WO2025199016A1

WO2025199016A1 - Prosthetic valves with anchoring sections

Info

Publication number: WO2025199016A1
Application number: PCT/US2025/020203
Authority: WO
Inventors: Nikolai Gurovich; Karin LAVON
Original assignee: Edwards Lifesciences Corp
Current assignee: Edwards Lifesciences Corp
Priority date: 2024-03-18
Filing date: 2025-03-17
Publication date: 2025-09-25
Anticipated expiration: 2026-09-18

Abstract

The present disclosure relates to prosthetic valves that can be implanted in non-calcified native heart valves. In an example, prosthetic valve comprises a plastically-expandable frame movable between a radially compressed configuration and a radially expanded configuration. The frame comprises a primary frame section extending between inflow junctions and outflow junctions, an inflow anchoring section coupled to the inflow junctions, and an outflow anchoring section coupled to the outflow junctions. The inflow anchoring section and the outflow anchoring section are configured to maintain an unbent configuration in a free state thereof, and to extend radially outwards relative to primary frame section upon inflation of a balloon over which the prosthetic valve is crimped.

Description

PROSTHETIC VALVES WITH ANCHORING SECTIONS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63/566,804, filed March 18, 2024, which is incorporated by reference herein.

FIELD

[0002] The present disclosure relates to prosthetic valves that include anchoring sections extending radially away from a primary frame section.

BACKGROUND

[0003] The heart is a muscular organ which pumps blood through the blood vessels of the circulatory system by contraction and expansion. In a healthy heart, blood flows in a single direction therethrough due to heart valves, which prevent backflow. During a normal heart contraction cycle, the heart valves open and close accordingly, while muscle heart tissues contracts. These muscle heart tissues can include various types of cavities and formations.

[0004] Various valvular diseases, which can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped configuration on the end of a delivery device and advanced through the patient’ s vasculature until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted.

[0005] Once expanded, the prosthetic valve contacts the surrounding native heart valve tissue to secure the prosthetic heart valve in place. The condition of the native heart valve tissue can vary widely from patient to patient. Also, the anatomy of the various native valves of a heart varies greatly.

SUMMARY [0006] Many conventional prosthetic valves are designed to be deployed in a native heart valve annulus in cases of native stenosis or calcification of the native leaflets. In the absence of stenosis or calcification, many typical prosthetic valves lack sufficient anchoring mechanisms to secure the prosthetic valve relative to the native anatomy, which poses a risk of the valve migration and/or slipping out of position under physiological pressures at the implantation site. Thus, it is desirable to provide a prosthetic heart valve that can be anchored against the native anatomy in the absence of local stenosis and/or calcified anatomy.

[0007] According to some aspects of the disclosure, there is provided a prosthetic valve comprising a plastically-expandable frame movable between a radially compressed configuration and a radially expanded configuration. The frame defines a central axis and comprises a primary frame section, an inflow anchoring section, and an outflow anchoring section. The primary frame section extends between inflow junctions and outflow junctions, and comprises a plurality of angled struts. The inflow anchoring section is coupled to the inflow junctions. The outflow anchoring section is coupled to the outflow junctions.

[0008] In some examples, the inflow anchoring section and the outflow anchoring section are configured to maintain an unbent configuration in a free state thereof.

[0009] In some examples, the inflow anchoring section and the outflow anchoring section are configured to extend radially outwards relative to primary frame section upon inflation of a balloon over which the prosthetic valve is crimped.

[0010] In some examples, the prosthetic valve is a balloon expandable valve.

[0011] In some examples, the prosthetic valve is devoid of shape-memory materials.

[0012] In some examples, in the radially expanded configuration, the inflow anchoring section defines a non-zero inflow bending angle relative to the central axis of the frame.

[0013] In some examples, in the radially expanded configuration, the outflow anchoring section defines a non-zero inflow bending angle relative to the central axis of the frame.

[0014] In some examples, the inflow anchoring section comprises a plurality of inflow anchoring struts arranged in an undulating pattern extending between inflow peak portions which are farther from the primary frame section and opposing inflow valley portions.

[0015] In some examples, the inflow anchoring struts extend in a wavy pattern between the inflow peak portions and the inflow valley portions.

[0016] In some examples, the inflow anchoring struts extend in a zig-zagged pattern between the inflow peak portions and the inflow valley portions. [0017] In some examples, the outflow anchoring section comprises a plurality of outflow anchoring struts arranged in an undulating pattern extending between outflow peak portions which are farther from the primary frame section and opposing outflow valley portions.

[0018] In some examples, the outflow anchoring struts extend in a wavy pattern between the outflow peak portions and the outflow valley portions.

[0019] In some examples, the outflow anchoring struts extend in a zig-zagged pattern between the outflow peak portions and the outflow valley portions.

[0020] In some examples, in the radially expanded configuration, the inflow peak portions collectively define a diameter that is greater than a diameter collectively defined by the inflow junctions.

[0021] In some examples, in the radially expanded configuration, the outflow peak portions collectively define a diameter that is greater than a diameter collectively defined by the outflow junctions.

[0022] In some examples, the inflow valley portions comprise a plurality of attachment inflow valley portions which are coupled to the inflow junctions, and a plurality of free inflow valley portions which are not coupled to the primary frame section.

[0023] In some examples, the outflow valley portions comprise a plurality of attachment outflow valley portions which are coupled to the outflow junctions, and a plurality of free outflow valley portions which are not coupled to the primary frame section.

[0024] In some examples, the inflow anchoring struts are wider than the angled struts of the primary frame section.

[0025] In some examples, the frame further comprises a plurality of inflow connector struts connecting at least some of the inflow valley portions to the inflow junctions.

[0026] In some examples, the frame further comprises a plurality of outflow connector struts connecting at least some of the outflow valley portions to the outflow junctions.

[0027] In some examples, the inflow connector struts are narrower than the inflow anchoring struts.

[0028] In some examples, the inflow connector struts are narrower than the angled struts of the primary frame section.

[0029] In some examples, the outflow connector struts are narrower than the outflow anchoring struts.

[0030] In some examples, the outflow connector struts are narrower than the angled struts of the primary frame section. [0031] In some examples, the at least one tissue engagement frame is disposed around the inner frame.

[0032] In some examples, the at least one tissue engagement frame further comprises a plurality of spikes extending from the tissue engagement struts, the spikes configured to engage with tissue against which the prosthetic valve is expanded.

[0033] In some examples, the angled struts of the primary frame section comprise inflow angled struts extending from the inflow junctions, outflow angled struts extending from the outflow junctions, and intermediate angled struts disposed between the inflow angled struts and the outflow angled struts.

[0034] In some examples, the primary frame section comprises a plurality of inflow cells, each inflow cell defined by two inflow angled struts and two intermediate angled struts.

[0035] In some examples, an angle defined between the two inflow angled struts of the inflow cell is greater than an angle defined between the two intermediate angled struts of the same inflow cell.

[0036] In some examples, the primary frame section further comprises a plurality of axial frame members.

[0037] In some examples, the axial frame members extend between the intermediate angled struts and the outflow angled struts.

[0038] In some examples, the primary frame section comprises a plurality of outflow cells, each outflow cell defined by two intermediate angled struts, two axial frame members, and two outflow angled struts.

[0039] In some examples, wherein each outflow cell is parallelogram-shaped.

[0040] In some examples, the outer skirt comprises a skirt inflow segment disposed around the inflow anchoring section, and an outflow anchoring segment disposed around the outflow anchoring section.

[0041] In some examples, a skirt inflow end portion of the skirt inflow segment is attached to the inflow anchoring segment, and wherein a skirt outflow end portion of the skirt outflow segment is attached to the outflow anchoring segment.

[0042] In some examples, a portion of the outer skirt extending between the skirt inflow end portion and the primary frame section is not attached to the frame.

[0043] In some examples, a portion of the outer skirt extending between the skirt outflow end portion and the primary frame section is not attached to the frame.

[0044] In some examples, the portions of the outer skirt extending between the skirt inflow end portion and the primary frame section, and between the skirt outflow end portion and the primary frame section, are configured to extend radially away from the frame in the radially expanded configuration.

[0045] In some examples, the inflow anchoring section comprises one or more rows of inflow section cells, wherein the outflow anchoring section comprises one or more rows of outflow section cells.

[0046] In some examples, the outflow anchoring section is configured to assume a flared configuration in the radially expanded configuration of the frame.

[0047] In some examples, the outflow anchoring section is configured to assume a semi- spherical configuration in the radially expanded configuration of the frame.

[0048] In some examples, the outflow anchoring section is configured to assume a ball-shaped configuration in the radially expanded configuration of the frame.

[0049] In some examples, the inflow anchoring section is configured to assume a flared configuration in the radially expanded configuration of the frame.

[0050] In some examples, the inflow anchoring section is configured to assume a semi- spherical configuration in the radially expanded configuration of the frame.

[0051] In some examples, the inflow anchoring section is configured to assume a ball- shaped configuration in the radially expanded configuration of the frame.

[0052] According to some aspects of the disclosure, there is provided a method of forming a prosthetic valve, comprising cutting a tube to form a frame of a prosthetic valve designed to expand to a range of working diameters, wherein the tube has diameter which is smaller than the diameter of a lower end of the working range of diameters.

[0053] In some examples, the method further comprises attaching a plurality of leaflets to the frame at the diameter in which the frame is cut from the tube, thereby assembling the prosthetic valve.

[0054] In some examples, when the prosthetic valve is subjected to pulsating flow in a diameter within the range of working diameters, the plurality of leaflets are configured to transition between a closed state in which the leaflets coapt in a manner that prevents backflow therethrough, and an open state in which the leaflets are opened against the frame.

[0055] In some examples, the tube comprises a plastically-deformable material.

[0056] In some examples, the attaching the plurality of leaflets comprises attaching inflow edge portions of the leaflets to struts of the frame.

[0057] In some examples, the frame comprises a primary frame section extending between inflow junctions and outflow junctions, an inflow anchoring section coupled to the inflow junctions, and an outflow anchoring section coupled to the outflow junctions. [0058] In some examples, the primary frame section comprising a plurality of angled struts.

[0059] In some examples, the inflow anchoring section and the outflow anchoring section are configured to maintain an unbent configuration in a free state thereof.

[0060] In some examples, the inflow anchoring section and the outflow anchoring section are configured to extend radially outwards relative to primary frame section upon inflation of a balloon over which the prosthetic valve is crimped.

[0061] In some examples, the inflow anchoring section comprises a plurality of inflow anchoring struts arranged in an undulating pattern extending between inflow peak portions which are farther from the primary frame section and opposing inflow valley portions.

[0062] In some examples, the inflow anchoring struts extend in a wavy pattern between the inflow peak portions and the inflow valley portions.

[0063] In some examples, the inflow anchoring struts extend in a zig-zagged pattern between the inflow peak portions and the inflow valley portions.

[0064] In some examples, the outflow anchoring section comprises a plurality of outflow anchoring struts arranged in an undulating pattern extending between outflow peak portions which are farther from the primary frame section and opposing outflow valley portions.

[0065] In some examples, the outflow anchoring struts extend in a wavy pattern between the outflow peak portions and the outflow valley portions.

[0066] In some examples, the outflow anchoring struts extend in a zig-zagged pattern between the outflow peak portions and the outflow valley portions.

[0067] 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

[0068] 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:

[0069] Fig. 1 shows a sectional view of a human heart.

[0070] Fig. 2A is a side view of an exemplary prosthetic valve.

[0071] Fig. 2B is a side view of a frame of the prosthetic valve of Fig. 2A.

[0072] Fig. 3 is a perspective view of an exemplary delivery assembly.

[0073] Fig. 4A is a flattened view of a portion of a frame of an exemplary prosthetic valve, in an expanded configuration.

[0074] Fig. 4B is a flattened view of the portion of the frame of Fig. 4A, in a partially compressed configuration.

[0075] Fig. 5 is a side view of an exemplary frame that includes connector struts, in an expanded configuration.

[0076] Fig. 6 is a side view of the frame of Fig. 5, in a crimped configuration.

[0077] Figs. 7A-7D illustrate optional phases in expansion of a prosthetic valve using an inflatable balloon.

[0078] Fig. 8A shows a prosthetic valve in a partially expanded configuration during an implantation procedure inside of a native heart valve.

[0079] Fig. 8B shows the prosthetic valve of Fig. 8A fully expanded inside the native heart valve.

[0080] Fig. 9 is a side view of an exemplary frame that includes short and long inflow anchoring struts, and short and long outflow anchoring struts.

[0081] Fig. 10 is a side view of an exemplary frame that includes an inflow anchoring sections which is shorter than the outflow anchoring section.

[0082] Fig. 11 is a side view of an exemplary frame that includes outflow anchoring struts which are wider than the inflow anchoring struts.

[0083] Fig. 12 is a side view of an exemplary frame that includes elongated axial frame members.

[0084] Fig. 13 is a side view of an exemplary frame that includes elongated connector struts.

[0085] Fig. 14A is an exploded view of an exemplary prosthetic valve that include tissue engagement frames that can be coupled to the anchoring sections.

[0086] Fig. 14B is an assembled view of the prosthetic valve of Fig. 14A.

[0087] Fig. 15 shows an exemplary leaflet. [0088] Fig. 16A show one third of an exemplary prosthetic valve having a leaflet attached to the frame, in an assembling diameter.

[0089] Fig. 16B show one third of an exemplary prosthetic valve having a leaflet attached to the frame, in an expanded configuration.

[0090] Fig. 17A shows a portion of a prosthetic valve with a valvular structure mounted inside the frame, in a partially compressed configuration.

[0091] Fig. 17B shows the portion of the prosthetic valve of Fig. 17A in an expanded configuration, with the leaflets illustrated in their open state.

[0092] Fig. 17C shows the portion of the prosthetic valve of Fig. 17A in an expanded configuration, with the leaflets illustrated in their closed state.

[0093] Fig. 18 shows a portion of an exemplary prosthetic valve that includes an outer skirt.

[0094] Figs. 19A-19C show exemplary stages in an implantation procedure of the prosthetic valve of Fig. 18 inside a native heart valve.

[0095] Fig. 20 shows an exemplary prosthetic valve that include ball-shaped anchoring sections.

DETAILED DESCRIPTION

[0096] 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.

[0097] 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.

[0098] 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.

[0099] 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".

[0100] 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.

[0101] 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.

[0102] 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.

[0103] The terms "axial direction," "radial direction," and "circumferential direction" have been used herein to describe the arrangement and assembly of components relative to the geometry of the frame of the prosthetic valve, or the geometry of an inflatable balloon that can be used to expand a prosthetic valve. Such terms have been used for convenient description, but the disclosed examples are not strictly limited to the description. In particular, where a component or action is described relative to a particular direction, directions parallel to the specified direction as well as minor deviations therefrom are included. Thus, a description of a component extending along an axial direction of the frame does not require the component to be aligned with a center of the frame; rather, the component can extend substantially along a direction parallel to a central axis of the frame.

[0104] As used herein, the terms "integrally formed" and "unitary construction" refer to a construction that does not include any welds, fasteners, or other means for securing separately formed pieces of material to each other.

[0105] As used herein, operations that occur "simultaneously" or "concurrently" occur generally at the same time as one another, although delays in the occurrence of operation relative to the other due to, for example, spacing between components, are expressly within the scope of the above terms, absent specific contrary language.

[0106] As used herein, terms such as "first," "second," and the like are intended to serve as respective labels of distinct components, steps, etc. and are not intended to connote or imply a specific sequence or priority. For example, unless otherwise stated, a step of performing a second action and/or of forming a second component may be performed prior to a step of performing a first action and/or of forming a first component.

[0107] As used herein, the term "substantially" means the listed value and/or property and any value and/or property that is at least 75% of the listed value and/or property. Equivalently, the term "substantially" means the listed value and/or property and any value and/or property that differs from the listed value and/or property by at most 25%. For example, "at least substantially parallel" refers to directions that are fully parallel, and to directions that diverge by up to 22.5 degrees.

[0108] In the present disclosure, a reference numeral that includes an alphabetic label (for example, "a," "b," "c," etc.) is to be understood as labeling a particular example of the structure or component corresponding to the reference numeral. Accordingly, it is to be understood that components sharing like names and/or like reference numerals (for example, with different alphabetic labels or without alphabetic labels) may share any properties and/or characteristics as disclosed herein even when certain such components are not specifically described and/or addressed herein.

[0109] 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.

[0110] Described herein are balloon expandable prosthetic valves that can be implanted inside native valves in a patient’s heart. In some examples, the native valve can be a non-calcified native heart valve. In some examples, the native valve can be an aortic valve, mitral valve, or a tricuspid valve. While described in some examples with respect to a tricuspid valve, it should be understood that the disclosed examples can be adapted to implant the prosthetic valve in other native heart valves (e.g., the aortic, pulmonary, and mitral valves) or within other prosthetic devices, such as a docking device or a previously implanted prosthetic valve, and can be used with any of various delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, transapical, etc.).

[0111] Fig. 1 shows a sectional view of a human heart 10. The heart has a four-chambered conical structure that includes the right atrium 18, the right ventricle 20, the left atrium 26 and the left ventricle 28. The wall separating between the left and right sides of the heart is referred to as the septum 24 (shown, for example, in Figs. 8A-8B). The native tricuspid valve 22 is positioned between the right atrium 18 and the right ventricle 20. The native mitral valve 30 is positioned between the left atrium 26 and the left ventricle 28. Additionally, the native aortic valve 14 separates the left ventricle 28 from the aorta 12. Deoxygenated blood is delivered to the right atrium 18 by the superior vena cava, the inferior vena cava 16, and the coronary sinus. [0112] During the diastolic phase, or diastole, as the right ventricle 20 expands, deoxygenated blood flows from the right atrium 18 into the right ventricle 20 through the tricuspid valve 22. In the subsequent systolic phase, or systole, leaflets of a normally functioning tricuspid valve 22 close to prevent the venous blood from regurgitating back into the right atrium 18. When the tricuspid valve 22 does not operate normally, blood can backflow or regurgitate into the right atrium 18.

[0113] Each native heart valve includes a plurality of native leaflets 34 that can extend from an annulus 32 in a downstream directions. For example, native leaflet 34 of the tricuspid valve 22 extend downward towards right ventricle, native leaflets 34 of the mitral valve 30 extend downward towards the left ventricle, and native leaflets 34 of the aortic valve 14 extend upwards into the aorta 12. When operating properly, native leaflets of a corresponding heart valve function together as a one-way valve to allow blood flow in a corresponding downstream direction, such as from the right atrium 18 to the right ventricle 20 in the case of a tricuspid valve 22, from the left atrium 26 to the left ventricle 28 in the case of a mitral valve 30, and from the left ventricle 28 to the aorta 12 in the case of an aortic valve 14.

[0114] Specifically, during the diastolic phase, as the left ventricle 28 expands, the oxygenated blood in the left atrium 26 is directed through the mitral valve 30 into the left ventricle 28. In the subsequent systolic phase, contraction by the left ventricle 28 forces the oxygenated blood through the aortic valve 14 into the ascending aorta 12 for circulation through the body. In addition, forcing the blood through the one-way aortic valve 14, the pressure of the contraction by the left ventricle 28 also urges the one-way mitral valve 30 closed, thereby preventing blood in the left ventricle 28 from re-entering the left atrium 26.

[0115] Any of the above noted native heart valves may fail to operate properly, for example, by allowing blood to backflow therethrough or regurgitate into an upstream heart chamber or blood vessel. In some implementations, a prosthetic valve can be implanted within the native heart valve to help prevent or inhibit such regurgitation and/or to address any other insufficiency of the native heart valve.

[0116] Many types of prosthetic valves are designed to be deployed in a native heart valve annulus (e.g., a native aortic valve annulus) in cases of native stenosis or calcification of the native leaflets. However, in some cases, a prosthetic valve needs to be implanted in a noncalcified native heart valve. For example, aortic insufficiency (Al) or aortic regurgitation is characterized by diastolic reflux of blood through the native aortic valve back into the left ventricle, and in most cases is not accompanied by stenosis or leaflet calcification. Mitral regurgitation or tricuspid regurgitation are also, in most cases, non-calcified pathologies. In the absence of stenosis or calcification, many typical prosthetic valves lack sufficient anchoring mechanisms to secure the prosthetic valve relative to the native anatomy. This can, in some instances, cause the prosthetic valve to migrate and/or slip out of position under physiological pressures at the implantation site. [0117] The term "prosthetic valve", as used herein, refers to any type of a prosthetic valve deliverable to a patient's target site over a catheter, which is radially expandable and compressible between a radially compressed, or crimped, state, and a radially expanded state. Thus, the prosthetic valve can be crimped on or retained by an implant delivery apparatus 50 (shown for example in Fig. 3) in the radially compressed state during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site. [0118] The expanded state may include a range of diameters to which the valve may expand, between the compressed state and a maximal diameter reached at a fully expanded state. Thus, a plurality of partially expanded states may relate to any expansion diameter between radially compressed or crimped state, and maximally expanded state. A prosthetic valve of the current disclosure (for example, prosthetic valve 100) may include any prosthetic valve configured to be mounted within the native aortic valve, the native mitral valve, the native pulmonary valve, and the native tricuspid valve.

[0119] Fig. 2A is a side view of an exemplary prosthetic valve 100 which can be a balloon expandable valve that includes a frame 102 having an inflow anchoring section 104, a primary frame section 116 optionally mounting a valvular structure 170, and an outflow anchoring section 158. Fig. 2B shows the frame 102 of the prosthetic valve 100 of Fig. 2A, with the inflow anchoring section 104 and the outflow anchoring section 158 flared radially outwards. In some instances, the outflow anchoring section 158 is the proximal section of the frame 102, and the inflow anchoring section 104 is the distal section of the frame 102. Alternatively, depending for example on the delivery approach of the valve, the outflow anchoring section can be the distal section of the frame, and the inflow anchoring section can be the proximal section of the frame.

[0120] The term "outflow", as used herein, refers to a region of the prosthetic valve through which the blood flows through and out of the prosthetic valve 100.

[0121] The term "inflow", as used herein, refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve 100.

[0122] 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.

[0123] In the context of the present application, the terms “lower” and “upper” are used interchangeably with the terms “distal to” and “proximal to”, respectively. Thus, for example, a lowermost component can refer to a distal-most component, and an uppermost component can similarly refer to a proximal-most component.

[0124] The terms “longitudinal” and “axial”, as used herein, refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0125] The frame 102 of prosthetic valve 100 is movable between a radially compressed configuration and a radially expanded configuration, and a valvular structure 170 of the prosthetic valve 100 is mounted within the frame 102, and in some examples, within the primary frame section 116. The frame 102 can be made of various suitable materials, including plastically-deformable materials such as, but not limited to, stainless steel, a nickel based alloy (e.g., a cobalt-chromium or a nickel-cobalt-chromium alloy such as MP35N alloy), polymers, or combinations thereof. When constructed of a plastically-deformable materials, the frame 102 can be crimped to a radially compressed state on a balloon catheter, and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism.

[0126] In the example illustrated in Figs. 2A-2B, the frame 102 is an annular, stent- like structure comprising a plurality of intersecting struts 118. In this application, the term "strut" encompasses axial struts, angled struts, laterally extendable struts, commissure windows, commissure support struts, support posts, and any similar structures described by U.S. Pat. Nos. 7,993,394 and 9,393,110, which are incorporated herein by reference. A strut 118 may be any elongated member or portion of the frame 102. The frame 102 can include a plurality of strut rungs that can collectively define one or more rows of cells 144. At least part of the frame 102, such as the primary frame section 116, can have a cylindrical or substantially cylindrical shape having a constant diameter along its height as shown, or the primary frame section 116 can vary in diameter along height, as disclosed in US Pat. No. 9,155,619, which is incorporated herein by reference.

[0127] Two or more struts 118 can intersect at junctions 150, which can be equally or unequally spaced apart from each other. At least some of the struts 118 can be pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame 102 can be formed from a single piece of material, such as a metal tube, via various processes such as, but not limited to, laser cutting, electroforming, and/or physical vapor deposition, while retaining the ability to collapse/expand radially in the absence of hinges and the like.

[0128] A valvular structure 170 can include a plurality of leaflets 172 (e.g., three leaflets), positioned at least partially within the frame 102, and optionally within the primary frame section 116. The leaflets 172 are configured to regulate flow of blood through the prosthetic valve 100 from the inflow anchoring section 104 to the outflow anchoring section 158. While three leaflets 172 arranged to collapse in a tricuspid arrangement, are shown in some examples illustrated herein (as shown, for example, in Figs. 17A-17C), it will be clear that a prosthetic valve 100 can include any other number of leaflets 172. The leaflets 172 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated by reference herein.

[0129] Adjacent leaflets 172 can be arranged together to form commissures 194 (indicated, for example, in Fig. 16A) that are coupled (directly or indirectly) to respective portions of the frame 102, thereby securing at least a portion of the valvular structure 170 to the frame 102. Further details regarding transcatheter prosthetic valves, including the manner in which the valvular structures 170 can be coupled to the frame 102 of the prosthetic valve 100, can be found, for example, in U.S. Patent Nos. 7,393,360, 7,510,575, 7,993,394, 8,652,202, 11,135,056, and 11,096,781, all of which are incorporated herein by reference in their entireties.

[0130] As shown for example in Fig. 17A-17C, three separate leaflets 172 can collectively define the valvular structure 170 in some examples. As shown in Figs. 1A and 15-16B, each leaflet 172 can have an inflow edge portion 174 opposite a free edge portion 178, and a pair of generally oppositely-directed commissure tabs 176 separating the inflow edge portion 174 and the free edge portion 178. The inflow edge portion 174 in such cases forms a single scallop.

[0131] When such leaflets 172 are coupled to the frame and to each other, the lower edge of the resulting valvular structure 170 desirably has an undulating, curved scalloped shape. By forming the leaflets with this scalloped geometry, stresses on the leaflets 172 are reduced which, in turn, improves durability of the prosthetic valve. Moreover, by virtue of the scalloped shape, folds and ripples at the movable body portion 180 (or belly) of each leaflet 172, which can cause early calcification in those areas, can be eliminated or at least minimized. The scalloped geometry also reduces the amount of tissue material used to form the valvular structure 170, thereby allowing a smaller, more even crimped profile at the inflow end of the valve.

[0132] The leaflets 172 can define a non-planar coaptation plane (not annotated) when their free edge portions 178 co-apt with each other to seal blood flow through the prosthetic valve 100. Leaflets 172 can be secured to one another at their commissure tabs 176 to form commissures 194 of the valvular structure 170, which can be secured, directly or indirectly, to structural elements connected to the frame 102 or integrally formed as portions thereof, such as commissure posts or struts, commissure windows, and the like.

[0133] In some examples, the leaflets 172 are 3D-shaped or not flattenable. The term "not flattenable", as used herein, means that movable body portions 180 of the leaflets cannot be flattened. That is to say, if an attempt is made to straighten out the curve of a free edge portion 178 of leaflet 172, the curve will not be able to be completely straightened such that leaflet belly 172 becomes flat. This is in contrast to leaflets that are cut from a flat patch and are then attached (e.g., sutured) to a frame of a prosthetic valve, wherein upon removal of such leaflets from the frame they can be laid flat on a flattened surface, with their free edges being able to completely straighten in their free state. In some examples, a movable body portion 180 which is not flattenable defines a non-developable surface. Further details regarding leaflets or movable body portions thereof, which are three-dimensional or not flattenable, are described in International Application No. PCT/US2022/032303, and U.S. Provisional Application No. 63/587,399, each of which is incorporated herein by reference in its entirety.

[0134] In some examples, the prosthetic valve 100 can comprise at least one skirt or sealing member. Fig. 18 shows an example of a prosthetic valve 100 that includes an outer skirt 182, which can be mounted on an outer surface of the frame 102. Such an outer skirt 182 can be configured to function, for example, as a sealing member retained between the frame 102 and the surrounding tissue of the native annulus or other anatomical structures against which the prosthetic valve is mounted, thereby reducing risk of paravalvular leakage (PVL) past the prosthetic valve 100. The outer skirt 182 can be coupled to the frame 102 via sutures or another form of coupler.

[0135] The prosthetic valve 100 can comprise, in some examples, an inner skirt (not shown) which can be secured to an inner surface of the frame 102. When present, an inner skirt can be configured to function, for example, as a sealing member to prevent or decrease perivalvular leakage. An inner skirt can further function as an anchoring region for valvular structure 170 to the frame 102, and/or function to protect the leaflets 172 against damage which may be caused by contact with the frame 102, for example during valve crimping or during working cycles of the prosthetic valve 100. An inner skirt can be coupled to the frame 102 via sutures or another form of coupler.

[0136] Any of the inner skirt and/or outer skirt 182 can be made of various suitable biocompatible materials, such as, but not limited to, various synthetic materials (e.g., PET) or natural tissue (e.g. pericardial tissue). In some cases, an inner skirt can be formed of a single sheet of material that extends continuously around an inner surface of frame 102. In some cases, the outer skirt 182 can be formed of a single sheet of material that extends continuously around an outer surface of frame 102.

[0137] Struts 118 of the inflow anchoring section 104 include a plurality of inflow anchoring struts 106, arranged in a zig-zagged pattern extending between inflow peak portions 108 which are farther from the primary frame section 116, and inflow valley portions 110 which are coupled to the primary frame section 116.

[0138] Similarly, struts 118 of the outflow anchoring section 158 include a plurality of outflow anchoring struts 160, arranged in a zig-zagged pattern extending between outflow peak portions 162 which are farther from the primary frame section 116, and outflow valley portions 164 which are coupled to the primary frame section 116.

[0139] Struts 118 of the primary frame section 116 can comprise angled struts 120 and axial frame members 128. The term "axial frame member" refers to a strut or a component of the frame 102 that generally extends in an axial direction, parallel of a central axis Ca of the frame 102, while the term "angled strut" generally refers to a strut that can extend at an angle relative to an axial line intersecting therewith along a plane defined by the frame 102. It is to be understood that the term "angled strut" encompasses both linear angled struts and curved struts. [0140] In the example illustrated in Figs. 2A-2B, the primary frame section 116 is shown to comprise three rungs of angled struts 120, namely a rung of inflow angled struts 122 which are coupled to the inflow anchoring section 104, a rung of outflow angled struts 126 which are coupled to the outflow anchoring section 158, and a rung of intermediate angled struts 124 disposed therebetween. A plurality of axial frame members 128 are shown to extend between the intermediate angled struts 124 and the outflow angled struts 126.

[0141] The junctions 150 of the primary frame section 116 can include inflow junctions 152 at a distal or inflow end of the primary frame section 116, outflow junctions 154 at a proximal or outflow end of the primary frame section 116, and a plurality of intermediate junctions 156 therebetween.

[0142] The primary frame section 116 is further shown, in the example illustrated in Figs. 2A- 2B, to comprise two rows of cells 144, namely a row of inflow cells 146 and a row of outflow cells 148, wherein the cells 144 in each row extend circumferentially such that each cell 144 is directly coupled to two circumferentially adjacent cells 144 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 struts 118.

[0143] An inflow cell 146 can be defined by two inflow angled struts 122 and two intermediate angled struts 124, together defining a rhombus or diamond-shaped cell. An outflow cell 148 can be defined by an intermediate angled strut 124, an outflow angled strut 126 parallel to the intermediate angled strut 124, and two axial frame members 128, together defining a parallelogram-shaped cell. Thus, inflow cells 146 can be coupled to adjacent inflow cells 146 via intermediate junctions 156, while outflow cells 148 can be coupled to adjacent outflow cells 148 via axial frame members 128. Axial frame members 128 can include, in some examples, commissure support members 132 and non-commissural axial struts 130. A commissure support member 132 can be configured to support a corresponding commissure 194 of the valvular structure 170. The axial frame members 128, including non-commissural axial struts 130 and commissure support members 132, can be parallel to each other and/or to the central longitudinal axis Ca of the frame 102.

[0144] In some examples, a commissure support member 132 can comprise a commissure window 134 defining an opening 136 between two axially-extending sidewalls 138. While commissure support members 132 that include commissure windows 134 are illustrated and described herein, it is to be understood that a frame 102 (and optionally, a primary frame section 116 thereof) can include other types of commissure support members configured to mount a commissure 194 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. The terms "non-commissural axial strut" and "axial strut", as used herein, are interchangeable, and refer to an axial frame member configured to remain unattached to the valvular structure 170. That is to say, an axial struts 130 is not configured to mount a commissure, and may be devoid of an opening such as that defined by a commissure window.

[0145] Each axial frame member 128 can have an outflow end portion 142 at which the axial frame member 128 is linked to outflow angled struts 126, and an inflow end portion 140 at which the axial frame member 128 is linked to inflow angled struts 122.

[0146] In some examples, the inflow anchoring section 104 and/or the outflow anchoring section 158 are integrally formed with the primary frame section 116. In some examples, the inflow anchoring section 104 and/or the outflow anchoring section 158 are provided as separate sections that can be affixed (e.g., welded) to the primary frame section 116. The term "integral" or "integrally formed", as used herein, refers to a construction of a component that does not include any welds, fasteners, adhesives or other means for securing separately formed pieces of material to each other.

[0147] As shown in Fig. 1A, the inflow anchoring section 104 and the outflow anchoring section 158 can extend axially, substantially parallel to the central axis Ca of the prosthetic valve 100, in a free state of the inflow anchoring section 104 and the outflow anchoring section 158. The inflow anchoring section 104 and the outflow anchoring section 158 are made from a material configured to retain the substantially straight configuration, parallel to the central axis Ca, in the absence of external forces acting there-against. This is in contrast to anchoring sections that can be alternatively made from shape-memory materials, configured to retain a specific geometry when retained inside an enclosure, such as a capsule of a delivery apparatus, and to assume a pre-shaped bent configuration when exposed from the enclosure.

[0148] The term “free state”, with respect to the inflow anchoring section 104 and the outflow anchoring section 158, refers to a state in which no force is applied to inner surfaces of the inflow anchoring section 104 and the outflow anchoring section 158 in a radial outward direction, and while the prosthetic valve 100 is not covered by an outer tube, shaft or capsule. This is in contrast to self-expandable valves with pre-shaped anchoring sections that need to be constrained inside a tube or a capsule to keep a cylindrical configuration of the anchoring sections.

[0149] In some examples, the inflow anchoring section 104 and the outflow anchoring section 158, or at least portion of the frame interconnecting these sections to the primary frame section 116, are formed of or comprise a plastically deformable material, such as stainless steel, cobalt, chromium, titanium, or alloys or combinations of the same (e.g., CoCr alloys), capable of deforming to assume an outwardly -bent shape when an outwardly-directed force is applied thereto.

[0150] Thus, while each of the inflow anchoring section 104 and the outflow anchoring section 158 are shown in Fig. 1A to extend parallel to the central axis Ca in a free or unbent configuration thereof, Fig. IB illustrates both the inflow anchoring section 104 and the outflow anchoring section 158 bent radially outwards, away from the central axis Ca and/or from the primary frame section 116, such that in a finally bent configuration, the inflow anchoring section 104 can define a non-zero inflow bending angle 0IF relative to the central axis Ca or an axis parallel thereto, and the outflow anchoring section 158 can define a non-zero outflow bending angle OOF relative to the central axis Ca or an axis parallel thereto. While the bending angles OIF and OOF are shown to be substantially identical in Fig. 2B, it is to be understood that in some examples, the inflow bending angle OIF can be different than the outflow bending angle 0oF-

[0151] When a relatively uniform force is applied to expand the frame 102 of the prosthetic valve 100, the inflow anchoring section 104 and the outflow anchoring section 158 can designed to offer smaller rigidity than that of the primary frame section 116, to facilitate bending of the inflow anchoring section 104 and the outflow anchoring section 158 relative to the more rigid primary frame section 116.

[0152] In some examples, the design of the struts 118 and the cells 144 of the primary frame section 116 is configured to provide a desired rigidity that can result in a relatively uniform expansion of the primary frame section 116, optionally subsequent to bending of the inflow anchoring section 104 and the outflow anchoring section 158.

[0153] While the valvular structure 170 is shown in Fig. 1 A to be attached solely to the primary frame section 1 16, it is to be understood that in some examples, at least a portion of the valvular structure 170, or the entire valvular structure 170, can be attached to the inflow anchoring section 104 and/or to the outflow anchoring section 158.

[0154] In some examples, as shown in Figs. 2A-2B, each inflow cell spans the width of two inflow cells 146. In the final expanded configuration of the frame 102 shown in Fig. 2B, an angle a is defined between intermediate angled struts 124 of an inflow cell 146, and an angle P is defined between inflow angled struts 122 of the inflow cell 146.

[0155] In some examples, leaflets 172 of the prosthetic valve 100 can be directly coupled along their inflow edge portions 174 to struts 118 of the primary frame section. For example, the inflow edge portions 174 of each leaflet 172 is shown in the example illustrated in Fig. 2 A to be coupled (e.g., sutured) to an intermediate angled strut 124 extending from a commissure support member 132 on one side of the leaflet, and to an inflow angled strut 122 extending continuously downwardly therefrom, followed by coupling to an upwardly extending inflow angled strut 122 and intermediate angled strut 124, towards a commissure support member 132 on the opposite side of the leaflet. Angled struts 120 can have different angular orientations along rungs to which the leaflets 172 are coupled, so as to form a scallop-shaped path of attachment of the leaflets 172. For that end, the angle between inflow angled struts 122 can be shallower or greater than the angle a between intermediate angled struts 124.

[0156] In some examples, greater flexibility of the inflow anchoring section 104 and the outflow anchoring section 158 is achieved by reducing the number of coupling points between these sections and the primary frame section 116. For example, and as illustrated in Figs. 2A- 2B, not all inflow valley portions 110 and not all outflow valley portions 164 are attached to the primary frame section 116.

[0157] In some examples, half of the inflow valley portions 110 are attachment inflow valley portions 110a which are coupled to the primary frame section 116, such as to the inflow junctions 152, while the other half are free inflow valley portions 110b which are free-ended and are not coupled to the primary frame section 116. Each free inflow valley portion 110a can be disposed between two adjacent attachment inflow valley portions 110b, and each attachment inflow valley portion 110b can be disposed between two adjacent free inflow valley portion 110a.

[0158] In some examples, half of the outflow valley portions 164 are attachment inflow valley portions 164a which are coupled to the primary frame section 116, such as to the outflow junctions 154, while the other half are free outflow valley portions 164b which are free-ended and are not coupled to the primary frame section 116. Each free outflow valley portion 164a can be disposed between two adjacent attachment outflow valley portions 164b, and each attachment outflow valley portion 164b can be disposed between two adjacent free outflow valley portion 164a.

[0159] Fig. 3 shows a perspective view of an exemplary delivery assembly 50 that includes a delivery apparatus 52 adapted to deliver a prosthetic device, which can be any of the exemplary valves 100 disclosed herein. The delivery apparatus 52 can include a handle 54 and at least one catheter extending therefrom, configured to carry a prosthetic valve 100 in a crimped 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 comprise a balloon catheter 60 having an inflatable balloon 62 mounted on its distal end. A prosthetic device, such as prosthetic valve 100, can be carried in a crimped state over the balloon catheter 60.

[0160] 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.

[0161] The outer shaft 58 and the balloon catheter 60 can 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 100 from the outer shaft 58.

[0162] A delivery apparatus 52 can further include a nosecone 70 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. 3) can extend proximally from the nosecone 70 through a lumen of the balloon catheter 60, towards the handle 54.

[0163] In Fig. 3, a prosthetic valve 100 is mounted on the balloon 62 and is shown in a crimped state, providing prosthetic valve 100 with a reduced diameter for delivery to the heart via the patient’s vasculature. While the prosthetic valve 100 is shown in Fig. 3 as being crimped or mounted on the balloon 62 for delivery to the treatment location, it should be understood that the prosthetic valve can be 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.

[0164] The proximal ends of the balloon catheter 60, the outer shaft 58, and/or the nosecone shaft, can 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 100 mounted on the balloon 62, and to deflate the balloon 62 and retract the delivery apparatus 52, for example once the prosthetic valve 100 is mounted in the implantation site. [0165] The handle 54 can 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 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.

[0166] 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 apparatus 52. Further details on the delivery apparatus 52 can be found in PCT Application No. PCT/US2021/047056, which is incorporated by reference herein. [0167] A prosthetic valve 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 32 or against a previously implanted prosthetic valve (for example, during valvein-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 be coupled, directly or indirectly, to another component of the delivery apparatus 52, such as the nosecone 70 or nosecone shaft.

[0168] 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 100. Once the prosthetic valve 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.

[0169] Any of the assemblies, valves, 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 radiation for use in sterilization include, without limitation, gamma radiation and ultra-violet radiation. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide and hydrogen peroxide.

[0170] 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.

[0171] For example, a prosthetic valve 100^a, illustrated in Figs. 2A-2B, 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 inflow anchoring struts 106 of inflow anchoring section 104^a, along with the inflow peak portions 108 and inflow valley portions 110, have uniform widths along their entire lengths, and the outflow anchoring struts 160 of outflow anchoring section 158^a, along with the outflow peak portions 162 and outflow valley portions 164, are also shown to have uniform widths along their entire lengths. Furthermore, the widths of at least some of the axial struts 130 of the primary frame section 116^a can be wider than angled struts 120 of the primary frame section 116^a.

[0172] Figs. 4A and 4B show flattened views of part of a frame 102^b of an exemplary prosthetic valve 100^a, in a final expanded configuration and a partially compressed configuration, respectively. Exemplary prosthetic valve 100^b 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 widths of at least some of the axial struts 130^b can be equal to the widths of angled struts 120 of the primary frame section 116^b.

[0173] As shown in Figs. 4A-4B, LA indicates a length of the anchoring struts, such as the inflow anchoring struts 106 and/or the outflow anchoring stmts 160, and WN indicates the width of anchoring stmts 106 and/or 160. Similar to prosthetic valve 100^a, the inflow anchoring stmts 106 of inflow anchoring section 104^b, along with the inflow peak portions 108 and inflow valley portions 110, are shown in Figs. 4A-4B to have a uniform width WN along their entire lengths, and the outflow anchoring stmts 160 of outflow anchoring section 158^b, along with the outflow peak portions 162 and outflow valley portions 164, are also shown to have the same uniform width WN along their entire lengths.

[0174] As further shown in Figs. 4A-4B, Lv indicates the length of axial frame members 128, WA indicates the width of axial stmts 130, Ww indicates the width of commissure support members 132, Lo indicates the length of an outflow angled stmt 126, Li indicates the length of an angled inflow stmt 122, and Ws indicates the width of an angled stmt 120 of the primary frame section 116. The length of the intermediate angled stmts 124 can be equal to the length Lo of the outflow angled stmt 126.

[0175] In the example illustrated in Figs. 2A-2B for a frame 102^a, the width WA of at least some of the axial stmts 130 is greater than the width Ws of angled struts, and can be comparable, in some examples, to the width Ww of the commissure support members. In the example illustrated in Figs. 4A-4B for a frame 102^b, the width WA of at least some of the axial stmts 130 is similar to the width Ws of angled stmts. In some examples, as shown for the frame 102^b of Figs. 4A-4B, the width WN of both the inflow anchoring stmts 106 and the outflow anchoring stmts 160 can be equal to the width Ws of angled stmts of the frame 102^b.

[0176] As the frame 102 expands from a partially compressed configuration, as shown in Fig. 4B, to a final expanded configuration, as shown in Fig. 4A, the angles a and 0 are increased, up to maximal values that can be achieved in the final expanded state shown in Fig. 4A for example. Various design parameters, such as lengths and widths of various stmts of the frame can influence the shape of the cells and opening angles. As mentioned above, it may be desired, in some implementations, to have a shallower angle P relative to the angle a. This can be achieved, in some examples, by forming inflow angled struts 122 which are shorter than the intermediate angled struts 124, such that Li < Lo.

[0177] Figs. 5 and 6 are side views of a frame 102^c of an exemplary prosthetic valve 100^c, in an expanded configuration and a compressed (or crimped) configuration, respectively. Exemplary prosthetic valve 100^c 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 frame 102^c further comprises a plurality of inflow connector struts 114 between the inflow anchoring section 104^c and primary frame section 116^c, and a plurality of outflow connector struts 168 between the outflow anchoring section 158^c and primary frame section 116^c.

[0178] As shown, Lc indicates the length of the connector struts, such as inflow connector struts 114 and/or outflow connector struts 168, and Wc indicates the width of the connector struts. In some examples, the inflow connector struts 114 and the outflow connector struts 168 can have the same lengths Lc. In some examples, the inflow connector struts 114 and the outflow connector struts 168 can have the same widths Wc.

[0179] The inflow connector struts 114 and outflow connector struts 168 can facilitate bendability of the inflow anchoring section 104 and the outflow anchoring section 158, respectively, relative to the primary frame section 116. This can be achieved by forming relatively thin inflow connector struts 114 and outflow connector struts 168. In some examples, the inflow connector struts 114 and/or outflow connector struts 168 are narrower than angled struts 120 of the primary frame section 116 (e.g., Wc < Ws), and/or narrower than the respective inflow anchoring struts 106 and/or outflow anchoring struts 160 (e.g., Wc < WN). The widths and lengths of the connectors struts 114, 168 can be designed to achieve a desired flexibility or bendability of the inflow and outflow anchoring sections relative to the primary frame section. [0180] As shown in Figs. 5-6, each inflow connector strut 114 is connected on one end to an inflow valley portion 110, such as an attachment inflow valley portions 110a, and on the other end to an inflow junction 152. Similarly, each outflow connector strut 168 is connected on one end to an outflow valley portion 164, such as an attachment outflow valley portions 164a, and on the other end to an outflow junction 154.

[0181] In some examples, the inflow connector struts 114 and/or outflow connector struts 168 are formed of or comprise a plastically deformable material, such as stainless steel, cobalt, chromium, titanium, or alloys or combinations of the same (e.g., CoCr alloys), capable of deforming to assume an outwardly-bent shape when an outwardly-directed force is applied thereto or to sections attached thereto, such as the inflow anchoring section 104 and the outflow anchoring section 158.

[0182] In some examples, any of the inflow peak portions 108 and/or inflow valley portions 110 can include thinned strut portion 112, and any of the outflow peak portions 162 and/or outflow valley portions 164 can include thinned strut portions 166. For example, the inflow anchoring section 104^c of exemplary frame 102^c is shown to have inflow peak portions 108^c and inflow valley portions 110^c that include thinned strut portion 112, and the outflow anchoring section 158^c is shown to have outflow peak portions 162^c and outflow valley portions 164^c that include thinned strut portions 166. WT indicates the width of the thinned strut portion 112 and/or 166, and is thinner than the width WN of the corresponding inflow anchoring struts 106 and/or outflow anchoring struts 160, such that WT < WN. In some examples, the thinned strut portions 112 of the inflow peak portions 108 and the inflow valley portions 110 have similar widths WT- In some examples, the thinned strut portions 166 of the outflow peak portions 162 and the outflow valley portions 164 have similar widths WT. In some examples, thinned strut portions 112 of the inflow anchoring section 104 and thinned strut portions 166 of the outflow anchoring section 158 have similar widths WT. The term “similar” used herein, with respect to dimensions such as widths or lengths of components of a prosthetic valve 100, refer to such dimensions being within a range of no more than 25% from each other.

[0183] In some examples, the width WT of thinned strut portions 112 and/or 166 can be similar to the width of inflow connector struts 114 and/or outflow connector struts 168, respectively. In some examples, the thinned strut portions 112 and/or 166 can be narrower than angled struts 120 of the primary frame section 116, such that WT < Ws.

[0184] An inflow anchoring strut 106 having a length LA can be defined between thinned strut portions 112 of the corresponding inflow peak portion 108 and inflow valley portion 110 at both ends thereof (excluding the thinned strut portions 112 themselves). Similarly, an outflow anchoring strut 160 having a length LA can be defined between thinned strut portions 166 of the corresponding outflow peak portion 162 and outflow valley portion 164 at both ends thereof (excluding the thinned strut portions 166 themselves).

[0185] In some examples, the inflow anchoring struts 106 and/or outflow anchoring struts 160 can be wider than angled struts 120 of the primary frame section 116. For example, frame 102^c is shown to have wider inflow anchoring struts 106^c and outflow anchoring struts 160^c, such that WN > Ws. Wider inflow anchoring struts 106 and/or outflow anchoring struts 160 can advantageously offer greater contact area with an inflatable balloon 62 utilized to expand the frame 102, to increase the force applied by the balloon 62 against the anchoring sections 104, 158 under the same pressure during balloon inflation.

[0186] Since a frame 102 can include relatively thinned connector struts 114, 168, optionally connected to thinned strut portions 112, 166 of corresponding valley portions 110, 164, a greater rigidity of the anchoring struts 106, 160 that can result from widened geometries thereof will have little effect on the bendability of the anchoring sections 104, 158 relative to the primary frame section 116. Nevertheless, in some examples, the radial thickness of any of the connector struts 1 14, 168 can be reduce, relative to radial thickness of other struts of the frame, such as angled struts 120 of the primary frame section 116, to compensate for the increase in width. Reduction of radial thickness of the connector struts 114, 168 can be accomplished by grinding or other suitable methods known in the art.

[0187] Figs. 7A-7D illustrate expansion of a prosthetic valve 100 in greater detail using an inflatable balloon 62. Soft components of the prosthetic valve 100, such as skirt 182 or valvular structure 170 are removed from view in Figs. 7A-7D for clarity. Fig. 7A shows the prosthetic valve 100 crimped onto the balloon 62, with the inflow anchoring section 104 and the outflow anchoring section 158 axially extending, in their free state, substantially parallel to the central axis Ca in a relatively cylindrical configuration, optionally having the same diameter as that of the primary frame section 116. Because the struts 118 of the primary frame section 116 are interconnected at various angles that define a higher density of closed cells 144, the primary frame section 116 is relatively stiffer or more resistant to radial expansion, compared to any of the inflow anchoring section 104 and the outflow anchoring section 158, which are loosely connected to the primary frame section 116 due to inclusion of free valley portions 110, 164 and/or relatively narrow connector struts 114, 168. When the balloon 62 is partially inflated, it can form a "dog bone" shape in which a proximal segment 64 and a distal segment 68 of the balloon 62 which are not constrained by the primary frame section 116, inflate to a greater degree than the primary segment 66 of the balloon around which the primary frame section 116 is crimped. During this phase, the outflow anchoring section 158 and the inflow anchoring section 104 can bend outwardly to a greater diameter than the remainder of the primary frame section 116, as shown in Fig. 7B, due to the relatively greater resistance of the primary frame section 116 to expansion.

[0188] In examples in which the outflow anchoring section 158 and the inflow anchoring section 104, and/or in which the outflow connector struts 168 and inflow connector struts 114, are plastically deformable, they retain their outwardly bent configuration, relative to the primary frame section 116, such that even when the primary frame section 116 begins to expand around the primary segment 66 of the balloon 62, the outflow anchoring section 158 and the inflow anchoring section 104 retain their angled configuration relative to the primary frame section 116, collectively defining an outwardly flared configuration of both the outflow anchoring section 158 and the inflow anchoring section 104, as shown in Fig. 7C. Continued inflation of the balloon, as shown in Fig. 7D, will further expand the frame 102 while retaining the bent configuration of the anchoring segments. The term “final expanded configuration”, as used herein with respect to any exemplary prosthetic valve 100, refers to the expanded configuration achieved by the frame 102 when the balloon 62 is no longer inflated, and after which the balloon 62 can be deflated to retrieve the delivery apparatus 52 while leaving the expanded prosthetic valve 100 expanded at the site of implantation. As shown for the final expanded configuration illustrated in Fig. 7D, the outflow peak portions 162 can collectively define a greater diameter than the diameter defined by the outflow junctions 154 of the primary frame section 116, and the inflow peak portions 108 can collectively define a greater diameter than the diameter defined by the inflow junctions 152 of the primary frame section 116.

[0189] Fig. 8A shows a prosthetic valve 100 in a partially expanded configuration during an implantation procedure inside of a native heart valve. Fig. 8B shows the prosthetic valve 100 of Fig. 8A fully expanded inside the native heart valve. The implantation stages are shown in Figs. 8A-8B, as well as in Figs. 19A-20, with respect to a prosthetic valve 100 positioned inside a native tricuspid valve 22. However, it is to be understood that this anatomical position is shown by way of illustration and not limitation, and that the prosthetic valve 100 can be similarly implanted in any other native heart valve, such as an aortic valve 14 or a mitral valve 30.

[0190] A delivery assembly 50, which can be similar to that described above with respect to Fig. 3, can be advanced via any suitable delivery approach towards the native valve, such as the tricuspid valve 22, while the prosthetic valve 100 is crimped over the balloon 62, in a similar manner to that shown in Fig. 7 A for example. The balloon 62 is then maneuvered to position the crimped inflow anchoring section 104 resides inside the right atrium 18 and the crimped outflow anchoring section 158 resides in right ventricle 20. Initiation of ballon inflation will cause the prosthetic valve 100 to expand in a sequence similar to that described above with respect to Figs. 7A-7D, wherein Fig. 8A demonstrates a partially expanded configuration of the prosthetic valve 100 which can be equivalent to that shown in Fig. 7C for example. The delivery apparatus 52 including balloon catheter 60 is not shown in Fig. 8A for clarity, yet it is to be understood that in the partially expanded state shown in Fig. 8A, the prosthetic valve 100 is still disposed around a partially inflated balloon 62. [0191] Continued inflation of the balloon 62 will further expand the prosthetic valve 100 up to its final expanded configuration shown in Fig. 8B, after which the balloon 62 can be deflated and the delivery apparatus 52 can be retrieved from the patient’s body. As shown in Fig. 8B, the prosthetic valve 100 can be designed such that in the final expanded configuration, the inflow anchoring section 104 can contact the inner walls 36 of the right atrium 18, and the outflow anchoring section 158 can contact the inner walls 40 of the right ventricle 20, thereby anchoring the prosthetic valve 100 in position.

[0192] In some examples, the maximal diameter to which the inflow anchoring section 104 may expand can be greater than the diameter or size of the right atrium 18 at the region of inflow anchoring section expansion, and the diameter to which the outflow anchoring section 158 may expand can be greater than the diameter or size of the right ventricle 20 at the region of outflow anchoring section expansion. For example, the inflow anchoring struts 106 can contact the walls 36 of the right atrium 18 and/or the outflow anchoring struts 160 can contact the walls 40 of the right ventricle 20 during expansion, and optionally even prior to reaching the final expanded configuration. In such cases, continued expansion (such as by continued balloon inflation) can press the inflow anchoring struts 106 and/or the outflow anchoring struts 160 against the anatomical chamber walls, which can cause the inflow anchoring struts 106 and/or the outflow anchoring struts 160 to bend radially inwards due to resistance of the corresponding chamber walls, such that any of the inflow anchoring section 104 and/or outflow anchoring section 158 can conform to the shape of the chamber in which it is expanded.

[0193] Inward bending can result from relative flexibility of the anchoring struts 106, 160, for example due to reduced thickness of the struts, which can be achieved by grinding or any other suitable method. Fig. 8B illustrates exemplary outflow anchoring struts 160 bent radially inwards at the region of contact with walls 40 of the right ventricle 20.

[0194] In some examples, each inflow peak portion 108 includes an arcuate region defined between upper and lower curved surfaces thereof. In some examples, each outflow peak portion 162 includes an arcuate region defined between upper and lower curved surfaces thereof. In this manner, the arcuate regions serve as atraumatic endings of the peak portions 108 and/or 162, thereby reducing the risk of causing damage to tissue walls that come into contact with the peak portions 108 and/or 162. In some examples, any of the inflow peak portion 108 and/or outflow peak portion 162 can be flattened, blunted, or inverted towards the primary frame sections, thereby similarly avoiding the risk of causing damage to tissue walls.

[0195] While most of the conventional prosthetic valves designed for implantation inside noncalcified anatomies, such as native tricuspid valve or native mitral valves, are self-expandable valves, the balloon expandable prosthetic valve 100 disclosed herein, comprising a plastically - deformable frame 102, are advantageous, because a plastically deformable frame avoids applying a chronic radial force against the surrounding anatomy and further because using a plastically deformable frame prevents or mitigates changes in the diameter of the prosthetic valve over time (e.g., decreases in the diameter caused by anatomic forces and/or increases in the diameter caused by laxity over time).

[0196] In some instances, the outwardly flared expansion of the inflow anchoring section 104 and the outflow anchoring section 158 pinches the anatomy trapped therebetween, including the native leaflets 34, such that the native leaflets can be pushed by the outflow anchoring section 158 in an upstream direction (e.g., towards the inflow anchoring section), sandwiching them between sections of the frame 102 in a manner that enables the folded or bunched-up native leaflets 34 to serve as an additional anchoring platform against the outflow anchoring section 158 and/or the primary frame section 116.

[0197] Since the native heart valve inside of which the prosthetic valve 100 expands has noncalcified native leaflets 34, the native leaflets can be forcibly pushed by the frame 102 without posing a risk of breaking and releasing calcified deposits into the blood stream, which would pose a significant risk in case of heavily calcified leaflets.

[0198] In contrast to an aortic valve 14, the tricuspid valve 22 or mitral valve 30, in many cases, do not define an annulus 32 that has a constricted diameter relative to the corresponding atrium and ventricle on both sides thereof. Advantageously, the pinching movement of the inflow anchoring section 104 and the outflow anchoring section 158, including the native leaflets pushed and bunched -up by the outflow anchoring section 158 during expansion of the framer 102, can create a “virtual” annulus 32 that defines a narrower diameter around the primary frame section 116.

[0199] As mentioned above, a prosthetic valve 100 can be similarly expanded inside any other native heart valve. For example, when a prosthetic valve 100 is implanted inside an aortic valve 14, the inflow anchoring section 104 is positioned in the left ventricle 28 and the outflow anchoring section 158 is positioned in the aorta 12, such that during expansion, the flared outflow anchoring section 158 can flare towards the aortic walls 38 and push the native leaflets 34 towards the sinuses, which can also offset the leaflet farther away from the coronary sinuses to reduce risk of curtaining blood flow into the coronary arteries. Similarly, when a prosthetic valve 100 is implanted inside a mitral valve 30, the inflow anchoring section 104 is positioned in the left atrium 26 and the outflow anchoring section 158 is positioned in the left ventricle 28, such that during expansion, the flared outflow anchoring section 158 can push the native leaflets 34 towards the left atrium and father from the left ventricular outflow tract (LVOT), which can also prevent risk of the anterior leaflet of the mitral valve limiting outflow through the LVOT and the aortic valve

[0200] Design parameters of various components of the frame 102, such as dimensions of struts at selected regions, can influence the shape of expansion and regional rigidity of the prosthetic valve. Fig. 9 shows a frame 102^d of an exemplary prosthetic valve 100^d, which 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 any of the inflow anchoring section 104^d and/or outflow anchoring section 158^d can include different lengths of the inflow anchoring struts 106 and/or of the outflow anchoring struts 160, respectively.

[0201] In the example illustrated in Fig. 9, the inflow anchoring section 104^d is shown to include long inflow anchoring struts 106a having a length LAL and short inflow anchoring struts 106b having a length LA2, such that LAI > L\2. Each two inflow anchoring struts diverging from an attachment inflow valley portions 110a are long inflow anchoring struts 106a, and each two inflow anchoring struts diverging from a free inflow valley portions 110b are short inflow anchoring struts 106b.

[0202] Similarly, the outflow anchoring section 158^d is shown to include long outflow anchoring struts 160a having a length LA3, and short outflow anchoring struts 160b having a length LA4, such that LA3 > LA4. Each two outflow anchoring struts diverging from an attachment outflow valley portions 164a are long outflow anchoring struts 160a, and each two outflow anchoring struts diverging from a free outflow valley portions 164b are short outflow anchoring struts 160b.

[0203] Having shorter anchoring struts 106b and/or 160b extending from the free valley portions 110b and/or 164b, respectively, can result in a flower-like opening of these shorter anchoring struts radially outwards during expansion of the frame 102^d, such that the portions of the anchoring sections 104^d and/or 158^d that terminate at the free valley portions 110b and/or 164b can collectively define a greater opening diameter, relative to alternative equal-length implementations.

[0204] It is to be understood that the frame 102^d is shown to include short and long inflow anchoring struts 106a, 106b in combination with short and long outflow anchoring struts 160a, 160b by way of illustration and not limitation, and that in some examples, the inflow anchoring section 104 can include short and long inflow anchoring struts 106a, 106b while the lengths of all outflow anchoring struts 160 are substantially equal, and in some examples, the outflow anchoring section 158 can include short and long outflow anchoring struts 160a, 160b while the lengths of all inflow anchoring struts 106 are substantially equal.

[0205] It is to be understood that the frame 102^d is shown to include short and long inflow anchoring struts 106a, 106b having lengths LAI and LA2 which are substantially equal to corresponding lengths LA3 and LA4 of short and long outflow anchoring struts 160a, 160b by way of illustration and not limitation, and that in some examples, each of the lengths LAI, LA2, LA3 and LA4 can be different, for example designed to facilitate a desired expansion configuration adapted for a different anatomy of surrounding any of the inflow anchoring section 104 and the outflow anchoring section 158.

[0206] Fig. 10 shows a frame 102^e of an exemplary prosthetic valve 100^e, which 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 lengths of the inflow anchoring struts 106 are different from the lengths of the outflow anchoring struts 160. For example, the lengths of all inflow anchoring struts 106a, 106b of the inflow anchoring section 104^e are shown to be equal, such that LAI = LA2, and the lengths of all outflow anchoring struts 160a, 160b of the outflow anchoring section 158^e are shown to be equal, such that LA3 = LA4, wherein the outflow anchoring struts 160 are longer than the inflow anchoring section 104 (e.g., LA3 > LAI).

[0207] Longer outflow anchoring struts 160 can be used in case of implantation in native mitral valve 30, native tricuspid valves 22, or native pulmonary valves, for example, in which case the greater length of the outflow anchoring struts 160 can facilitate bunching up of longer native leaflet 34 of such valve. Shorter inflow anchoring struts 106 may be desirable in some examples, such as during implantation in a native aortic valve, in which case, the inflow anchoring struts 106 residing in the left ventricle 28 may be short enough so as not to contact anatomical regions that may cause conduction disturbances. Nevertheless, it is to be understood that in some examples, a prosthetic valve 100 can include inflow anchoring struts 106 which are longer than the outflow anchoring struts 160.

[0208] Fig. 11 shows a frame 102^f of an exemplary prosthetic valve 100^f, which 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 width of the inflow anchoring struts 106 is different from the width of the outflow anchoring struts 160. For example, the width WNI of the inflow anchoring struts 106 of inflow anchoring section 104^f is shown to be narrower than the width WN2 of the outflow anchoring struts 160 of outflow anchoring section 158^f, such that WN2 > WNI. It is to be understood that the inflow anchoring struts 106 are shown to be shorter in Fig. 11 than the outflow anchoring struts 160 by way of illustration and not limitation, and that the lengths of any of the inflow anchoring struts 106 and outflow anchoring struts 160 of frame 102^f can be modified according to any of the exemplary lengths described throughout the specification.

[0209] Increasing the width and/or thickness of any of the anchoring struts 106, 160 can influence the stress distribution along the anchoring sections 104, 158 and rigidity of the anchoring struts 106, 160. For example, wider outflow anchoring struts 160 as shown in the illustrated example can distribute stresses along the outflow anchoring struts 160 such that higher stress concentration may develop along thinner connector struts 168 or thinned strut portions 166. Moreover, wider outflow anchoring struts 160 can increase stiffness of the outflow anchoring struts 160 in a manner that facilitates easier pushing against the native leaflets 34 during expansion of the frame 102^f, while narrower inflow anchoring struts 106 can increase flexibility of these struts to reduce risk of forcibly pushing against anatomical regions that can cause conduction disturbances, for example when implanted against the native aortic valve 14. Nevertheless, it is to be understood that in some examples, wider inflow anchoring struts 106 can be similarly provided.

[0210] Fig. 12 shows a frame 102^g of an exemplary prosthetic valve 100^s, which 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 frame 102^s can include a relatively higher (e.g., longer in the axial direction) primary frame section 116^s. A higher (or more elongated) primary frame section 116^s can be achieved, in some examples, by providing longer axial frame members 128. For example, the length Lv of the axial frame members 128 can be equal to or greater than the length Lo of the outflow angled struts 126, as illustrated in Fig. 12.

[0211] Higher axial frame members 128 can result in overall higher outflow cells 148, which can ensure adequate blood flow therethrough into the coronaries in the case of implantation in a native aortic valve 14, and provide a larger cell opening through which a coronary catheter (for example, a 6 Fr. sized catheter) can be passed in case a future interventional procedure is required in the coronary arteries, assuming that the outflow cells 148 are positioned, after valve implantation, in front of the coronary ostia.

[0212] When the axial frame members 128 include commissure support members 132 having commissure windows 134, the opening 136 of the commissure window 134 is usually dictated by the side of the commissure 194, which can depend on the size of the commissure tabs 176 of the leaflets. Thus, designing a frame 102^s that include longer commissure support members 132 may preserve the size of the opening 136 of the commissure window 134, while the outflow end portion 142 and/or the inflow end portion 140 are elongated to achieve the desired length of the commissure support member 132.

[0213] Fig. 13 shows a frame 102^h of an exemplary prosthetic valve 100¹¹, which 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 frame 102^h can include elongated connectors struts, such as elongated inflow connector struts 114 and/or elongated outflow connector struts 168. In the example illustrated in Fig. 1 , the frame 102^h is shown to include inflow connector struts 114 having a first length Lcl, and outflow connector struts 168 having a second length Lc2, such that Lc2 > Lcl.

[0214] The lengths of connectors struts 114 and/or 168 can influence the shape or flaring angle of the corresponding anchoring section 104 and/or 158. For example, the longer outflow connector struts 168 shown in Fig. 13 can result in a larger radius of curvature assumed by the outflow connector struts 168 during expansion. Shorter inflow connector struts 114 can increase the inflow flaring angle 0IF, such that extremely short first lengths Lcl can optionally result in an inflow flaring angle OIF of about 90°.

[0215] It is to be understood that a combination of longer outflow connector struts 168 and shorter inflow connector struts 114 is shown in Fig. 13 by way of illustration and not limitation, and that any of the outflow connector struts 168 and inflow connector struts 114 can have any other lengths that can be equal or different from each other.

[0216] Figs. 14A-14B show exploded and assembled views, respectively, of an exemplary prosthetic valve 100^g, illustrated without soft components such as skirts or leaflet for clarity. Prosthetic valve 100^g 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 prosthetic valve 100^g further comprises one or more tissue engagement frames 200 coupled to its frame valve 102^g. A tissue engagement frame 200 disclosed herein is configured for securing sections of the prosthetic valve to the native tissue.

[0217] Figs. 14A-14B show an assembly that includes two tissue engagement frames, namely a first tissue engagement frame 200a coupled to the inflow anchoring section 104, and a second tissue engagement frame 200b coupled to the outflow anchoring section 158. Due to their relative locations, the one or more tissue engagement frames 200 can be also referred to as one or more “outer frames”, and the frame 102 can be referred to as the “inner frame”. A tissue engagement frame 200 comprises tissue engagement struts 202 that can track the shape and orientation of struts 118 of the section of the frame 102 to which the tissue engagement frame is coupled, and align with the corresponding struts 118 of the frame section to which they are coupled. For example, the first tissue engagement frame 200a is shown to include tissue engagement struts 202a extending between peaks 204a and valleys 206a, and the second tissue engagement frame 200b is shown to include tissue engagement struts 202b extending between peaks 204b and valleys 206b.

[0218] As shown in the assembled configuration of Fig. 14B, the tissue engagement struts 202a of the first tissue engagement frame 200a are aligned with the inflow anchoring struts 106, and the tissue engagement struts 202b of the second tissue engagement frame 200h are aligned with the outflow anchoring struts 160. Coupling of any tissue engagement frame 200 to a corresponding section of the frame 102 can be accomplished, in some examples, by sutures. It should be noted that, for purposes of illustration, sutures are not shown in Fig. 14B. In some examples, a tissue engagement frame 200 can be coupled to the corresponding section of a frame 102 frame in various other ways (e.g., fasteners, welding, adhesive, etc.). In some examples, peaks 204 and valleys 206 of a tissue engagement frame 200 can be coupled to corresponding peak portions and valley portions of the frame, such as to peak portions 108 and/or 162 and valley portions 110 and/or 164. By coupling the peaks and valleys of a tissue engagement frame 200 to peak portions and valley portions of the frame 102, the tissue engagement frame 200 can, for example, expand and/or or compress simultaneously with the corresponding frame section to which it is attached, such as the inflow anchoring section 104 and/or outflow anchoring section 158.

[0219] In some examples, a tissue engagement frame 200 is removably coupled to the frame 102 (e.g., with the sutures and/or fasteners). As used herein, “removably coupled” means coupled in such a way that two components are coupled together and can be separated without plastically deforming either of the components. In some examples, a tissue engagement frame 200 can be permanently coupled to the frame 102 (e.g., via welding). As used herein, “permanently coupled” means coupled in such a way that the two components cannot be separated without plastically deforming at least one of the components.

[0220] A tissue engagement frame 200 can be made, in some examples, of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.). In some examples, the radial thickness of the tissue engagement struts 202 is equal to or thinner than a radial thickness of the corresponding inflow anchoring struts 106 and/or outflow anchoring struts 160.

[0221] A tissue engagement frame 200 further comprises tissue engaging features, such as spikes 208, configured to help secure the prosthetic valve 100⁸ to native heart valve tissue and/or to help promote tissue ingrowth between the native tissue and the prosthetic valve 100^s. [0222] As the inflow anchoring section 104 and/or outflow anchoring section 158 are expanded and assume their outwardly flared configuration, the spikes 208 are configured to engage (and in some instances penetrate) the native heart valve tissue. In this manner, the spikes 208 can increase the frictional engagement between the prosthetic valve 100^g and native heart valve tissue, which can help to reduce migration of the prosthetic valve 100^g relative to the native heart valve tissue after it is released from the delivery apparatus. The spikes can also help to improve tissue ingrowth and/or reduce PVL.

[0223] The spikes 208 can extend in various directions from the tissue engagement struts 202. In some instances, the spikes 208 are perpendicular or at least substantially perpendicular (e.g., forming an angle of 80-100 degrees) to the tissue engagement struts 202 from which they extend. In some examples, the spikes 208 can extend from their respective tissue engagement struts 202 at various other angles (e.g., between 1-79 degrees). The spikes 208 can comprise various shapes and lengths such that the spikes 208 provide sufficient retention force for the prosthetic valve 100^g, while reducing potential harm to the surrounding tissue. For example, while tissue engaging features in the form of tines or spikes are shown in the illustrated example, it is to be understood that other forms of tissue engaging features are contemplated. In some examples, the tissue engaging features comprise ball-shaped bulges and/or a rectangularly shape-projections. In some examples, tissue engaging features can be provided in the form of projections having a curved shape, a hook shape, a cross shape, a T-shape, and/or a barbed shape. Various combinations of shapes and/or sizes of tissue engaging features can be used.

[0224] It is to be understood that the first and second tissue engagement frame 200a and 200b are similarly shaped in Figs. 14A-14B by way of illustration and not limitation, and that in some examples, differently shaped tissue engagement frames 200a and 200b can be provided. The frame 102 of a prosthetic valve 100⁸ can be shaped according to any of the examples of frames 102 disclosed throughout the specification.

[0225] While two tissue engagement frame 200a and 200b are shown in the example illustrated in Figs. 14A-14B, it is to be understood that other shapes and/or numbers of tissue engagement frames 200 are contemplates. In some examples, a prosthetic valve 100⁸ can include a single tissue engagement frame 200. For example, a single tissue engagement frame 200 that resembles tissue engagement frame 200b of Figs. 14A-14B can be coupled to the outflow anchoring section 158 to secure against native leaflets engaged thereby. In some examples, a single tissue engagement frame that includes inflow and outflow sections that resemble the two tissue engagement frame 200a and 200b shown in Figs. 14A-14B can be provided, interconnected therebetween by additional struts that can optionally align with struts 118 of the primary frame section 116. In such examples, struts extending along the primary frame section 116 can either include spikes 208 or be devoid of spikes. In some examples, a tissue engagement frame 200 can extend around the primary frame section 116.

[0226] It is to be understood that any reference to a zig-zagged arrangement or pattern of struts disclosed herein, such as zig-zagged arrangements of any of the inflow anchoring struts 106, outflow anchoring struts 160, and/or tissue engagement struts 202, is not limited to linear struts extending between corresponding peak and valley portions, but may also refer to curved struts that can optionally undulate following a wavy or sinusoidal pattern between the corresponding peak and valley portions.

[0227] Fig. 15 shows a flattened view of an exemplary leaflet 172. Figs. 16A and 16B show one third of a prosthetic valve 100 having the leaflet 172 of Fig. 15 attached to the frame 102, illustrated in a compressed configuration and an expanded configuration, respectively. Fig. 17A shows a portion of a prosthetic valve 100 with a valvular structure 170 mounted inside the frame 102, in a partially compressed configuration. Figs. 17B and 17C show a portion of the prosthetic valve 100 of Fig. 17A in an expanded configuration, with the leaflets illustrated in their open state and close state, respectively. The outflow anchoring section 158 is shown in Figs. 16B and 17B-17C in a cylindrical configuration instead of an outwardly-flared configuration for illustrative purpose. Figs. 15-17C are described herein together.

[0228] As shown in Fig. 15, the inflow edge portion 174 can be formed as a single scallop extending between two adjacent commissure tabs 176, opposite to the free edge portion 178. An inflow midpoint 175 can be defined at the middle of the leaflet’s inflow edge portion 174. As shown in Figs. 16A-16B, the inflow edge portion 174 can be shaped so as to track selected struts 118 of the frame 102, such as angled struts 120 of the primary frame section 116, to which it can be directly coupled. The leaflet can be made of a variety of materials, such as tissue (e.g., pericardium) or synthetic materials (e.g., polymers, metals, etc.). Coupling of the leaflet to the frame can be accomplished in any suitable manner, such as by sutures or other type of coupler, by adhering, by fusing (for example, in the case of polymeric leaflets), and the like.

[0229] In the example illustrated in Figs. 16A-16B, the inflow edge portion 174 is shown to align with angled struts 120 of the primary frame section 116, the inflow midpoint 175 is shown to align with an inflow junction 152, and the commissure tabs 176 are shown to extend through openings 136 of commissure windows 134. While the inflow edge portion 174 is shown to be directly coupled to the frame 102, it is to be understood that in some examples, intermediate components can be used. For example, the inflow edge portion 174 can be attached to an inner skirt (not shown), which can be attached, in turn, to the frame 102 (such as to the primary frame section 116), in which case the inflow edge portion 174 can have any other shape that does not necessarily track or align with struts 118 of the frame 102.

[0230] The movable body portion 180 of the leaflet 172 is the portion of the leaflet defined between the inflow edge portion 174 and the free edge portion 178, excluding the commissure tabs 176, configured to move towards and away from the frame 102 during working cycles of the prosthetic valve 100, as shown in Figs. 17B-17C.

[0231] While two commissure tabs 176 are illustrated, it is to be understood that a leaflet 172 can include other forms of commissure attachment features. In some examples, instead of a single commissure tab, the leaflet 172 can include an upper tab connected by a neck portion to a lower tab, configured to be folded thereover to offset the articulation axes of the leaflets radially inwards relative to the frame. In some examples, a leaflet can include other forms of commissure regions, defined between the inflow edge portion 174 and the free edge portion 178, which can be devoid of outwardly extending tabs.

[0232] It is to be understood that an upwardly-extending free edge portion 178 is shown in Fig. 15 by way of illustration and not limitation, and that other shapes of the free edge portion 178 are contemplated. In some examples, the free edge portion 178 can include a central upper protrusion or “bump”. In some examples, the free edge can be relatively straight. In some examples, the free edge can be convex or concave in shape.

[0233] In some examples, the prosthetic valve 100 is adapted for use in a range of expansion diameters, instead of being configured to be usable for a specific single expansion diameter. For example, one type of a prosthetic valve can be sized for implantation in a range of diameters from 23 to 26 mm, while another type of the of the prosthetic valve can be sized for implantation in a range of diameters from 26 to 29 mm. Soft components of the prosthetic valve 100, such as skirts or leaflets, can be adapted, in such cases, to function across the range of diameters, which can be also referred to as the working diameters of the prosthetic valve.

[0234] A leaflet 172 can be made of a stretchable material, such as pericardial tissue, which can be cut from a tissue patch in a size that matches the lower end of the working range of diameter, and can be stretched by about 10-15% to properly function even when the prosthetic valve 100 is expanded to the higher end of the working range of diameter. Any reference to proper functioning of the leaflets 172 of a valvular structure 170 in a given expansion diameter, refers to proper opening of the leaflets (see Fig. 17B) in a manner that does not constrict the effective orifice area (EOA) through which blood flows, and proper coaptation of the leaflets in their closed state (see Fig. 17C) to prevent backflow of blood through a central hole that may be otherwise formed between the leaflets.

[0235] In some examples, the frame 102 can be cut (such as by laser cutting) from a tube having a diameter that can be equal to or smaller than the lower end of the working diameters. For example, for a prosthetic valve configured to have a working range of diameters from 26 to 29 mm, the frame 102 can be cut from a tube having a diameter of 26 mm, and soft components of the prosthetic valve 100, such as skirts and/or leaflet 172, can be attached to the frame 102 at the as-cut diameter of 26 mm. In some examples, a frame 102 can be cut (such as by laser cutting) from a tube having a diameter that is significantly smaller than the lower end of the working diameters. For example, for a prosthetic valve configured to have a working range of diameters from 26 to 29 mm, the frame 102 can be cut from a tube having a diameter of 26 mm, and soft components of the prosthetic valve 100, such as skirts and/or leaflet 172, can be attached to the frame 102 at the as-cut diameter of 20 mm.

[0236] Fig. 16A can be representative of the as-cut diameter of the frame 102, such as 20 mm for a prosthetic valve configured to have a working range of diameters from 26 to 29 mm. The soft components, including leaflets 172, can be coupled to the frame in this diameter, as also shown in Fig. 16 A. Fig. 16B can be representative of the prosthetic valve expanded to the lower end of the working diameters, such as to 26 mm, which may be the diameter to which the leaflet 172 was formed to match. Further expansion of the prosthetic valve 100, for example to the higher end of 29 mm, will optionally stretch the leaflet in a manner that allows it to maintain adequate functioning, i.e. to properly close and open during working cycles of the prosthetic valve.

[0237] Conventional leaflet attachment procedures include attachment of the leaflet to a frame cut from a tube having a nominal diameter to which the prosthetic valve is designed to expand, in the case of prosthetic valves having a single nominal expansion diameter, or to a frame cut from a tube having the upper end diameter of the working range, for frames designed to have a range of working diameters. In such cases, the leaflets is stretched along its inflow edge portion 174 during the assembly procedure. In contrast, when the leaflet 172 is attached to the frame 102 at a diameter that can be smaller than the lower end of the working diameter of the prosthetic valve, its inflow edge portion 174 can be more compressed when expanded to any diameter of the working range of diameters, which results in bulging billowing (and a more concave and/or 3D shape) of the movable body portion 180. This in turn can advantageously increase mobility of the leaflet 172 when the prosthetic valve 100 is implanted in a patient. As a result, the efficiency of such a prosthetic valve 100 can be improved. [0238] It is to be understood that a range of diameters from 26 to 29 mm, and a frame formation diameter of 20 mm, are mentioned by way of example only, and that other ranges of diameter and cutting diameters are contemplated. Moreover, a prosthetic valve 100 can be adapted to have a single nominal expansion diameter, and cut from a tube having a significantly smaller diameter that the nominal expansion diameter, wherein attachment of the leaflet 172 to the frame 102 in such cases can achieve a similar effect when the prosthetic valve 100 is expanded to the nominal diameter.

[0239] In some examples, the frame 102 can be cut from any other diameter, such as a nominal diameter for prosthetic valves configured to expand to a single nominal expansion diameter, or a diameter within the working range of diameter (including the higher end diameter) for prosthetic valve configured to have a range of expansion diameters, and the frame 102 can be then compressed to a smaller-than-cut diameter, followed by assembly of soft components, such as skirts and/or leaflets 172, at the compressed diameter. For example, a frame of a prosthetic valve configured to have a working range of diameters from 26 to 29 mm can be cut from a tube having a diameter of 26 mm or even 29 mm, and then compressed to a smaller diameter, such as to a 20 mm diameter, after which the leaflets 172 can be coupled to the frame 102 in this partially compressed diameter, to achieve a similar effect after expansion to a nominal diameter or a diameter within a working range.

[0240] In some examples, leaflets 172 are coupled to a frame 102 having a partially compressed diameter, either following cutting from this diameter or cutting from a larger diameter and compressing the frame, wherein the partially compressed diameter at which the leaflets 172 are assembled can be also referred to as an assembling diameter. In some examples, the assembling diameter is smaller than a nominal diameter or a lower end of a working range of diameters of the prosthetic valve 100. In some examples, the assembling diameter is less than 90% of a nominal diameter or a lower end of a working range of diameters of the prosthetic valve 100. In some examples, the assembling diameter is less than 80% of a nominal diameter or a lower end of a working range of diameters of the prosthetic valve 100. In some examples, the assembling diameter is less than 75% of a nominal diameter or a lower end of a working range of diameters of the prosthetic valve 100. In some examples, the assembling diameter is less than 66% of a nominal diameter or a lower end of a working range of diameters of the prosthetic valve 100. In some examples, the assembling diameter is as close to the crimped diameter of the prosthetic valve (which can be, for example, in the range of about 6-8 mm) as possible, while still allowing for convenient access for stitching or other form of coupling of the leaflets to the frame. [0241] In some examples, the frame is cut from a tube having a diameter equal to the crimped diameter (which can be, for example, in the range of about 6-8 mm), which can advantageously obviate the use of a crimper to compress the prosthetic valve prior to delivery into a patient’s body.

[0242] Fig. 18 shows a portion of an exemplary prosthetic valve 100^h, which 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 prosthetic valve 100^h can further include an outer skirt 182 disposed around the frame 102. Figs. 19A-19C show exemplary stages in an implantation procedure of the prosthetic valve 100^h of Fig. 18 inside a native heart valve. Figs. 18-19C are described herein together.

[0243] The outer skirt 182 can extend from a skirt inflow end portion 184 to a skirt outflow end portion 188, and define a skirt inflow segment 190 extending from the skirt inflow end portion 184, and a skirt outflow segment 192 extending from the skirt outflow end portion 188. In some examples, the skirt inflow segment 190 can be a segment of the outer skirt 182 disposed around the inflow anchoring section 104, and the skirt inflow segment 190 can be a segment of the outer skirt 182 disposed around the outflow anchoring section 158. In some examples, the outer skirt is coupled to the frame 102 by sutures or other form of couplers.

[0244] In some examples, the outer skirt 182 is attached to the frame 102 at discrete regions of attachment, such as the skirt inflow end portion 184 and the skirt outflow end portion 188. For example, the skirt inflow end portion 184 can be attached (e.g., sutured) to, or in close proximity to, the inflow peak portion 108, and the skirt outflow end portion 188 can be attached (e.g., sutured) to, or in close proximity to, the outflow peak portion 162. In some examples, the skirt can be further attached (e.g., sutured) to the primary frame section 116, optionally at a discrete region of attachment, which can be defined as a skirt intermediate attachment portion 186.

[0245] In some examples, the portion of the outer skirt 182 extending between the skirt inflow end portion 184 and the primary frame section 116 is not attached to the frame 102. In some examples, the portion of the outer skirt 182 extending between the skirt inflow end portion 184 and the skirt intermediate attachment portion 186 is not attached to the frame 102.

[0246] In some examples, the portion of the outer skirt 182 extending between the skirt outflow end portion 188 and the primary frame section 116 is not attached to the frame 102. In some examples, the portion of the outer skirt 182 extending between the skirt outflow end portion 188 and the skirt intermediate attachment portion 186 is not attached to the frame 102. [0247] As shown in Fig. 19A, the prosthetic valve 100 can be positioned, in its crimped configuration, inside a native heart valve, such as the tricuspid valve 22 in the illustrated example, the skirt can be disposed around the frame in a relatively cylindrical configuration. As the prosthetic valve 100 is expanded and the inflow anchoring section 104 and outflow anchoring section 158 begin to flare radially outwards, as shown in Fig. 17B, the outer skirt 182 assumes an hourglass-shaped configuration, “tenting” the skirt inflow segment 190 and the skirt outflow segment 192, such that the unattached portions of the outer skirt 182 are tensioned and can extend away from the corresponding frame portions.

[0248] In the final expansion diameter shown in Fig. 19C, the final hourglass-shape of the outer skirt 182 is illustrated, in which portion of the outer skirt 182 which are not attached to the frame 102 can extend radially away from the frame 102 and into the surrounding anatomy, such that the outer skirt 182 better conforms to the anatomy surrounding the prosthetic valve 100^h, thereby improving PVL sealing around the prosthetic valve.

[0249] In some examples, the outer skirt 182 does not necessarily include a skirt intermediate attachment portion 186, but is rather coupled to the frame 102 only at the skirt inflow end portion 184 and skirt outflow end portion 188, allowed to extend radially away from the frame 102 in the final expanded configuration, between the flared ends of the inflow anchoring section 104 and the outflow anchoring section 158.

[0250] It is to be understood what while the outer skirt 182 is shown in the illustrated example to include both a skirt inflow segment 190 and a skirt outflow segment 192 configured to extend radially away from the frame 102 in the expanded configuration, in some examples, the outer skirt can be disposed only along part of the prosthetic valve’s height. For example, an outer skirt 182 can be disposed around the inflow anchoring section 104 and some or the entire height of the primary frame section 116, without covering the outflow anchoring section 158, or the outer skirt 182 can be disposed around the outflow anchoring section 158 and some or the entire height of the primary frame section 116, without covering the inflow anchoring section 104.

[0251] In some examples, a prosthetic valve 100 can be devoid of an outer skirt. Since prosthetic valves 100 disclosed herein can be expanded against non-calcified native heart valves, the final expansion diameter of such prosthetic valves 100 can be relatively greater than that of prosthetic valves expanded inside calcified anatomies. The larger expansion diameter is possible due to the reduced risk of breaking and releasing calcified deposits that can be released to the blood stream in the case of calcified leaflets. Since larger expansion diameter can forcibly press the frame into the surrounding anatomy, portions of the anatomy, such as surrounding native leaflets 34, can be tightly pressed against the frame 102, or even bulge inwards to some extent through cells 144 of the frame 102, such that PVL sealing around the prosthetic valve 100 can be achieved, in such cases, even without the use of an outer skirt.

[0252] Fig. 20 shows a portion of an exemplary prosthetic valve 100¹, which 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 any of the inflow anchoring section 104' and/or outflow anchoring section 158¹ of the prosthetic valve 100¹ can further include additional rows of cells 144. Such as the two rows of inflow section cells 1441 and the two rows of outflow section cells 1440 shown in the example illustrated in Fig. 20.

[0253] Any of the inflow section cells 1441 and/or outflow section cells 1440 can extend from the corresponding inflow anchoring struts 106¹ and/or outflow anchoring struts 160', respectively. In the example illustrated in Fig. 20, a first row of inflow section cells 14411 is connected to the inflow peak portions 108', and a second row of inflow section cells 14412 is connected by mutual junctions 150 to the first row of inflow section cells 14411. Similarly, a first row of outflow section cells 14401 is shown to be connected to the outflow peak portions 162', and a second row of outflow section cells 14402 is connected by mutual junctions 150 to the first row of outflow section cells 14401.

[0254] As shown, the addition of one or more rows of cells 144 to any of the inflow anchoring section 104' and/or outflow anchoring section 158' can be adapted to obtain generally semi- spherical or ball-shaped expanded configurations of the inflow anchoring section 104' and/or outflow anchoring section 158', such that instead of merely flaring radially outwards, the inflow anchoring section 104' and/or outflow anchoring section 158' can also curve radially inwards closer to their free ends, allowing the inflow anchoring section 104' and/or outflow anchoring section 158' to better conform to the shape of the anatomical chambers in which they are expanded, thereby improving anchoring of the prosthetic valve 100'.

[0255] Advantageously, due to the semi-spherical expanded shape of the inflow anchoring section 104' and/or outflow anchoring section 158', apices defined at the inflow and/or outflow ends of the inflow anchoring section 104' and/or outflow anchoring section 158' are oriented radially inwards, away from the walls of the chambers inside of which they are expanded, thereby reducing the risk of causing damage to tissue walls by such apices.

[0256] In some examples, rows of inflow section cells 1441 can offer greater rigidity than that of the inflow anchoring struts 106 and/or inflow connector struts 114, and rows of outflow section cells 1440 can offer greater rigidity than that of the outflow anchoring struts 160 and/or outflow connector struts 168, such that upon balloon inflation, as the less rigid portions of the inflow anchoring section 104 and outflow anchoring section 158 that include the inflow anchoring struts 106 and the outflow anchoring struts 160, respectively, assume an outwardly flared configuration, the following more rigid portions of the inflow section cells 1441 and the outflow section cells 1440 sufficiently resist expansion during initial stages of inflation, resulting in semi-spherical or ball-shaped configuration of the inflow anchoring section 104 and the outflow anchoring section 158.

[0257] While two rows of cells 144 are shown for both the inflow anchoring section 104¹ and/or outflow anchoring section 158¹, it is to be understood that any other number of cell rows is contemplated for each, and that each of the inflow anchoring section 104¹ and/or outflow anchoring section 158¹ can have a different number of cells 144 and differently shaped cells. Moreover, in some examples, only one of the inflow anchoring section 104¹ or outflow anchoring section 158‘ can include additional cells 144. Any of the cells 144 of an inflow anchoring section 104¹ and/or outflow anchoring section 158¹ can have various shapes and dimensions, including diamond-shaped cells, triangular cells, kite-shaped cells, hexagonal cells, and the like.

[0258] 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 radiation for use in sterilization include, without limitation, gamma radiation and ultra-violet radiation. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide and hydrogen peroxide.

Some Examples of the Disclosed Implementations

[0259] 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.

[0260] Example 1. A prosthetic valve comprising: a plastically-expandable frame movable between a radially compressed configuration and a radially expanded configuration, the frame defining a central axis and comprising: a primary frame section extending between inflow junctions and outflow junctions, the primary frame section comprising a plurality of angled struts; an inflow anchoring section coupled to the inflow junctions; and an outflow anchoring section coupled to the outflow junctions; wherein the inflow anchoring section and the outflow anchoring section are configured to maintain an unbent configuration in a free state thereof; and wherein the inflow anchoring section and the outflow anchoring section are configured to extend radially outwards relative to primary frame section upon inflation of a balloon over which the prosthetic valve is crimped.

[0261] Example 2. The prosthetic valve of any example herein, particularly of example 1, wherein the prosthetic valve is a balloon expandable valve.

[0262] Example 3. The prosthetic valve of any example herein, particularly of any one of examples 1 or 2, wherein the prosthetic valve is devoid of shape-memory materials.

[0263] Example 4. The prosthetic valve of any example herein, particularly of any one of examples 1 to 3, wherein the inflow anchoring section and the outflow anchoring section are less rigid than the primary frame section.

[0264] Example 5. The prosthetic valve of any example herein, particularly of any one of examples 1 to 4, wherein the inflow anchoring section and the outflow anchoring section are less resistant to radial bending than the primary frame section.

[0265] Example 6. The prosthetic valve of any example herein, particularly of any one of examples 1 to 5, wherein the inflow anchoring section, the outflow anchoring section, and the primary frame section are integrally formed.

[0266] Example 7. The prosthetic valve of any example herein, particularly of any one of examples 1 to 6, wherein, in the radially expanded configuration, the inflow anchoring section defines a non-zero inflow bending angle relative to the central axis of the frame.

[0267] Example 8. The prosthetic valve of any example herein, particularly of any one of examples 1 to 7, wherein, in the radially expanded configuration, the outflow anchoring section defines a non-zero inflow bending angle relative to the central axis of the frame.

[0268] Example 9. The prosthetic valve of any example herein, particularly of any one of examples 1 to 8, wherein the inflow anchoring section comprises a plurality of inflow anchoring struts arranged in a zig-zagged pattern extending between inflow peak portions which are farther from the primary frame section and opposing inflow valley portions, and wherein the outflow anchoring section comprises a plurality of outflow anchoring struts arranged in a zig-zagged pattern extending between outflow peak portions which are farther from the primary frame section and opposing outflow valley portions. [0269] Example 10. The prosthetic valve of any example herein, particularly of example 9, wherein, in the radially expanded configuration, the inflow peak portions collectively define a diameter that is greater than a diameter collectively defined by the inflow junctions.

[0270] Example 11. The prosthetic valve of any example herein, particularly of any one of examples 9 or 10, wherein, in the radially expanded configuration, the outflow peak portions collectively define a diameter that is greater than a diameter collectively defined by the outflow junctions.

[0271] Example 12. The prosthetic valve of any example herein, particularly of any one of examples 9 to 11, wherein at least some of the inflow valley portions are coupled to the inflow junctions.

[0272] Example 13. The prosthetic valve of any example herein, particularly of any one of examples 9 to 12, wherein the inflow valley portions comprise a plurality of attachment inflow valley portions which are coupled to the inflow junctions, and a plurality of free inflow valley portions which are not coupled to the primary frame section.

[0273] Example 14. The prosthetic valve of any example herein, particularly of example 13, wherein the inflow anchoring struts diverging from the attachment inflow valley portions are longer than the inflow anchoring stmts diverging from the free inflow valley portions.

[0274] Example 15. The prosthetic valve of any example herein, particularly of any one of examples 9 to 14, wherein at least some of the outflow valley portions are coupled to the outflow junctions.

[0275] Example 16. The prosthetic valve of any example herein, particularly of any one of examples 9 to 15, wherein the outflow valley portions comprise a plurality of attachment outflow valley portions which are coupled to the outflow junctions, and a plurality of free outflow valley portions which are not coupled to the primary frame section.

[0276] Example 17. The prosthetic valve of any example herein, particularly of examplel6, wherein the outflow anchoring stmts diverging from the attachment outflow valley portions are longer than the outflow anchoring stmts diverging from the free outflow valley portions.

[0277] Example 18. The prosthetic valve of any example herein, particularly of any one of examples 9 to 17, wherein the inflow valley portions comprise thinned stmt portions which are narrower than the inflow anchoring stmts.

[0278] Example 19. The prosthetic valve of any example herein, particularly of example 18, wherein the thinned stmt portions of the inflow valley portions are narrower than the angled stmts of the primary frame section. [0279] Example 20. The prosthetic valve of any example herein, particularly of any one of examples 9 to 19, wherein the inflow peak portions comprise thinned strut portions which are narrower than the inflow anchoring struts.

[0280] Example 21. The prosthetic valve of any example herein, particularly of any one of examples 9 to 20, wherein the outflow valley portions comprise thinned strut portions which are narrower than the outflow anchoring struts.

[0281] Example 22. The prosthetic valve of any example herein, particularly of any one of examples 21 , wherein the thinned strut portions of the outflow valley portions are narrower than the angled struts of the primary frame section.

[0282] Example 23. The prosthetic valve of any example herein, particularly of any one of examples 9 to 22, wherein the outflow peak portions comprise thinned strut portions which are narrower than the outflow anchoring struts.

[0283] Example 24. The prosthetic valve of any example herein, particularly of any one of examples 9 to 23, wherein the inflow anchoring struts are wider than the angled struts of the primary frame section.

[0284] Example 25. The prosthetic valve of any example herein, particularly of any one of examples 9 to 24, wherein the inflow anchoring stmts are thinner than the angled stmts of the primary frame section.

[0285] Example 26. The prosthetic valve of any example herein, particularly of any one of examples 9 to 25, wherein the outflow anchoring stmts are wider than the angled stmts of the primary frame section.

[0286] Example 27. The prosthetic valve of any example herein, particularly of any one of examples 9 to 26, wherein the outflow anchoring stmts are thinner than the angled stmts of the primary frame section.

[0287] Example 28. The prosthetic valve of any example herein, particularly of any one of examples 9 to 27, wherein the outflow anchoring section is longer than the inflow anchoring section.

[0288] Example 29. The prosthetic valve of any example herein, particularly of any one of examples 9 to 28, wherein the inflow anchoring section is longer than the outflow anchoring section.

[0289] Example 30. The prosthetic valve of any example herein, particularly of any one of examples 9 to 29, wherein the frame further comprises a plurality of inflow connector stmts connecting at least some of the inflow valley portions to the inflow junctions, and a plurality of outflow connector struts connecting at least some of the outflow valley portions to the outflow junctions.

[0290] Example 31. The prosthetic valve of any example herein, particularly of example 30, wherein the inflow connector struts are narrower than the inflow anchoring struts.

[0291] The prosthetic valve of claim 30 or 31, wherein the inflow connector struts are narrower than the angled struts of the primary frame section.

[0292] Example 33. The prosthetic valve of any example herein, particularly of any one of examples 30 to 32, wherein the outflow connector struts are narrower than the outflow anchoring struts.

[0293] Example 34. The prosthetic valve of any example herein, particularly of any one of examples 30 to 33, wherein the outflow connector struts are narrower than the angled struts of the primary frame section.

[0294] example 35. The prosthetic valve of any example herein, particularly of any one of examples 30 to 34, wherein the outflow connector struts are longer than the inflow connector struts.

[0295] Example 36. The prosthetic valve of any example herein, particularly of any one of examples 30 to 34, wherein the inflow connector struts are longer than the outflow connector struts.

[0296] Example 37. The prosthetic valve of any example herein, particularly of any one of examples 9 to 36, wherein the inflow anchoring struts are wider than the outflow anchoring struts.

[0297] Example 38. The prosthetic valve of any example herein, particularly of any one of examples 9 to 36, wherein the outflow anchoring struts are wider than the inflow anchoring struts.

[0298] Example 39. The prosthetic valve of any example herein, particularly of any one of examples 1 to 38, wherein the frame of the prosthetic valve is an inner frame, and wherein the prosthetic valve further comprises at least one tissue engagement frame attached to the inner frame.

[0299] Example 40. The prosthetic valve of any example herein, particularly of example 39, wherein the at least one tissue engagement frame is disposed around the inner frame.

[0300] Example 41. The prosthetic valve of any example herein, particularly of any one of examples 39 or 40, wherein the at least one tissue engagement frame comprises a plurality of tissue engagement struts. [0301] Example 42. The prosthetic valve of any example herein, particularly of example 41, wherein the at least one tissue engagement frame further comprises a plurality of spikes extending from the tissue engagement struts, the spikes configured to engage with tissue against which the prosthetic valve is expanded.

[0302] Example 43. The prosthetic valve of any example herein, particularly of any one of examples 9 to 38, wherein the frame of the prosthetic valve is an inner frame, wherein the prosthetic valve further comprises a first tissue engagement frame coupled to the inflow anchoring section, and a second tissue engagement frame coupled to the outflow anchoring section, and wherein each of the first tissue engagement frame and the second tissue engagement frame comprises a plurality of tissue engagement struts and a plurality of spikes extending from the tissue engagement struts.

[0303] Example 44. The prosthetic valve of any example herein, particularly of any one of examples 42 or 43, wherein the spikes are perpendicular to the tissue engagement struts they extend from.

[0304] Example 45. The prosthetic valve of any example herein, particularly of any one of examples 42 or 43, wherein the spikes extend from the tissue engagement struts they extend at an angle of 80-100 degrees.

[0305] Example 46. The prosthetic valve of any example herein, particularly of example 45, wherein the tissue engagement struts of the first tissue engagement frame extend in a zigzagged configuration between peaks and valleys of the first tissue engagement frame.

[0306] Example 47. The prosthetic valve of any example herein, particularly of example 46, wherein the tissue engagement struts of the first tissue engagement frame are aligned with the inflow anchoring struts.

[0307] Example 48. The prosthetic valve of any example herein, particularly of any one of examples 45 to 47, wherein the tissue engagement struts of the second tissue engagement frame extend in a zig-zagged configuration between peaks and valleys of the second tissue engagement frame.

[0308] Example 49. The prosthetic valve of any example herein, particularly of example 48, wherein the tissue engagement struts of the second tissue engagement frame are aligned with the outflow anchoring struts.

[0309] Example 50. The prosthetic valve of any example herein, particularly of any one of examples 1 to 49, wherein the angled struts of the primary frame section comprise inflow angled struts extending from the inflow junctions, outflow angled struts extending from the outflow junctions, and intermediate angled struts disposed between the inflow angled struts and the outflow angled struts.

[0310] Example 51. The prosthetic valve of any example herein, particularly of example 50, wherein the primary frame section comprises a plurality of inflow cells, each inflow cell defined by two inflow angled struts and two intermediate angled struts.

[0311] Example 52. The prosthetic valve of any example herein, particularly of example 51, wherein an angle defined between the two inflow angled struts of the inflow cell is greater than an angle defined between the two intermediate angled struts of the same inflow cell.

[0312] Example 53. The prosthetic valve of any example herein, particularly of any one of examples 51 to 52, wherein the intermediate angled struts are longer than the inflow angled struts.

[0313] Example 54. The prosthetic valve of any example herein, particularly of any one of examples 51 to 53, wherein the primary frame section further comprises a plurality of axial frame members.

[0314] Example 55. The prosthetic valve of any example herein, particularly of example 54, wherein the plurality of axial frame members comprises a plurality of non-commissural axial struts, and a plurality of commissure support members.

[0315] Example 56. The prosthetic valve of any example herein, particularly of any one of examples 55, wherein each of the commissure support members comprises a commissure window defining an opening between two adjacent sidewalls.

[0316] Example 57. The prosthetic valve of any example herein, particularly of any one of examples 54 to 56, wherein the axial frame members extend between the intermediate angled struts and the outflow angled struts.

[0317] Example 58. The prosthetic valve of any example herein, particularly of example 57, wherein the primary frame section comprises a plurality of outflow cells, each outflow cell defined by two intermediate angled struts, two axial frame members, and two outflow angled struts.

[0318] Example 59. The prosthetic valve of any example herein, particularly of example 58, wherein lengths of the intermediate angled struts and the outflow angled struts are equal.

[0319] Example 60. The prosthetic valve of any example herein, particularly of example 58 or 59, wherein the intermediate angled struts and the outflow angled struts are parallel to each other.

[0320] Example 61. The prosthetic valve of any example herein, particularly of any one of examples 58 to 60, wherein each outflow cell is parallelogram-shaped. [0321] Example 62. The prosthetic valve of any example herein, particularly of any one of examples 55 to 61, further comprising a valvular structure mounted inside the primary frame section and comprising a plurality of leaflets.

[0322] Example 63. The prosthetic valve of any example herein, particularly of example 62, wherein commissure tabs of adjacent leaflets are coupled to each other to form commissures attached to the commissure support members.

[0323] Example 64. The prosthetic valve of any example herein, particularly of example 63, wherein each of the leaflets comprises an inflow edge portion attached to the angled stmts of the primary frame section.

[0324] Example 65. The prosthetic valve of any example herein, particularly of any one of examples 1 to 64, further comprising an outer skirt disposed around the frame.

[0325] Example 66. The prosthetic valve of any example herein, particularly of example 65, wherein the outer skirt comprises a skirt inflow segment disposed around the inflow anchoring section, and an outflow anchoring segment disposed around the outflow anchoring section.

[0326] Example 67. The prosthetic valve of any example herein, particularly of example 66, wherein a skirt inflow end portion of the skirt inflow segment is attached to the inflow anchoring segment, and wherein a skirt outflow end portion of the skirt outflow segment is attached to the outflow anchoring segment.

[0327] Example 68. The prosthetic valve of any example herein, particularly of example 67, wherein a portion of the outer skirt extending between the skirt inflow end portion and the primary frame section is not attached to the frame, and wherein a portion of the outer skirt extending between the skirt outflow end portion and the primary frame section is not attached to the frame.

[0328] Example 69. The prosthetic valve of any example herein, particularly of example 67, wherein the portions of the outer skirt extending between the skirt inflow end portion and the primary frame section, and between the skirt outflow end portion and the primary frame section, are configured to extend radially away from the frame in the radially expanded configuration.

[0329] Example 70. The prosthetic valve of any example herein, particularly of any one of examples 67 to 69, wherein the outer skirt further comprises a skirt intermediate attachment portion which is attached to the primary frame section.

[0330] Example 71. The prosthetic valve of any example herein, particularly of any one of examples 1 to 70, wherein the inflow anchoring section comprises one or more rows of inflow section cells, and wherein the outflow anchoring section comprises one or more rows of outflow section cells.

[0331] Example 72. The prosthetic valve of any example herein, particularly of example 71, wherein the one or more rows of outflow section cells comprises a plurality of rows of outflow section cells.

[0332] Example 73. The prosthetic valve of any example herein, particularly of any one of examples 9 to 38, wherein the inflow anchoring section further comprises one or more rows of inflow section cells, and wherein the outflow anchoring section further comprises one or more rows of outflow section cells.

[0333] Example 74. The prosthetic valve of any example herein, particularly of example 73, wherein the one or more rows of inflow section cells comprises a first row of inflow section cells connected to the inflow peak portions.

[0334] Example 75. The prosthetic valve of any example herein, particularly of example 74, wherein the one or more rows of inflow section cells further comprises a second row of inflow section cells connected to the first row of inflow section cells.

[0335] Example 76. The prosthetic of any example herein, particularly of any one of examples 73 to 75, wherein the one or more rows of outflow section cells comprises a first row of outflow section cells connected to the outflow peak portions.

[0336] Example 77. The prosthetic valve of any example herein, particularly of example 76, wherein the one or more rows of outflow section cells further comprises a second row of outflow section cells connected to the first row of outflow section cells.

[0337] Example 78. The prosthetic valve of any example herein, particularly of any one of examples 73 to 77, wherein the one or more rows of inflow section cells are more rigid than the inflow anchoring struts.

[0338] Example 79. The prosthetic valve of any one of claims 73 to 78, wherein the one or more rows of outflow section cells are more rigid than the outflow anchoring struts.

[0339] Example 80. The prosthetic valve of any example herein, particularly of any one of examples 71 to 79, wherein the outflow anchoring section is configured to assume a ball-shaped configuration in the radially expanded configuration of the frame.

[0340] Example 81. The prosthetic valve of any example herein, particularly of any one of examples 71 to 80, wherein the inflow anchoring section is configured to assume a ball-shaped configuration in the radially expanded configuration of the frame.

[0341] Example 82. A method of forming a prosthetic valve, comprising: cutting a tube to form a frame of a prosthetic valve designed to expand to a range of working diameters, wherein the tube has diameter which is smaller than the diameter of a lower end of the working range of diameters; and attaching a plurality of leaflets to the frame at the diameter in which the frame is cut from the tube, thereby assembling the prosthetic valve; wherein, when the prosthetic valve is subjected to pulsating flow in a diameter within the range of working diameters, the plurality of leaflets are configured to transition between a closed state in which the leaflets coapt in a manner that prevents backflow therethrough, and an open state in which the leaflets are opened against the frame.

[0342] Example 83. The method of any example herein, particularly of example 82, wherein the tube comprises a plastically-deformable material.

[0343] Example 84. The method of any example herein, particularly of any one of examples 82 or 83, wherein the attaching the plurality of leaflets comprises attaching inflow edge portions of the leaflets to struts of the frame.

[0344] Example 85. The method of any example herein, particularly of example 84, wherein the maximal distance of each of the plurality of leaflets, between opposite ends of its inflow edge portion, is equal to or greater than the lower end of the working range of diameters.

[0345] Example 86. The method of any example herein, particularly of any one of examples 82 to 85, wherein the diameter of the tube is less than 90% of the lower end of the working range of diameters.

[0346] Example 87. The method of any example herein, particularly of any one of examples 82 to 85, wherein the diameter of the tube is less than 75% of the lower end of the working range of diameters.

[0347] Example 88. The method of any example herein, particularly of any one of examples 82 to 85, wherein the diameter of the tube is less than 66% of the lower end of the working range of diameters.

[0348] Example 89. The method of any example herein, particularly of any one of examples 82 to 85, wherein the diameter of the tube is a crimped diameter of the prosthetic valve.

[0349] Example 90. The method of any example herein, particularly of any one of examples 82 to 89, wherein the assembling the prosthetic valve further comprises attaching one or more skirts to the frame at the diameter in which the frame is cut from the tube. [0350] Example 91. The method of any example herein, particularly of any one of examples 82 to 90, wherein the leaflets are stretchable by at least 10% of their width in the circumferential direction.

[0351] Example 92. The method of any example herein, particularly of any one of examples 82 to 91, wherein the leaflets are made of tissue.

[0352] Example 93. The method of any example herein, particularly of example 92, wherein the tissue comprises bovine pericardium.

[0353] Example 94. The method of any example herein, particularly of any one of examples 82 to 93, wherein the frame comprises: a primary frame section extending between inflow junctions and outflow junctions, the primary frame section comprising a plurality of angled struts; an inflow anchoring section coupled to the inflow junctions; and an outflow anchoring section coupled to the outflow junctions.

[0354] Example 95. The method of any example herein, particularly of example 94, wherein the inflow anchoring section and the outflow anchoring section are configured to maintain an unbent configuration in a free state thereof, and wherein the inflow anchoring section and the outflow anchoring section are configured to extend radially outwards relative to primary frame section upon inflation of a balloon over which the prosthetic valve is crimped.

[0355] Example 96. The method of any example herein, particularly of any one of examples 94 or 95, wherein the inflow anchoring section and the outflow anchoring section are less rigid than the primary frame section.

[0356] Example 97. The method of any example herein, particularly of any one of examples 94 to 96, wherein the inflow anchoring section and the outflow anchoring section are less resistant to radial bending than the primary frame section.

[0357] Example 98. The method of any example herein, particularly of any one of examples 94 to 97, wherein the inflow anchoring section comprises a plurality of inflow anchoring struts arranged in a zig-zagged pattern extending between inflow peak portions which are farther from the primary frame section and opposing inflow valley portions, and a plurality of outflow anchoring struts arranged in a zig-zagged pattern extending between outflow peak portions which are farther from the primary frame section and opposing outflow valley portions.

[0358] Example 99. The method of any example herein, particularly of example 98, wherein the inflow valley portions comprise thinned strut portions which are narrower than the inflow anchoring struts. [0359] Example 100. The method of any example herein, particularly of example 99, wherein the thinned strut portions of the inflow valley portions are narrower than the angled struts of the primary frame section.

[0360] Example 101. The method of any example herein, particularly of any one of examples 98 to 100, wherein the inflow peak portions comprise thinned strut portions which are narrower than the inflow anchoring struts.

[0361] Example 102. The method of any example herein, particularly of any one of examples 98 to 101 , wherein the outflow valley portions comprise thinned strut portions which are narrower than the outflow anchoring struts.

[0362] Example 103. The method of any example herein, particularly of example 102, wherein the thinned strut portions of the outflow valley portions are narrower than the angled struts of the primary frame section.

[0363] Example 104. The method of any example herein, particularly of any one of examples 98 to 103, wherein the outflow peak portions comprise thinned strut portions which are narrower than the outflow anchoring struts.

[0364] Example 105. The method of any example herein, particularly of any one of examples 98 to 104, wherein the inflow anchoring stmts are wider than the angled stmts of the primary frame section.

[0365] Example 106. The method of any example herein, particularly of any one of examples 98 to 105, wherein the inflow anchoring stmts are thinner than the angled stmts of the primary frame section.

[0366] Example 107. The method of any example herein, particularly of any one of examples 98 to 106, wherein the outflow anchoring stmts are wider than the angled stmts of the primary frame section.

[0367] Example 108. The method of any example herein, particularly of any one of examples 98 to 107, wherein the outflow anchoring stmts are thinner than the angled stmts of the primary frame section.

[0368] Example 109. The method of any example herein, particularly of any one of examples 98 to 108, wherein the outflow anchoring section is longer than the inflow anchoring section.

[0369] Example 110. The method of any example herein, particularly of any one of examples 98 to 109, wherein the inflow anchoring section is longer than the outflow anchoring section.

[0370] Example 111. The method of any example herein, particularly of any one of examples 98 to 110, wherein the frame further comprises a plurality of inflow connector struts connecting at least some of the inflow valley portions to the inflow junctions, and a plurality of outflow connector struts connecting at least some of the outflow valley portions to the outflow junctions.

[0371] Example 112. The method of any example herein, particularly of example claim 111, wherein the inflow connector struts are narrower than the inflow anchoring struts.

[0372] Example 113. The method of any example herein, particularly of any one of examples 111 or 112, wherein the inflow connector struts are narrower than the angled struts of the primary frame section.

[0373] Example 114. The method of any example herein, particularly of any one of examples 111 to 113, wherein the outflow connector struts are narrower than the outflow anchoring struts.

[0374] Example 115. The method of any example herein, particularly of any one of examples 111 to 114, wherein the outflow connector struts are narrower than the angled struts of the primary frame section.

[0375] Example 116. The method of any example herein, particularly of any one of examples 111 to 115, wherein the outflow connector struts are longer than the inflow connector struts.

[0376] Example 117. The method of any example herein, particularly of any one of examples 111 to 115, wherein the inflow connector struts are longer than the outflow connector struts.

[0377] Example 118. The method of any example herein, particularly of any one of examples 111 to 116, wherein the inflow anchoring struts are wider than the outflow anchoring struts.

[0378] Example 119. The method of any example herein, particularly of any one of examples 111 to 116, wherein the outflow anchoring struts are wider than the inflow anchoring struts.

[0379] Example 120. The method of any example herein, particularly of any one of examples 94 to 119, wherein the angled struts of the primary frame section comprise inflow angled struts extending from the inflow junctions, outflow angled struts extending from the outflow junctions, and intermediate angled struts disposed between the inflow angled struts and the outflow angled struts.

[0380] Example 121. The method of any example herein, particularly of example 120, wherein the primary frame section comprises a plurality of inflow cells, each inflow cell defined by two inflow angled struts and two intermediate angled struts.

[0381] Example 122. The method of any example herein, particularly of example 121, wherein an angle defined between the two inflow angled struts of the inflow cell is greater than an angle defined between the two intermediate angled struts of the same inflow cell.

[0382] Example 123. The method of any example herein, particularly of any one of examples 120 to 122, wherein the intermediate angled struts are longer than the inflow angled struts. [0383] Example 124. The method of any example herein, particularly of any one of examples 120 to 123, wherein the primary frame section further comprises a plurality of axial frame members.

[0384] Example 125. The method of any example herein, particularly of example 124, wherein the plurality of axial frame members comprises a plurality of non-commissural axial struts, and a plurality of commissure support members.

[0385] Example 126. The method of any example herein, particularly of example 125, wherein the attaching the plurality of leaflets comprises attaching two commissure tabs of adjacent leaflets to each of the commissure support members.

[0386] Example 127. The method of any example herein, particularly of example 125, wherein each of the commissure support members comprises a commissure window defining an opening between two adjacent sidewalls.

[0387] Example 128. The method of any example herein, particularly of example 127, wherein the attaching the plurality of leaflets comprises extending two commissure tabs of adjacent leaflets through the opening of each of the commissure support members.

[0388] Example 129. The method of any example herein, particularly of any one of examples 125 to 128, wherein the axial frame members extend between the intermediate angled stmts and the outflow angled stmts.

[0389] Example 130. The method of any example herein, particularly of example 129, wherein the primary frame section comprises a plurality of outflow cells, each outflow cell defined by two intermediate angled stmts, two axial frame members, and two outflow angled struts.

[0390] Example 131. The method of any example herein, particularly of example 130, wherein lengths of the intermediate angled stmts and the outflow angled stmts are equal.

[0391] Example 132. The method of any example herein, particularly of any one of examples 130 or 131, wherein the intermediate angled stmts and the outflow angled stmts are parallel to each other.

[0392] Example 133. The method of any example herein, particularly of any one of examples 130 to 132, wherein each outflow cell is parallelogram-shaped.

[0393] Example 134. The method of any example herein, particularly of any one of examples 94 to 133, wherein the inflow anchoring section comprises one or more rows of inflow section cells, and wherein the outflow anchoring section comprises one or more rows of outflow section cells. [0394] Example 135. The method of any example herein, particularly of example 134, wherein the one or more rows of outflow section cells comprises a plurality of rows of outflow section cells.

[0395] Example 137. The method of any example herein, particularly of any one of examples 134 or 135, wherein the outflow anchoring section is configured to assume a ball-shaped configuration in the radially expanded configuration of the frame.

[0396] Example 137. The method of any example herein, particularly of any one of examples 134 to 136, wherein the inflow anchoring section is configured to assume a hall-shaped configuration in the radially expanded configuration of the frame.

[0397] 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.

[0398] 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

1. A prosthetic valve comprising: a plastically-expandable frame movable between a radially compressed configuration and a radially expanded configuration, the frame defining a central axis and comprising: a primary frame section extending between inflow junctions and outflow junctions, the primary frame section comprising a plurality of angled stmts; an inflow anchoring section coupled to the inflow junctions; and an outflow anchoring section coupled to the outflow junctions; wherein the inflow anchoring section and the outflow anchoring section are configured to maintain an unbent configuration in a free state thereof; and wherein the inflow anchoring section and the outflow anchoring section are configured to extend radially outwards relative to primary frame section upon inflation of a balloon over which the prosthetic valve is crimped.

2. The prosthetic valve of claim 1, wherein the prosthetic valve is a balloon expandable valve.

3. The prosthetic valve of claim 1 or 2, wherein the prosthetic valve is devoid of shape- memory materials.

4. The prosthetic valve of any one of claims 1 to 3, wherein, in the radially expanded configuration, the inflow anchoring section defines a non-zero inflow bending angle relative to the central axis of the frame.

5. The prosthetic valve of any one of claims 1 to 4, wherein, in the radially expanded configuration, the outflow anchoring section defines a non-zero inflow bending angle relative to the central axis of the frame.

6. The prosthetic valve of any one of claims 1 to 5, wherein the inflow anchoring section comprises a plurality of inflow anchoring stmts arranged in a zig-zagged pattern extending between inflow peak portions which are farther from the primary frame section and opposing inflow valley portions, and wherein the outflow anchoring section comprises a plurality of outflow anchoring stmts arranged in a zig-zagged pattern extending between outflow peak portions which are farther from the primary frame section and opposing outflow valley portions.

7. The prosthetic valve of claim 6, wherein, in the radially expanded configuration, the inflow peak portions collectively define a diameter that is greater than a diameter collectively defined by the inflow junctions.

8. The prosthetic valve of claim 6 or 7, wherein, in the radially expanded configuration, the outflow peak portions collectively define a diameter that is greater than a diameter collectively defined by the outflow junctions.

9. The prosthetic valve of any one of claims 6 to 8, wherein the inflow valley portions comprise a plurality of attachment inflow valley portions which are coupled to the inflow junctions, and a plurality of free inflow valley portions which are not coupled to the primary frame section.

10. The prosthetic valve of any one of claims 6 to 9, wherein the outflow valley portions comprise a plurality of attachment outflow valley portions which are coupled to the outflow junctions, and a plurality of free outflow valley portions which are not coupled to the primary frame section.

11. The prosthetic valve of any one of claims 6 to 10, wherein the frame further comprises a plurality of inflow connector struts connecting at least some of the inflow valley portions to the inflow junctions, and a plurality of outflow connector struts connecting at least some of the outflow valley portions to the outflow junctions.

12. The prosthetic valve of any one of claims 1 to 11, wherein the frame of the prosthetic valve is an inner frame, and wherein the prosthetic valve further comprises at least one tissue engagement frame attached to the inner frame.

13. The prosthetic valve of claim 12, wherein the at least one tissue engagement frame is disposed around the inner frame.

14. The prosthetic valve of claim 12 or 13, wherein the at least one tissue engagement frame comprises a plurality of tissue engagement struts, and wherein the at least one tissue engagement frame further comprises a plurality of spikes extending from the tissue engagement struts, the spikes configured to engage with tissue against which the prosthetic valve is expanded.

15. The prosthetic valve of any one of claims 1 to 14, wherein the inflow anchoring section comprises one or more rows of inflow section cells, and wherein the outflow anchoring section comprises one or more rows of outflow section cells.

16. The prosthetic valve of claim 15, wherein the outflow anchoring section is configured to assume a ball- shaped configuration in the radially expanded configuration of the frame.

17. The prosthetic valve of any one of claims 15 to 16, wherein the inflow anchoring section is configured to assume a ball-shaped configuration in the radially expanded configuration of the frame.

18. A method of forming a prosthetic valve, comprising: cutting a tube to form a frame of a prosthetic valve designed to expand to a range of working diameters, wherein the tube has diameter which is smaller than the diameter of a lower end of the working range of diameters; and attaching a plurality of leaflets to the frame at the diameter in which the frame is cut from the tube, thereby assembling the prosthetic valve; wherein, when the prosthetic valve is subjected to pulsating flow in a diameter within the range of working diameters, the plurality of leaflets are configured to transition between a closed state in which the leaflets coapt in a manner that prevents backflow therethrough, and an open state in which the leaflets are opened against the frame.

19. The method of claim 18, wherein the tube comprises a plastically-deformable material.

20. The method of claim 18 or 19, wherein the attaching the plurality of leaflets comprises attaching inflow edge portions of the leaflets to struts of the frame.

21. The method of any one of claims 18 to 20, wherein the frame comprises: a primary frame section extending between inflow junctions and outflow junctions, the primary frame section comprising a plurality of angled struts; an inflow anchoring section coupled to the inflow junctions; and an outflow anchoring section coupled to the outflow junctions.

22. The method of claim 21, wherein the inflow anchoring section and the outflow anchoring section are configured to maintain an unbent configuration in a free state thereof, and wherein the inflow anchoring section and the outflow anchoring section are configured to extend radially outwards relative to primary frame section upon inflation of a balloon over which the prosthetic valve is crimped.