Prosthetic valves

Abstract

The present disclosure relates to prosthetic valves. In an example, a prosthetic valve comprises a frame that has an initial fabricated diameter. The frame includes a plurality of strut rungs, each comprising a plurality of struts pairs arranged around a circumference of the frame. Each strut pair comprises two angled struts diverging from a mutual vertex to opposite junctures at which the angled struts are connected to axial frame members which are circumferentially spaced from each other, the frame is configured to be compressed from the initial fabricated diameter to a compressed diameter, and to be expanded from the compressed diameter to any expanded working diameter in a range of expanded working diameters that includes a smallest expanded working diameter and a largest expanded working diameter, wherein the initial fabricated diameter is less than the largest expanded working diameter in the range of expanded working diameters.

Description

PROSTHETIC VALVESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 719,088, filed November 11, 2024, which is incorporated by reference herein.FIELD

[0002] The present disclosure relates to prosthetic heart valves and methods for fabricating prosthetic heart valves.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 defining generally V-shaped pairs of angled struts between adjacent axial frame members thereof, and methods for fabricating prosthetic heart valves. The disclosed prosthetic heart valves and methods can, for example, provide for improved prosthetic heart valves that are designed have a range of working diameters. As such,the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves.

[0006] In one of its basic configurations, a prosthetic valve comprises a frame having an initial fabricated diameter, wherein the frame is configured to be compressed from the initial fabricated diameter to a compressed diameter for delivery into a patient via catheterization. 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 is configured to be expanded from the compressed diameter to any expanded working diameter in a range of expanded working diameters that includes a smallest expanded working diameter and a largest expanded working diameter.

[0008] In some examples, the initial fabricated diameter is less than the largest expanded working diameter in the range of expanded working diameters.

[0009] In some examples, the frame comprises a plurality of axial frame members circumferentially spaced from each other and a plurality of strut rungs, wherein each stmt rung a plurality of stmts pairs arranged around a circumference of the frame.

[0010] In some examples, each stmt pair comprises two angled stmts diverging from a mutual vertex to opposite junctures at which the angled stmts are connected to two of the axial frame members.

[0011] In some examples, the plurality of stmt mngs comprises an outflow mng defining an outflow end of the frame, and an inflow mng defining an inflow end of the frame.

[0012] In some examples, the plurality of stmt mngs comprises an intermediate mng disposed between the outflow mng and the inflow mng.

[0013] In some examples, the prosthetic valve further comprises a valvular stmcture mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.

[0014] In some examples, all of the stmt pairs of the outflow mng are oriented towards the inflow end.

[0015] In some examples, all of the stmt pairs of the inflow mng are oriented towards the outflow end.

[0016] In some examples, the initial fabricated diameter is greater than the smallest expanded working diameter.

[0017] In some examples, the initial fabricated diameter is equal to the smallest expanded working diameter.

[0018] In some examples, the initial fabricated diameter is less than the smallest expanded working diameter.

[0019] In some examples, each of the plurality of strut pairs defines an angle less than a critical angle when the annular frame is at the initial fabricated diameter.

[0020] In some examples, the angle defined by each of the strut pairs of the outflow rung is greater than the angle defined by each of the strut pairs of at least one of the other rungs of the frame.

[0021] In some examples, an axial distance defined between the junctures of the inflow rung and the junctures of the intermediate rung is less than an axial distance defined between the junctures of the intermediate rung and the junctures of the outflow rung.

[0022] In some examples, the angle defined by each of the strut pairs of the inflow rung is greater than the angle defined by each of the strut pairs of at least one of the intermediate rung.

[0023] In some examples, the critical angle is in a range from 120 degrees to 140 degrees.

[0024] In some examples, the axial frame members comprise: a plurality of commissure support axial members, and a plurality of non-commissural axial members.

[0025] In one of its basic configurations, a method for fabricating a prosthetic valve comprises fabricating a frame having an initial fabricated state in which the frame has an initial fabricated diameter. 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.

[0026] In some examples, the fabricating the frame comprises forming a plurality of strut rungs, each comprising a plurality of struts pairs arranged around a circumference of the frame, wherein each strut pair comprises two angled stmts diverging from a mutual vertex to opposite junctures at which the angled stmts are connected to axial frame members which are circumferentially spaced from each other.

[0027] In some examples, the plurality of stmt mngs comprises an outflow mng defining an outflow end of the frame, and an inflow mng defining an inflow end of the frame.

[0028] In some examples, the plurality of strut rungs comprises an intermediate rung disposed between the outflow rung and the inflow rung.

[0029] In some examples, the frame is configured to radially expand to any one of a smallest radially expanded working state in which the frame is configured to have a smallest working diameter and a largest radially expanded working state in which the frame is configured to have a largest working diameter.

[0030] In some examples, the largest working diameter is greater than the initial fabricated diameter.

[0031] In some examples, fabricating the frame comprises cutting a tube having the initial fabricated diameter.

[0032] In some examples, the tube is formed from a plastically-expandable metal.

[0033] In some examples, the angled struts of each strut pair define an angle therebetween.

[0034] In some examples, the angle is less than a critical angle in the initial fabricated diameter.

[0035] In some examples, the angle is configured to be greater than the critical angle after the frame is expanded to the largest working diameter.

[0036] In some examples, the critical angle is in a range from 120 degrees to 140 degrees.

[0037] In some examples, a method or device can include any of the features recited in Examples 1-39 below.

[0038] The aspects of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.BRIEF DESCRIPTION OF THE FIGURES

[0039] 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:

[0040] Fig. 1 A is a perspective side view of an exemplary prosthetic valve that includes three rungs of angled struts.

[0041] Fig. IB is a side view of the frame of the prosthetic valve of Fig. 1 A.

[0042] Fig. 1C shows a flattened view of the frame of Fig. IB.

[0043] Figs. 2 A and 2B are side views of the frame of Fig. IB in a radially crimped state and a radially expanded state, respectively.

[0044] Fig. 3A is a side view of an exemplary frame that includes four rungs of angled struts.

[0045] Fig. 3B shows a flattened view of the frame of Fig. 3 A.

[0046] Fig. 4 shows an exemplary delivery apparatus carrying an exemplary prosthetic valve.

[0047] Fig. 5A-5C show various radially expanded states of a portion of the frame of Fig. 1C.

[0048] Fig. 6A-6C show various radially expanded states of a portion of an exemplary frame having shorter struts along the outflow rung.

[0049] Fig. 7A-7C show various radially expanded states of a portion of an exemplary frame having an inflow rung and an intermediate rung thereof in close proximity to each other.

[0050] Fig. 8A-8C show various radially expanded states of a portion of an exemplary frame having shorter struts along both the outflow rung and the inflow rung.

[0051] Fig. 9A-9C show various radially expanded states of a portion of an exemplary frame that includes four rungs of angled struts, with struts along the outflow rung and the inflow rung being shorter than struts along the intermediate rungs.DETAILED DESCRIPTION

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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".

[0056] 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.

[0057] 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.

[0058] The terms "proximal" and "distal" are defined relative to the use position of a delivery apparatus. In general, the end of the delivery apparatus closest to the user of the apparatus is the proximal end, and the end of the delivery apparatus farthest from the user (e.g., the end that is inserted into a patient’s body) is the distal end. The term "proximal" when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the proximal end of the delivery apparatus. The term "distal" when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the distal end of the delivery apparatus. The terms "longitudinal" and "axial" are interchangeable, and refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0059] 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.

[0060] Figs. 1A and IB show perspective and side views, respectively, of an example of a prosthetic valve 10, with and without soft components (such as skirts and a leaflet assembly). 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 working state. Thus, the prosthetic valve can optionally be crimped on or retained by an implant delivery apparatus 52 (see Fig. 4) in the radially compressed state during delivery, and then expanded to the radially expanded working state once the prosthetic valve reaches the implantation site.

[0061] In some examples, the prosthetic valve can be expandable to any one of a plurality of radially expanded, functional states inside a patient. For example, the prosthetic valve can be expandable to any one of a first radially expanded working state and a second radially expanded working state. In this way, the prosthetic heart valve can beneficially be adapted and / or configured to be implanted into different sizes of native annuluses and / or other anatomic features (for example, vessels communicating with the heart such as the pulmonary artery, the superior vena cava, the inferior vena cava, or other various veins, arteries, and vessels).

[0062] Similar to the overall prosthetic valve, a frame of the prosthetic valve can be radially compressible and expandable between a radially compressed state and a radially expanded working state. For example, the frame can be configured to be compressible to the radially compressed state, in which the frame has a compressed diameter (which is also referred to herein as a "crimped diameter"). In some examples, the frame can be configured to be expandable to any one of a plurality of radially expanded working states in order to facilitate the variable expansion of the prosthetic valve to a desired working diameter in a range of working diameters. For example, the frame can be configured to be expandable to any one of a smallest radially expanded working state (which is also referred to herein as a "low-end state") in which the frame has a diameter equal to a smallest expanded working diameter in a range of expanded working diameters and a largest radially expanded working state (which is also referred to herein as a "high-end state") in which the frame has a diameter equal to a largest expanded working diameter in the range of expanded working diameters. Thus, the frame can be configured to be expandable across a range of expanded working diameters.

[0063] In some examples, the frame of the prosthetic valve can be formed from a tube. The frame can be formed by removing material from the tube to form a plurality of struts and / or a plurality of open cells. In some examples, the frame can be cut (for example, laser cut) to remove the material in order to form the plurality of stmts and / or the plurality of open cells.

[0064] The frame can have an initial fabricated state in which the frame has an initial fabricated diameter that is equal to the diameter of the tube. In some examples, the initial fabricated diameter can be greater than the smallest expanded working diameter in the range of expanded working diameters and smaller than the largest expanded working diameter in the range of expanded working diameters. In some examples, the initial fabricated diameter can be equal to the smallest expanded working diameter. As used herein, a "low end tube" is a tube from which the frame is cut to form a frame having an initial fabricated diameter equal to the smallest expanded working diameter of the frame. In some examples, the initial fabricated diameter can be less than the smallest expanded working diameter.

[0065] The frame can comprise the plurality of angled struts that can be arranged to form generally V-shaped pairs of struts intersecting at a vertex. The angle defined between the struts of a stmt pair can be below a threshold angle (which is also referred to herein as a "critical angle", which is discussed below) when the frame is in the initial fabricated state. In some examples, the threshold angle can be in a range from 120 degrees to 140 degrees, such from 125 degrees to 135 degrees. In this way, the plurality of angled stmts of the frame can be moreeasily pivoted or bent at the plurality of vertices such that the frame and / or the prosthetic valve can be more easily crimped from the initial fabricated state to the radially compressed state.

[0066] Each one of the plurality of pairs of struts can define an angle that is above the threshold angle when the frame is in the largest radially expanded working state corresponding to the largest working diameter of the frame. In this way, when the angle of each one of the plurality of pairs of struts is greater than the threshold angle, the plurality of angled struts of the frame can be oriented in a relatively circumferential direction that allows the frame to better resist forces acting thereupon. In this way, configuring the frame to expand such that the angle of each one of the plurality of pairs of stmts is greater than the threshold angle provides for more uniform expansion of the frame along an axial length of the frame.

[0067] A prosthetic valve of the cunent disclosure (e.g., prosthetic valve 10, 100) may include any prosthetic valve configured to be mounted within the native aortic valve, the native mitral valve, the native pulmonary valve, and the native tricuspid valve. The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve), or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0068] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Patent No. 10,363,130, which is incorporated by reference herein. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in US Publication No. 2022 / 0079749, which is incorporated herein by reference. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Patent No. 11,291,540, which is incorporated herein by reference.

[0069] It is to be understood that any 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 balloonis deflated and retrieved along with a delivery apparatus 52 (see Fig. 4). 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.

[0070] The prosthetic valve 10 and any prosthetic valve disclosed herein (for example, prosthetic valve 100) can be radially compressible and expandable between a radially compressed state and at least one radially expanded working state. For example, the prosthetic valve 10 can be expandable to any one of a plurality of radially expanded working states that includes a smallest radially expanded working state and a largest radially expanded working state. In this way, the prosthetic heart valve can beneficially be adapted and / or configured to be implanted into different sizes of native annuluses and / or other anatomic features (for example, vessels communicating with the heart such as the pulmonary artery, the superior vena cava, the inferior vena cava, or other various veins, arteries, and vessels).

[0071] The prosthetic valve 10 comprises a frame 106 movable between a radially compressed state and a radially expanded state, and a valvular structure 170 comprising a plurality of leaflets 172 mounted within the frame 106. The frame extends between an inflow end 104 and an outflow end 102, and defines a central longitudinal axis CA extending in a direction from the inflow end 104 to the outflow end 102. In some instances, the inflow end 104 is the distal end of the frame 106, and the outflow end 102 is the proximal end of the frame 106. Alternatively, depending for example on the delivery approach of the valve, the inflow end can be the proximal end of the frame, and the outflow end can be the distal end of the frame.

[0072] The term "proximal", as used herein, generally refers to a position, direction, or portion of a device or a component of a device, which is closer to the user (for example, during an implantation procedure) and further away from the implantation site.

[0073] The term "distal", as used herein, generally refers to a position, direction, or portion of a device or a component of a device, which is further away from the user and closer to the implantation site.

[0074] 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.

[0075] The term "inflow", as used herein, refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve.

[0076] 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.

[0077] The terms "longitudinal" and "axial", as used herein, refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0078] The frame 106 can be radially compressible and expandable. The frame 106 can be configured to be readily compressible from an initial fabricated state to a radially compressed state (which is also referred to herein as a "radially compressed configuration", a "radially collapsed state", and / or a "radially collapsed configuration"). The frame 106 can be configured to be radially expandable from the initial fabricated state or the radially compressed state to at least one radially expanded working state (which is also referred to herein as a "radially expanded state", a "radially expanded configuration", a "working configuration", a "working state", an "annular configuration", and / or an "annular state"). For example, the frame 106 can be configured to be expandable to any one of a plurality of radially expanded working states, including any one of a smallest radially expanded working state and a largest radially expanded working state. The frame 106 in an exemplary radially expanded (annular) state is shown in Figs. 1A-1B. As used herein, a "radially expanded working state" is a state or configuration in which the frame 106 allows the leaflets 172 coupled to the frame 106 to sufficiently open and close (coapt) to regulate the flow of blood through the frame 106 (in other words, a state that allows the valvular structure 170 coupled to the frame 106 to work or operate).

[0079] Fig. 1C shows the frame 106 in a flat configuration for purposes of illustration. The frame 106 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 106 (and thus the prosthetic valve 10, 100) can be crimped to a radially compressed (or crimped) state on a delivery catheter (e.g., balloon catheter 60 shown in Fig. 4) and then expanded inside a patient by an inflatable balloon (e.g., balloon 62 shown in Fig. 4) or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 106 (and thus the prosthetic valve 10, 100) can be crimped to a radially compressed state and restrained in the compressed state by 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 (for example, any one of the plurality of radially expanded working states).

[0080] Suitable plastically-expandable materials that can optionally be used to form the frames disclosed herein (e.g., the frame 106) include metal alloys, polymers, or combinations thereof. Example metal alloys can optionally comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, rhenium, or other biocompatible metal. In some examples, the frame 106 comprises stainless steel. In some examples, the frame 106 comprises cobaltchromium. In some examples, the frame 106 comprises nickel-cobalt-chromium. In some examples, the frame 106 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight. In some examples, the frame 106 comprises a refractory metal alloy. In some examples, the frame 106 comprises a metal alloy that includes at least 20% atomic weight of at least one of: MoRe alloy, ReW alloy, MoReCr alloy, MoReTa alloy, MoReTi alloy, WCu alloy, ReCr, molybdenum alloy, rhenium alloy, tungsten alloy, tantalum alloy, niobium alloy, or any combination thereof. In some examples, the frame 106 comprises a metal allow that includes at least 20 atomic weight percentage of rhenium.

[0081] In the example illustrated in Figs. 1A-1C, the frame 106 is an annular, stent-like structure comprising a plurality of intersecting struts 108 which form multiple rows 130 of cells 128 between the outflow end 102 and the inflow end 104 of the frame 106. 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 106. The frame 106 can include a plurality of stmt rungs 114 that can collectively define a plurality of cells 128 arranged in several cell rows 130. The frame 106 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 104 to the outflow end 102 as shown, or the frame can vary in diameter alongthe height of the frame, as disclosed in US Pat. No. 9,155,619, which is incorporated herein by reference.

[0082] Figs. 1A-1C show an exemplary prosthetic valve 10 that can be representative of, but is not limited to, a balloon expandable prosthetic valve. The interconnected struts 108 include a plurality of angled struts 110 arranged in a plurality of rungs 114 of circumferentially extending rungs of angled struts, with the strut rungs 114 being arrayed along the length of the frame 106 between the outflow end 102 and the inflow end 104. Struts 108 of the frame 106 can optionally further include a plurality of axial frame members 116 angularly spaced apart from each other around the circumference of the frame. The term "axial frame member" refers to a stmt or a component of the frame 106 that generally extends in an axial direction (parallel to the central longitudinal axis CA), while the term "angled stmt" generally refers to a stmt that can extend at an angle relative to an axial line intersecting therewith along a plane defined by the frame 106. It is to be understood that the term "angled stmt" encompasses both linear angled stmts and curved stmts, including, in some examples, stmts that can have one or more undulations along their lengths.

[0083] The angled stmts 110 in each mng 114 are arranged is stmt pairs 112, wherein each pair 112 forms a V shape between adjacent axial frame members 116. The angled stmts 110 of each pair 112 intersect with each other at a vertex 134, which is illustrated in Figs. 1A-1C in the form of a generally U-shaped stmcture, though any other suitable shape of the vertex is contemplated. Opposite to the vertex 134, each angled stmt 110 is connected to the corresponding axial frame member 1 16 at a joint 132. Thus, each pair 112 of stmts is connected by two joints 132 to the corresponding two axial frame members 116. The terms "pair", "stmt pair", and "pair of stmts", as used throughout the description and the claims, are interchangeable.

[0084] The frame 106 further defines a plurality of outflow apices 136 at the outflow end 102 of the frame, and a plurality of inflow apices 138 at the inflow end 104 of the frame. The angled stmts 110 may be pivotable or bendable relative to each other, to the central longitudinal axis CA, and / or relative to the axial frame members 116, so as to permit frame expansion or compression. For example, the frame 106 can be optionally 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.

[0085] Any frame disclosed herein can include at least three stmt mngs, namely an outflow mng 1140 of outflow angled stmts 110O at the outflow end 102 of the frame, an inflow mngintermediate rung 114S therebetween. Any frame disclosed herein can include at least two cell rows 130, namely an outflow cell row 1300 of outflow cells 1280 at the outflow end 102 of the frame, and an inflow cell row 1301 of inflow cells 1281 at the inflow end 104 of the frame. Optionally, but not necessarily, one or more intermediate cells rows 130S can be further defined between the outflow cell row 1300 and the inflow cell row 1301.

[0086] Various exemplary implementations for 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 10a, illustrated in Figs. 1A-1C, is an exemplary implementation of a prosthetic valve 10, and thus can include any of the features described for a prosthetic valve 10 throughout the current disclosure, except that the frame 106aof the prosthetic valve 10acomprises exactly three strut rungs 114 that define exactly two cell rows 130 therebetween. Namely, frame 106ais shown to include a single intermediate rung 114S comprising a plurality of intermediate struts 110S, and no intermediate cell rows between the outflow cell row 1300 and inflow cell row 1301. It is to be understood that a frame 106 can optionally include less or more than three rungs.

[0087] The valvular structure 170 can comprise a plurality of leaflets 172 (e.g., three leaflets), positioned at least partially within the frame 106, and configured to regulate flow of blood through the prosthetic valve 10 from the inflow end 104 to the outflow end 102. While three leaflets 172 arranged to collapse in a tricuspid arrangement, are shown in the example illustrated in Fig. 1A, it will be clear that a prosthetic valve 10 can include any other number of leaflets 172.

[0088] The inflow or cusp edges (concealed from view in Fig. 1A) of the leaflets 172 can be secured to the frame 106 directly or indirectly, such as by being sutured directly to the frame, being sutured to an inner skirt, and / or via one or more connecting skirts. The cusp portions of the leaflets 172 can collectively define a scalloped line of attachment. Further examples and methods of attaching skirts and seal members to a frame, as well as method and techniques forcoupling leaflets 172 to the frame 106, with or without connecting skirts, are disclosed in US Pat. No. 11,096,781, which is incorporated herein by reference.

[0089] Adjacent leaflets 172 can be arranged together to form commissures 184 that are coupled (directly or indirectly) to respective portions of the frame 106, thereby securing an upper portion (e.g., above the scalloped line) of the valvular structure 170 to the frame 106. In some examples, each leaflet 172 can comprise opposing tabs 176. Each tab 176 can be secured to an adjacent tab 176 of an adjacent leaflet 172 to form a commissure 184 that is secured to the frame 106. The tabs 176 can be folded in various manners, for example to form radially extending layers and circumferentially extending layers facing the frame. Radially extending layers can extends radially inward from a location on the frame 106 to free edges 180, also termed coaptation edges, of the leaflets.

[0090] During valve cycling, the leaflets 172 can articulate at the inner most edges of the tab layers, which helps space the leaflets away from the frame 106 during normal operation of the prosthetic valve. This is particular advantageous in cases where the prosthetic valve 10 is not fully expanded to its nominal size when implanted in a patient. As such, the prosthetic valve 10 can be implanted in a wider range of patient annulus sizes. Further details regarding transcatheter prosthetic valves, including the manner in which leaflets 172 can be coupled to the frame 106 of the prosthetic valve 10, can be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,652,202, and 11,135,056, and in PCT Publication No. WO 2023 / 086548, all of which are incorporated herein by reference in their entireties.

[0091] The frame 106 includes an outflow cell row 1300, an inflow cell row 1301, and optionally (but not necessarily) one or more intermediate cell rows 130S therebetween. Each cell row 130 comprises a plurality of cells 128 extending circumferentially such that each cell 128 is directly coupled to two circumferentially adjacent cells 128 on both sides thereof within the same row of cells. The term "cell", as used herein, refers to a closed cell, having an enclosed perimeter defined by at least four stmts 108. In the example illustrated in Figs. 1A-1C, the frame 106ais shown to include exactly two cell rows 130, namely the outflow cell row 1300 and the inflow cell row 1301, without any intermediate cell rows therebetween.

[0092] In some examples, such as shown in Figs. 1A-1C, each cell row 130 comprises nine cells 128. Thus, the frame 106 can be referred to as a nine -cell frame. In other examples, the frame 106 can have a greater or fewer number of circumferentially extending cell rows 130 and / or a greater or fewer number of cells 128 in each cell row.

[0093] In some examples, cells 128 are coupled to adjacent cells 128 within the same row via axial frame members 116. Each axial frame member 116 can be comprised of axial segment 118, wherein an axial segment 118 of an axial frame member 116 is defined as a portion of the corresponding axial frame member 116 extending between axially-adjacent joints 132 of the same axial frame member 116. Thus, the number of segments 118 of each axial frame member 116 can match the number of cell rows 130 of the frame. In the example illustrated in Figs. 1A- IC, adjacent inflow cells 1281 share common inflow axial segments 1181, and adjacent outflow cells 1280 share common outflow axial segments 1 180.

[0094] Axial frame members 116 include, in some examples, commissure support axial members 122 and non-commissural axial members 120. A commissure support axial member 122 has one of its axial segments 118 defined as a commissure support segment 124, configured to support a corresponding commissure 184 of the valvular structure 170. In contrast, a non- commissural axial members 120 can be defined such that non of its axial segments 118 is a commissure support segment. The axial frame members 116, including non-commissural axial members 120 and commissure support axial members 122, can optionally be parallel to each other and / or to the central longitudinal axis CA of the frame 106.

[0095] In some examples, commissure support segments 124 are outflow axial segments 1180, wherein each pair of immediately adjacent commissure support segments 124 can be separated by one or more outflow axial segments 1180 of non-commissural axial members 1120 disposed therebetween. The term "immediately adjacent" refers to circumferentially adjacent commissure support segments 124 that do not include another commissure support segment 124 disposed therebetween.

[0096] In some examples, a commissure support segment 124 can optionally comprise a commissure window opening 126 defined between two axially-extending sidewalls. While commissure support segments 124 that include commissure window openings 126 are illustrated and described herein, it is to be understood that a frame 106 can include other types of commissure support segments configured to mount a commissure 184 in any other suitable manner, such as by supporting portions of the valvular structure 170 that can be wrapped therearound, can include apertures through which sutures for attaching the commissures can be passed, and the like.

[0097] While the width of most of the axial segments 118 is shown in Figs. 1A-1C to be substantially similar to that of the angled struts Ws, it is to be understood that in some examples, at least some axial frame members 116 or axial segments 118 thereof can have a width WA that is larger than a width Ws of at least some of the angled struts 110. As used herein, a "width" ofa strut is measured between opposing locations on opposing surfaces of a strut that extend between the radially facing inner and outer surfaces of the strut (relative to the central axis CA). A "thickness" of a strut is measured between opposing locations on the radially facing inner and outer surfaces of a strut and is perpendicular to the width of the strut. In some examples, a width of the commissure support segment 124 can be greater than that of other axial segments, for example due to inclusion of a commissure window opening 126 formed therein.

[0098] The V-shaped configuration of the strut pairs 112 can be oriented either towards the inflow end (i.e., the direction oriented from the outflow end to the inflow end) or towards the outflow end (i.e., the direction oriented from the inflow end to the outflow end). In some examples, as shown for frame 106ain Fig. 1A-1C, all strut pairs 112 of the same rung 114 are oriented in the same direction. Stated otherwise, a strut pair 112 is termed to be oriented toward the inflow end when its vertex 134 is closer to the inflow end 104 while its two joints 132 are closer to the outflow end 102. Similarly, a strut pair 112 is termed to be oriented toward the outflow end when its vertex 134 is closer to the outflow end 102 while its two joints 132 are closer to the inflow end 104. In the example illustrated in Figs. 1A-1C, all strut pairs 112 of the outflow rung 1140 are oriented towards the inflow end, while all strut pairs 112 of the inflow rung 1141 are oriented towards the outflow end.

[0099] In the example shown for frame 106ain Figs. 1A-1C, all strut pairs 112 of the single intermediate rung 114S are further shown to be oriented towards the inflow end, such that the outflow rung 1140 and the intermediate rung 114S are substantially parallel to each other.

[0100] Each outflow cell 1280 is defined between a pair of outflow angled struts 1120, a pair of intermediate angled struts 112S, and two outflow axial segments 1180 extending between the two pairs of angled struts. Each inflow cell 1281 is defined between a pair of inflow angled struts 1121, a pair of intermediate angled struts 112S, and two inflow axial segments 1181 extending between the two pairs of angled struts.

[0101] As mentioned above, while two rows 130 of cells 128 defined between three rungs 114 of angled struts 110 are illustrated, it is to be understood that any exemplary prosthetic valve disclosed herein can include any other number of cell rows 130 and strut rungs 114.

[0102] In some examples, the prosthetic valve 10 can optionally include at least one skirt 190 disposed around the frame 106. In some examples, the at least one skirt 190 can include an inner skirt secured to an inner surface of the frame 106. The inner skirt can function as a sealing member to prevent or decrease perivalvular leakage, to anchor the valvular structure 170 to the frame 106, and / or to protect the leaflets 172 against damage caused by contact with the frame 106 during crimping and during working cycles of the prosthetic valve 10. In some examples,cusp end portions of the leaflets 172 can be sutured to the inner skirt generally along a scallopshaped line. The inner skirt can in turn be coupled to the frame 106 by one or more fasteners, such as sutures. In some examples, an inner skirt comprises a single sheet of material that extends continuously around frame 106. In some examples, the inner skirt can optionally comprise one or more skirt portions that are connected together and / or individually connected to the frame 106.

[0103] Due to the orientation of the strut pairs 112 along the inflow rung 1141 and the outflow rung 1 140, the outflow apices 136 are defined at the upper joints 132 of the axial frame members 116 with the outflow rung of stints 1140, and the inflow apices 138 are defined at the lower joints 132 of the axial frame members 116 with the inflow rung of stmts 1141.

[0104] In some examples, the inflow axial segments 1181 are longer than the outflow axial segments 1180, as shown for exemplary prosthetic valve 10ain Figs. 1A-1C. When the stmt pairs 112 of the inflow mng 1141 and the outflow mng are oriented towards each other, the inflow axial segments 1181 can be designed to be long enough to prevent these mngs from crossing each other in the compressed or expanded states of the frame. In contrast, the parallel orientation of the outflow mng 1140 and the intermediate mng 114S allow for a relatively shorter length of the outflow axial segments 1180, thereby enabling, in some examples, formation of an overall shorter prosthetic valve 10 if desired.

[0105] Figs. 2A and 2B are side views of the frame 106aof Figs. 1 A-1C, in a radially crimped state and in a radially expanded state, respectively. As shown, the height of the frame, defined as the axial distance between the inflow end 104 and outflow end 102 of the frame 106, does not change between the compressed and expanded state of the frame. Specifically, a frame configuration in which the stmt pairs 112 of the outflow mng 1140 are oriented towards the inflow end 104, and the stmt pairs 112 of the inflow mng 1141 are oriented towards the outflow end 102, such that all vertices 134 of any stmt pairs 112 are disposed between both ends of the frame at all times, can result in no foreshortening during expansion from the compressed state.

[0106] As the frame of such a configuration moves from the radially compressed state shown in Fig. 2A, to the radially expanded state shown in Fig. 2B, the circumferential distance between adjacent axial frame members 116 increases due to pivoting or angular movement of the angled stmt 110. However, since the inflow end 104 and outflow end 102 coincide with the ends of the axial frame members 116, which do not change orientation during frame compression or expansion, the frame's height remains unchanged and equal to the length of the axial frame members 116, thereby substantially eliminating valve foreshortening. Stated otherwise, when the upper and lower ends of the axial frame members 116, at which the axialframe members 116 intersect with the outflow rung of angled struts 1140 and the inflow rung of angled struts 1141, define the outflow apices 136 and the inflow apices 138, respectively, the height (or axial length) of the frame 106 is substantially equal to the unchanging length of the axial frame members 116, irrespective of the state or diameter of the prosthetic valve. This can facilitate more accurate and / or predictable deployment of the prosthetic valve from the radially compressed state.

[0107] In some examples, the frame 106 can further include one or more top markers 146 extending proximally from the outflow end 102 of the frame. For example, a top marker 146 can be generally continuous with a corresponding axial frame member 116 from which it extends. A top marker is configured to serve as an indicator of the angular orientation of the frame 106, and can have various suitable shapes and dimensions. For example, the top marker 146 illustrated for exemplary frame 106ais shown to be flag-shaped, including a neck portion extending substantially in an axial direction from the outflow end 102 of the frame, and terminating with a head portion 150 that extends in a lateral or circumferential direction, substantially perpendicularly to the neck portion 148. It is to be understood that any reference to an outflow end 102 of a frame 106aas shown in Figs. 1A-2B, for example, refers to an end defined at the level of the outflow apices 136, such that the top markers 146 can be termed to extend past the level of the outflow end 102. Likewise, any reference herein to a height (or axial length) of a frame 106, refers to a distance between the inflow end 104 and the outflow end 102, without accounting for top markers 146 considered to extend pas the outflow end 102.

[0108] In some examples, the at least one skirt 190 can include an outer skirt disposed around an outer surface of the frame 106, and configure to function, for example, as a sealing member retained between the frame 106 and the surrounding tissue of the native annulus against which the prosthetic valve is mounted, thereby reducing risk of paravalvular leakage (PVL) past the prosthetic valve 10. In some examples, the outer skirt comprises a single sheet of material that extends continuously around the frame 106. In some examples, the outer skirt can optionally comprise one or more skirt portions that are connected together and / or individually connected to the frame 106.

[0109] Any of an inner skirt and / or outer skirt can optionally comprise various suitable biocompatible materials, such as, but not limited to, natural tissue (e.g. pericardial tissue), a fabric, or polymeric material (such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc.).

[0110] It is to be understood that an inner skirt and an outer skirt are described herein by way of illustration and not limitation. For example, a prosthetic valve 10 can optionally be provided with an inner skirt and without an outer skirt, in which case, the inner skirt further serves as aPVL sealing member of the valve against the surrounding anatomy. Similarly, a prosthetic valve 10 can optionally be provided with an outer skirt (such as skirt 190 illustrated in Fig. 1 A) and without an inner skirt, in which case, the leaflet's cusp end portion can be optionally directly coupled (e.g., sutured) to struts 108 of the frame 106.

[0111] The two angled struts 110 of any strut pair 112 can define an angle 192 (which is also referred to herein as a "strut pair angle" and / or a "vertex angle"). Pairs of stmts 112 along the outflow rung 1140 can define outflow angles 1920 between angled stmts 110O thereof. Pairs of stmts 112 along the intermediate mng 114S can define intermediate angles 192S between angled stmts 11 OS thereof. Pairs of stmts 112 along the inflow mng 1141 can define inflow angles 1921 between angled stmts 1101 thereof. Although angles 192 formed between angled stmts of pairs or stmts 112 along all stmt mngs 114 are shown in Figs. 1 A-1C to form the same angle 192, in some examples, pairs of stmts 112 along two or more of the plurality of mngs 114 can each form a different angle.

[0112] Figs. 3A and 3B show perspective and flattened views of a frame 106bof exemplary prosthetic valve 10b, illustrated without soft components such as leaflets or skirts for simplicity. Prosthetic valve 10bcan be structurally and functionally similar to any example of prosthetic valve 10 described herein, except that the frame 106bof prosthetic valve 10bincludes two intermediate mngs 114S of angled stmts, namely a first intermediate mng 114S1 of first intermediate angled stmts 110S1 distal to the outflow mng 1140, and a second intermediate mng 114S2 of second intermediate angled stmts 110S2 distal to the first intermediate mng 114S 1 and proximal to the inflow rang 1141. Thus, frame 106bdefines a single intermediate cell row 130S between the outflow cell row 1300 and the inflow cell row 1301.

[0113] All stmt pairs 112 of the outflow mng 1140 and all stmt pairs 112 of the first intermediate rang 114S 1 are oriented towards the inflow end, such that the outflow mng 1140 and the first intermediate mng 114S 1 are substantially parallel to each other. All stmt pairs 112 of the inflow mng 1141 and all stmt pairs 112 of the second intermediate mng 114S2 are oriented towards the outflow end, such that the inflow mng 1141 and the second intermediate mng 114S2 are substantially parallel to each other.

[0114] Each outflow cell 1280 of frame 106bis defined between a pair of outflow angled stmts 1 120, a pair of first intermediate angled stmts 112S1, and two outflow axial segments 1180 extending between the two pairs of angled stmts. Each inflow cell 1281 of frame 106bis defined between a pair of inflow angled stmts 1121, a pair of second intermediate angled stmts 112S2, and two inflow axial segments 1181 extending between the two pairs of angled stmts. Each intermediate cell 128S of frame 106bis defined between a pair of first intermediate angledstruts 112S1, a pair of second intermediate angled struts 112S2, and two intermediate axial segments 118S extending between the two pairs of angled struts.

[0115] Pairs of struts 112 along the first intermediate rung 114S1 can define first intermediate angles 192S1 between angled stmts 110S1 thereof. Pairs of stmts 112 along the second intermediate rung 114S2 can define second intermediate angles 192S2 between angled stmts 110S 2 thereof. Although angles 192 formed between angled stmts of pairs or stmts 112 along both first and second intermediate rungs 114S 1, 114S2 are shown in Figs. 3A-3B to form the same angle 192, in some examples, pairs of stmts 1 12 of the first intermediate rang 1 14S 1 and the second intermediate rang 114S2 can each form a different angle.

[0116] Fig. 4 shows an exemplary delivery assembly 50 that includes a delivery apparatus 52 adapted to deliver a prosthetic device, which can be any exemplary prosthetic valve 10 described above, or any exemplary prosthetic valve 100 described below with respect to Figs. 6-26. The delivery apparatus 52 can optionally include a handle 54 and at least one catheter extending therefrom, configured to carry a prosthetic valve 10, 100 in a radially compressed state through the patient's vasculature. An exemplary delivery assembly 50 comprises an exemplary delivery apparatus 52 configured to carry a balloon expandable prosthetic valve. The delivery apparatus 52 can optionally comprise a balloon catheter 60 having an inflatable balloon 62 mounted on its distal end. A prosthetic device, such as prosthetic valve 10, 100, can be optionally carried in a crimped state over the balloon catheter 60.

[0117] In some examples, a delivery apparatus 52 further comprises an outer shaft 58. Optionally, an outer shaft 58 of a delivery apparatus 52 can concentrically extend over the balloon catheter 60.

[0118] The outer shaft 58 and the balloon catheter 60 can optionally be configured to be axially movable relative to each other. For example, a proximally oriented movement of the outer shaft 58 relative to the balloon catheter 60, or a distally oriented movement of the balloon catheter 60 relative to the outer shaft 58, can expose the prosthetic valve 10, 100 from the outer shaft 58.

[0119] A delivery apparatus 52 can optionally further include a nosecone 64 to facilitate advancement of the delivery apparatus 52 through the patient's vasculature to the site of treatment. A nosecone shaft (concealed from view in Fig. 4) can optionally extend proximally from the nosecone 64 through a lumen of the balloon catheter 60, towards the handle 54.

[0120] In Fig. 4, a prosthetic valve 10, 100 is mounted on the balloon 62 and is shown in a crimped state, providing prosthetic valve 10, 100 with a reduced diameter for delivery to the heart via the patient's vasculature. While the prosthetic valve 10, 100 is shown in Fig. 4 asbeing crimped or mounted on the balloon 62 for delivery to the treatment location, it should be understood that the prosthetic valve can be optionally crimped or mounted at a location different from the location of balloon 62 (e.g., proximal to the balloon 62) and repositioned over the balloon at some time before inflating the balloon and deploying the prosthetic valve. This off-balloon delivery allows the prosthetic valve to be crimped to a lower profile than would be possible if the prosthetic valve was crimped on top of the balloon 62. The lower profile permits the clinician to more easily navigate the delivery apparatus (including the crimped prosthetic valve) through a patient’s vasculature to the treatment location. The lower profile of the crimped prosthetic valve can be particularly helpful when navigating through portions of the patient's vasculature which are particularly narrow, such as the iliac artery.

[0121] The proximal ends of the balloon catheter 60, the outer shaft 58, and / or the nosecone shaft, can optionally be coupled to the handle 54. During delivery, the handle 54 can be maneuvered by an operator (e.g., a clinician or a surgeon) to axially advance or retract components of the delivery apparatus 52, such as the nosecone shaft, the outer shaft 58, and / or the balloon catheter 60, through the patient's vasculature and / or along the target site of implantation, as well as to inflate the balloon 62 mounted on the balloon catheter 60, for example to expand a prosthetic valve 10, 100 mounted on the balloon 62, and to deflate the balloon 62 and retract the delivery apparatus 52, for example once the prosthetic valve 10, 100 is mounted in the implantation site.

[0122] The handle 54 can optionally include a steering mechanism configured to adjust the curvature of a distal end portion of the delivery apparatus 52. In the illustrated example, the handle 54 includes an adjustment member, such as the illustrated rotatable knob 56a, which in turn is operatively coupled to the proximal end portion of a pull wire (not shown). The pull wire can optionally extend distally from the handle 54 through the outer shaft 58 and has a distal end portion affixed to the outer shaft 58 at or near the distal end of the outer shaft 58. Rotating the knob 56a can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 52. 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.

[0123] In some examples, the handle 54 can include an adjustment member such as the illustrated rotatable knob 56b, configured to adjust the axial position of the balloon catheter 60 relative to the outer shaft 58, for example for fine positioning at the implantation site. The handle can include additional knobs to control additional components of the delivery apparatus52. Further details on the delivery apparatus 52 can be found in PCT Application No. PCT / US2021 / 047056, which is incorporated by reference herein.

[0124] A prosthetic valve 10, 100 can be carried by the delivery apparatus 52 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). In some examples, the balloon 62 is secured to a distal end portion of the balloon catheter 60 at its proximal end, while the balloon's distal end can optionally be coupled, directly or indirectly, to another component of the delivery apparatus 52, such as the nosecone 64 or nosecone shaft.

[0125] Balloon 62 is configured to transition between a deflated and inflated states. Upon reaching the site of implantation, the balloon 62 can be inflated to radially expand the prosthetic valve 10, 100. Once the prosthetic valve 10, 100 is expanded to its functional diameter within a native annulus, the balloon 62 can be deflated, and the delivery apparatus 52 can be retrieved from the patient's body.

[0126] In some examples, the delivery apparatus 52 with the prosthetic valve 10, 100 assembled thereon, can be packaged in a sterile package that can be supplied to end users for storage and eventual use. In some examples, when the leaflets of the prosthetic valve are made from, or include at least an inner core made from, bovine pericardium tissue or other natural or synthetic tissues, the leaflets can be 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 prosthetic valve and the delivery apparatus, 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.

[0127] As previously discussed, the frame 106 can be configured to be compressible from the initial fabricated state to the radially compressed state (on a delivery apparatus for delivery into patient) and can be configured to be expandable from the initial fabricated state or the radially compressed state to at least one radially expanded working state. For example, the frame 106 can be expandable to any one of a plurality of radially expanded working states defining a range of working diameters for the prosthetic valve, wherein the radially expanded working states include a smallest radially expanded working state corresponding to the smallest working diameter for the prosthetic valve and a largest radially expanded working state corresponding to the largest working diameter for the prosthetic valve.

[0128] The smallest and largest expanded working diameters of the frame 106 can define a range of expanded working diameters (which is also referred to herein as a "range of deployed diameters") at which the leaflets 172 of the prosthetic valve 10 can adequately open and close (in other words, coapt) to regulate the flow of blood through the prosthetic valve 10. As used herein, "the smallest radially expanded working state" corresponds to the state of the prosthetic valve 10 at the smallest working diameter for the prosthetic valve 10 and "the largest radially expanded working state" corresponds to the state of the prosthetic valve 10 at the largest working diameter for the prosthetic valve 10.

[0129] In some examples, the difference between the smallest working diameter and the largest working diameter in this range can at least 1 mm, at least 2 mm, at least 3 mm, at least 4 mm, at least 4.5 mm, or at least 5 mm. In some examples, a prosthetic valve can have a range of expanded working diameters spanning from 21 to 24 mm, such as from 21.5 mm to 24 mm, from 22 mm to 24 mm, 22 mm to 23.5 mm, or from 22 mm to 23 mm. In some examples, the prosthetic valve 10 can have a range of working diameters spanning from 25.5 mm to 30 mm, such as from 26 mm to 30 mm, from 26 mm to 29 mm, from 27 mm to 30 mm, from 28 mm to 30 mm, or from 29 mm to 30 mm. In this way, the frame 106 (and the prosthetic valve 10) can beneficially be adapted and / or configured to be implanted into different sizes of native annuluses and / or other anatomic features (for example, vessels communicating with the heart such as the pulmonary artery, the superior vena cava, the inferior vena cava, or other various veins, arteries, and vessels).

[0130] The frame 106 in the initial fabricated state (such as when laser cut from a tube) can have an initial fabricated diameter. The initial fabricated diameter can be less than the largest working diameter. In some examples, the initial fabricated diameter can be less than the largest working diameter and greater than the smallest working diameter. In some examples, the initial fabricated diameter can be substantially equal to (for example, within 10%) the smallest working diameter. In some examples, the initial fabricated diameter can be less than the smallest working diameter.

[0131] The frame 106 in the radially compressed, delivery state can have a diameter that is less than the initial fabricated diameter.

[0132] It has been discovered that designing the frame 106 such that the angle 192 formed by each one of the pairs of struts 112 is below a "threshold angle" (which is also referred to herein as a "critical angle") when the frame 106 is in the initial fabricated state can beneficially provide for improved crimping of the frame 106 and / or the prosthetic valve 10. For example, when the frame 106 is in the initial fabricated state and the angle 192 is below the threshold angle, theplurality of angled stmts 110 of the frame 106 can be more easily pivoted or bent at the plurality of vertices 134, thereby allowing the frame 106 and / or the prosthetic valve 10 to be more easily radially compressed from the initial fabricated state to the radially compressed state.

[0133] Furthermore, it has been discovered that designing the frame 106 such that the angle 192 formed by each one of the stmt pairs 112 is above the threshold angle when the frame 106 is in the largest radially expanded working state can beneficially increase the strength of the frame 106. For example, when the frame 106 is in the largest radially expanded working state and the angle 192 is above the threshold angle, the plurality of angled stmts 1 10 of the frame 106 can be oriented in a relatively circumferential direction that allows the frame 106 to better resist radial forces acting thereupon. Furthermore, designing the frame 106 in this way provides for more uniform expansion along its axial length when the frame 106 is expanded to certain radially expanded working states (for example, the largest radially expanded working state).

[0134] Thus, it has been discovered that the disclosed frame 106, which is configured have an initial fabricated state in which the angle 192 is less than the threshold angle and is further configured to be expandable to a largest radially expanded working state in which the angle 192 is greater than the threshold angle, provides for a frame that exhibits a desirable balance between strength and compressibility.

[0135] The threshold angle can be any angle in a range from 120 degrees to 140 degrees. In some examples, the threshold angle can be substantially equal to (for example, within 10%) any one of 120 degrees, 125 degrees, 130 degrees, 135 degrees, and 140 degrees, etc.

[0136] In some examples, the angle 192 can be in a range from 100 degrees to 130 degrees, such as from 110 degrees to 130 degrees, from 110 degrees to 120 degrees, from 115 degrees to 125 degrees, etc. when the frame is in the initial fabricated state.

[0137] In some examples, the angle 192 can be in a range from 130 degrees to 179 degrees, such as from 130 degrees to 150 degrees, from 130 degrees to 150 degrees, from 135 degrees to 145 degrees, from 140 degrees to 179 degrees, from 150 degrees to 179 degrees, from 140 degrees to 160 degrees, from 140 degrees to 150 degrees, from 145 degrees to 155 degrees, etc. when the frame is in the largest radially expanded working state.

[0138] Figs. 5A-5C are side views of a portion of the frame 106ain various radially expanded states. The illustrated portion of the frame 106 includes two columns of cells extending between the outflow end 102 and the inflow end 104. Fig. 5A shows the portion of the frame 106ain an exemplary state that is between the compressed state and the low-end state, defining a diameter that is greater than the crimped diameter and less than the smallest expanded working diameter. Fig. 5B shows the portion of the frame 106ain low-end state, expanded to the smallestexpanded working diameter. Fig. 5C shows the portion of the frame 106ain high-end state, expanded to the largest expanded working diameter.

[0139] As previously discussed, the angle 192 can be less than the threshold angle when the frame 106 is in the initial fabricated state and the angle 192 can be greater than the threshold angle when the frame 106 is in the largest radially expanded working state. In some examples, the state shown in Fig. 5A, in which the diameter of the frame is less than the smallest working diameter, can also be the initial fabricated state. In other examples, the low-end state shown in Fig. 5B can also be the initial fabricated state.

[0140] Described herein are examples of prosthetic valves 100 that can be structurally and functionally similar to any exemplary prosthetic valve 10 described above, except where indicated otherwise.

[0141] As mentioned above, any one of the frames described herein can be formed from a tube having a diameter equal to the initial fabricated diameter of the frame (and thus be less than the largest expanded diameter). Since the angles formed by the pairs of stmts in the initial fabricated state are smaller than the angles formed by the pairs of stmts in the largest radially expanded working state, forming the frame to have an initial fabricated diameter that is less than the largest expanded diameter can help reduce the amount of movement experienced by the plurality of angled stmts during crimping and / or radial compression, thereby beneficially further reducing the risk of deformation during crimping and / or radial compression.

[0142] Fig. 6A-6C are side views of a portion of the frame 106cof an exemplary prosthetic valve 100cin various radially expanded states. Prosthetic valve 100cis an exemplary implementation of a prosthetic valve 10, 100, and thus can include any of the features described for a prosthetic valve 10 or 100 throughout the current disclosure, except that the angled stmts 110O along the outflow mng 1140 of the frame 106care shorter than other angled stmts of the frame, such as angled stmts 110 of the intermediate rang 114S and / or the inflow rang 1141. Fig. 6 A shows the portion of the frame 106cin an exemplary state that is between the compressed state and the low-end state, defining a diameter that is greater than the crimped diameter and less than the smallest expanded working diameter. Fig. 6B shows the portion of the frame 106cin low-end state, expanded to the smallest expanded working diameter. Fig. 6C shows the portion of the frame 106cin high-end state, expanded to the largest expanded working diameter.

[0143] In some examples, all strut pairs 112 of the outflow rang 1140 and the intermediate rang 114S of the frame 106ccan be oriented towards the inflow end, while all strut pairs 112 of the inflow rang 1141 can be oriented towards the outflow end. In some examples, the outflowstruts 1100 of the outflow rung 1140 are shorter than any of the angled struts 1 IOS, 1101 of the intermediate and inflow rungs 114S, 1141. This will result in the angle 1920 defined at the outflow rung 1140 being larger than the angles 192S, 1921 defined at the intermediate and inflow rungs 114S, 1141. In some examples, the length of the angled struts 11 OS along the intermediate rung 114S can be substantially equal (e.g., within 10%) to the length of the angled struts 1101 along the inflow rung 1141. In some examples, the angle 192S defined at the intermediate rung 114S can be substantially equal (e.g., within 10%) to the angle 1921 defined at the inflow rung 1141.

[0144] An important design parameter of a prosthetic valve is the shape or profile assumed thereby upon expansion to a working diameter. The expanded shape of the prosthetic valve is important because it can affect how the prosthetic valve anchors or interfaces with the native valve annulus, the proportions of the prosthetic valve that are located in one chamber versus the other chamber across the native valve, and / or the location(s) where the prosthetic valve engages the native tissue. The shape of the expanded prosthetic valve can also affect various hemodynamic parameters of the prosthetic valve, such as the pressure drop across the prosthetic valve, the orifice area at the inflow and outflow, and the degree to which the leaflets open and close during valve operation.

[0145] In some examples, it is possible to influence the shape of the frame during deployment (e.g., the shape of the frame as it transitions between the radially crimped state and the expanded working state) by varying the stiffness or resistance to radial expansion of various portions of the frame relative to each other. It is also possible to influence the shape of the fully expanded frame 106 in a similar manner. One way of tuning the resistance to expansion is by varying the one or more of the angles 192 defined by strut pairs 112 of the various strut rungs 114, such as rungs 1140, 114S, 1141. For example, by varying the angles 192 defined by strut pairs 112 of the various strut rungs 114, a frame 106 can be manufactured in a cylindrical shape (e.g., from cylindrically-shaped tube), and crimped to a reduced diameter on a balloon (or other expansion mechanism) that is configured to expand to a cylindrical shape. The angle parameters can be tuned such that when expanded using a cylindrical balloon, the frame 106 can assume any of a variety of cylindrical or non-cylindrical shapes in an expanded working diameter. This can allow the frame shape to be optimized, for example, to achieve improved hemodynamic properties, to influence the location in the native valve at which the prosthetic valve is anchored, to control the position of the frame relative to sensitive anatomical features, and / or to control the pressure applied by the prosthetic valve to the surrounding anatomy. Such parameters can also be used to influence the proportion of the overall frame length that isdisposed in a vessel or chamber upstream of the native valve and downstream of the native valve.

[0146] Additional parameters that can influence the shape of the prosthetic valve in the expanded working state relate to the density of the stmts along different portion of the frame, and the width of the stmts along different stmt mngs 114. For example, a higher density of angled stmts 110, which can result from certain rungs 114 of stmts positioned closer to each other at certain portion of the frame, can increase stiffness or resistance to radial expansion along these frame portions.

[0147] Some prosthetic valves 10, 100 may have an overall height (or axial length), in their expanded working state, that can place the outflow cell row 1300 at the level of the coronary arteries (not shown) when implanted in the native aortic valve, posing a risk of covering at least a portion of the openings of the coronary arteries. In some instances, a patient may require implantation of a coronary stent or 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 1280 of the outflow cell row 1300 facing the opening into the coronary arteries.

[0148] Thus, it may be desirable, in some cases, to define higher outflow cells 1280 along the outflow cell row 1300 to provide a larger opening for blood flow and / or coronary access. This can be achieved, for example, by offsetting the intermediate mng 114S father from the outflow mng 1140 to increase the distance between both mngs 1140 and 114S, thereby increasing the height of the outflow cells 1280 defined between these two mngs 1140, 114S. Assuming that the overall height of the frame 106 remains substantially the same, offsetting the intermediate mng 114S farther from the outflow mng 1140 will place it closer to the inflow mng 1141, which can eventually result in a higher density of stmts 110 along an inflow portion of the frame 106, including the stmts 110 of the two closer mngs 1 141 and 114S, as opposed to the more spacious configuration along the outflow portion of the frame. This approximation of the mngs 114S and 1141 to each other can eventually result in higher resistance to expansion along an inflow portion of the frame, which can result in a substantially V-shaped expanded configuration upon reaching an expanded working diameter.

[0149] Exemplary frame 106cis shown, in Figs. 6A-6C, to define an angle 1920 along stmt pairs of the outflow mng that is greater than angle 192S or 1 21 defined at the intermediate and inflow mngs. Because of the larger angle 1920, stmts along the outflow mng 1140 can resist expansion to a greater degree than the stmts along mngs defining a smaller angled therebetween. In some examples, such as when the axial distance between the outflow mng1140 and the intermediate rung 114S is greater than the axial distance between the intermediate rung 114S and the inflow rung 1141, the angle 1920 at the outflow rung 1140 can be designed to result in a relatively uniform or cylindrically-shaped expanded configuration of the frame 106cin a radially expanded working state, such that resistance to expansion of the upper portion of the frame, which includes the shorter outflow struts 1100, will balance the resistance of the lower portion of the frame that includes the rungs 114S and 1141.

[0150] In some examples, the angle 1920 defined at the outflow rung 1140 of exemplary frame 106ccan be less than the threshold angle when the frame 106cis in the initial fabricated state and the angle 1920 can be greater than the threshold angle when the frame 106cis in the largest radially expanded working state. In some examples, the state shown in Fig. 6A, in which the diameter of the frame is less than the smallest working diameter, can also be the initial fabricated state. In other examples, the low-end state shown in Fig. 6B can also be the initial fabricated state.

[0151] Fig. 7A-7C are side views of a portion of the frame 106dof an exemplary prosthetic valve 100din various radially expanded states. Prosthetic valve 100dis similar to any example described herein for prosthetic valve 100c, except that the intermediate rung 114S of the frame 106dis flipped relative to its orientation shown for frame 106cin Figs. 6A-6C, such that the intermediate rung 114S and the inflow rung 1141 are parallel to each other. Fig. 7A shows the portion of the frame 106din an exemplary state that is between the compressed state and the low-end state, defining a diameter that is greater than the crimped diameter and less than the smallest expanded working diameter. Fig. 7B shows the portion of the frame 106din low-end state, expanded to the smallest expanded working diameter. Fig. 7C shows the portion of the frame 106din high-end state, expanded to the largest expanded working diameter.

[0152] In some examples, all strut pairs 112 of the outflow rung 1140 of the frame 106dcan be oriented towards the inflow end, while all strut pairs 112 of the intermediate rung 114S and the inflow rung 1141 can be oriented towards the outflow end. In some examples, the outflow struts 1100 of the outflow rung 1140 are shorter than any of the angled struts 1 IOS, 1101 of the intermediate and inflow rungs 114S, 1141. This will result in the angle 1920 defined at the outflow rung 1140 being larger than the angles 192S, 1921 defined at the intermediate and inflow rungs 114S, 1141. In some examples, the length of the angled struts 11 OS along the intermediate rung 114S can be substantially equal (e.g., within 10%) to the length of the angled struts 1101 along the inflow rung 1141. In some examples, the angle 192S defined at the intermediate rung 114S can be substantially equal (e.g., within 10%) to the angle 1921 defined at the inflow rung 1141.

[0153] Advantageously, the configuration shown in Figs. 7A-7C allows the inflow axial segments 1181 to be significantly shorter than their axial lengths shown for frame 106cin Figs. 6A-6C, when the rungs 114S and 1141 are approximated to each other from any of the reasons described above with respect to enlargement of the outflow cells 1280, without posing a risk of struts of the flipped intermediate rung 114S crossing the inflow rung 1141.

[0154] In some examples, the angle 1920 defined at the outflow rung 1140 of exemplary frame 106dcan be less than the threshold angle when the frame 106dis in the initial fabricated state and the angle 1920 can be greater than the threshold angle when the frame 106dis in the largest radially expanded working state. In some examples, the state shown in Fig. 7A, in which the diameter of the frame is less than the smallest working diameter, can also be the initial fabricated state. In other examples, the low-end state shown in Fig. 7B can also be the initial fabricated state.

[0155] Fig. 8A-8C are side views of a portion of the frame 106eof an exemplary prosthetic valve 100ein various radially expanded states. Prosthetic valve lOOe 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 the angled struts 1100 along the outflow rung 1140 and the angled stmts 1101 along the inflow rung 1141 of the frame 106eare shorter than angled stmts 1 IOS of the intermediate rung 114S. Fig. 8A shows the portion of the frame 106ein an exemplary state that is between the compressed state and the low-end state, defining a diameter that is greater than the crimped diameter and less than the smallest expanded working diameter. Fig. 8B shows the portion of the frame 106ein low-end state, expanded to the smallest expanded working diameter. Fig. 8C shows the portion of the frame 106ein high-end state, expanded to the largest expanded working diameter.

[0156] In some examples, all stmt pairs 112 of the outflow rung 1140 and the intermediate mng 114S of the frame 106ecan be oriented towards the inflow end, while all stmt pairs 112 of the inflow mng 1141 can be oriented towards the outflow end. Nevertheless, it is to be understood that any other orientation of any of the mngs 114 of frame 106eis contemplated.

[0157] In some examples, the outflow stmts 1100 of the outflow mng 1140 and the inflow stmts 1101 of the inflow rang 1141 are shorter than angled stmts 1 IOS of the intermediate mng 114S. This will result in the angles 1920 and 1921 defined at the outflow mng 1140 and the inflow rang 1141, respectively, being larger than the angle 192S defined at the intermediate mng 114S.

[0158] In some examples, the length of the angled stmts 1100 along the outflow mng 1140 can be substantially equal (e.g., within 10%) to the length of the angled stmts 1101 along theinflow rung 1141. In some examples, the lengths of the angled struts 1100 along the outflow rung 1140 and the angled struts 1101 along the inflow rung 1141 are different from each other, wherein each is shorter than the length of angled struts 1 IOS of the intermediate rung 114S.

[0159] In some examples, the angle 1920 defined at the outflow rung 1140 can be substantially equal (e.g., within 10%) to the angle 1921 defined at the inflow rung 1141. In some examples, the angle 1920 at the outflow rung 1140 and the angle 1921 at the inflow rung 1141 are different from each other, wherein each is smaller than the angle 192S of the intermediate rung 114S.

[0160] In some examples, the angles 192 defined at the intermediate rung 114S and the inflow rung 1141 can be substantially equal (e.g., within a range of 10% from each other), though it is to be understood that these angles can also differ from each other, as long each is still larger than the angle 192S of the intermediate rung 114S.

[0161] Because of the larger angle 1920 and 1921, struts along the outflow rung 1140 and the inflow rung 1141, respectively, can resist expansion to a greater degree than the struts along the intermediate rung 114S, thereby resulting in a substantially barrel shape of the frame 106ewhen expanded to a working diameter, such that the any of the diameters at the inflow end 104 and at the outflow end 102 of the frame 106eis smaller than a diameter defined therebetween, for example at the axial level of the intermediate rung 114S.

[0162] The barrel-shaped profile of the expanded working state of the frame 106ecan also provide certain advantages. For example, the reduced diameter at the inflow end 104 can space the frame 106caway from the His bundle, thereby reducing the risk of electrical conduction abnormalities and rupture of the native valve annulus. When implanted in the native aortic valve, the reduced diameter at the outflow end 102 of the frame 106ecan space the frame away from the coronary ostia, and thereby reduce the risk of blocking the coronary arteries with, for example, the native leaflets displaced by the frame. This can also improve access to the coronary ostia post-implantation.

[0163] The barrel-shaped profile can also provide certain hemodynamic performance advantages. For example, the reduced diameter at the outflow end 102 can improve coaptation of the prosthetic valve leaflets 172, resulting in reduction or elimination of an opening between the leaflets 172 during ventricular diastole. The barrel-shaped profile can also reduce contact between the prosthetic leaflets 172 and the frame 106eduring valve operation, prolonging the service life of the prosthetic valve 100e. The leaflets 172 can also have more space in which to open and close within the frame 106e, improving flow through the valve 100e.

[0164] In some examples, the angles 1920 and 1921 defined at the outflow rung 1140 and inflow rung 1141 of exemplary frame 106ecan be less than the threshold angle when the frame 106eis in the initial fabricated state and the angles 1920 and 1921 can be greater than the threshold angle when the frame 106cis in the largest radially expanded working state. In some examples, the state shown in Fig. 8A, in which the diameter of the frame is less than the smallest working diameter, can also be the initial fabricated state. In other examples, the low- end state shown in Fig. 8B can also be the initial fabricated state.

[0165] Fig. 9A-9C are side views of a portion of the frame 106fof an exemplary prosthetic valve 100fin various radially expanded states. Prosthetic valve 100fis similar to any example described herein for prosthetic valve 100e. except that the frame 106fis shown to include two intermediate rungs 114S1 and 114S2. Fig. 9A shows the portion of the frame 106fin an exemplary state that is between the compressed state and the low-end state, defining a diameter that is greater than the crimped diameter and less than the smallest expanded working diameter. Fig. 9B shows the portion of the frame 106fin low-end state, expanded to the smallest expanded working diameter. Fig. 9C shows the portion of the frame 106fin high-end state, expanded to the largest expanded working diameter.

[0166] In some examples, all strut pairs 112 of the outflow rung 1140 and the first intermediate rung 114S1 of the frame 106fcan be oriented towards the inflow end, parallel to each other, while all strut pairs 112 of the inflow rung 1141 and the second intermediate rung 114S2 can be oriented towards the outflow end, also parallel to each other. Nevertheless, it is to be understood that any other orientation of any of the rungs 114 of frame 106fis contemplated.

[0167] In some examples, the outflow struts 1100 of the outflow rung 1140 and the inflow struts 1101 of the inflow rung 1141 are shorter than angled struts 11 OS 1 , 110S2 of the first and second intermediate rungs 114S1, 114S2. This will result in the angles 1920 and 1921 defined at the outflow rung 1140 and the inflow rung 1141, respectively, being larger than the angles 192S 1, 192S2 defined at the first and second intermediate rungs 114S1, 114S2.

[0168] In some examples, the length of the angled stmts 1100 along the outflow rung 1140 can be substantially equal (e.g., within 10%) to the length of the angled stmts 1101 along the inflow rang 1141. In some examples, the lengths of the angled stmts 1100 along the outflow mng 1140 and the angled stmts 1101 along the inflow mng 1141 are different from each other, wherein each is shorter than the length of any of the angled stmts 110S1, 110S2 of the first or second intermediate mngs 114S1, 114S2.

[0169] In some examples, the length of the angled stmts 1 IOS 1 along the first intermediate mng 114S1 can be substantially equal (e.g., within 10%) to the length of the angled stmts11 OS 2 along the second intermediate rung 114S2. In some examples, the lengths of the angled struts 1 IOS 1 along the first intermediate rung 114S1 and the angled struts 110S2 along the second intermediate rung 114S2 are different from each other, wherein each is longer than the length of any of the angled stmts 1100, 1101 of the outflow or inflow rungs 1140, 1141.

[0170] In some examples, the angle 1920 defined at the outflow rung 1140 can be substantially equal (e.g., within 10%) to the angle 1921 defined at the inflow rung 1141. In some examples, the angle 1920 at the outflow rung 1140 and the angle 1921 at the inflow rung 1141 are different from each other, wherein each is smaller than the angle 192S 1, 192S2 of any of the first or second intermediate rungs 114S1, 114S2.

[0171] In some examples, the angle 192S1 defined at the first intermediate rung 114S1 can be substantially equal (e.g., within 10%) to the angle 192S2 defined at the second intermediate rung 114S2. In some examples, the angle 192S1 at the first intermediate rang 1 14S1 and the angle 192S2 at the second intermediate rang 114S2 are different from each other, wherein each is larger than any of the angles 1920, 1921 of the outflow or inflow rungs 1140, 1141.

[0172] Because of the larger angle 1920 and 1921, struts along the outflow rang 1140 and the inflow rang 1141, respectively, can resist expansion to a greater degree than the struts along the intermediate rungs 114S1, 114S2, thereby resulting in a substantially barrel shape of the frame 106fwhen expanded to a working diameter, in the same manner described above with respect to exemplary frame 106eof Figs. 8A-8C.

[0173] In some examples, the angles 1920 and 1921 defined at the outflow rang 1140 and inflow rang 1141 of exemplary frame 106fcan be less than the threshold angle when the frame 106fis in the initial fabricated state and the angles 1920 and 1921 can be greater than the threshold angle when the frame 106fis in the largest radially expanded working state. In some examples, the state shown in Fig. 9A, in which the diameter of the frame is less than the smallest working diameter, can also be the initial fabricated state. In other examples, the low- end state shown in Fig. 9B can also be the initial fabricated state.

[0174] While the frame 106fis shown and described herein to include two intermediate rungs 114S1 and 114S2, it is to be understood that more than two intermediate rungs 114S can be similarly present in the frame. While a frame 106fdemonstrates an hourglass -shaped expansion design of the type shown in Figs. 8A-8C for a single intermediate rang 114S, implemented in Fig. 9A-9C for a plurality of intermediate rungs, it is to be understood that any other frame design disclosed herein, including, for example, frames 106a, 106cor 106ddescribed above with respect to Figs. 5A-5C, 6A-6C or 7A-7C, respectively, can be similarly adapted to frames that include a plurality of intermediate rungs, mutatis mutandis.

[0175] While exemplary frames 106eand 106fare described above to define larger angles 1920 and 1921 along both the outflow rung 1140 and the inflow rung 1141, it is to be understood that any other configuration that includes angles 192 along at least one rung 114 being larger than angles 192 of at least one other rung 114. For example, a frame can include larger angles 192 along one or more rungs 114 which are distal to the outflow rung, such as any of the inflow rung 1141 and / or one or more intermediate mng(s) 114S. This can optionally result in a V- shaped configuration in a radially expanded working state of the frame, defining a larger diameter at the outflow end 102 than the inflow end 104. When implanted within the native annulus of a patient, the larger outflow cross-sectional area relative to the inflow cross- sectional area created by the tapered V-shape can reduce the pressure gradient across the prosthetic heart valve, which may improve hemodynamics and / or mitigate the risk of paravalvular leakage.

[0176] Any of the assemblies, devices, apparatuses, etc. herein can be sterilized (for example, with heat, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated assembly, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.Some Examples of the Disclosed Implementations

[0177] 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.

[0178] Example 1. A prosthetic valve comprising: a frame comprising: a plurality of strut rungs, each comprising a plurality of struts pairs arranged around a circumference of the frame, wherein each strut pair comprises two angled struts diverging from a mutual vertex to opposite junctures at which the angled struts are connected to axial frame members which are circumferentially spaced from each other, the plurality of strut rungs comprising: an outflow rung defining an outflow end of the frame, an inflow rung defining an inflow end of the frame, and an intermediate rung therebetween; and a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve;wherein the frame has an initial fabricated diameter; wherein the frame is configured to be compressed from the initial fabricated diameter to a compressed diameter for delivery into a patient via catheterization; and wherein the frame is configured to be expanded from the compressed diameter to any expanded working diameter in a range of expanded working diameters that includes a smallest expanded working diameter and a largest expanded working diameter, wherein the initial fabricated diameter is less than the largest expanded working diameter in the range of expanded working diameters.

[0179] Example 2. The prosthetic valve of any example herein, particularly of example 1 , wherein all of the strut pairs of the outflow rung are oriented towards the inflow end.

[0180] Example 3. The prosthetic valve of any example herein, particularly of any one of examples 1-2, wherein all of the strut pairs of the inflow rung are oriented towards the outflow end.

[0181] Example 4. The prosthetic valve of any example herein, particularly of any one of examples 1-3, wherein the initial fabricated diameter is greater than the smallest expanded working diameter.

[0182] Example 5. The prosthetic valve of any example herein, particularly of any one of examples 1-3, wherein the initial fabricated diameter is equal to the smallest expanded working diameter.

[0183] Example 6. The prosthetic valve of any example herein, particularly of any one of examples 1-3, wherein the initial fabricated diameter is less than the smallest expanded working diameter.

[0184] Example 7. The prosthetic valve of any example herein, particularly of any one of examples 1-6, wherein the range of expanded working diameters spans from 22 millimeters to 24 millimeters.

[0185] Example 8. The prosthetic valve of any example herein, particularly of any one of examples 1 -6, wherein the range of expanded working diameters spans from 26 millimeters to 29 millimeters.

[0186] Example 9. The prosthetic valve of any example herein, particularly of any one of examples 1-8, wherein a difference of the largest expanded working diameter and the smallest expanded working diameter is greater than or equal to two millimeters.

[0187] Example 10. The prosthetic valve of any example herein, particularly of any one of examples 1-8, wherein a difference of the largest expanded working diameter and the smallest expanded working diameter is greater than or equal to three millimeters.

[0188] Example 11. The prosthetic valve of any example herein, particularly of any one of examples 1-8, wherein each of the plurality of stmt pairs defines an angle less than a critical angle when the annular frame is at the initial fabricated diameter.

[0189] Example 12. The prosthetic valve of any example herein, particularly of example 11, wherein the frame is configured such that each of the stmt pairs of at least one of the mngs defines an angle that is greater than the critical angle when the annular frame is expanded to the largest expanded working diameter.

[0190] Example 13. The prosthetic valve of any example herein, particularly of any one of examples 11-12, wherein the angled stmts of the outflow mng are shorter than the angled stmts of at least one of the other mngs of the frame.

[0191] Example 14. The prosthetic valve of any example herein, particularly of any one of examples 11-13, wherein the angle defined by each of the stmt pairs of the outflow mng is greater than the angle defined by each of the stmt pairs of at least one of the other mngs of the frame.

[0192] Example 15. The prosthetic valve of any example herein, particularly of any one of examples 1 1-14, wherein the angled stmts of the outflow mng are shorter than the angled stmts of all of the other mngs of the frame.

[0193] Example 16. The prosthetic valve of any example herein, particularly of any one of examples 11-15, wherein the angle defined by each of the stmt pairs of the outflow mng is greater than the angle defined by each of the stmt pairs of all of the other mngs of the frame.

[0194] Example 17. The prosthetic valve of any example herein, particularly of any one of examples 11-16, wherein an axial distance defined between the junctures of the inflow mng and the junctures of the intermediate mng is less than an axial distance defined between the junctures of the intermediate mng and the junctures of the outflow mng.

[0195] Example 18. The prosthetic valve of any example herein, particularly of any one of examples 11-17, wherein the intermediate mng is parallel to the inflow mng.

[0196] Example 19. The prosthetic valve of any example herein, particularly of any one of examples 11-17, wherein all of the stmt pairs of the intemrediate mng are oriented towards the outflow end.

[0197] Example 20. The prosthetic valve of any example herein, particularly of any one of examples 11-19, wherein the angled stmts of the intermediate mng and the inflow mng have equal lengths.

[0198] Example 21. The prosthetic valve of any example herein, particularly of any one of examples 11-20, wherein the angle defined by each of the strut pairs of the intermediate rung is equal to the angle defined by each of the stmt pairs of the inflow rung.

[0199] Example 22. The prosthetic valve of any example herein, particularly of any one of examples 11-14, wherein the angled struts of the inflow rung are shorter than the angled stmts of the intermediate rung.

[0200] Example 23. The prosthetic valve of any example herein, particularly of any one of examples 1 1 -14, the angle defined by each of the stmt pairs of the inflow rang is greater than the angle defined by each of the strut pairs of at least one of the intermediate rang.

[0201] Example 24. The prosthetic valve of any example herein, particularly of any one of examples 11-23, wherein the critical angle is in a range from 120 degrees to 140 degrees.

[0202] Example 25. The prosthetic valve of any example herein, particularly of any one of examples 1-24, wherein the intermediate rang is a first intermediate rang distal to the outflow rang, and wherein the plurality of rungs further comprises a second intermediate rang disposed between the first intermediate rung and the inflow rung.

[0203] Example 26. The prosthetic valve of any example herein, particularly of example 25, wherein the first intermediate rang is parallel to the outflow rang.

[0204] Example 27. The prosthetic valve of any example herein, particularly of any one of examples 25-26, wherein all of the strut pairs of the first intermediate rang are oriented towards the inflow end.

[0205] Example 28. The prosthetic valve of any example herein, particularly of any one of examples 25-27, wherein the second intermediate rang is parallel to the inflow rung.

[0206] Example 29. The prosthetic valve of any example herein, particularly of any one of examples 25-28, wherein all of the strut pairs of the second intermediate rang are oriented towards the outflow end.

[0207] Example 30. The prosthetic valve of any example herein, particularly of any one of examples 1-29, wherein the axial frame members comprise: a plurality of commissure support axial members, and a plurality of non-commissural axial members.

[0208] Example 31. The prosthetic valve of any example herein, particularly of example 30, wherein each two adjacent leaflets are coupled to each other at commissures attached to the commissure support members.

[0209] Example 32. The prosthetic valve of any example herein, particularly of any one of examples 30-31, wherein each of the plurality of commissure support members comprises a commissure window opening.

[0210] Example 33. A method of fabricating a prosthetic valve, the method comprising: fabricating a frame having an initial fabricated state in which the frame has an initial fabricated diameter, the frame formed to comprise a plurality of stmt rungs, each comprising a plurality of stmts pairs arranged around a circumference of the frame, wherein each stmt pair comprises two angled stmts diverging from a mutual vertex to opposite junctures at which the angled struts are connected to axial frame members which are circumferentially spaced from each other, and wherein the plurality of stmt mngs comprising: an outflow mng defining an outflow end of the frame, an inflow rang defining an inflow end of the frame, and an intermediate rang therebetween; wherein the frame is configured to radially expand to any one of a smallest radially expanded working state in which the frame is configured to have a smallest working diameter and a largest radially expanded working state in which the frame is configured to have a largest working diameter; and wherein the largest working diameter is greater than the initial fabricated diameter.

[0211] Example 34. The method of any example herein, particularly of example 33, wherein fabricating the frame comprises cutting a tube having the initial fabricated diameter.

[0212] Example 35. The method of any example herein, particularly of example 34, wherein the tube is formed from a plastically-expandable metal.

[0213] Example 36. The method of any example herein, particularly of any one of examples 33-35, wherein the angled stmts of each stmt pair define an angle therebetween.

[0214] Example 37. The method of any example herein, particularly of example 36, wherein the angle is less than a critical angle in the initial fabricated diameter.

[0215] Example 38. The method of any example herein, particularly of example 37, wherein the angle is configured to be greater than the critical angle after the frame is expanded to the largest working diameter.

[0216] Example 39. The method of any example herein, particularly of any one of examples 37-38, wherein the critical angle is in a range from 120 degrees to 140 degrees.

[0217] 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.

[0218] 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

CLAIMS1. A prosthetic valve comprising: a frame comprising: a plurality of strut rungs, each comprising a plurality of struts pairs arranged around a circumference of the frame, wherein each stmt pair comprises two angled stmts diverging from a mutual vertex to opposite junctures at which the angled stmts are connected to axial frame members which are circumferentially spaced from each other, the plurality of stmt mngs comprising: an outflow mng defining an outflow end of the frame, an inflow mng defining an inflow end of the frame, and an intermediate mng therebetween; and a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve; wherein the frame has an initial fabricated diameter; wherein the frame is configured to be compressed from the initial fabricated diameter to a compressed diameter for delivery into a patient via catheterization; and wherein the frame is configured to be expanded from the compressed diameter to any expanded working diameter in a range of expanded working diameters that includes a smallest expanded working diameter and a largest expanded working diameter, wherein the initial fabricated diameter is less than the largest expanded working diameter in the range of expanded working diameters.

2. The prosthetic valve of claim 1 , wherein all of the stmt pairs of the outflow mng are oriented towards the inflow end.

3. The prosthetic valve of any one of claims 1-2, wherein all of the stmt pairs of the inflow mng are oriented towards the outflow end.

4. The prosthetic valve of any one of claims 1-3, wherein the initial fabricated diameter is greater than the smallest expanded working diameter.

5. The prosthetic valve of any one of claims 1-3, wherein the initial fabricated diameter is equal to the smallest expanded working diameter.

6. The prosthetic valve of any one of claims 1-3, wherein the initial fabricated diameter is less than the smallest expanded working diameter.

7. The prosthetic valve of any one of claims 1-6, wherein each of the plurality of stmt pairs defines an angle less than a critical angle when the frame is at the initial fabricated diameter.

8. The prosthetic valve of claim 7, wherein the frame is configured such that each of the strut pairs of at least one of the rungs defines an angle that is greater than the critical angle when the frame is expanded to the largest expanded working diameter.

9. The prosthetic valve of any one of claims 7-8, wherein the angle defined by each of the strut pairs of the outflow rung is greater than the angle defined by each of the strut pairs of at least one of the other rungs of the frame.

10. The prosthetic valve of any one of claims 7-9, wherein the angled struts of the outflow rung are shorter than the angled struts of all of the other rungs of the frame.

11. The prosthetic valve of any one of claims 7-10, wherein an axial distance defined between the junctures of the inflow rung and the junctures of the intermediate rung is less than an axial distance defined between the junctures of the intermediate rung and the junctures of the outflow rung.

12. The prosthetic valve of any one of claims 7-9, the angle defined by each of the strut pairs of the inflow rung is greater than the angle defined by each of the stmt pairs of at least one of the intermediate rang.

13. The prosthetic valve of any one of claims 7-12, wherein the critical angle is in a range from 120 degrees to 140 degrees.

14. A method of fabricating a prosthetic valve, the method comprising: fabricating a frame having an initial fabricated state in which the frame has an initial fabricated diameter, the frame formed to comprise a plurality of strut rungs, each comprising a plurality of struts pairs arranged around a circumference of the frame, wherein each strut pair comprises two angled struts diverging from a mutual vertex to opposite junctures at which the angled struts are connected to axial frame members which are circumferentially spaced from each other, and wherein the plurality of strut rungs comprising: an outflow rungdefining an outflow end of the frame, an inflow rung defining an inflow end of the frame, and an intermediate rung therebetween; wherein the frame is configured to radially expand to any one of a smallest radially expanded working state in which the frame is configured to have a smallest working diameter and a largest radially expanded working state in which the frame is configured to have a largest working diameter; and wherein the largest working diameter is greater than the initial fabricated diameter.

15. The method of claim 14, wherein fabricating the frame comprises cutting a tube having the initial fabricated diameter.

16. The method of claim 15, wherein the tube is formed from a plastically- expandable metal.

17. The method of any one of claims 14-16, wherein the angled stmts of each stmt pair define an angle therebetween.

18. The method of claim 17, wherein the angle is less than a critical angle in the initial fabricated diameter.

19. The method of claim 18, wherein the angle is configured to be greater than the critical angle after the frame is expanded to the largest working diameter.

20. The method of any one of claims 18-19, wherein the critical angle is in a range from 120 degrees to 140 degrees.

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