of outflow eyelets, and wherein the inflow eyelet is one of a plurality of inflow eyelets.

[0291] Example 85. The delivery assembly of any example herein, particularly of any one of examples 64 to 84, wherein the outflow eyelet and the inflow eyelet are integrally formed with the frame.

[0292] Example 86. The delivery assembly of any example herein, particularly of any one of examples 64 to 85, wherein the frame comprises a plastically deformable material.

[0293] Example 87. A delivery assembly comprising: a prosthetic valve comprising: an annular frame movable between a radially compressed state and a radially expanded state, wherein the frame comprises: an outflow cell row comprising a plurality of first outflow cells and a plurality of second outflow cells which are wider than the first outflow cells; a plurality of subsequent cell rows distal to the outflow cell row, each subsequent cell row comprising a plurality of subsequent cells; an inflow cell row distal to the plurality of subsequent cell rows, the inflow cell row comprising a plurality of inflow cells; an outflow eyelet extending from one of the first outflow cells; and an inflow eyelet extending from one of the inflow cells; wherein each second outflow cell spans a width of two subsequent cells of a proximal-most cell row of the plurality of subsequent cell rows.

[0294] Example 88. The delivery assembly of any example herein, particularly of example 87, wherein each first outflow cell has a width equal to that of a subsequent cell of the proximal- most subsequent cell row.

[0295] Example 89. The delivery assembly of any example herein, particularly of example 87 or 88, wherein all of the subsequent cells of all of the subsequent cell rows have equal widths.

[0296] Example 90. The delivery assembly of any example herein, particularly of example 89, wherein each inflow cell has a width equal to that of any of the subsequent cells.

[0297] Example 91. The delivery assembly of any example herein, particularly of any one of examples 87 to 90, wherein the proximal-most subsequent cell row comprises fifteen subsequent cells.

[0298] Example 92. The delivery assembly of any example herein, particularly of example 91 , wherein the outflow cell row comprises three first outflow cells and six second outflow cells.

[0299] Example 93. The delivery assembly of any example herein, particularly of any one of examples 87 to 92, wherein the frame further comprises: an outflow rung comprising a plurality of first outflow angled struts and a plurality second outflow angled struts which are longer than the first outflow angled struts; a plurality of subsequent rungs distal to the outflow rung, eachAttorney Docket No: THVVA-23974WO01 of the subsequent rungs comprising a plurality of subsequent angled struts; and an inflow rung distal to the plurality of subsequent rungs and comprising a plurality of inflow angled struts.

[0300] Example 94. The delivery assembly of any example herein, particularly of example 93, wherein the outflow eyelet is connected to, and extends from, a junction connecting a pair of the first outflow angled struts.

[0301] Example 95. The delivery assembly of any example herein, particularly of example 93 or 94, wherein each pair of second outflow angled struts defines an outflow apex at an outflow end of the frame.

[0302] Example 96. The delivery assembly of any example herein, particularly of any one of examples 93 to 95, wherein the frame further comprises a plurality of axially extending struts that extend between the outflow rung and a proximal-most subsequent rung of the plurality of subsequent rungs.

[0303] Example 97. The delivery assembly of any example herein, particularly of example 96, wherein the proximal-most subsequent rung further defines a plurality of free apices which are circumferentially aligned with the outflow apices.

[0304] Example 98. The delivery assembly of any example herein, particularly of example 96 or 97, wherein each first outflow cell is defined by two of the first outflow angled struts, two of the axially extending struts, and two of the subsequent angled struts of the proximal-most subsequent rung.

[0305] Example 99. The delivery assembly of any example herein, particularly of any one of examples 96 to 98, wherein each second outflow cell is defined by two of the second outflow angled struts, two of the axially extending struts, and four of the subsequent angled struts of the proximal-most subsequent rung.

[0306] Example 100. The delivery assembly of any example herein, particularly of any one of examples 96 to 99, wherein the plurality of axially extending struts comprises a plurality of axial struts and a plurality of commissure support members.

[0307] Example 101. The delivery assembly of any example herein, particularly of any one of examples 87 to 100, wherein the inflow eyelet and the outflow eyelet are circumferentially aligned with each other.

[0308] Example 102. The delivery assembly of any example herein, particularly of any one of examples 87 to 101, wherein the outflow eyelet is one of a plurality of outflow eyelets, and wherein the inflow eyelet is one of a plurality of inflow eyelets.

[0309] Example 103. The delivery assembly of any example herein, particularly of any one of examples 87 to 102, wherein the prosthetic valve further comprises a valvular structure coupledAttorney Docket No: THVVA-23974WO01 to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.

[0310] Example 104. The delivery assembly of any example herein, particularly of any one of examples 87 to 103, wherein the prosthetic valve further comprises a skirt coupled to the frame.

[0311] Example 105. The delivery assembly of any example herein, particularly of example 104, wherein the skirt comprises a base layer disposed around an inner surface of the frame, and a plurality of protruding cells attached to the skirt and extending radially outwards through the frame.

[0312] Example 106. The delivery assembly of any example herein, particularly of any one of examples 87 to 105, wherein the outflow eyelet and the inflow eyelet are integrally formed with the frame.

[0313] Example 107. The delivery assembly of any example herein, particularly of any one of examples 87 to 106, wherein the frame comprises a plastically deformable material.

[0314] Example 108. The delivery assembly of any example herein, particularly of any one of examples 87 to 107, further comprising a delivery apparatus comprising: a balloon catheter; an inflatable balloon mounted on the balloon catheter, wherein the prosthetic valve is disposed around the balloon; a first adjustment string extending through the outflow eyelet and terminating at a first loop disposed radially outwards to the prosthetic valve; a second adjustment string extending through the inflow eyelet and terminating at a second loop disposed radially outwards to the prosthetic valve; and a locking wire extending through the first loop and the second loop; wherein the locking wire is axially slidable through and relative to the first loop and the second loop.

[0315] Example 109. The delivery assembly of any example herein, particularly of example 108, wherein the locking wire is configured to limit axial displacement of the prosthetic valve when it extends through the first loop and the second loop.

[0316] Example 110. The delivery assembly of any example herein, particularly of example 108 or 109, wherein the locking wire is configured to prevent the first loop from slipping out of the outflow eyelet when it extends through the first loop.

[0317] Example 111. The delivery assembly of any example herein, particularly of any one of examples 108 to 110, wherein the locking wire is configured to prevent the second loop from slipping out of the inflow eyelet when it extends through the second loop.

[0318] Example 112. The delivery assembly of any example herein, particularly of any one of examples 108 to 111, wherein, when the locking wire is pulled out of the first loop and the second loop, the first adjustment string is configured to slide out of the outflow eyelet, and theAttorney Docket No: THVVA-23974WO01 second adjustment string is configured to slide out of the inflow eyelet, upon expansion of the prosthetic valve.

[0319] 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.

[0320] In view of the many possible examples to which the principles of the disclosure may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope. Rather, the scope is defined by the following claims. We therefore claim all that comes within the scope and spirit of these claims.

Claims

Attorney Docket No: THVVA-23974WO01CLAIMS1. A delivery assembly comprising: a prosthetic valve comprising: an annular frame movable between a radially compressed state and a radially expanded state, wherein the frame comprises: an outflow eyelet extending from an outflow cell of the frame; and an inflow eyelet extending from an inflow cell of the frame; and a delivery apparatus comprising: a balloon catheter; an inflatable balloon mounted on the balloon catheter, wherein the prosthetic valve is disposed around the balloon; a first adjustment string extending radially inwards through the outflow eyelet, across a junction connecting the outflow eyelet to the outflow cell, and radially outwards through the outflow cell, terminating at a first loop disposed radially outwards to the prosthetic valve; a second adjustment string extending through the inflow eyelet and terminating at a second loop disposed radially outwards to the prosthetic valve; and a locking wire extending through the first loop and the second loop; wherein the locking wire is axially slidable through and relative to the first loop and the second loop.

2. The delivery assembly of claim 1, wherein the prosthetic valve further comprises a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.

3. The delivery assembly of claim 2, wherein each leaflet extends between a cusp edge and a free edge thereof, and wherein the free edges of the leaflets are distal to an outflow end of the frame.

4. The delivery assembly of claim 3, wherein the free edges of the leaflets are distal to the outflow eyelet.

5. The delivery assembly of claim 3 or 4, wherein a portion of the first adjustment wire which is positioned radially inwards to the frame, is axially offset from the free edge of the leaflet which is circumferentially aligned therewith.Attorney Docket No: THVVA-23974WO016. A delivery assembly comprising: a prosthetic valve comprising: an annular frame movable between a radially compressed state and a radially expanded state, wherein the frame comprises: an outflow eyelet extending from an outflow cell of the frame; and an inflow eyelet extending from an inflow cell of the frame; and a delivery apparatus comprising: a handle; a balloon catheter extending distally from the handle; an inflatable balloon mounted on the balloon catheter, wherein the prosthetic valve is disposed around the balloon; a first adjustment string extending distally from the handle, through the outflow eyelet, and terminating at a first loop disposed radially outwards to the prosthetic valve; a second adjustment string extending distally from the handle to a position distal to the prosthetic valve, then bending backwards and extending proximally towards the prosthetic valve, through the inflow eyelet, and terminating at a second loop disposed radially outwards to the prosthetic valve; and a locking wire extending through the first loop and the second loop; wherein the locking wire is axially slidable through and relative to the first loop and the second loop; and wherein each of the first adjustment string and the second adjustment string is configured to be independently tensioned or released.

7. The delivery assembly of claim 6, wherein the locking wire is configured to prevent the first loop from slipping out of the outflow eyelet when it extends through the first loop, and to prevent the second loop from slipping out of the inflow eyelet when it extends through the second loop.

8. The delivery assembly of claim 7, wherein, when the locking wire extends through the first loop and the second loop, tensioning the first adjustment string and releasing the second adjustment string is configured to move the prosthetic valve in the proximal direction.

9. The delivery assembly of claim 7 or 8, wherein, when the locking wire extends through the first loop and the second loop, tensioning the secondAttorney Docket No: THVVA-23974WO01 adjustment string and releasing the first adjustment string is configured to move the prosthetic valve in the distal direction.

10. The delivery assembly of any one of claims 7 to 9, wherein, when the locking wire extends through the first loop and the second loop, simultaneously tensioning the first adjustment string and the second adjustment string is configured to axially lock the prosthetic valve in position.

11. The delivery assembly of any one of claims 7 to 10, wherein, when the first adjustment string and the second adjustment string are released and the locking wire is pulled out of the first loop and the second loop, the first adjustment string is configured to slide out of the outflow eyelet, and the second adjustment string is configured to slide out of the inflow eyelet, upon expansion of the prosthetic valve.

12. A delivery assembly comprising: a prosthetic valve comprising: an annular frame movable between a radially compressed state and a radially expanded state, wherein the frame comprises: an outflow cell row comprising a plurality of first outflow cells and a plurality of second outflow cells which are wider than the first outflow cells; a plurality of subsequent cell rows distal to the outflow cell row, each subsequent cell row comprising a plurality of subsequent cells; an inflow cell row distal to the plurality of subsequent cell rows, the inflow cell row comprising a plurality of inflow cells; an outflow eyelet extending from one of the first outflow cells; and an inflow eyelet extending from one of the inflow cells; wherein each second outflow cell spans a width of two subsequent cells of a proximal-most cell row of the plurality of subsequent cell rows.

13. The delivery assembly of claim 12, wherein each first outflow cell has a width equal to that of a subsequent cell of the proximal-most subsequent cell row.

14. The delivery assembly of any one of claims 12 to 13, wherein the proximal- most subsequent cell row comprises fifteen subsequent cells.

15. The delivery assembly of claim 14, wherein the outflow cell row comprises three first outflow cells and six second outflow cells.Attorney Docket No: THVVA-23974WO0116. The delivery assembly of any one of claims 12 to 15, wherein the frame further comprises: an outflow rung comprising a plurality of first outflow angled struts and a plurality second outflow angled struts which are longer than the first outflow angled struts; a plurality of subsequent rungs distal to the outflow rung, each of the subsequent rungs comprising a plurality of subsequent angled struts; and an inflow rung distal to the plurality of subsequent rungs and comprising a plurality of inflow angled struts.

17. The delivery assembly of claim 16, wherein the outflow eyelet is connected to, and extends from, a junction connecting a pair of the first outflow angled struts.

18. The delivery assembly of claim 16 or 17, wherein each pair of second outflow angled struts defines an outflow apex at an outflow end of the frame.

19. The delivery assembly of any one of claims 16 to 18, wherein the frame further comprises a plurality of axially extending struts that extend between the outflow rung and a proximal-most subsequent rung of the plurality of subsequent rungs.

20. The delivery assembly of claim 19, wherein the proximal-most subsequent rung further defines a plurality of free apices which are circumferentially aligned with the outflow apices.

21. The delivery assembly of claim 19 or 20, wherein each first outflow cell is defined by two of the first outflow angled struts, two of the axially extending struts, and two of the subsequent angled struts of the proximal-most subsequent rung.

22. The delivery assembly of any one of claims 19 to 21, wherein each second outflow cell is defined by two of the second outflow angled struts, two of the axially extending struts, and four of the subsequent angled struts of the proximal-most subsequent rung.

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