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WO2025194032A1 - Prothèses valvulaires - Google Patents

Prothèses valvulaires

Info

Publication number
WO2025194032A1
WO2025194032A1 PCT/US2025/019926 US2025019926W WO2025194032A1 WO 2025194032 A1 WO2025194032 A1 WO 2025194032A1 US 2025019926 W US2025019926 W US 2025019926W WO 2025194032 A1 WO2025194032 A1 WO 2025194032A1
Authority
WO
WIPO (PCT)
Prior art keywords
subsequent
outflow
rung
prosthetic valve
frame
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/019926
Other languages
English (en)
Inventor
Anatoly Dvorsky
Elena Sherman
Tamir S. LEVI
Eran GROSU
Venkateswaran SHANMUGAM
Christine Uyen Dang
Bich Hoang PHAM
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Edwards Lifesciences Corp
Original Assignee
Edwards Lifesciences Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Publication of WO2025194032A1 publication Critical patent/WO2025194032A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents

Definitions

  • the present disclosure relates to implantable, radially expandable prosthetic devices, such as prosthetic valves, and in particular, to frames and valvular structures of prosthetic valves.
  • Native heart valves such as the aortic, pulmonary and mitral valves, function to assure adequate directional flow from and to the heart, and between the heart's chambers, to supply blood to the whole cardiovascular system.
  • Various valvular diseases can render the valves ineffective and require replacement with artificial valves.
  • Surgical procedures can be performed to repair or replace a heart valve.
  • Surgeries are prone to an abundance of clinical complications, hence alternative less invasive techniques of delivering a prosthetic heart valve over a catheter and implanting it over the native malfunctioning valve, have been developed over the years.
  • Different types of prosthetic heart valves are known to date, including balloon expandable valve, self-expandable valves and mechanically-expandable valves.
  • Different methods of delivery and implantation are also known, and may vary according to the site of implantation and the type of prosthetic valve.
  • One exemplary technique includes utilization of a delivery assembly for delivering a prosthetic valve in a crimped state, from an incision which can be located at the patient's femoral or iliac artery, towards the native malfunctioning valve. Once the prosthetic valve is properly positioned at the desired site of implantation, it can be expanded against the surrounding anatomy, such as an annulus of a native valve, and the delivery assembly can be retrieved thereafter.
  • Described herein are prosthetic valves and method of manufacturing of at least some components of the prosthetic valves, such as valvular structures configured to be mounted inside frames of the prosthetic valves and method of manufacturing, assembling and/or attaching the valvular structures to the frames.
  • a prosthetic valve comprising a frame movable between a radially compressed configuration and a radially expanded configuration, and a valvular structure coupled to the frame.
  • the frame comprises an outflow rung comprising outflow angled struts defining a plurality of outflow apices, a first subsequent rung distal to the outflow rung and comprising first subsequent angled struts, a second subsequent rung distal to the first subsequent rung and comprising second subsequent angled struts, a third subsequent rung distal to the second subsequent rung and comprising third subsequent angled struts, and an inflow rung distal to the third subsequent rung and comprising inflow angled struts defining a plurality of inflow apices.
  • the frame further comprises a plurality of axial frame members extending between the outflow rung and the first subsequent rung, and a plurality of commissure posts extending proximally from the outflow rung.
  • the valvular structure comprises a plurality of leaflets configured to regulate flow through the prosthetic valve.
  • the first subsequent angled struts, the second subsequent angled struts, and the third subsequent angled struts have equal lengths.
  • the plurality of subsequent rungs comprises a first subsequent rung comprising a plurality of first subsequent angled struts.
  • the free apices are aligned with the outflow apices.
  • the frame further comprises a plurality of axial frame members extending between the outflow rung and the first subsequent rung, and a plurality of commissure posts extending proximally from the outflow rung.
  • the frame further comprises a plurality of vertical stabilization struts extending distally from the outflow apices, and a plurality of pairs of angled stabilization struts, each pair of angled stabilization struts diverging from a corresponding one of the vertical stabilization struts towards inflow end portions of the axial frame members disposed on both ends of the corresponding vertical stabilization strut.
  • the vertical stabilization struts are aligned with the free apices.
  • the outflow angled struts are longer than the first subsequent angled struts.
  • the outflow angled struts are longer than any of the subsequent angled struts.
  • the angled stabilization struts are longer than any of the subsequent angled struts.
  • each first outflow sub-cell is defined between an outflow angled strut, an angled stabilization strut, an axial frame member, and a vertical stabilization strut. [0037] In some examples, each first outflow sub-cell is parallelogram-shaped.
  • each second outflow sub-cell is defined between two angled stabilization struts and four subsequent angled struts of the first subsequent rung.
  • each second outflow sub-cell spans a width of two of the first outflow sub-cells.
  • the plurality of subsequent rungs further comprises a second subsequent rung distal to the first subsequent rung and comprising second subsequent angled struts.
  • the plurality of subsequent rungs further comprises a third subsequent rung distal to the second subsequent rung and comprising third subsequent angled struts.
  • the frame further comprises a plurality of first subsequent cells defined between the first subsequent rung and the second subsequent rung.
  • each first subsequent cell is a diamond-shaped cell defined between two first subsequent angled struts of the first subsequent rung and two second subsequent angled struts.
  • each second outflow sub-cell spans a width of two of the first subsequent cells.
  • the frame comprises an outflow cell row comprising a plurality of outflow cells.
  • each outflow cell defined by two of the outflow angled struts, two of the axial frame members, two of the first subsequent angled struts, and two of the second subsequent angled struts.
  • each outflow cell spans a width of two of the first subsequent cells.
  • the frame comprises a second subsequent cell row comprising a plurality of second subsequent cells defined between the second subsequent rung and the third subsequent rung.
  • the first cell row is a discontinuous cell row.
  • the first subsequent rung is a discontinuous rung.
  • the first subsequent rung comprises pairs of the first subsequent angled struts which are circumferentially spaced from each other.
  • each pair of the first subsequent angled struts is connected to a corresponding one of the axial frame members.
  • the first subsequent cells are circumferentially spaced from each other.
  • each outflow cell is defined by two of the outflow angled struts, two of the axial frame members, two of the first subsequent angled struts, and two of the second subsequent struts.
  • each first subsequent cell is defined by two first subsequent angled struts and two second subsequent angled struts.
  • the first subsequent angled struts are longer than the second subsequent angled struts.
  • the first subsequent angled struts are two times longer than the second subsequent angled struts.
  • the frame further comprises a plurality of pairs of curved stabilization struts, each pair of curved stabilization struts diverging from an upper junction of the first subsequent rung of the plurality of subsequent rungs, towards axial frame members at both sides of the corresponding upper junction.
  • the upper junctions from which the pairs of curved stabilization struts diverge are circumferentially aligned with the outflow apices.
  • the frame further comprises a plurality of first outflow sub-cells and a plurality of second outflow sub-cells, disposed between the outflow rung and the first subsequent rung.
  • each first outflow sub-cell is defined between a pair of outflow angled strut and a pair of curved stabilization struts.
  • each second outflow sub-cell is defined by a pair of first subsequent angled struts, one curved stabilization strut, and at least a portion of an axial frame member extending proximally from the first subsequent rung.
  • each first outflow sub-cell spans a width of two of the second outflow sub-cells.
  • each first outflow sub-cell spans a width of two of the first subsequent cells.
  • the frame further comprises a plurality of struts extending from intermediate junctions of first subsequent angled struts of the first subsequent rung.
  • the struts extending from first subsequent angled struts are disposed between the first subsequent rung and the second subsequent rung.
  • the intermediate junctions are defined at positions between lower junctions and upper junctions of the first subsequent rung.
  • the struts extending from the intermediate junctions define a plurality of distally-oriented free apices circumferentially aligned with the upper junctions of the first subsequent rung.
  • At least some of the distally-oriented free apices are circumferentially aligned with the axial frame members.
  • the frame further comprises a plurality of first subsequent minor sub-cell and a plurality of a first subsequent major sub-cell, disposed between the first subsequent rung and the second subsequent rung.
  • the first subsequent major sub-cell are distal to the first subsequent minor sub-cell.
  • the first subsequent major sub-cells are wider than the first subsequent minor sub-cell.
  • the first subsequent minor sub-cell are circumferentially spaced from each other.
  • the plurality of struts extending from the intermediate junctions comprises a plurality of arched struts, and the plurality of distally-oriented free apices comprises a plurality of inner arcuate regions.
  • the arched struts are proximally concaved.
  • the first subsequent angled struts are wider than the second subsequent angled struts.
  • the plurality of subsequent rungs further comprises an inflow rung distal to all other subsequent rungs, and comprising inflow angled struts.
  • the frame further comprises an inflow cell row comprising a plurality of inflow cells.
  • each outflow cell is defined between two outflow angled struts, portions of two axial frame members extending between the outflow rung and the first subsequent rung, and four first subsequent angled struts.
  • the axial frame members are connected to the outflow rung and all of the subsequent rungs.
  • the plurality of free apices of the first subsequent rung comprises two free apices disposed between each two circumferentially adjacent axial frame members.
  • the inflow angled struts are longer than any of the first subsequent angled struts and the second subsequent angled struts.
  • the frame further comprises an inflow cell row comprising a plurality of inflow cells, and wherein each inflow cell spans a width of two of the first subsequent cells.
  • the inflow cells and the outflow cells have equal widths.
  • each second subsequent cell spans a width of two of the first subsequent cells.
  • each second subsequent cell is defined between four second subsequent angled struts, portions of two axial frame members extending between the second subsequent rung and the third subsequent rung, and four third subsequent angled struts.
  • the second subsequent rung and the third subsequent ruing are parallel to each other.
  • the third subsequent rung and the inflow rung are parallel to each other.
  • each inflow cell is a diamond- shaped cell defined between two third subsequent angled struts and two inflow angled struts.
  • a prosthetic valve comprising a frame formed at a frame cutting diameter and movable between the frame cutting diameter to a radially compressed configuration defining a smaller diameter than the frame cutting diameter, and from the compressed configuration to a radially expanded configuration defining a diameter that is greater than the frame cutting diameter.
  • the frame comprises a plurality of rungs of angled struts, defining a plurality of cell rows.
  • Each cell row comprises a plurality of diamond-shaped cells.
  • an angle defined between angled struts of any of the diamond- shaped cells, in the frame cutting diameter is not greater than 120°.
  • the angle defined between angled struts of any of the diamondshaped cells, in the frame cutting diameter is not greater than 1 10°.
  • the prosthetic valve further comprises an outflow cell row comprising a plurality of outflow cells proximal to the rungs of angled struts.
  • the frame further comprises a plurality of commissure posts extending proximally from the outflow rung.
  • each of the axial frame members comprises at least one region defining a thinned width that does not exceed 0.5 mm.
  • the inflow end portion of at least one of the axial frame members comprises a thinned region defining the thinned width.
  • the outflow end portion of at least one of the axial frame members a thinned region defining the thinned width.
  • a prosthetic valve comprising a frame movable between a radially compressed configuration and a radially expanded configuration.
  • the frame comprises an outflow rung comprising outflow angled struts defining a plurality of outflow apices, and a plurality of subsequent rungs distal to the outflow rung.
  • Each subsequent rung comprises a plurality of subsequent angled struts.
  • the frame further comprises a plurality of axial frame members extending between the outflow rung and a first subsequent rung of the plurality of subsequent rungs.
  • the plurality of axial frame members comprise a plurality of axial post struts and a plurality of axial support members.
  • the frame further comprises a plurality of commissure posts extending proximally from the outflow rung.
  • the axial post struts are circumferentially aligned with the commissure posts.
  • each of the axial support members comprises at least one opening.
  • each of the axial support members defines outer edges which are linear along at least 50% of the height of the axial support member.
  • the prosthetic valve further comprises protective covering members attached to the axial support members.
  • the protective covering members are disposed over an inner surface of the axial support members.
  • each axial support member comprises at least two openings.
  • the axial post struts and the axial support members are alternately arranged around the circumference of the frame.
  • At least some of the axial frame members comprise an upper opening and a lower opening.
  • the combined shape of the upper opening and the lower opening is different between at least some of the axial frame members.
  • the plurality of axial post struts comprises three axial post struts
  • the plurality of axial support members comprises three axial support members
  • the axial frame members comprising the upper openings and the lower openings are the axial support members.
  • the upper and lower openings of the axial support members are D- shaped.
  • the axial support members comprise a first axial support member having its upper opening and lower opening oriented in opposite directions relative to each other, a second axial support member having its upper opening and lower opening aligned with each other, and a third axial support member having its upper opening and lower opening aligned with each other and oriented in a direction opposite to the openings of the second axial support member.
  • a prosthetic valve comprising a frame movable between a radially compressed configuration and a radially expanded configuration, and a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.
  • the frame comprises an outflow rung comprising outflow angled struts defining a plurality of outflow apices, and a plurality of subsequent rungs distal to the outflow rung. Each subsequent rung comprising a plurality of subsequent angled struts.
  • the valvular structure comprises a plurality of leaflets configured to regulate flow through the prosthetic valve.
  • the frame further comprises a plurality of axial frame members extending between the outflow rung and a first subsequent rung of the plurality of subsequent rungs.
  • the frame further comprises a plurality of commissure posts extending proximally from the outflow rung.
  • each commissure post comprises a slot.
  • the valvular structure defines a plurality of commissure attachment regions between adjacent leaflets.
  • the commissure attachment regions form commissures coupled to the commissure posts.
  • the valvular structure is a one-piece material.
  • each commissure support region is folded so as to form a commissure region fold disposed on an inner surface of the corresponding commissure post and secured thereto.
  • each commissure further comprises a fold stitch line formed along the commissure region fold and comprising plurality of loops extending radially outwards.
  • each commissure further comprises stitches extending through the patch fold and passed through the loops of the fold stitch line.
  • the prosthetic valve further comprises an in-and-out stitch line extending through the commissure region side portions.
  • each commissure further comprises, for each side of the commissure, a side stitch line formed along the commissure region side portion and comprising plurality of loops extending towards the corresponding patch portion.
  • each commissure further comprises, for each side of the commissure, stitches extending through the patch portion and passed through the loops of the side stitch line.
  • the commissure support regions comprise commissure slots defining commissure tabs extending radially outwards along sidewalls of the commissure posts.
  • two of the commissure tabs are wrapped around each of the commissure posts.
  • the commissure tabs disposed around each commissure post are coupled to each other.
  • the valvular structure further comprises sub-commissure slots defining sub-commissure tabs below the commissure attachment regions.
  • two of the sub-commissure tabs are wrapped around each of a corresponding one of the axial frame members.
  • each two of the sub-commissure tabs disposed around a corresponding one of the axial frame members are coupled to each other.
  • the frame comprises an inflow section extending proximally from an inflow end of the frame, an outflow section extending distally from an outflow of the frame, and a transition section between the inflow section and the outflow section of the frame, wherein the outflow section of the frame has a larger diameter than that of the inflow section of the frame, in the expanded configuration of the frame.
  • the valvular structure comprises an inflow section aligned with the inflow section of the frame, an outflow section aligned with the outflow section of the frame, and a transition section between the inflow section and the outflow section of the valvular structure, wherein the outflow section of the valvular structure has a larger cross section than that of the inflow section of the valvular structure, in the expanded configuration of the frame.
  • the plurality of axial frame members comprises a plurality of axial post struts and a plurality of axial support members.
  • the axial post struts are circumferentially aligned with the commissure posts.
  • the axial post struts and the axial support members are alternately arranged around the circumference of the frame.
  • each axial post strut further comprises one or more grooves on each of outer edge thereof.
  • the valvular structure is further coupled to the axial post struts by one or more sutures extending through the valvular structure and wrapped along the grooves over the axial post struts.
  • the groove is sized to receive the suture extending therealong in a manner that prevents axial displacement of the suture out of the groove.
  • corresponding grooves on both sides of the axial post struts are axially aligned with each other.
  • the one or more grooves comprise a plurality of grooves formed on each outer edge of the axial post strut.
  • Fig. 1A is a perspective side view of an exemplary prosthetic valve.
  • Fig. IB is a perspective view of an annular frame of the prosthetic valve of Fig. 1A.
  • Fig. 1C is a flattened view of the frame of Fig. IB.
  • Fig. 2 shows a portion of an exemplary prosthetic valve having an inflow rung that includes regular and elongated angled struts.
  • Fig. 3 shows a portion of an exemplary prosthetic valve having hexagonal inflow cells.
  • Fig. 4 shows an example of a distorted frame following crimping and expansion thereof.
  • Fig. 5 shows a portion of an exemplary frame having vertical and angled stabilization struts.
  • Figs. 6A and 6B show an exemplary frame having diamond-shaped cells defining a maximal threshold angle between angled struts, in a frame cutting diameter and compressed configuration of the frame, respectively.
  • Fig. 7A is a side view of an exemplary prosthetic valve that includes protective covering members.
  • Fig. 7B is a perspective view of the frame of the prosthetic valve of Fig. 7A, with protective covering members disposed over an inner side of axial support members thereof.
  • Fig. 7C is a flattened view of the frame of Fig. 7B.
  • FIG. 8 shows a portion of an exemplary frame having thinned regions along an axial support strut and defining linear outer edges along an axial support member.
  • Fig. 9 shows a portion of an exemplary frame having a rectangularly-shaped axial support member.
  • Fig. 10 shows a portion of an exemplary frame having an axial support member with differently shaped openings.
  • Figs. 11 A- 11C show three axial support members that include differently shaped combinations of upper and lower openings.
  • Figs. 12A-12C show three axial post struts that include differently shaped combinations of upper and lower openings.
  • Fig. 13A shows a 3D-shaped patch.
  • Fig. 13B shows an optional step in a method for forming a tubular valvular structure by rolling the 3D-shaped patch.
  • Fig. 13C shows an exemplary valvular structure that includes an engagement portion.
  • Fig. 14 shows a top view of an exemplary prosthetic valve.
  • Fig. 15 is a perspective view of a portion of a prosthetic valve that includes an exemplary commissure.
  • Fig. 16 is a cross-sectional view of the commissure of Fig. 15.
  • Fig. 17 is a cross-sectional view of an exemplary commissure that includes a reinforcement member in the form of a strip of fabric.
  • Fig. 18 is a cross-sectional view of an exemplary commissure that includes a reinforcement member in the form of a thick suture.
  • Figs. 19A-19D show some optional stages in exemplary methods of forming exemplary commissures.
  • Fig. 24 shows the valvular structure of Fig. 23.
  • Figs. 25A-25B show exemplary frames having discontinuous first subsequent cell rows.
  • Fig. 26 shows a portion of an exemplary frame having outflow angled struts defining inflection points.
  • Fig. 28 shows a portion of an exemplary frame having arched struts extending from intermediate junctions of the first subsequent angled struts.
  • Fig. 29 shows a portion of an exemplary frame having widened first subsequent angled struts.
  • Figs. 30-32 are flattened views of exemplary frames having axial frame members extending from the outflow rung to the inflow rung.
  • Fig. 33 is a perspective view of an exemplary frame having axial frame members formed with grooves along their outer edges.
  • Fig. 34 is a perspective view of a portion of a prosthetic valve that includes subcommissure portion of the valvular structure sutured to an axial post strut of the frame of Fig. 33.
  • 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.
  • 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.
  • Figs. 1A and IB show perspective views of an example of a prosthetic valve 100, with and without soft components (such as skirts and a valvular structure), respectively.
  • 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.
  • the prosthetic valves can be crimped on or retained by an implant delivery apparatus (not shown) in the radially compressed state during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site.
  • the expanded state may include a range of diameters to which the valve may expand, between the compressed state and a maximal diameter reached at a fully expanded state.
  • 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 100 of the current disclosure may include any prosthetic valve configured to be mounted within the native aortic valve, the native mitral valve, the native pulmonary valve, and the native tricuspid valve.
  • Balloon expandable valves generally involve a procedure of inflating a balloon within a prosthetic valve, thereby expanding the prosthetic valve within the desired implantation site. Once the valve is sufficiently expanded, the balloon is deflated and retrieved along with a delivery apparatus.
  • Self-expandable valves include a frame that is shape-set to automatically expand as soon an outer retaining shaft or capsule (not shown) is withdrawn proximally relative to the prosthetic valve.
  • Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion.
  • the mechanical actuation mechanism usually includes a plurality of expansion and locking assemblies (such as the prosthetic valves described in U.S. Patent No. 10,603,165, International Application No. PCT/US2021/052745, and U.S. Provisional Application Nos. 63/085,947 and 63/209904, each of which is incorporated herein by reference in its entirety), releasably coupled to respective actuation assemblies of a delivery apparatus, controlled via a handle (not shown) for actuating the expansion and locking assemblies to expand the prosthetic valve to a desired diameter.
  • expansion and locking assemblies such as the prosthetic valves described in U.S. Patent No. 10,603,165, International Application No. PCT/US2021/052745, and U.S. Provisional Application Nos. 63/085,947 and 63/209904, each of which is incorporated herein by reference in its entirety
  • the expansion and locking assemblies may optionally lock the valve's diameter to prevent undesired recompression thereof, and disconnection of the actuation assemblies from the expansion and locking assemblies, to enable retrieval of the delivery apparatus once the prosthetic valve is properly positioned at the desired site of implantation.
  • the prosthetic valve 100 comprises an inflow end 106 and an outflow end 104.
  • the inflow end 106 is the distal end of the prosthetic valve 100
  • the outflow end 104 is the proximal end of the prosthetic valve 100.
  • the inflow end can be the proximal end of the prosthetic valve
  • the outflow end can be the distal end of the prosthetic valve.
  • outflow refers to a region of the prosthetic valve through which the blood flows through and out of the prosthetic valve 100.
  • inflow refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve 100.
  • the frame 102 When constructed of a plastically-deformable materials, the frame 102 can be crimped to a radially compressed state on a balloon catheter (not shown), and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism.
  • the frame 102 can be made of shape-memory materials such as, but not limited to, nickel-titanium alloy (e.g., Nitinol).
  • the frame 102 is an annular, stent-like structure comprising a plurality of intersecting struts 110.
  • strut encompasses vertical struts, angled or curved struts, support posts, commissure windows, and any similar structures described by U.S. Pat. Nos. 7,993,394 and 9,393,110, which are incorporated herein by reference.
  • a strut 110 may be any elongated member or portion of the frame 102.
  • the frame 102 can include a plurality of strut rungs 114 that can collectively define a plurality of cells 144 arranged in several cell rows 146.
  • the frame 102 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 106 to the outflow end 104 as shown, or the frame can vary in diameter along the height of the frame, as disclosed in US Pat. No. 9,155,619, which is incorporated herein by reference.
  • Two or more struts 110 can intersect at junctions 151, which can be equally or unequally spaced apart from each other.
  • the struts 110 may be pivotable or bendable relative to each other, so as to permit frame expansion or compression.
  • the frame 102 can be formed from a single piece of material, such as a metal tube, via various processes such as, but not limited to, laser cutting, electroforming, and/or physical vapor deposition, while retaining the ability to collapse/expand radially in the absence of hinges and like.
  • Figs. 1A-1C show an exemplary prosthetic valve 100 that can be representative of, but is not limited to, a balloon expandable prosthetic valve.
  • the struts 110 comprise angled struts 112 and axial frame members 116.
  • the term "axial frame member” refers to a strut or a component of the frame 102 that generally extends in an axial direction
  • 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.
  • the frame 102 can further comprise a plurality of outflow apices 148 at the outflow end 104 of the frame, and a plurality of inflow apices 150 at the inflow end 106 of the frame.
  • a plurality of intermediate junctions 151 are disposed between the inflow end 106 and outflow end 104.
  • the frame 102 further comprises an outflow cell row 1460 of outflow cells 1440 at the outflow end 104 of the frame, and a plurality of subsequent cell rows 146S distal to the outflow cell row 1460, each comprising a plurality of subsequent cells 144S.
  • the distal-most cell row at the inflow end 106 of the frame can be also referred to as an inflow cell row 1461 comprising a plurality of inflow cells 1441.
  • prosthetic valve 100 and/or components thereof can be referred to, throughout the specification, with superscripts, for ease of explanation of features that refer to such exemplary implementations. It is to be understood, however, that any reference to structural or functional features of any device, apparatus or component, without a superscript, refers to these features being commonly shared by all specific exemplary implementations that can be also indicated by superscripts. In contrast, features emphasized with respect to an exemplary implementation of any device, apparatus or component, referred to with a superscript, may be optionally shared by some but not necessarily all other exemplary implementations. For example, a prosthetic valve 100 a , illustrated in Figs.
  • FIG. 1A-1C 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 a of the prosthetic valve 100 a comprises five subsequent rungs 114 distal to the outflow rung 1140, defining four subsequent cells rows 146 distal to the outflow cell row 1460.
  • frame 102 a is shown to include a first subsequent rung 114S1 distal to the outflow rung 1140 and comprising subsequent angled struts 112S 1 , a second subsequent rung 114S2 distal to the first subsequent rung 114S1 and comprising subsequent angled struts 112S2, a third subsequent rung 114S3 distal to the second subsequent rung 114S2 and comprising subsequent angled struts 112S3, a fourth subsequent rung 114S4 distal to the third subsequent rung 114S3 and comprising subsequent angled struts 112S4, and an inflow rung 1141 distal to the fourth subsequent rung 114S4 and comprising inflow angled struts 1121.
  • frame 102 a is shown to include a first subsequent cell row 146S1 distal to the outflow cell row 1460 and comprising subsequent cells 144S 1, a second subsequent cell row
  • a frame 102 of a prosthetic valve 100 can include a plurality of axial frame members 116 vertically extending between the outflow rung 1140 of angled struts 1120, and the first or proximal-most subsequent rung 114S1 of angled struts 112S1.
  • the upper end portions of the outflow angled struts 1120 of the outflow rung 1140 are forming the outflow apices 148 at or proximate to the outflow end 104, and end portions of the inflow angled struts 1121 of the distal inflow rung 1141 are forming the inflow apices 150 at the inflow end 106.
  • the outflow angled struts 1120 of the outflow rung 1140 are further connected to axial frame members 116 at lower junctions 15 IL which are distal to the outflow apices 148, such that the outflow angled struts 1120 circumferentially extend in a zig-zagged formation between the outflow apices 148 and the lower junctions 151L of the outflow rung 1140.
  • the struts of each of the subsequent rungs 114S can also extend circumferentially in a zig-zagged formation between upper junctions 151U and lower junctions 15 IL thereof.
  • the first subsequent rung 114S1 can further define a plurality of free apices 152 which are circumferentially aligned with the outflow apices 148.
  • Free apices 152 are defined as apices of the first subsequent rung 114S1 which are not attached to any other struts 110 other than the first subsequent angled struts 112S1 of the first subsequent rung 114S1.
  • the remainder of the upper junctions 151U of the first subsequent rung 114S1, which are not free apices 152, can be further connected to axial frame members 116 extending proximally therefrom.
  • Each axial frame member 116 can have an outflow end portion 118 at which the axial frame member 1 16 is linked to outflow angled struts 1 120 of the outflow rung 1140, and an inflow end portion 120 at which the axial frame member 116 is linked to first subsequent angled struts 112S1 of the first subsequent rung 114S1.
  • the valvular structure 156 can include a plurality of leaflets 160 (e.g., three leaflets), positioned at least partially within the frame 102, and configured to regulate flow of blood through the prosthetic valve 100 from the inflow end 106 to the outflow end 104. While three leaflets 160 arranged to collapse in a tricuspid arrangement, are shown in the example illustrated in Fig. 1A, it will be clear that a prosthetic valve 100 can include any other number of leaflets 160. Adjacent leaflets 160 can be arranged together to form commissures 192 that are coupled (directly or indirectly) to respective portions of the frame 102, thereby securing at least a portion of the valvular structure 156 to the frame 102.
  • commissures 192 that are coupled (directly or indirectly) to respective portions of the frame 102, thereby securing at least a portion of the valvular structure 156 to the frame 102.
  • the valvular structure 156 can be formed as a unitary component having dedicated regions thereof defining integrally formed leaflets 160 that can be continuously interconnected at commissure attachment regions 168 (indicated, for example, in Fig. 13C). Such commissure attachment regions 168 can be secured to the frame 102 to form commissures 192.
  • the plurality of leaflets 160 can be integrally formed as regions of a one-piece valvular structure 156, meaning that all of the leaflets 160 are continuous with each other without the need to otherwise couple them to each other (such as by suturing, adhering, and the like) to form the valvular structure 156.
  • the plurality of leaflets can be formed and provided as separate components, which can be in turn joined to each other and/or to the frame 102 (e.g., by suturing) to form the valvular structure 156.
  • the leaflets 160 can be made from, in whole or part, biological material (e.g., pericardium), bio-compatible synthetic materials, or other such materials. Further details regarding transcatheter prosthetic valves, including the manner in which the valvular structure 156 can be coupled to the frame 102 of the prosthetic valve 100, can be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,652,202, and 11,135,056, all of which are incorporated herein by reference in their entireties. [0237] The prosthetic valve 100 can further comprise at least one skirt or sealing member.
  • a prosthetic valve can include an inner skirt 189 secured to an inner surface of the frame 102, and configured to function, for example, as a sealing member to prevent or decrease perivalvular leakage.
  • an inner skirt can be provided as an integrally formed region of the valvular structure 156.
  • an inner skirt can be provided as a separate component that can further function as an anchoring region for the leaflets 160 to the frame 102, and/or function to protect the leaflets 160 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.
  • a prosthetic valve 100 can include an outer skirt 190 mounted on an outer surface of the frame 102, and configure to function, for example, as a sealing member retained between the frame 102 and the surrounding tissue of the native annulus against which the prosthetic valve is mounted, thereby reducing risk of paravalvular leakage (PVL) past the prosthetic valve 100.
  • PVL paravalvular leakage
  • an inner skirt 189 and/or outer skirt 190 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).
  • an inner skirt 189 comprises a single sheet of material that extends continuously around the inner surface of the frame 102.
  • the outer skirt 190 comprises a single sheet of material that extends continuously around the outer surface of the frame 102.
  • frame 102 can further include a plurality of commissure posts 132 coupled to the outflow rung 1140 and extending axially therefrom.
  • the frame 102 is shown to include commissure posts 132 extending proximally from the lower junctions 15 IL of the outflow rung 1140.
  • Each commissure post 132 is configured to support a commissure 192 coupled thereto, such as by including an attachment feature that can facilitate coupling of the commissure 192 to the frame 102.
  • the attachment feature can include an opening or slot 134 defined between two axially- extending sidewalls 136.
  • respective commissure attachment regions 168 can be coupled to the commissure posts 132 by sutures that can extend through the slots 134 to form commissures 192.
  • the number of commissure posts 132 can match the number of leaflets 160.
  • the frame 102 can include three commissure posts 132.
  • attachment features are contemplated, such as including of one or more or apertures through which sutures for attachment of the commissures to the commissure posts 132 can be passed, or wider window-like openings through which the commissure attachment regions 168 can optionally extend.
  • the attachments features can comprise hooks or protrusions (not shown).
  • a commissure post 132 can be devoid of an attachment feature, instead being formed as an axially extending strut around which appropriate portions of the leaflet 160 or valvular structure 156, such as commissure attachment regions 168, can be wrapped and sutured to.
  • the commissure posts 132 can extend from lower junctions 15 IL of the outflow rung 1 140 beyond the outflow apices 148 in the proximal direction, terminating proximal to the outflow apices 148, in the expanded state of the frame 102.
  • commissure attachment regions 168 of a valvular structure 156 when coupled to the commissure posts 132 to form commissures 192, can terminate proximal to the outflow apices 148.
  • the axial frame members 116 can extend between upper junctions 151U of the first subsequent rung 114S 1 and lower junctions 15 IL of the outflow rung 1140.
  • the axial frame members 116 comprise a plurality of axial support members 122 and a plurality of axial post struts 128, wherein the axial post struts 128 are attached to lower junctions 15 IL of the outflow rung 1140 from which commissure posts 132 extend, while the axial support members 122 are attached to lower junctions 15 IL of the outflow rung 1140 which are not connected to commissure posts 132.
  • the axial post struts 128 are aligned with respective commissure posts 132, and can together form continuous axial frame portions passing through corresponding lower junctions 15 IL of the outflow rung 1140, while the axial support members 122 terminate at corresponding lower junctions 15 IL of the outflow rung 1140 disposed between commissure posts 132.
  • the axial frame members 116 including axial support members 122 and axial post struts 128, can be parallel to each other and/or to a central longitudinal axis of the prosthetic valve 100.
  • Each cell row 146 of the frame 102 comprises a plurality of cells 144 extending circumferentially such that each cell 144 is directly coupled to two circumferentially adjacent cells 144 on both sides thereof within the same cell row 146.
  • the term "cell”, as used herein, refers to a closed cell, having an enclosed perimeter defined by at least four struts 110.
  • Cells 144S, 1441 of the subsequent cell rows 146S, 1461 can be generally diamondshaped cells.
  • the frame 102 a of exemplary prosthetic valve 100 a is shown to include first subsequent cells 144S1 defined by two first subsequent angled struts 112S1 and two second subsequent angled struts 112S2, second subsequent cells 144S2 defined by two second subsequent angled struts 112S2 and two third subsequent angled struts 112S3, third subsequent cells 144S3 defined by two third subsequent angled struts 1 12S3 and two fourth subsequent angled struts 112S4, and inflow cells 1441 defined by two fourth subsequent angled struts 112S4 and two inflow angled struts 1121.
  • a prosthetic valve 100 may be expanded against a calcified aortic annulus, requiring it to overcome the relatively increased rigidity of the calcified tissue during expansion.
  • One of the factors known to affect the radial force exerted by the frame 102 of a valve 100 on the surrounding anatomy is the number of cells 144 in corresponding cell rows, wherein a greater number of cells 144 (i.e., a higher cell density) will result in a greater radial force during expansion.
  • frames 102 of some types of prosthetic valves 100 may be provided with a relatively large number of cells 144 to increase the radial force to overcome the resistance of the calcified annular pathologies.
  • Some prosthetic valves may have an overall axial length, in their expanded state, that can place the outflow cell row 1460 at the level of the coronary ostia.
  • such valves 100 can be designed to have their outflow apices 148 contacting or being placed in the vicinity of the sinuses or the Sinotubular Junction (STJ) when expanded at the site of implantation.
  • STJ Sinotubular Junction
  • a patient may require implantation of a coronary stent or other procedure that requires access to a coronary artery after prosthetic valve implantation.
  • a physician may need to access the coronary artery through the opening defined by an outflow cell 1440 of the outflow cell row 1460 facing the coronary ostium.
  • the outflow cells 1440 of the prosthetic valve 100 can have a height (measured in the axial direction) which is greater than the height of cells 144S, 1441 of the subsequent cell rows 146S, 1461, due to the axial frame members 116 interconnecting the outflow rung 1140 and the first subsequent rung 114S1.
  • the outflow cells 1440 can have a width (measured in the circumferential direction, such as between two neighboring axial frame members 116) which is greater than the width of cells 144S, 1441 of the subsequent cell rows 146S, 1461.
  • apices of the frame 102 such as any of the outflow apices 148, inflow apices 150, and free apices 152, comprise arcuate regions defined between upper and lower curved surfaces.
  • Each outflow apex 148 and/or free apex 152 can include an arcuate apex region 154 defined between an upwardly convex-shaped upper curved surface 153 and an opposing lower curved surface 155 that can form an inner depression of the outflow apex 148.
  • the leaflets when the leaflets are in an open state when implanted in a patient, the leaflets can contact the free apices 152. In such cases, it is beneficial for the free apices 152 to have arcuate regions with curved outer surfaces, as illustrated in Figs. 1A-1C.
  • the curved outer surface is more atraumatic and may not interfere with the leaflets of the prosthetic valve as the leaflets open and close during operation of the prosthetic valve. Thus, a long term durability of the leaflets can be increased.
  • any of the outflow apices 148, inflow apices 150, or free apices 152 can have any other shape, including being in the form of "pointed" apices devoid of arcuate regions, being shaped as M-shaped double-pointed apices, and the like.
  • each outflow cell 1440 can span a width of two subsequent cells 144S1 of the first subsequent cell row 146S1 and/or any other subsequent cell row 146S, 1461.
  • the outflow cell row 1460 includes six outflow cells 1440, while any subsequent cell row 146S, 1461 can include twelve cells 144.
  • the axial support members 122 and axial post struts 128 can be alternately arranged around the circumference of the outflow cell row 1460, such that a single axial support member 122 can be disposed between each two successive axial post struts 128, and a single axial post strut 128 can be disposed between each two successive axial support member 122.
  • cells 144 of the subsequent cell rows 146S, 1461 are shown in the example illustrated in Figs. 1A-1C to have substantially the same size and shape, it is to be understood that in some examples, cells 144 of the subsequent cell rows 146S, 1461 can have different sizes and shapes.
  • Each leaflet 160 includes a leaflet belly 162 (indicated, for example, in Fig. 13C) which is the movable and unattached part of the leaflet, defined between a lower cusp line 164 and an upper free edge 166 of the leaflet.
  • leaflet bellies 162 described herein can have a three-dimensional and concave shape, thereby resulting in increased mobility of the leaflet when the prosthetic valve is implanted in a patient. As a result, the efficiency of the prosthetic valve including the valvular structure can be improved.
  • An exemplary prosthetic valve 100 a that includes four subsequent cell rows 146S1, 146S2, 146S3, 1461 distal to the outflow cell row 1460 may result in a relatively elongated valve, defined as the length between the outflow end 104 and the inflow end 106. Longer valves can lead to conduction disturbances due to the risk of the inflow end of the valve contacting the septal conductive pathways, or have the outflow portion positioned high enough (for example, above the STJ level) so as to interfere with coronary flow and access.
  • Fig. 2 shows one third of an exemplary prosthetic valve 100 b , 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 b of prosthetic valve 100 b can include fewer cell rows 146 than prosthetic valve 100 a , such as no more than three subsequent cell rows 146S, 1461 distal to the outflow cell row 1460.
  • first subsequent cell row 146S 1 defined between the first subsequent rung 114S 1 and the second subsequent rung 114S2
  • second subsequent cell row 146S2 defined between the second subsequent rung 114S2 and the third subsequent rung 114S3
  • inflow cell row 1461 defined between the third subsequent rung 114S3 and the inflow rung 1141.
  • each leaflet 160 can be directly coupled along its cusp line 164 to the frame 102.
  • the cusp line 164 of a leaflet 160 can define a single scallop having a midpoint 164m that can be the lowermost or distal-most point of the leaflet 160. While fewer cell rows 146 can reduce the overall length of the frame 102, it may be desired to locally extend the frame at region of the cusp line midpoints 164m to support attachment of leaflets 160 at the lowermost regions. For that end, certain cells 144 of the inflow cell row 1461 rung can be modified to have an overall axial length or height that is greater than other cells 144 of the inflow cell row 1461.
  • the inflow rung 1141 of the exemplary frame 102 b illustrated in Fig. 2 is shown to include two types of inflow angled struts 1121, namely regular inflow angled struts 112IR and elongated inflow angled struts 112IL.
  • the regular inflow angled struts 112IR may be equal in length to the subsequent angled struts 112S of any other subsequent rung 114S, such as any of the first, second and third subsequent rungs 114S 1, 114S2, 114S3, while the elongated inflow angled struts 112IL are longer than the regular inflow angled struts 112IR.
  • the inflow cell row 1461 of the exemplary frame 102 b illustrated in Fig. 2 includes two types of inflow cells 1441, namely regular inflow cells 144IR and elongated inflow cells 144IL.
  • Each regular inflow cell 144IR can be defined by two angled struts 112S3 of the third subsequent rung 114S3 and two regular inflow angled struts 112IR
  • each elongated inflow cell 144IL can be defined by two angled struts 112S3 of the third subsequent rung 114S3 and two elongated inflow angled struts 112IL.
  • the regular inflow cells 144IR can be diamond- shaped cells which have equal axial heights as those of the subsequent cells 144S of any other subsequent cell row 146S, such as any of the first or second subsequent cell rows 146S1, 146S2, while the elongated inflow cells 144IL can be kite-shaped, having an axial height that is longer than that of the regular inflow cells 144IR.
  • the regular inflow angled struts 112IR intersect at first inflow apices 150R and the elongated inflow angled struts 1 12TL intersect at second inflow apices 150L which are distal to the first inflow apices 150R.
  • the elongated inflow cells 144IL and the second inflow apices 150L defined thereby are circumferentially aligned with the cusp line midpoints 164m of the leaflets 160, such that the cusp line midpoints 164m can be coupled (e.g., sutured) to the second inflow apices 150L.
  • the length of the elongated inflow angled struts 112IL can be designed to axially align the inflow apices 150L with the cusp line midpoints 164m.
  • the elongated inflow cells 144IL and the second inflow apices 150L defined thereby are circumferentially aligned with the axial support members 122.
  • FIG. 3 shows one third of an exemplary prosthetic valve 100 c , 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 inflow cell row 1461 of the frame 102 c of exemplary prosthetic valve 100 c further comprises a plurality of axial inflow struts 138.
  • the frame 102 c can include fewer cell rows 146 than prosthetic valve 100 a , such as no more than three subsequent cell rows 146S, 1461 distal to the outflow cell row 1460.
  • the frame 102 c illustrated in Fig. 3 is shown to include a first subsequent cell row 146S1, a second subsequent cell row 146S2, and an inflow cell row 1461.
  • all inflow cells 1441 of frame 102 c can have equal axial heights, which can be greater than the axial heights of subsequent cells 144S of any of the other cell rows 146S, such as first and second subsequent cells rows 146S1, 146S2.
  • the inflow cells 1441 of the exemplary valve 100 c shown in Fig. 3 can be generally hexagonal, each inflow cell 1441 defined between two angled struts 112S3 of the third subsequent rung 114S3, two inflow angled struts 1121, and two axial inflow struts 138 extending between the third subsequent rung 114S3 and the inflow rung 1141.
  • the axial inflow struts 138 are parallel to each other, extending vertically in a manner similar to that of the axial support members 122 and/or axial post struts 128. However, the axial inflow struts 138 can be shorter in length, in some examples, than any of the axial support members 122 and/or axial post struts 128.
  • the length of the axial inflow struts 138 can be designed to axially align the inflow apices 150 with the cusp line midpoints 164m, such that the cusp line midpoints 164m can be coupled (e.g., sutured) to the corresponding inflow apices 150 of the frame 102 c .
  • any of the exemplary prosthetic valves 100 b or 100 c can include less than three subsequent cells rows 146S, 1461, such as by including a first subsequent cell row 146S 1 and an inflow cell row 1461, without an additional subsequent cell row disposed therebetween.
  • the frame 102 or a prosthetic can be cut (such as by laser cutting) from a tube having a diameter that is greater than the crimped diameter of the valve, which can be also referred to herein as the frame cutting diameter.
  • Soft components of the prosthetic valve such as a valvular structure 156 and/or skirts, can be coupled to the frame after formation thereof at the frame cutting diameter, after which the prosthetic valve is crimped to a smaller diameter, such as within a range of 6-8 millimeters (mm), and is expanded, after being delivered to over a delivery apparatus (not shown) to the site of implantation, to a desired expanded configuration.
  • the forces applied to the frame during crimping and/or during expansion may distort the frame, as shown in Fig. 4.
  • Frame distortion during crimping and/or expansion can result from the design of cells 144 of the frame, and/or due to mismatch between the rigidity of different portions of the frame, such as a mismatch between the rigidity of the upper portion of the frame that includes the outflow rung 1140 and/or commissure posts 132, and the rigidity of the lower portion of the frame that includes the subsequent cell rows 146S, 1461.
  • FIG. 5 shows one third of a frame 102 d of an exemplary prosthetic valve 100 d .
  • Frame 102 d is an exemplary implementation of a frame 102, and thus can include any of the features described for a frame 102 throughout the current disclosure, except that the frame 102 d further comprises vertical stabilization struts 140 extending distally from the outflow apices 148, and pairs of angled stabilization struts 142 diverging from the lower end (i.e., opposite to the outflow apex 148) of each vertical stabilization struts 140 towards the inflow end portions 120 of the axial frame members 116 at both sides of the corresponding stabilization strut 142.
  • each vertical stabilization struts 140 and pair of angled stabilization struts 142 disposed in an outflow cell 1440 effectively divide the outflow cell 1440 into two first outflow sub-cells 144OP and a second outflow sub-cell 144OA distal to the first outflow sub-cells 144OP.
  • Each first outflow sub-cell 144OP can be parallelogram-shaped, defined between an outflow angled strut 1120, an angled stabilization strut 142, and an axial frame member 116 and a vertical stabilization strut 140 connecting the outflow angled strut 1120 to the angled stabilization strut 142.
  • Each second outflow sub-cell 144OA can be generally arrowheadshaped, defined by a pair of angled stabilization struts 142 and four subsequent angled struts 112S1 of the first subsequent rung 114S1.
  • the vertical stabilization struts 140 can be circumferentially aligned with the free apices 152.
  • the upper portion of the frame 102 d between the outflow rung 1140 and the first subsequent rung 114S1 can be strengthened by the addition of the vertical stabilization struts 140 and angled stabilization struts 142, which can reduce the risk of frame distortion during crimping and/or expansion.
  • FIGs. 6A and 6B are side views of a frame 102 e of an exemplary prosthetic valve 100 e in expanded and compressed configurations, respectively.
  • Frame 102 c is an exemplary implementation of a frame 102, and thus can include any of the features described for a frame 102 throughout the current disclosure, except that the frame 102 e defines an angle a between intersecting angled struts 112 of diamond-shaped cells 144 that is not greater than 120°, in the frame cutting diameter.
  • Fig. 6A shows an exemplary frame 102 e at the frame cutting diameter DI, wherein each two subsequent angled struts 112S of the same subsequent rung 114S define an angle a therebetween that is not greater than 120°, such as an angle of 110° in the illustrated example.
  • the frame 102 is formed (e.g., tube-cut) so as to define a maximal angle a between the angled struts 112 as described above, it can be compressed or crimped to a smaller diameter D2, as shown in Fig. 6B, and then expanded either to the diameter DI or to a diameter that can be greater than the frame cutting diameter DI, without being distorted, optionally while retaining a generally cylindrical configuration in all diameters.
  • the angle a in the frame cutting diameter is not greater than 120°. In some examples, the angle a in the frame cutting diameter is not greater than 110°. In some examples, the angle a in the frame cutting diameter is not greater than 100°. In some examples, the angle a in the frame cutting diameter is in a range of 100° to 120°, inclusive. [0278] While the threshold for an angle a in the frame cutting diameter is described above and illustrated in Figs.
  • the movable portions of the leaflets 160 move radially outwards due to the pressure gradient across the valve 100.
  • Direct contact of the leaflets 160 with struts 110 of the frame 102 can lead to wear due to the vast number of repetitive cycles of systolic-driven movement of the leaflets towards and against the frame during the life cycle of a prosthetic valve 100, which can eventually reduce long-term durability of the leaflets 160.
  • FIGs. 25A-25B show various examples of frames 102‘ of exemplary prosthetic valves 100‘.
  • Frame 102' is an exemplary implementation of a frame 102, and thus can include any of the features described for a frame 102 throughout the current disclosure, except that the first subsequent cell row 146S1‘ of frame 102' is a discontinuous cell row, such that it does not include first subsequent cells 144S1 that define free apices aligned with corresponding outflow apices 148.
  • Fig. 25A shows one third of an exemplary frame 102 t] in which the first subsequent rung 1 14S 1" is a discontinuous rung, with the first angled struts 112S1 that originally defined free apices 152 aligned with corresponding outflow apices 148 removed from rung 114S1 11 .
  • the first subsequent rung 114S1 of frame 102" includes circumferentially spaced pairs of first subsequent angled struts 112S 1, each pair connected to a corresponding axial frame member 116, such as to its inflow end portion 120.
  • each outflow cell 1440 of frame 102‘ can span a width of two first subsequent cells 144S1 of the first subsequent cell row 146S 1 1 and/or any other subsequent cell row 146S, 1461.
  • the first subsequent rung 114S I 11 is devoid of free apices 152, such that all of the first subsequent angled struts 112S1 are connected to corresponding axial frame members 116.
  • a frame 102’ can include 4-way junctions 151', defined as junctions connecting four angled struts 112, and 3-way junctions 152", which connect less then three angled struts 112 to each other, such as connecting 4 angled struts 112 to each other in the example illustrated for frame 102’ 1 in Fig. 25 A.
  • each 3-way junction 152 connects between two second subsequent angles struts 112S2 and a single first subsequent angled struts 112S 1 .
  • Each first subsequent angled strut 1 12S 1 of the first subsequent rung 1 14” of frame 102” extends from an axial frame member 116 to a -way junction 152", and can generally have the same length as that of other subsequent angled struts 112S, such as the second subsequent angled struts 112S2.
  • An outflow cell 1440 of the exemplary frame 102” shown in Fig. 25A can be defined between two outflow angled struts 1120 of the outflow rung 1140, two axial frame members 116 extending between the outflow rung 1140 and the first subsequent rung 114S1, two first subsequent angled struts 112S1 of the first subsequent rung 114S1”, and two second subsequent angled struts 112S2 of the second subsequent rung 114S2.
  • Fig. 25B shows one third of an exemplary frame 102’ 2 that includes elongated first subsequent angled struts 112S1’ 2 .
  • the elongated first subsequent angled struts 112S1’ 2 of first subsequent rung 114S1’ 2 extend from upper junctions 151U thereof, at which they are connected to the axial frame member 116, and lower junctions 15 IL thereof, which are 4- way junctions 151" that connect between two elongated first subsequent angled struts 112S1’ 2 and two third subsequent angled struts 112S3.
  • a 3-way junction 151" of frame 102’ 2 can be defined as a junction connecting a second subsequent angled strut 112S2 to an elongated first subsequent angled strut 112S I’ 2 , at a position between the upper junctions 151U and the lower junctions 151L of the elongated first subsequent angled strut 112S1’ 2 .
  • the length of an elongated first subsequent angled strut 112S1’ 2 is about twice the length of a second subsequent angled strut 112S2, such that the position of the 3-way junction 151” from which the second subsequent angled strut 112S2 is branched, can be mid-way between the upper junctions 151U and the lower junctions 15 IL of the elongated first subsequent angled strut 112S1’ 2 .
  • a first subsequent cell 144S1 of the exemplary frame 102’ 2 shown in Fig. 25B can be defined between two second subsequent angled struts 112S2 and portions of two first subsequent angled strut 112S1’ 2 that extend proximally from 3-way junction 151” thereof.
  • a second subsequent cell 144S2 of the exemplary frame 102’ 2 can be defined between two third subsequent angled struts 112S3, a second subsequent angled strut 112S2, and a portion of a first subsequent angled strut 112S1’ 2 that extends distally from 3-way junction 151" thereof.
  • An outflow cell 1440 of the exemplary frame 102 t2 can be defined between two outflow angled struts 1120 of the outflow rung 1140, two axial frame members 116 extending between the outflow rung 1140 and the first subsequent rung 114S l t2 , and two elongated first subsequent angled struts 112S l t2 of the first subsequent rung 114S l t2 .
  • the outflow cell row 1460 of an exemplary frame 102' includes six outflow cells 1440, the first subsequent cell row 146S1 ‘ includes six first subsequent cells 144S1, and the second subsequent cell row 146S2 includes twelve second subsequent cells 144S2.
  • all cells 144 of the subsequent cell rows 146S, 1461 of an exemplary frame 102 t can optionally have substantially the same size and shape.
  • the outflow cells 1440 of a prosthetic valve 100' can have an even greater height (measured in the axial direction), compared, for example, to the height of the outflow cells 1440 illustrated in Figs. 1A-1C for exemplary prosthetic valve 100 a , which can further improve access to the coronary arteries.
  • the proposed configuration of prosthetic valve 100‘, by which the first subsequent cell row 146S1 is a discontinuous cell row, can advantageously reduce rigidity of the lower portion of the frame that includes the subsequent cell rows 146S, 1461, wherein the smaller difference in frame rigidity along both sides of the axial frame members 116 can potentially increase stability of the frame 102* during compression and/or expansion.
  • the proximally convex segment 111 extends from a lower junction 15 IL of the outflow strut 1120, such as at an outflow end portion 118 of an axial frame member 116 from which the outflow struts 1120 extends, to the inflection point 115.
  • the proximally concave segment 113 extends from the inflection point 115 to the corresponding outflow apex 148.
  • the outflow angled struts 1120 of frame 102“ are devoid of linear strut segments.
  • the inflection point 115 can be substantially mid-way between the lower junction 151L and the outflow apex 148 of the respective strut 1120, as illustrated for example in Fig. 26, though it is to be understood that the inflection point 115 can optionally be closer, in some examples, to either the lower junction 151L or the outflow apex 148.
  • the length ratio between the proximally convex segment 111 and the proximally concave segment 113, and/or the curvatures of the proximally convex segment 111 and the proximally concave segment 113, can be designed so as to reduce difference in rigidity between the upper portion of the frame 102 u that includes the outflow rung 1140, and the lower portion of the frame 102 u that includes the subsequent cell rows 146S, 1461.
  • the proximally convex segment 111 can extend along at least 20% of the length of the outflow rung 1140, at least 30% of the length of the outflow rung 1140, or at least 40% of the length of the outflow rung 1140.
  • the proximally concave segment 113 can extend along at least 20% of the length of the outflow rung 1140, at least 30% of the length of the outflow rung 1140, or at least 40% of the length of the outflow rung 1140.
  • FIG. 27 shows one third of a frame 102 v of an exemplary prosthetic valve 100 v .
  • Frame 102 v is an exemplary implementation of a frame 102, and thus can include any of the features described for a frame 102 throughout the current disclosure, except that the frame 102 v further comprises pairs of curved stabilization struts 143 diverging from the upper junctions 151U of angled struts 112S 1 of the first subsequent rung 114S1, which are circumferentially aligned with the outflow apices 148, towards axial frame members 116 at both sides of the corresponding junctions 15 IL from which they diverge, optionally connected to the outflow end portions 118 of the respective axial frame members 116.
  • the curved stabilization struts 143 are disposed between the first subsequent rung 114S 1 and the outflow rung 1140, and are longer than the angled struts 112S 1 of the first subsequent rung 114S1.
  • each pair of curved stabilization struts 143 disposed in an outflow cell 1440 effectively divides the outflow cell 1440 into one first outflow sub-cell 144OP and two second outflow sub-cells 144OA distal to the first outflow sub-cell 144OP.
  • Each first outflow sub-cell 144OP can be defined between a pair of outflow angled strut 1120 and a pair of curved stabilization struts 143, optionally (but not necessarily) with short portions of two axial frame members 116, such as along outflow end portions 118 thereof, extending between the outflow angled strut 1120 and the curved stabilization struts 143.
  • Each second outflow sub-cell 144OA can be defined a pair of first subsequent angled struts 112S1 of the first subsequent rung 114S 1 , one curved stabilization strut 143, and at least a portion of an axial frame member 116 extending proximally from the first subsequent rung 114S1.
  • Fig. 28 shows one third of a frame 102 w of an exemplary prosthetic valve 100 w .
  • Frame 102"’ is an exemplary implementation of a frame 102, and thus can include any of the features described for a frame 102 throughout the current disclosure, except that the frame 102" further comprises a plurality of struts 137 that extend from intermediate junctions 151M of the first subsequent angled struts 112S1, the struts 137 defining distally-oriented free apices 149 which can be circumferentially aligned with upper junctions 151U of the first subsequent rung 114S 1, such as upper junctions 151U of the first subsequent rung 114S1 that define proximally- oriented free junctions 152 and upper junctions 151 U of the first subsequent rung 1 14S 1 that connect with corresponding axial frame members 116.
  • the intermediate junctions 15 IM are defined between lower junctions 15 IL and upper junctions 151U of the first subsequent rung 114S1.
  • the struts 137 extending from the first subsequent angled struts 112S 1 can be implemented as arched struts 137 disposed between the first subsequent rung 114S1 and the second subsequent rung 114S2, as illustrated, for example, in Fig. 28.
  • Each arched strut 137 is attached at intermediate junctions 15 IM, at both ends thereof, to a pair of first subsequent angled struts 112S1 of the first subsequent rung 114S1, and is proximally (or upwardly) concaved so as to define an inner arcuate region 149 which is circumferentially aligned with a corresponding upper junction 151U of the first subsequent angled struts 112S1, such as free apices 152 or axial frame members 116.
  • the arched struts 137 are circumferentially spaced from each other.
  • the arched struts 137 can be connected to the corresponding pairs of first subsequent angled struts 112S1 at intermediate junctions 15 IM defined between the upper junctions 151U and lower junctions 15 IL of the corresponding first subsequent angled struts 112S1.
  • at least some of the distally-oriented free apices 149 such as half of the inner arcuate region 149, are circumferentially aligned with free apices 152 of the first subsequent rung 114S1 and/or outflow apices 148 of the frame 102 w .
  • at least some of the inner arcuate region 149, such as half of the inner arcuate region 149 are circumferentially aligned with axial frame members 116.
  • each arched strut 137 disposed in a first subsequent cell 144S 1 effectively divides the first subsequent cell 144S1 into a first subsequent minor sub-cell 144S1P and a first subsequent major sub-cell 144S1A distal to the first subsequent minor sub-cell 144S1P.
  • Each first subsequent minor sub-cell 144S1P can be defined between an arched strut 137 and proximal portions of a pair of first subsequent angled struts 112S1 defined between an upper junctions 151U and corresponding intermediate junctions 151M.
  • Each first subsequent major sub-cell 144S1A can be defined by an arched strut 137, distal portions of a pair of first subsequent angled struts 112S1, and a pair of second subsequent angled struts 112S2 of the second subsequent rung 114S2.
  • the first subsequent major sub-cells 144S1A are larger and wider than the first subsequent minor sub-cells 144S1P.
  • an arched strut 137 in a shape of a generally curved or upwardly concave shape is illustrated in Fig. 28 and described above, having an inner arcuate region 149 that can be defined between upper and lower curved surfaces, it is to be understood that in some examples, an arched strut 137 can be defined or replaced by two angled struts or struts portions that can be angled, and can be either curved or linearly shaped, converging at distally-oriented free apices 149 that can be either curved apices or otherwise-shaped apices.
  • FIG. 29 shows one third of a frame 102 x of an exemplary prosthetic valve 100 x .
  • Frame 102 x is an exemplary implementation of a frame 102, and thus can include any of the features described for a frame 102 throughout the current disclosure, except that the first subsequent angled struts 112S1 of the first subsequent rung 114S1 of frame 102 x are wider than angled struts 112 of at least one subsequent rung 114 distal to the first subsequent rung 114S1.
  • the angled struts 112 of at least one subsequent rung 114, distal to the first subsequent rung 114S1, can have a width WB as described above with respect to Fig. 1C for example, while the first subsequent angled struts 112S1 of the first subsequent rung 114S1 can have a width Ws which is larger than WB (i.e., Ws > WB).
  • Ws width Ws of the first subsequent angled struts 112S 1
  • the width Ws of the first subsequent angled struts 112S 1 can be larger than a width WB of the second subsequent angled struts 112S2.
  • angles struts 112 of some or all subsequent rungs 114 distal to the first subsequent rung 114S 1, can have a uniform width WB-
  • the width Ws of the first subsequent angled struts 112S1 can be larger than a width WB of angled struts 112 of the second subsequent rung 114S2, the third subsequent rung 114S3, the fourth subsequent rung 114S4, and optionally the inflow rung 1141.
  • the width WB of first subsequent angled struts Ws is at least 25% larger than the width WB of angled struts 112 distal to the first subsequent rung 114S 1. In some examples, the width WB of first subsequent angled struts Ws is at least 50% larger than the width WB of angled struts 112 distal to the first subsequent rung 114S 1. In some examples, the width WB of first subsequent angled struts Ws is at least 75% larger than the width WB of angled struts 112 distal to the first subsequent rung 114S1.
  • the width WB of first subsequent angled struts Ws is at least 100% larger than (e.g., double) the width WB of angled struts 112 distal to the first subsequent rung 114S1. In some examples, the width WB of first subsequent angled struts Ws is similar to the width Wo of the outflow angled struts 1120. In some examples, the width WB of first subsequent angled struts Ws is similar to the width Wp of one or more axial frame members 116, such as the axial posts struts 128 and/or axial support members 122.
  • axial frame members 116 y of valves 100 y can improve stability of frames 102 y during compression and/or expansion thereof, due to their connectivity, via junctions 151, to all rungs 114 of such frames 102 y .
  • Fig. 30 is a flattened view of an example frame 102 yl that includes two subsequent cell rows 146S equipped with diamond shaped cells 144S, which are axially space from each other, optionally by a subsequent cell row 146S that includes otherwise-shaped cells 144S.
  • Each outflow cell 1440 is defined by two outflow angled struts 112, four first subsequent angled struts 112S1, and portions of two axial frame members 116 y extending between the outflow angled struts 1120 and the first subsequent angled struts 112S1.
  • first subsequent cell row 146S1 and an inflow cell row 1461 that include generally diamond-shaped cells 144S1 and 1441, respectively.
  • Each first subsequent cell 144S1 is defined by two first subsequent angled struts 112S1 and two second subsequent angled struts 112S2.
  • Each inflow cell 1441 is defined by two third subsequent angled struts 112S3 and two inflow angled struts 1121.
  • the second subsequent rung 114S2 of angled struts 112S2 and the third subsequent rung 114S3 of angled struts 112S3 are axially spaced from each other, without being joined by mutual junctions 151.
  • the first subsequent cell row 146S1 and the inflow cell row 1461 are axially spaced from each other, separated by the second subsequent cell row 146S2 disposed therebetween.
  • Each second subsequent cell 144S2 of the second subsequent cell row 146S2 is defined by four second subsequent angled struts 112S2, four third subsequent angled struts 112S3, and portions of two axial frame members 116 y extending between the second subsequent angled struts 112S2 and the third subsequent angled struts 112S3.
  • the second subsequent cells 144S2 can have a width which is greater than the width of cells 144S1, 1441 of the subsequent cell rows 146S1, 1461.
  • each second subsequent cell 144S2 can span a width of two first subsequent cells 144S1 of the first subsequent cell row 146S1 and/or two inflow cells 144S1 of the inflow cell row 1461.
  • the second subsequent cells 144S2 can have a width that is substantially equal to that of the outflow cells 1440.
  • the second subsequent cell row 146S2 includes six cells 144S2, while any of the first subsequent cell row 146S1 and the inflow cell row 1461 can include twelve cells 144.
  • Fig. 31 is a flattened view of an example frame 102 y2 that includes inflow angled struts 1121 having a length that is greater than the length of other subsequent angles struts 112S of the frame 102 y2 .
  • a single subsequent cell row 146S1 equipped with diamond shaped cells 144S 1 is shown in the example illustrated in Fig. 31 to be disposed between the outflow cell row 1460 and the inflow cell row 1461, though it is to be understood that in some examples, more that one subsequent cell row 146S having generally diamond- shaped cells 144S can be disposed between the outflow cell row 1460 and the inflow cell row 1461.
  • Each outflow cell 1440 is defined by two outflow angled struts 112, four first subsequent angled struts 112S1, and portions of two axial frame members 116 y extending between the outflow angled struts 1120 and the first subsequent angled struts 112S1.
  • Each first subsequent cell 144S1 is defined by two first subsequent angled struts 112S1 and two second subsequent angled struts 112S2.
  • Each inflow cell 1441 is defined by four second subsequent angled struts 112S2, two inflow angled struts 1121, and portions of two axial frame members 116 y extending between the second subsequent angled struts 112S2 and the inflow angled struts 1121.
  • the second subsequent rung 114S2 of angled struts 112S2 and the inflow rung 1141 of inflow angled struts 1121 are axially spaced from each other, without being joined by mutual junctions 151.
  • the inflow cell row 1461 can mirror the outflow cell row 1460.
  • each inflow cell 1441 can span a width of two first subsequent cells 144S1 of the first subsequent cell row 146S1.
  • the inflow cells 144SI can have a width that is substantially equal to that of the outflow cells 1440.
  • the inflow cell row 146S2 includes six inflow cells 1441, while the first subsequent cell row 146S 1 can include twelve cells 144S1.
  • Fig. 31 is a flattened view of an example frame 102 y3 that includes inflow cells 1441 defined between undulating or zig-zagged portions of strut rungs 114S, 1141 which are parallel to each other.
  • a single subsequent cell row 146S1 equipped with diamond shaped cells 144S1, followed by a second subsequent cell row 146S 1 and an inflow cell row 1461 that include, each, cells 144S, 1441 defined between undulating or zig-zagged portions of strut rungs 114 which are parallel to each other, are shown in the example illustrated in Fig.
  • a frame 102 y3 can include any other number of subsequent cells rows 146S that include generally diamond-shaped cells 144S, and can include any other number of subsequent cells rows 146S that include cells defined between undulating or zigzagged portions of subsequent strut rungs 114S which are parallel to each other.
  • Each second subsequent cell 144S2 of the second subsequent cell row 146S2 is defined by four second subsequent angled struts 112S2, four third subsequent angled struts 112S3, and portions of two axial frame members 116 y extending between the second subsequent angled struts 112S2 and the third subsequent angled struts 112S3, wherein the second subsequent angled struts 112S2 and the third subsequent angled struts 112S3 extend parallel to each other.
  • each inflow cell 1441 of the inflow cell row 1461 is defined by four third subsequent angled struts 112S3, four inflow angled struts 1121, and portions of two axial frame members 116 y extending between the third subsequent angled struts 112S3 and the inflow angled struts 1121, wherein the third subsequent angled struts 112S3 and the inflow angled struts 1121 extend parallel to each other.
  • the inflow cells 1441 and/or the second subsequent cells 144S2 can have a width which is greater than the width of first subsequent cells 144S1 of the first subsequent cell row 146S1. In some examples, each inflow cell 1441 and/or second subsequent cell 144S2 can span a width of two first subsequent cells 144S 1 of the first subsequent cell row 146S 1. In some examples, the inflow cells 1441 can have a width that is substantially equal to that of the outflow cells 1440. In some examples, the second subsequent cells 144S2 can have a shape and a width that is substantially equal to that of the inflow cells 1441. In some examples, each of the second subsequent cell row 146S2 and the inflow cell row 1461 includes six cells 144S2, 1441, while the first subsequent cell row 146S 1 can include twelve first subsequent cells 144S1.
  • Fig. 7A is a side view of an exemplary prosthetic valve 100 f that includes protective covering members 188.
  • Fig. 7B is a perspective view of a frame 102 f of the prosthetic valve 100 f of Fig. 7A, with protective covering members 188 disposed over an inner side of axial support members 122 f thereof.
  • Fig. 7C shows the frame 102 f of Fig. 7B in a flat configuration for purposes of illustration.
  • Prosthetic valve 100 f 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 f further includes a plurality of protective covering members 188 attached to axial support members 122 f at locations facing the movable portions of the leaflets 160, such as leaflet bellies 162.
  • the protective covering members 188 are configured to inhibit or prevent the leaflets 160 from contacting the frame 102 when the leaflets open outwardly, such as during diastolic cycles, so as to reduce risk of leaflet abrasion and improve long term durability of the valvular structure 156.
  • the protective covering members 188 can be made from or comprise tissue (e.g., bovine pericardium) or synthetic suitable material. In some examples, the protective covering members 188 comprise a relatively non-abrasive or smooth material.
  • the protective covering members 188 can comprise a polymeric material.
  • the polymeric material can be relatively thromboresistant or have a thromboresistance that is greater than that of a fabric.
  • the polymeric material of the protective covering members 188 can comprise thermoplastic polyurethane (TPU), silicone, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), and/or other similar materials.
  • the axial support members 122 are shaped to define an overall width that is large enough to support wider protective covering members 188 coupled thereto.
  • the exemplary prosthetic valve 100 f is shown to include 8- shaped axial support members 122 f that include two openings 126, namely an upper opening 126U and a lower opening 126L.
  • An outer 8-shaped configuration of an axial support member 122 f is defined by two serpentine outer edges 124 extending between the outflow end portion 118 and the inflow end portion 120 of the axial support member 122 f .
  • Other shapes of axial support members 122 can be also implemented, such as generally O-shaped axial support member 122 or other shapes defined by relatively curved outer edges 124.
  • a frame 102 can be cut from a tube, or cut from a flat sheet which is then rolled into a cylindrical configuration, employing any suitable cutting technology, such as laser cutting and the like. While laser-cutting an 8-shaped structure is fairly easy, verification of proper dimensions after manufacturing, along curved corners of such a structure, is much more challenging.
  • an axial support member 122 is formed with linear outer edges, while one or more openings 126 thereof have any other shape having inner curved or linear edges.
  • FIG. 8 shows a portion of a frame 102 g of an exemplary prosthetic valve 100 8 .
  • Frame 102 g is an exemplary implementation of a frame 102, and thus can include any of the features described for a frame 102 throughout the current disclosure, except that each axial support member 122 s of the frame 102 8 comprises outer edges 124 which are linear along most of the axial height of the axial support member 122 8 .
  • the exemplary axial support member 122 s is shown to include generally D-shaped upper and lower openings 126U, 126L inversely oriented relative to each other, such that inner horizontally-oriented straight edges of the openings 126 are parallel and adjacent to each other, though other shapes of the openings 126 are contemplated.
  • the linear portions of the outer edges 124 can make it significantly easier to measure dimensions and shape of the axial support members 122 after manufacturing, during quality assurance procedures for example.
  • the outer edges 124 are linear along at least 50% of the height of the axial support member 122.
  • the outer edges 124 are linear along at least 60% of the height of the axial support member 122.
  • the outer edges 124 are linear along at least 75% of the height of the axial support member 122.
  • the outer edges 124 are linear along at least 80% of the height of the axial support member 122.
  • One of the factors that can influence stability of the frame 102 during crimping and/or expansion thereof relates to the rigidity of the axial frame members 116 extending between the outflow rung 1140 and the subsequent cell rows 146S, 1461, and/or a potential mismatch between portions of the frame 102 coupled to both ends of the axial frame members 116.
  • the longer outflow angled struts 1120 and the shorter subsequent angled struts 112S, 1121 can result in stiffness difference between the frame portions on both ends of the axial frame members 116.
  • the outflow end portions 118 and the inflow end portions 120 of the axial frame members 116, connected to the outflow and inflow portions of the frame can thus experience different bending moments that may cause them to deform (e.g., assume an S-shaped deformation) after crimping and/or expansion.
  • any of the axial frame members 116 has at least one region that does not exceed a width of 0.5 mm.
  • the frame 102 g is shown to include an axial post strut 128 s having a post width Wp that can be wider than 0.5 mm along most of its length between the inflow end portion 120 and outflow end portion 118, while both the inflow end portion 120 and the outflow end portion 118 are shown to include thinned regions having a thinned width WT that can be less than 0.5 mm. While two thinned regions having a thinned width WT along both the inflow end portion 120 and outflow end portion 118 are illustrated in Fig.
  • a single thinned portion or more than two thinned portions having a thinned width WT that does not exceed 0.5 mm can be provided at any region along the length of the axial post strut 128.
  • the inflow end portion 120 of an axial post strut 128 can include a thinned region defining a width WT that does not exceed 0.5 mm.
  • the outflow end portion 118 of an axial post strut 128 can include a thinned region defining a width WT that does not exceed 0.5 mm.
  • an axial post strut 128 can include one or more thinned region(s) between the inflow end portion 120 and outflow end portion 118. In some regions, the axial post strut 128 can have a uniform thinned width WT that does not exceed 0.5 mm along its entire length.
  • the thinned width WT does not exceed 0.5 mm. In some examples, the thinned width WT does not exceed 0.45 mm. In some examples, the thinned width WT does not exceed 0.4 mm. In some examples, the thinned width WT does not exceed 0.35 mm. In some examples, the thinned width WT does not exceed 0.3 mm. In some examples, the thinned width WT does not exceed 0.25 mm.
  • the axial support member 122 g is further shown in Fig. 8 to define a member width WM at its inflow end portion 120 and outflow end portion 118.
  • the member width WM at any of the inflow end portion 120 and/or outflow end portion 118 does not exceed 0.5 mm. While both inflow end portion 120 and outflow end portion 118 are shown in the illustrated example to have the same width WM, it is to be understood that in some examples, the inflow end portion 120 and outflow end portion 118 can have different widths.
  • the member width WM does not exceed 0.5 mm. In some examples, the member width WM does not exceed 0.45 mm. In some examples, the member width WM does not exceed 0.4 mm. In some examples, the member width WM does not exceed 0.35 mm. In some examples, the member width WM does not exceed 0.3 mm. In some examples, the member width WM does not exceed 0.25 mm.
  • thinned regions of the axial frame members 116 can serve as strainrelief regions so as to provide some degree of separation that will allow the inflow region of the frame to be crimped and expanded with a reduced degree of influence on the outflow behavior.
  • axial frame members 116 having at least one region along a length thereof defining a width that does not exceed 0.5 mm are described above and illustrated in Fig.
  • an axial support member 122 having outer edges 124 which are linear along most of their lengths, and axial frame members 116 having at least one region along their lengths defining a width that does not exceed 0.5 mm, are shown in combination for a frame 102 g by way of illustration and not limitation, and that these features can be separately implemented in any exemplary prosthetic valve 100 disclosed herein.
  • FIG. 9 shows a portion of a frame 102 h of an exemplary prosthetic valve 100 h .
  • Frame 102 h is an exemplary implementation of a frame 102, and thus can include any of the features described for a frame 102 throughout the current disclosure, except that the frame 102 s can include a rectangularly-shaped axial support member 122 h defined by linear outer edges 124.
  • the axial support member 122 h can include a single opening 126 which can be also rectangularly-shaped as shown in Fig. 9, though it is to be understood that any other number of opening, having any other shape, is contemplated.
  • FIG. 10 shows a portion of a frame 102 1 of an exemplary prosthetic valve 100 1 .
  • Frame 102 1 includes an axial support member 122 h that can be similar to any example described above with respect to axial support member 122 g , except that the axial support member 122 h includes two differently shaped opening 126. While a circular upper opening 126U and a D-shaped lower opening 126L are illustrated in Fig. 10, it is to be understood that any other shape for any of the openings 126 is contemplated. Furthermore, while axial support member 122 g and 122 h are shown to have two openings 126, it is to be understood that any other number of openings is contemplated.
  • a prosthetic valve When a prosthetic valve is deployed at the native valve, optionally using a delivery apparatus equipped with a balloon catheter for controlled expansion, it is possible for the radially expanded prosthetic valve to be deployed at a random radial orientation relative to the native valve.
  • a delivery apparatus equipped with a balloon catheter for controlled expansion it is possible for the radially expanded prosthetic valve to be deployed at a random radial orientation relative to the native valve.
  • different axial frame members 116 of a prosthetic valve 100 can include differently shaped or arranged openings in order to allow visualization of the commissure under imaging (for example, fluoroscopy) during the implantation procedure.
  • FIGs. 11 A- 11C show three portions of a frame 102' of an exemplary prosthetic valve 100'.
  • Frame 102' is an exemplary implementation of a frame 102, and thus can include any of the features described for a frame 102 throughout the current disclosure, except that each of the three axial support members 122 J of the frame 102' includes a differently shaped combination of the upper opening 126U and the lower opening 126L.
  • at least one of the openings 126 of the axial support members 122' can be non-circular, such that it will be possible to distinguish between different orientation thereof.
  • the openings 126 are D-shaped, having a vertical linear edge and an opposite curved edge, wherein the orientation of the D-shaped openings is varied between the different axial support members 122'.
  • Fig. 11A shows a first axial support member I 22'a that includes upper 126U and lower 126L D-shaped openings which are oriented in opposite directions to each other.
  • Fig. 11B shows a second axial support member 122'b that includes upper 126U and lower 126L D-shaped openings which are oriented in the same direction, such that their linear edges are aligned with each other.
  • Fig. 11A shows a first axial support member I 22'a that includes upper 126U and lower 126L D-shaped openings which are oriented in opposite directions to each other.
  • Fig. 11B shows a second axial support member 122'b that includes upper 126U and lower 126L D-shaped openings which are oriented in the same direction, such that their linear edges are aligned with each other.
  • 11C shows a third axial support member 122'c that includes upper 126U and lower 126L D-shaped openings which are oriented in the same direction - opposite to the second axial support member 122'b. This configuration may assist a clinician with alignment and orientation of the prosthetic valve 100 during deployment.
  • FIGs. 12A-12C show three portions of a frame 102 k of an exemplary prosthetic valve 100 k .
  • Frame 102 k is an exemplary implementation of a frame 102, and thus can include any of the features described for a frame 102 throughout the current disclosure, except that each axial post strut 128 k of the frame 102 k includes an upper opening 130U and a lower opening 130L formed therein.
  • each of the three axial post struts 128 k includes a differently shaped combination of the upper opening 130U and the lower opening 130L.
  • at least one of the openings 130 of the axial post struts 128 k can be non-circular, such that it will be possible to distinguish between different orientation thereof.
  • the openings 130 are D-shaped, having a vertical linear edge and an opposite curved edge, wherein the orientation of the D-shaped openings is varied between the different axial post struts 128 k .
  • Fig. 12A shows a first axial post strut 128 k a that includes upper 130U and lower 130L D-shaped openings which are oriented in opposite directions to each other.
  • Fig. 12B shows a second axial post strut 128 k b that includes upper 130U and lower 130L D-shaped openings which are oriented in the same direction, such that their linear edges are aligned with each other.
  • Fig. 12A shows a first axial post strut 128 k a that includes upper 130U and lower 130L D-shaped openings which are oriented in opposite directions to each other.
  • Fig. 12B shows a second axial post strut 128 k b that includes upper 130U and lower 130L D-shaped openings which are oriented in the same direction, such that
  • FIG. 12C shows a third axial post strut 128 k c that includes upper 130U and lower 130L D-shaped openings which are oriented in the same direction - opposite to the second axial post strut 128 k b. Similar to the exemplary frame 102 j , such a configuration may assist a clinician with alignment and orientation of the prosthetic valve 100 during deployment.
  • Figs. 12A-12C are shown by way of illustration and not limitation, and that other combinations are similarly contemplated.
  • D-shaped openings are shown merely by way of example, and that openings 130 formed inside axial post struts 128 k can have any other shape, and that that various openings 130 in different axial post struts 128 k may vary from each other not only in their orientation but may have different shapes as well.
  • the valvular structure 156 can comprise shaped tissue material.
  • the valvular structure 156 including leaflet bellies 162 of leaflets 160 thereof, is a single-piece three-dimensional construct formed from a single patch 70 of tissue, as shown, for example, in Fig. 13A.
  • leaflet bellies 162 disclosed herein are not flattenable.
  • the term "not flattenable”, as used herein, means that the leaflet belly 162 cannot be flattened. That is to say, if an attempt is made to straighten out the curve of a free edge 166 of leaflet 160, the curve will not be able to be completely straightened such that leaflet belly 162 becomes flat.
  • 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.
  • a leaflet belly 162 which is not flattenable defines a non-developable surface. Further details regarding leaflets or leaflet bellies 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. [0340] Figs.
  • FIG. 13A-13C show some stages in a method of forming an exemplary valvular structure 156 1 .
  • Fig. 13A shows a 3D-shaped patch 70 of material, which can be a tissue patch that can have, prior to 3D-shaping thereof, a generally rectangular patch extending between side edges 72a and 72b.
  • a flat rectangular patch 70 can be inserted into a mold assembly and pressed between upper and lower templates, forcing it to assume the shape defined by the various surfaces of such templates.
  • Fig. 13A shows the patch 70 in a 3D-shaped configuration, after removal from such a mold assembly.
  • the patch is formed of a tissue material (e.g., bovine pericardium)
  • cross-linking the tissue patch 70 can result in the tissue maintaining its shape after being removed or separated from the mold assembly.
  • Fig. 13B shows an optional subsequent step of forming a tubular valvular structure 156 1 by rolling the 3D-shaped patch 70.
  • the side edges 72a and 72b can be brought together in a mating or otherwise abutting relationship.
  • both side edges 72a, 72b can be coupled to each other, such as by sewing, adhering, or otherwise attaching the side edges 72, thus resulting in a substantially cylindrical valvular structure 156 1 as shown in Fig. 13C.
  • each commissure attachment region 168 can be folded so as to form a commissure region fold 170 extending radially outwards, defining two commissure region side portions 172 extending therefrom.
  • Each leaflet 160 of the valvular structure 156 1 has a free edge 166 and a cusp line 164 that can have, in some examples, a curved shape, opposite to the free edge 166.
  • the cusp line 164 of each leaflet 160 can form a single scallop that can be, for example, parabolic in shape.
  • Commissure attachment regions 168 of the valvular structure 156 1 can be defined between adjacent leaflets 160, as regions of the valvular structure 156 1 that extend to a certain axial length from the level of the free edges 166.
  • a leaf-shaped leaflet belly 162 of each leaflet 160 is defined between the cusp line 164 and the free edge 166, excluding the commissure attachment regions 168.
  • a line of attachment can extend along the cusp lines 164 (see, for example, Fig. 7A) of all leaflets 160, together forming a scalloped shaped attachment pattern that can be stitched or otherwise coupled to the frame, directly or indirectly.
  • the scalloped line of attachment following at least a portion of the cusp lines 164, such as parallel to and somewhat distal to the cusp lines, optionally without extending into the commissure attachment regions 168, can have an undulating, curved scalloped shape.
  • each leaflet 160 is the part of the leaflet 160 remaining unattached to the frame or other components of the valve after assembly, configured to open and close (or coapt) during operation of the prosthetic valve 100, such as during systole and diastole.
  • FIG. 13C shows an exemplary valvular structure 156 1 , which can be similar to any example of a valvular structure 156 disclosed herein, except that the valvular structure 156 1 further comprises an engagement portion 194 extending between a distal end 196 thereof and the cusp lines 164, wherein the distal end 196 of the engagement portion 194 can be circular in the cylindrical configuration of the valvular structure 156 1 as shown in Fig. 13C, or substantially linear in a flattened configuration of the valvular structure 156 1 as shown in Fig. 13A for example.
  • the engagement portion 194 can be cylindrically disposed along an inner surface of the frame 102, and coupled thereto, such as by sutures or other couplers that extend both through the scalloped line following at least a portion of the cusp lines 164, and the distal end 196 of the engagement portion 194.
  • the engagement portion 194 can remain flattenable after the 3D-shaping process of the leaflets 160. Having a flattenable engagement portion 194 can assist in attachment thereof to the frame 102, wherein a flattenable engagement portion 194 can be rolled into a cylindrical or semi-cylindrical shape that can conveniently cover the inner surface of the frame 102, while the leaflet bellies 162, which are movable portions that remain unattached to the frame, can be formed as portions which are not-flattenable to improve performance of the valvular structure 156 1 .
  • the distal end 196 of the engagement portion 194 can extend all the way towards, or terminate in close proximity to, the inflow end 106 of the frame 102. In some examples, the distal end 196 of the engagement portion 194 can extend all the way towards, or terminate in close proximity to, the inflow apices 150. In some examples, the distal end 196 of the engagement portion 194 is parallel to the inflow end 106. In some examples, the distal end 196 of the engagement portion 194 is curved, for example by generally tracking the scalloped shape of the cusp lines 164.
  • FIG. 14 shows a top view of an exemplary prosthetic vale 100 having a valvular structure 156 mounted inside the frame 102.
  • each commissure attachment region 168 is overfolded, wherein the commissure region fold 170 is facing an inner surface 132i of a corresponding commissure port 132, and two commissure region side portions 172 are shown to extend from the commissure region fold 170 to the leaflet bellies 162 of both leaflets 160 defined on both sides of the commissure attachment region 168.
  • Fig. 15 shows an enlarged perspective view of a portion of the prosthetic valve 100 of Fig. 14, including a commissure 192 viewed from the outer side of the prosthetic valve 100.
  • each commissure 192 further comprises a patch 182 folded over the commissure post 132 and commissure attachment region 168.
  • a patch 182 can be used to secure the commissure attachment region 168 to the commissure post 132.
  • the patch 182 can be made from or comprise tissue (e.g., bovine pericardium) or synthetic suitable material.
  • the patch 182 comprises a relatively non-abrasive or smooth material.
  • the patch 182 can comprise a polymeric material.
  • the polymeric material can be relatively thromboresistant or have a thromboresistance that is greater than that of a fabric.
  • the polymeric material of the patch 182 can comprise thermoplastic polyurethane (TPU), silicone, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), and/or other similar materials.
  • the valvular structure 156 in addition to attachment of a commissure attachment region 168 to the commissure post 132 of a frame 102 at a commissure 192, can be coupled along a sub-commissure region (e.g., below the commissure attachment region 168) to the corresponding axial post strut 128, such as by a suture 90 forming a series of stitches shown in the illustrated example.
  • a sub-commissure region e.g., below the commissure attachment region 162
  • suture 90 forming a series of stitches shown in the illustrated example.
  • FIG. 15 shows an exemplary commissure 192 m , illustrated in cross-section in Fig. 16, wherein the patch 182 is folded so as to form a patch fold 184 disposed over an outer surface 132o of the commissure post 132, with two patch portion 186 of the patch 182 extending radially inwards from the patch fold 184, along sidewalls 136 of the commissure post 132 and at least part of the commissure region side portions 172.
  • Various sutures and stitching patterns can be optionally used to couple the commissure attachment region 168 and the patch 182 to the commissure post 132 and to each other.
  • a first stitch line 80a is illustrated in Fig. 16 to extend through the patch fold 184 and the commissure region fold 170 across the slot 134 of the commissure post 132 so as to secure both folds to each other and to the commissure post 132.
  • a second stitch line 80b which can be radially inwards to the commissure post 132 and extend in a direction that can be generally perpendicular to the radial direction of the first stitch line 80a, can extend through the two patch portions 186 and the two commissure region side portions 172 to secure them to each other. It is to be understood that the same suture or different sutures can be used to form any of the stitch lines 80a, 80b.
  • stitch lines 80a, 80b and their positions are shown by way of illustration and not limitation, and that other stitching patterns can be employed to secure the commissure attachment region 168 and the patch 182 to the commissure post 132 and to each other.
  • commissure attachment region 168 In the example illustrated for a commissure 192 m in Fig. 16, one or more sutures are shown to pass through the commissure attachment region 168 while forming the stitch lines 80a, 80b.
  • pulling forces applied on the tissue at regions of suture penetration into the commissure attachment region 168 can cause tearing of the tissue material and impact long-term durability.
  • a reinforcement member 198 is added to an inner surface of the commissure attachment region 168, so as to distribute the pulling forces more evenly along the reinforcement member 198 at the regions of suture penetration.
  • FIG. 17 shows a cross-sectional view of a commissure 192 n , which is an exemplary implementation of a commissure 192, and thus can include any of the features described for a commissure 192 throughout the current disclosure, except that commissure 192 n further comprises a reinforcement member 198 shown to include a strip of fabric 198 n disposed inside of the folded commissure attachment region 168, such that the stitch lines 80a and 80b are passed through the reinforcement member 198 n .
  • Fig. 18 shows a cross-sectional view of a commissure 192°, which can be similar to the commissure 192 11 , except that the reinforcement member 198 is shown to include a thick chord or suture 198°, such as a multi-filament suture (e.g., an Ethibond suture), disposed inside of the folded commissure attachment region 168, such that the stitch lines 80a and 80b are passed through the reinforcement member 198°.
  • a thick chord or suture 198° such as a multi-filament suture (e.g., an Ethibond suture)
  • Figs. 19A-19C show some stages in a method of forming an exemplary commissure 192.
  • Fig. 19A shows an exemplary fold stitch line 82f formed along the commissure region fold 170.
  • the fold stitch line 82f can include an in-and-out stitching pattern comprising a plurality of loops 84f (which can also be referred to as bights or looped stitches) that loop over the outer end of the commissure region fold 170 and are spaced apart from one another in the axial direction (or in direction of the in-and-out stitches).
  • the loops 84f can be connected together within the fold stitch line 82f by in-and-out stitches thereof.
  • FIG. 19B shows the commissure region fold 170 positioned at the inner surface 132i of the commissure post 132, wherein the loops 84f of the fold stitch line 82f are aligned with, and are oriented towards, the slot 134 of the commissure post 132.
  • the loops 84f of the fold stitch line 82f can extend into and/or through the slot 134 of the commissure post 132.
  • additional stitches 86f can extend through the patch fold 184 and pass through the loops 84f of the fold stitch line 82f, thereby attaching the patch fold 184 and the commissure region fold 170 to each other and to the commissure post 132.
  • the stitches 86f are aligned with, and can extend through, the slot 134 of the commissure post 132.
  • loop(s) 88d and an in-and-out stitch line 88p are shown in combination in Fig. 19C for illustrative purpose, and that any of the loop(s) 88d or in-and-out stitch line 88p can be separately implemented during formation of a commissure 192.
  • an in-and-out stitch line 88p is shown in Fig. 19C to extend through the two commissure region side portions 172 without passing through the two patch portions 186, in some examples, an in-and-out stitch line 88p can extend through all four layers.
  • Fig. 19D shows an exemplary commissure 192 q in which each patch portion 186 can be separately stitched to the corresponding commissure region side portion 172 covered thereby.
  • An exemplary side stitch line 82s can be formed along the commissure region side portion 172.
  • the side stitch line 82s can include an in-and-out stitching pattern comprising a plurality of loops 84s (which can also be referred to as bights or looped stitches) that loop over the outer surface of the commissure region side portion 172 (e.g., the surface facing the corresponding patch portion 186) and are spaced apart from one another in the axial direction (or in direction of the in-and-out stitches).
  • the loops 84s can be connected together within the side stitch line 82s by in-and-out stitches thereof. Additional stitches 86s (e.g., in- and-out stitches) can extend through the patch portion 186 and pass through the loops 84s of the side stitch line 82s, thereby attaching the patch portion 186 and the commissure region side portion 172 to each other. While a single patch portion 186 is shown to be coupled in this manner to a single commissure region side portion 172 on one side of the commissure 192 q , it is to be understood that the same can be performed to couple the opposite patch portion 186 and commissure region side portion 172 to each other. [0362] While a fold stitch line 82f is illustrated in Fig.
  • any of the exemplary commissures 192 illustrated throughout Figs. 19A-19D can optionally include any of the reinforcement members 198 described above with respect to Figs. 17-18.
  • FIGs. 20A-20C show some stages in a method of forming an exemplary valvular structure 156 r .
  • Fig. 20A shows a flattened view of a patch 70 defining leaflet 160 that can be optionally 3D-shaped as described above with respect to Figs. 13 A- 13C, for example.
  • Fig. 20B shows the patch 70 of Fig. 20A, wherein commissure slots 174 formed at the commissure attachment regions, the slots 174 defining commissure tabs 176 which can be folded radially away from the plane of the patch 70, as illustrated in a perspective view of Fig. 20C.
  • sub-commissure slots 178 can be further formed below (e.g., distal to) the commissure slots, as shown in Fig. 20B, the slots 178 defining sub-commissure tabs 180 which can be folded radially away from the plane of the patch 70, as illustrated in a perspective view of Fig. 20C.
  • sub-commissure slots 178 can be Lshaped to define sub-commissure tabs 180 in the form of foldable flaps.
  • commissure slots 174 can extend from the level of the free edges 166 of the patch 70, and may be inverse T-shaped to define commissure tabs 176 in the form of foldable flaps. While inverse T-shape commissure slots 174 are illustrated in Fig. 20B, in some examples, the commissure slots 174 do not necessarily extend from the level of the free edges 166, in which case the commissure slots 174 can be I- shaped in a similar manner shown for the sub-commissure slots 178.
  • Each commissure slot 174 formed in a commissure attachment region 168 bound between two leaflets 160 can be T-shapes as illustrated (or I-shaped) to define two commissure tabs 176 on both sides thereof, while a commissure slot 174 formed next to a side edge 72 of the patch 70 can be L-shaped or form a generally horizontally-extending slit to form a single commissure tab 176, such that when the patch 70 is rolled to a cylindrical form, the two commissure tabs 176 extending from the side edges 72 are disposed next to each other.
  • each sub-commissure slot 178 formed between two leaflets 160 can be I- shaped to define two sub-commissure tabs 180 on both sides thereof, while a sub-commissure slot 178 formed next to a side edge 72 of the patch 70 can include two horizontally-shaped parallel slits to form a single sub-commissure tab 180, such that when the patch 70 is rolled to a cylindrical form, the two sub-commissure tabs 180 extending from the side edges 72 are disposed next to each other.
  • FIG. 21 is a top view of an exemplary prosthetic valve 100 r having a valvular structure 156 r coupled to the frame 102.
  • Fig. 22 is a cross-sectional view along line 22-22 of Fig. 21.
  • a commissure 192 r of a prosthetic valve 100 r can be formed by extending the commissure tabs 176 radially outwards and around the respective commissure posts 132.
  • the commissure tabs 176 can be optionally coupled to each other (e.g., sutured) on the outer side of the frame 102.
  • the commissure 192 r can be optionally formed, in some examples, without the use of an additional patch 182.
  • a commissure post 132 to which the commissure 192 is coupled can be either provided with a slot 134 or without a slot.
  • the sub-commissure tabs 180 are formed below the level of the commissure posts 132, such that the valvular structure 156 r can be additionally secured to the frame 102 by extending the sub-commissure tabs 180 radially outwards and around the respective axial post struts 128.
  • the sub-commissure tabs 180 can be optionally coupled to each other (e.g., sutured) on the outer side of the frame 102.
  • a prosthetic valve 100 r can include a valvular structure 156 r having only commissure tabs 176 formed by commissure slots 174, or only sub-commissure tabs 180 formed by subcommissure slots 178.
  • a valvular structure 156 of a prosthetic valve 100 defines an effective outflow area (EOA) through which blood can flow in the open state of the leaflets 160.
  • EOA effective outflow area
  • the folded portions of the commissure attachment regions 168 extending radially inwards from the inner surface of the frame 102 result in a narrower EOA, producing a relatively high pressure gradient across the prosthetic valve 100.
  • Fig. 23 shows an exemplary prosthetic valve 100 s
  • Fig. 24 shows an exemplary valvular structure 156 s of the prosthetic valve 100 s shown in Fig. 23.
  • Prosthetic valve 100 s 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 and the valvular structure 156 s of prosthetic valve 100 s define non-uniform diameters along their axial heights in the expanded configuration of the prosthetic valve 100 s .
  • the frame 102 s is shown to include multiple frame sections 108, including an inflow section 1081 extending proximally from the inflow end 106, an enlarged outflow section 1080 extending distally from the outflow end 104, and a transition section 108T between the inflow section 1081 and the outflow section 1080.
  • the outflow section 1080 has a larger cross-section or diameter than that of the inflow section 1081 in the expanded configuration of the prosthetic valve 100 s , while the transition section 108T may taper outwardly from the inflow section 1081 to the outflow section 1080.
  • the valvular structure 156 s shown in Figs. 23-24 can be formed to include multiple valvular structure sections 158 that can match the frame sections 108, including an inflow section 1081 extending proximally from the distal end 196 of the engagement portion 194, an enlarged outflow section 1580 extending distally from the free edges 166, and a transition section 158T between the inflow section 1581 and the outflow sections 1580.
  • the outflow section 1580 similarly has a larger cross- section or diameter than that of the inflow section 1581 in the expanded configuration of the prosthetic valve 100 s , while the transition section 158T may taper outwardly from the inflow section 1581 to the outflow section 1580.
  • Fig. 33 is a perspective view of a frame 102 z of an exemplary prosthetic valve 100 z .
  • Frame 102 z is an exemplary implementation of a frame 102, and thus can include any of the features described for a frame 102 throughout the current disclosure, except that each axial post strut 128 z of the frame 102 z is formed with a plurality of recesses, or grooves 125, formed along its outer edges 124.
  • the grooves 125 can be sized to receive a suture 90 extending therealong.
  • grooves 125 along each outer edge 124 can be axially spaced from each other, either at equal or non-equal distanced from each other.
  • both outer edges 124 of an axial post strut 128 z can include the same number of grooves 125.
  • corresponding grooves 125 on both edges 124 can be axially aligned with each other.
  • Fig. 34 shows an enlarged perspective view of a portion of a prosthetic valve 100 z , including a commissure 192 viewed from the outer side of the prosthetic valve 100 z .
  • the valvular structure 156 of a prosthetic valve 100 z can be coupled along a sub-commissure region (e.g., below the commissure attachment region 168) to the corresponding axial post strut 128 z .
  • a suture 90 can be used to form a series of stitches connecting the sub-commissure region to the corresponding axial post strut 128 z , as illustrated.
  • the grooves can advantageously serve to maintain the axial position of the stitches and prevent them from sliding along the axial post struts 128 z , thereby improving securement of the valvular structure 156 to the frame 102 z and reducing risk of suture wear.
  • Portions of one or more sutures 90 can be passed between the grooves 125 so as to cross each other on the outer side of the axial post strut 128, forming X-patterned stitches as illustrated, for example, in Fig. 34, though it is to be understood that any other stitching pattern is contemplated. It is to be understood that five grooves 125 formed on each outer edge 124 are shown in Fig. 34 by way of illustration and not limitation, and that any other number, including any other plurality of grooves 125 or, in some examples, a single groove 125, is contemplated. [0381] In some examples, axial support members 122 can also include one or more grooves 125 formed along their outer edges 124, as illustrated, for example, in Fig. 33.
  • grooves 125 formed along axial support members 122 can follow any of the examples described herein for grooves 125 of axial post struts 128 z .
  • the number, size and distribution of grooves 125 of axial support members 122 can be similar or different than that of the axial post struts 128 z .
  • grooves 125 can be utilized to pass a suture 90 therealong, forming stitches connecting soft components of a prosthetic valve 100 z to the axial support members 122, such as, but not limited to, connecting protective covering members 188 to the axial support members 122.
  • a prosthetic valve 100 z can include axial post struts 128 z having grooves 125, while the axial support members 122 can be devoid of grooves, and can optionally have any shape as disclosed herein, such as 8-shaped axial support members 122, O-shaped axial support member 122, or other shapes as described herein.
  • Example 3 The prosthetic valve of any example herein, particularly of example 1 or 2, wherein the commissures terminate proximal to the outflow apices.
  • Example 5 The prosthetic valve of any example herein, particularly of any one of examples 1 to 4, wherein the first subsequent angled struts, the second subsequent angled struts, and the third subsequent angled struts, have equal lengths.
  • Example 6 The prosthetic valve of any example herein, particularly of any one of examples 1 to 5, wherein each outflow apex comprises an arcuate apex region defined between an upwardly convex-shaped upper curved surface and an opposing lower curved surface.
  • Example 7 The prosthetic valve of any example herein, particularly of any one of examples 1 to 6, wherein each inflow apex comprising an arcuate apex region defined between a downwardly concave-shaped lower curved surface and an opposing upper curved surface.
  • Example 8 The prosthetic valve of any example herein, particularly of any one of examples 1 to 7, wherein the inflow angled struts comprise a plurality of elongated inflow angled struts and a plurality of regular inflow angled struts, and wherein the elongated inflow angled struts are longer than the regular inflow angled struts.
  • Example 9 The prosthetic valve of any example herein, particularly of example 8, wherein the regular inflow angled struts and the third subsequent angled struts have equal lengths.
  • Example 10 The prosthetic valve of any example herein, particularly of example 8 or 9, wherein the inflow apices comprise a plurality of first inflow apices defined by the regular inflow angled struts, and a plurality of second inflow apices defined by the elongated inflow angled struts, and wherein the second inflow apices are distal to the first inflow apices.
  • Example 11 The prosthetic valve of any example herein, particularly of example 10, wherein the second inflow apices are not aligned circumferentially with any of the outflow apices.
  • Example 12 The prosthetic valve of any example herein, particularly of example 10 or 11 , wherein the axial frame members comprise a plurality of axial post struts aligned with the commissure posts, and a plurality of axial support members disposed between the axial post struts, and wherein the second inflow apices are aligned with the axial support members.
  • Example 13 The prosthetic valve of any example herein, particularly of any one of examples 10 to 12, wherein the leaflets comprise cusp lines defining midpoints aligned with the second inflow apices.
  • Example 14 The prosthetic valve of any example herein, particularly of example 13, wherein the midpoints of the cusp lines of the leaflets are coupled to the second inflow apices.
  • Example 15 The prosthetic valve of any example herein, particularly of any one of examples 8 to 14, wherein the frame further comprises an inflow cell row comprising a plurality of regular inflow cells and a plurality of elongated inflow cells, and wherein the elongated inflow cells are axially longer than the regular inflow cells.
  • Example 16 The prosthetic valve of any example herein, particularly of example 15, wherein each regular inflow cell is a diamond-shaped cell defined between two third subsequent angled struts and two regular inflow angled struts.
  • Example 17 The prosthetic valve of any example herein, particularly of example 15 or 16, wherein each elongated inflow cell is a kite-shaped cell defined between two third subsequent angled struts and two elongated inflow angled struts.
  • Example 18 The prosthetic valve of any example herein, particularly of any one of examples 1 to 7, wherein the frame further comprises a plurality of axial inflow struts extending between the third subsequent rung and the inflow rung.
  • Example 19 The prosthetic valve of any example herein, particularly of example 18, wherein the axial inflow struts are shorter than the axial frame members.
  • Example 20 The prosthetic valve of any example herein, particularly of example 19, wherein the frame further comprises an inflow cell row comprising a plurality of inflow cells, and wherein each inflow cell is a hexagonal cell defined between two third subsequent angled struts, two axial inflow struts, and two inflow angled struts.
  • Example 21 The prosthetic valve of any example herein, particularly of example 20, wherein the frame further comprises a first subsequent cell row comprising a plurality of first subsequent cells, wherein each first subsequent cells is a diamond-shaped cell defined between two first subsequent angled struts and two second subsequent angled struts.
  • Example 22 The prosthetic valve of any example herein, particularly of example 21, wherein the inflow cells are axially longer than the first subsequent cells.
  • Example 23 The prosthetic valve of any example herein, particularly of any one of examples 1 to 20, wherein the frame further comprises an outflow cell row comprising a plurality of outflow cells, and a first subsequent cell row comprising a plurality of first subsequent cells, wherein each outflow cell spans a width of two of the first subsequent cells.
  • Example 24 The prosthetic valve of any example herein, particularly of example 23, wherein each outflow cell is defined between two outflow angled struts, two axial frame members, and two first subsequent angled struts.
  • Example 25 The prosthetic valve of any example herein, particularly of example 23 or 24, wherein each first subsequent cell is a diamond- shaped cell defined between two first subsequent angled struts and two second subsequent angled struts.
  • Example 26 The prosthetic valve of any example herein, particularly of any one of examples 23 to 25, wherein the outflow cells are axially longer than the first subsequent cells.
  • Example 27 A prosthetic valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame comprising: an outflow rung comprising outflow angled struts defining a plurality of outflow apices; a plurality of subsequent rungs distal to the outflow rung, each subsequent rung comprising a plurality of subsequent angled struts, wherein a first subsequent rung of the plurality of subsequent rungs defines a plurality of free apices aligned with the outflow apices; a plurality of axial frame members extending between the outflow rung and the first subsequent rung; a plurality of commissure posts extending proximally from the outflow rung; a plurality of vertical stabilization struts extending distally from the outflow a
  • Example 28 The prosthetic valve of any example herein, particularly of example 27, further comprising a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.
  • Example 29 The prosthetic valve of any example herein, particularly of example 28, wherein the valvular structure comprises a plurality of commissure attachment regions defined between adjacent leaflets, the commissure attachment regions forming commissures coupled to the commissure posts.
  • Example 30 The prosthetic valve of any example herein, particularly of example 29, wherein the commissures terminate proximal to the outflow apices.
  • Example 31 The prosthetic valve of any example herein, particularly of any one of examples 28 to 30, wherein the valvular structure is a one-piece material.
  • Example 32 The prosthetic valve of any example herein, particularly of any one of examples 27 to 31, wherein the outflow angled struts are longer than any of the subsequent angled struts.
  • Example 33 The prosthetic valve of any example herein, particularly of any one of examples 27 to 32, wherein the angled stabilization struts are longer than any of the subsequent angled struts.
  • Example 34 The prosthetic valve of any example herein, particularly of any one of examples 27 to 33, wherein the frame further comprises a plurality of first outflow sub-cells and a plurality of second outflow sub-cells, disposed between the outflow rung and the first subsequent rung.
  • Example 35 The prosthetic valve of any example herein, particularly of example 34, wherein each first outflow sub-cell is defined between an outflow angled strut, an angled stabilization strut, an axial frame member and a vertical stabilization strut.
  • Example 36 The prosthetic valve of any example herein, particularly of example 35, wherein each first outflow sub-cell is parallelogram-shaped.
  • Example 37 The prosthetic valve of any example herein, particularly of any one of examples 34 to 36, wherein each second outflow sub-cell is defined between two angled stabilization struts and four subsequent angled struts of the first subsequent rung.
  • Example 40 The prosthetic valve of any example herein, particularly of example 39, wherein each first subsequent cell is a diamond- shaped cell defined between two subsequent angled struts of the first subsequent rung and two subsequent angled struts of the second subsequent rung.
  • Example 41 The prosthetic valve of any example herein, particularly of example 39 or 40, wherein each second outflow sub-cell spans a width of two of the first subsequent cells.
  • Example 42 The prosthetic valve of any example herein, particularly of any one of examples 27 to 41, wherein each free apex comprises an arcuate apex region defined between an upwardly convex-shaped upper curved surface and an opposing lower curved surface.
  • Example 43 The prosthetic valve of any example herein, particularly of any one of examples 27 to 42, wherein the plurality of axial frame members comprises a plurality of axial post struts and a plurality of axial support members, and wherein the axial post struts are circumferentially aligned with the commissure posts.
  • Example 44 The prosthetic valve of any example herein, particularly of example 43, wherein the axial post struts and the axial support members are alternately arranged around the circumference of the frame.
  • Example 45 The prosthetic valve of any example herein, particularly of example 43 or 44, wherein the plurality of axial post struts comprises three axial post struts, and wherein the plurality of axial support members comprises three axial support members.
  • Example 46 The prosthetic valve of any example herein, particularly of any one of examples 27 to 45, wherein the plurality of commissure posts comprises three commissure posts.
  • Example 47 The prosthetic valve of any example herein, particularly of any one of examples 27 to 46, wherein each commissure post comprises a slot.
  • Example 48 A prosthetic valve comprising: a frame formed at a frame cutting diameter and movable between the frame cutting diameter to a radially compressed configuration defining a smaller diameter than the frame cutting diameter, and from the compressed configuration to a radially expanded configuration defining a diameter that is greater than the frame cutting diameter, wherein the frame comprises: a plurality of rungs of angled struts, defining a plurality of cell rows, each cell row comprising a plurality of diamond-shaped cells; wherein an angle defined between angled struts of any of the diamondshaped cells, in the frame cutting diameter, is not greater than 120°.
  • Example 49 The prosthetic valve of any example herein, particularly of examples 48, wherein the angle defined between angled struts of any of the diamond-shaped cells, in the frame cutting diameter, is not greater than 110°.
  • Example 50 The prosthetic valve of any example herein, particularly of example 48, wherein the angle defined between angled struts of any of the diamond-shaped cells, in the frame cutting diameter, is not greater than 100°.
  • Example 51 The prosthetic valve of any example herein, particularly of any one of examples 48 to 50, wherein the angle is defined between angled struts of the same rung.
  • Example 52 The prosthetic valve of any example herein, particularly of any one of examples 48 to 51, further comprising a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.
  • Example 53 The prosthetic valve of any example herein, particularly of examples 52, wherein the valvular structure is a one-piece material.
  • Example 54 The prosthetic valve of any example herein, particularly of any one of examples 48 to 53, further comprising an outflow cell row comprising a plurality of outflow cells proximal to the rungs of angled stmts, wherein each outflow cell spans a width of two of the diamond-shaped cells.
  • Example 55 The prosthetic valve of any example herein, particularly of example 54, wherein each of the outflow cells is coupled to adjacent outflow cells via axial frame members of the frame.
  • Example 56 The prosthetic valve of any example herein, particularly of example 55, wherein the axial frame members comprise a plurality of axial post stmts and a plurality of axial support members, and wherein the axial post stmts are circumferentially aligned with commissure posts extending proximally from an outflow mng of the frame.
  • Example 57 The prosthetic valve of any example herein, particularly of example 56, wherein the axial post stmts and the axial support members are alternately arranged around the circumference of the frame.
  • Example 59 The prosthetic valve of any example herein, particularly of any one of examples 56 to 58, wherein the frame further comprises a plurality of commissure posts extending proximally from the axial post stmts.
  • Example 60 The prosthetic valve of any example herein, particularly of example 59, wherein the plurality of commissure posts comprises three commissure posts.
  • a prosthetic valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame comprising: an outflow mng comprising outflow angled stmts defining a plurality of outflow apices; a plurality of subsequent rungs distal to the outflow rung, each subsequent rung comprising a plurality of subsequent angled struts; a plurality of axial frame members extending between the outflow rung and a first subsequent rung of the plurality of subsequent rungs, each axial frame member comprising an inflow end portion connected to the first subsequent rung, and an outflow end portion connected to the outflow rung; and a plurality of commissure posts extending proximally from the outflow rung; wherein each of the axial frame members comprises at least one region defining a thinned width that does not exceed 0.5 mm.
  • Example 63 The prosthetic valve of any example herein, particularly of example 62, wherein the thinned width does not exceed 0.45 mm.
  • Example 64 The prosthetic valve of any example herein, particularly of example 62, wherein the thinned width does not exceed 0.40 mm.
  • Example 65 The prosthetic valve of any example herein, particularly of example 62, wherein the thinned width does not exceed 0.3 mm.
  • Example 66 The prosthetic valve of any example herein, particularly of example 62, wherein the thinned width does not exceed 0.25 mm.
  • Example 67 The prosthetic valve of any example herein, particularly of any one of examples 62 to 66, wherein the inflow end portion of at least one of the axial frame members comprises a thinned region defining the thinned width.
  • Example 68 The prosthetic valve of any example herein, particularly of any one of examples 62 to 67, wherein the outflow end portion of at least one of the axial frame members a thinned region defining the thinned width.
  • Example 69 The prosthetic valve of any example herein, particularly of any one of examples 62 to 68, wherein at least one of the axial frame members has a uniform width equal to the thinned width along a length thereof.
  • Example 70 The prosthetic valve of any example herein, particularly of any one of examples 62 to 69, wherein the plurality of axial frame members comprises a plurality of axial post struts and a plurality of axial support members, and wherein the axial post struts are circumferentially aligned with the commissure posts.
  • Example 71 The prosthetic valve of any example herein, particularly of example 70, wherein the axial post struts and the axial support members are alternately arranged around the circumference of the frame.
  • Example 77 The prosthetic valve of any example herein, particularly of example 76, wherein each of the subsequent cells is diamond-shaped.
  • Example 79 The prosthetic valve of any example herein, particularly of any one of examples 62 to 78, wherein first subsequent rung defines a plurality of free apices.
  • Example 80 The prosthetic valve of any example herein, particularly of example 79, wherein the free apices are circumferentially disposed between the axial frame members.
  • Example 81 The prosthetic valve of any example herein, particularly of example 79 or 80, wherein the free apices are aligned with the outflow apices.
  • Example 82 A prosthetic valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame comprising: an outflow rung comprising outflow angled struts defining a plurality of outflow apices; a plurality of subsequent rungs distal to the outflow rung, each subsequent rung comprising a plurality of subsequent angled struts; a plurality of axial frame members extending between the outflow rung and a first subsequent rung of the plurality of subsequent rungs, the plurality of axial frame members comprising a plurality of axial post struts and a plurality of axial support members; and a plurality of commissure posts extending proximally from the outflow rung; wherein the axial post struts are circumferentially aligned with the commissure posts; and wherein each of the axial support members comprises at least one opening and defines outer edges which are linear along at least 50% of the height of the axial support
  • Example 83 The prosthetic valve of any example herein, particularly of example 82, wherein outer edges which are linear along at least 60% of the height of the axial support member.
  • Example 84 The prosthetic valve of any example herein, particularly of example 82, wherein outer edges which are linear along at least 75% of the height of the axial support member.
  • Example 85 The prosthetic valve of any example herein, particularly of any one of examples 82 to 84, further comprising a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.
  • Example 86 The prosthetic valve of any example herein, particularly of example 85, wherein the valvular structure comprises a plurality of commissure attachment regions defined between adjacent leaflets, the commissure attachment regions forming commissures coupled to the commissure posts.
  • Example 87 The prosthetic valve of any example herein, particularly of any one of examples 82 to 86, further comprising protective covering members attached to the axial support members.
  • Example 88 The prosthetic valve of any example herein, particularly of example 87, wherein the protective covering members are disposed over an inner surface of the axial support members.
  • Example 89 The prosthetic valve of any example herein, particularly of any one of examples 82 to 88, wherein the at least one opening of each axial support member comprises at least two openings.
  • Example 90 The prosthetic valve of any example herein, particularly of any one of examples 82 to 89, wherein the axial post struts and the axial support members are alternately arranged around the circumference of the frame.
  • Example 91 The prosthetic valve of any example herein, particularly of any one of examples 82 to 90, wherein the plurality of axial post struts comprises three axial post struts, and wherein the plurality of axial support members comprises three axial support members.
  • Example 92 The prosthetic valve of any example herein, particularly of any one of examples 82 to 91 , wherein the plurality of commissure posts comprises three commissure posts.
  • Example 93 The prosthetic valve of any example herein, particularly of any one of examples 82 to 92, wherein each commissure post comprises a slot.
  • Example 94 The prosthetic valve of any example herein, particularly of any one of examples 82 to 93, wherein the frame further comprises an outflow cell row comprising a plurality of outflow cells coupled to each other via the axial frame members.
  • Example 95 The prosthetic valve of any example herein, particularly of example 94, wherein the frame further comprises a plurality of subsequent cell rows distal to the outflow cell row, each of the subsequent cell rows comprising a plurality of subsequent cells.
  • Example 96 The prosthetic valve of any example herein, particularly of example 95, wherein each of the subsequent cells is diamond-shaped.
  • Example 97 The prosthetic valve of any example herein, particularly of example 95 or 96, wherein each outflow cell spans a width of two of the subsequent cells.
  • Example 98 The prosthetic valve of any example herein, particularly of any one of examples 82 to 97, wherein first subsequent rung defines a plurality of free apices.
  • Example 99 The prosthetic valve of any example herein, particularly of example 98, wherein the free apices are circumferentially disposed between the axial frame members.
  • Example 100 The prosthetic valve of any example herein, particularly of example 98 or 99, wherein the free apices are aligned with the outflow apices.
  • Example 101 A prosthetic valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame comprising: an outflow rung comprising outflow angled struts defining a plurality of outflow apices; a plurality of subsequent rungs distal to the outflow rung, each subsequent rung comprising a plurality of subsequent angled struts; a plurality of axial frame members extending between the outflow rung and a first subsequent rung of the plurality of subsequent rungs; and a plurality of commissure posts extending proximally from the outflow rung; wherein at least some of the axial frame members comprise an upper opening and a lower opening, such that the combined shape of the upper opening and the lower opening is different between at least some of the axial frame members.
  • Example 102 The prosthetic valve of any example herein, particularly of example 101, wherein the plurality of axial frame members comprises a plurality of axial post struts and a plurality of axial support members.
  • Example 103 The prosthetic valve of any example herein, particularly of example 102, wherein the axial post struts are circumferentially aligned with the commissure posts.
  • Example 104 The prosthetic valve of any example herein, particularly of example 102 or 103, the axial post struts and the axial support members are alternately arranged around the circumference of the frame.
  • Example 105 The prosthetic valve of any example herein, particularly of any one of examples 101 to 104, wherein the plurality of axial post struts comprises three axial post struts, and wherein the plurality of axial support members comprises three axial support members.
  • Example 106 The prosthetic valve of any example herein, particularly of example 105, wherein the axial frame members comprising the upper openings and the lower openings are the axial support members.
  • Example 107 The prosthetic valve of any example herein, particularly of example 106, wherein the upper and lower openings of the axial support members are D-shaped.
  • Example 108 The prosthetic valve of any example herein, particularly of example 107, wherein the axial support members comprise a first axial support member having its upper opening and lower opening oriented in opposite directions relative to each other, a second axial support member having its upper opening and lower opening aligned with each other, and a third axial support member having its upper opening and lower opening aligned with each other and oriented in a direction opposite to the openings of the second axial support member.
  • Example 109 The prosthetic valve of any example herein, particularly of example 105, wherein the axial frame members comprising the upper openings and the lower openings are the axial post struts.
  • Example 110 The prosthetic valve of any example herein, particularly of example 109, wherein the upper and lower openings of the axial post struts are D-shaped.
  • Example 111 The prosthetic valve of any example herein, particularly of example 110, wherein the axial post struts comprise a first axial post strut having its upper opening and lower opening oriented in opposite directions relative to each other, a second axial post strut having its upper opening and lower opening aligned with each other, and a third axial post strut having its upper opening and lower opening aligned with each other and oriented in a direction opposite to the openings of the second axial post stmt.
  • the axial post struts comprise a first axial post strut having its upper opening and lower opening oriented in opposite directions relative to each other, a second axial post strut having its upper opening and lower opening aligned with each other, and a third axial post strut having its upper opening and lower opening aligned with each other and oriented in a direction opposite to the openings of the second axial post stmt.
  • Example 112 The prosthetic valve of any example herein, particularly of any one of examples 101 to 111, further comprising a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.
  • Example 114 The prosthetic valve of any example herein, particularly of any one of examples 101 to 113, further comprising protective covering members attached to the axial support members.
  • Example 115 The prosthetic valve of any example herein, particularly of example 114, wherein the protective covering members are disposed over an inner surface of the axial support members.
  • Example 116 The prosthetic valve of any example herein, particularly of any one of examples 101 to 115, wherein the plurality of commissure posts comprises three commissure posts.
  • Example 117 The prosthetic valve of any example herein, particularly of any one of examples 101 to 116, wherein each commissure post comprises a slot.
  • Example 118 The prosthetic valve of any example herein, particularly of any one of examples 101 to 117, wherein the frame further comprises an outflow cell row comprising a plurality of outflow cells coupled to each other via the axial frame members.
  • Example 119 The prosthetic valve of any example herein, particularly of example 118, wherein the frame further comprises a plurality of subsequent cell rows distal to the outflow cell row, each of the subsequent cell rows comprising a plurality of subsequent cells.
  • Example 120 The prosthetic valve of any example herein, particularly of example 119, wherein each of the subsequent cells is diamond-shaped.
  • Example 121 The prosthetic valve of any example herein, particularly of example 119 or 120, wherein each outflow cell spans a width of two of the subsequent cells.
  • Example 122 The prosthetic valve of any example herein, particularly of any one of examples 101 to 121, wherein first subsequent rung defines a plurality of free apices.
  • Example 123 The prosthetic valve of any example herein, particularly of example 122, wherein the free apices are circumferentially disposed between the axial frame members.
  • Example 124 The prosthetic valve of any example herein, particularly of example 122 or 123, wherein the free apices are aligned with the outflow apices.
  • a prosthetic valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame comprising: an outflow rung comprising outflow angled struts defining a plurality of outflow apices; a plurality of subsequent rungs distal to the outflow rung, each subsequent rung comprising a plurality of subsequent angled struts; a plurality of axial frame members extending between the outflow rung and a first subsequent rung of the plurality of subsequent rungs; and a plurality of commissure posts extending proximally from the outflow rung, each commissure post comprising a slot; and a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, the valvular structure defining a plurality of commissure attachment regions between adjacent leaflets, the commissure attachment regions forming commissures coupled to the commissure posts; wherein the valvular structure is
  • Example 126 The prosthetic valve of any example herein, particularly of example 125, wherein each commissure further comprises a folded patch forming a patch fold disposed over an outer surface of the corresponding commissure post, and two patch portions extending along sidewalls of the commissure post and over commissure region side portions of the corresponding commissure attachment region.
  • Example 127 The prosthetic valve of any example herein, particularly of example 126, wherein each commissure further comprises a reinforcement member disposed between the commissure region side portions of the corresponding commissure attachment region.
  • Example 128 The prosthetic valve of any example herein, particularly of example 127, wherein the reinforcement members comprises a strip of fabric.
  • Example 129 The prosthetic valve of any example herein, particularly of example 127, wherein the reinforcement members comprises a thick suture.
  • Example 130 The prosthetic valve of any example herein, particularly of example 129, wherein the thick suture comprises a multi-filament suture.
  • Example 131 The prosthetic valve of any example herein, particularly of any one of examples 127 to 130, wherein each commissure comprises a first stitch line extending through the patch fold and the commissure region fold.
  • Example 132 The prosthetic valve of any example herein, particularly of example 131, wherein the first stitch line extend through the slot of the commissure post.
  • Example 133 The prosthetic valve of any example herein, particularly of example 131 or 132, wherein the first stitch line further extends through the reinforcement member.
  • Example 134 The prosthetic valve of any example herein, particularly of any one of examples 127 to 132, wherein each commissure comprises a second stitch line extend through the patch portions and the commissure region side portions.
  • Example 135. The prosthetic valve of any example herein, particularly of example 134, wherein the second stitch line further extends through the reinforcement member.
  • Example 136 The prosthetic valve of any example herein, particularly of any one of examples 127 to 130, wherein each commissure further comprises a fold stitch line formed along the commissure region fold and comprising plurality of loops extending radially outwards.
  • Example 137 The prosthetic valve of any example herein, particularly of examplel36, wherein the loops are aligned with the slot of the corresponding commissure post.
  • Example 138 The prosthetic valve of any example herein, particularly of example 137, wherein the loops extend into the slot of the corresponding commissure post.
  • Example 139 The prosthetic valve of any example herein, particularly of any one of examples 136 to 138, wherein each commissure further comprises stitches extending through the patch fold and passed through the loops of the fold stitch line.
  • Example 140 The prosthetic valve of any example herein, particularly of example 139, wherein the stitches extend through the slot of the corresponding commissure post.
  • Example 141 The prosthetic valve of any example herein, particularly of any one of examples 127-130 or 136-140, further comprising one or more loops extending through the patch portions and the commissure region side portions.
  • Example 142 The prosthetic valve of any example herein, particularly of any one of examples 127-130 or 136-141, further comprising an in-and-out stitch line extending through the commissure region side portions.
  • Example 143 The prosthetic valve of any example herein, particularly example 142, wherein the in-and-out stitch line further extends through the patch portions.
  • Example 144 The prosthetic valve of any example herein, particularly of any one of examples 127-130 or 136-140, wherein each commissure further comprises, for each side of the commissure, a side stitch line formed along the commissure region side portion and comprising plurality of loops extending towards the corresponding patch portion.
  • Example 145 The prosthetic valve of any example herein, particularly of example 144, wherein each commissure further comprises, for each side of the commissure, stitches extending through the patch portion and passed through the loops of the side stitch line.
  • Example 147 The prosthetic valve of any example herein, particularly of example 146, wherein the axial post struts are circumferentially aligned with the commissure posts.
  • Example 148 The prosthetic valve of any example herein, particularly of example 146 or 147, wherein the axial post struts and the axial support members are alternately arranged around the circumference of the frame.
  • Example 149 The prosthetic valve of any example herein, particularly of any one of examples 125 to 148, wherein the plurality of axial post struts comprises three axial post struts, and wherein the plurality of axial support members comprises three axial support members.
  • Example 150 The prosthetic valve of any example herein, particularly of any one of examples 125 to 148, wherein the plurality of commissure posts comprises three commissure posts.
  • Example 153 The prosthetic valve of any example herein, particularly of example 152, wherein each of the subsequent cells is diamond-shaped.
  • Example 154 The prosthetic valve of any example herein, particularly of examplel52 or 153, wherein each outflow cell spans a width of two of the subsequent cells.
  • Example 155 The prosthetic valve of any example herein, particularly of any one of examples 125 to 154, wherein first subsequent rung defines a plurality of free apices.
  • Examples 156 The prosthetic valve of any example herein, particularly of example 155, wherein the free apices are circumferentially disposed between the axial frame members.
  • Example 157 The prosthetic valve of any example herein, particularly of example 155 or 156, wherein the free apices are aligned with the outflow apices.
  • a prosthetic valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame comprising: an outflow rung comprising outflow angled struts defining a plurality of outflow apices; a plurality of subsequent rungs distal to the outflow rung, each subsequent rung comprising a plurality of subsequent angled struts; a plurality of axial frame members extending between the outflow rung and a first subsequent rung of the plurality of subsequent rungs; and a plurality of commissure posts extending proximally from the outflow rung; and a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, the valvular structure defining a plurality of commissure attachment regions between adjacent leaflets, the commissure attachment regions forming commissures coupled to the commissure posts; wherein the valvular structure is a one-piece material; and wherein commissure
  • Example 160 The prosthetic valve of any example herein, particularly of example 158 or 159, wherein the commissure tabs disposed around each commissure post are coupled to each other.
  • Example 161 The prosthetic valve of any example herein, particularly of any one of examples 158 to 160, wherein at least some of the commissure slots are inverse T-shaped.
  • Example 162 The prosthetic valve of any example herein, particularly of any one of examples 158 to 160, wherein at least some of the commissure slots are I-shaped.
  • Example 163 The prosthetic valve of any example herein, particularly of any one of examples 158 to 162, wherein the valvular structure further comprises sub-commissure slots defining sub-commissure tabs below the commissure attachment regions.
  • Example 164 The prosthetic valve of any example herein, particularly of example 163, wherein at least some of the sub-commissure slots are I-shaped.
  • Example 165 The prosthetic valve of any example herein, particularly of example 163 or 164, wherein two of the sub-commissure tabs are wrapped around each of the corresponding one of the axial frame members.
  • Example 166 The prosthetic valve of any example herein, particularly of any one of examples 163 to 165, wherein each two of the sub-commissure tabs disposed around a corresponding one of the axial frame members are coupled to each other.
  • Example 167 The prosthetic valve of any example herein, particularly of any one of examples 158 to 166, wherein the plurality of axial frame members comprises a plurality of axial post struts and a plurality of axial support members.
  • Example 168 The prosthetic valve of any example herein, particularly of example 167, wherein the axial post struts are circumferentially aligned with the commissure posts.
  • Example 169 The prosthetic valve of any example herein, particularly of example 167 or 168, wherein the axial post struts and the axial support members are alternately arranged around the circumference of the frame.
  • Example 170 The prosthetic valve of any example herein, particularly of any one of examples 158 to 169, wherein the plurality of axial post struts comprises three axial post struts, and wherein the plurality of axial support members comprises three axial support members.
  • Example 171 The prosthetic valve of any example herein, particularly of any one of examples 158 to 170, wherein the plurality of commissure posts comprises three commissure posts.
  • Example 172 The prosthetic valve of any example herein, particularly of any one of examples 158 to 171, wherein the frame further comprises an outflow cell row comprising a plurality of outflow cells coupled to each other via the axial frame members.
  • Example 173 The prosthetic valve of any example herein, particularly of example 172, wherein the frame further comprises a plurality of subsequent cell rows distal to the outflow cell row, each of the subsequent cell rows comprising a plurality of subsequent cells.
  • Example 174 The prosthetic valve of any example herein, particularly of example 173, wherein each of the subsequent cells is diamond-shaped.
  • Example 175. The prosthetic valve of any example herein, particularly of example 173 or 174, wherein each outflow cell spans a width of two of the subsequent cells.
  • Example 176 The prosthetic valve of any example herein, particularly of any one of examples 158 to 175, wherein first subsequent rung defines a plurality of free apices.
  • Example 177 The prosthetic valve of any example herein, particularly of example 176, wherein the free apices are circumferentially disposed between the axial frame members.
  • Example 178 The prosthetic valve of any example herein, particularly of example 176 or 177, wherein the free apices are aligned with the outflow apices.
  • a prosthetic valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame comprising: an outflow rung comprising outflow angled struts defining a plurality of outflow apices; a plurality of subsequent rungs distal to the outflow rung, each subsequent rung comprising a plurality of subsequent angled struts; a plurality of axial frame members extending between the outflow rung and a first subsequent rung of the plurality of subsequent rungs; and a plurality of commissure posts extending proximally from the outflow rung; and a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, the valvular structure defining a plurality of commissure attachment regions between adjacent leaflets, the commissure attachment regions forming commissures coupled to the commissure posts; wherein the valvular structure is a one-piece material; wherein each commissure
  • Example 180 The prosthetic valve of any example herein, particularly of example 179, wherein the plurality of axial frame members comprises a plurality of axial post struts and a plurality of axial support members.
  • Example 181 The prosthetic valve of any example herein, particularly of example 180, wherein the axial post struts are circumferentially aligned with the commissure posts.
  • Example 182 The prosthetic valve of any example herein, particularly of example 180 or 181, the axial post struts and the axial support members are alternately arranged around the circumference of the frame.
  • Example 183 The prosthetic valve of any example herein, particularly of any one of examples 180 to 182, wherein the plurality of axial post struts comprises three axial post struts, and wherein the plurality of axial support members comprises three axial support members.
  • Example 184 The prosthetic valve of any example herein, particularly of any one of examples 179 to 183, wherein the plurality of commissure posts comprises three commissure posts.
  • Example 185 The prosthetic valve of any example herein, particularly of any one of examples 179 to 184, wherein the frame further comprises an outflow cell row comprising a plurality of outflow cells coupled to each other via the axial frame members.
  • Example 186 The prosthetic valve of any example herein, particularly of example 185, wherein the frame further comprises a plurality of subsequent cell rows distal to the outflow cell row, each of the subsequent cell rows comprising a plurality of subsequent cells.
  • Example 187 The prosthetic valve of any example herein, particularly of examplel86, wherein each of the subsequent cells is diamond-shaped.
  • Example 188 The prosthetic valve of any example herein, particularly of example 186 or 187, wherein each outflow cell spans a width of two of the subsequent cells.
  • Example 189 The prosthetic valve of any example herein, particularly of any one of examples 179 to 188, wherein first subsequent rung defines a plurality of free apices.
  • Example 190 The prosthetic valve of any example herein, particularly of example 189, wherein the free apices are circumferentially disposed between the axial frame members.
  • Example 191 The prosthetic valve of any example herein, particularly of example 189 or 190, wherein the free apices are aligned with the outflow apices.
  • a prosthetic valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame comprising: an outflow rung comprising outflow angled struts defining a plurality of outflow apices; a plurality of subsequent rungs distal to the outflow rung, each subsequent rung comprising a plurality of subsequent angled struts; a plurality of axial frame members extending between the outflow rung and first subsequent angles struts of a first subsequent rung of the plurality of subsequent rungs; a plurality of commissure posts extending proximally from the outflow rung; an outflow cell row comprising a plurality of outflow cells, wherein each two of the plurality of outflow cells share a common one of the plurality of axial frame members; a first subsequent cell row comprising a plurality of first subsequent cells, connected to and extending distally from the axial frame members; and a second subsequent cell row comprising
  • Example 194 The prosthetic valve of any example herein, particularly of example 193, wherein the first subsequent rung comprises pairs of the first subsequent angled stmts which are circumferentially spaced from each other.
  • Example 195 The prosthetic valve of any example herein, particularly of example 194, wherein each pair of the first subsequent angled stmts is connected to a corresponding one of the axial frame members.
  • Example 196 The prosthetic valve of any example herein, particularly of any one of examples 193 to 195, wherein the outflow angled stmts are longer than the first subsequent angled struts.
  • Example 197 The prosthetic valve of any example herein, particularly of any one of examples 193 to 196, wherein the first subsequent angled stmts and the second subsequent angled stmts have equal lengths.
  • Example 198 The prosthetic valve of any example herein, particularly of any one of examples 193 to 197, wherein the first subsequent cells are circumferentially spaced from each other.
  • Example 199 The prosthetic valve of any example herein, particularly of any one of examples 193 to 198, wherein each outflow cell is defined by two of the outflow angled stmts, two of the axial frame members, two of the first subsequent angled stmts, and two of the second subsequent stmts.
  • Example 200 The prosthetic valve of any example herein, particularly of any one of examples 193 to 199, wherein each first subsequent cell is defined by two first subsequent angled struts and two second subsequent angled stmts.
  • Example 201 The prosthetic valve of any example herein, particularly of example 192, wherein the first subsequent angled stmts are longer than the second subsequent angled stmts.
  • Example 202 The prosthetic valve of any example herein, particularly of example 201 , wherein the first subsequent angled stmts are two times longer than the second subsequent angled stmts.
  • Example 203 The prosthetic valve of any example herein, particularly of example 201 or 202, wherein the first subsequent angled stmts extend from the axial frame members to a third subsequent mng of the plurality of subsequent mngs.
  • Example 204 The prosthetic valve of any example herein, particularly of any one of examples 201 to 203, wherein the second subsequent angled stmts are connected to the first subsequent angled struts at 3-way junctions positioned between upper junctions and lower junctions of the first subsequent angled struts.
  • Example 205 The prosthetic valve of any example herein, particularly of example 204, wherein each first subsequent cell is defined by two second subsequent angled struts and portions of two first subsequent angled struts extending proximally from 3 -way junctions thereof.
  • Example 206 The prosthetic valve of any example herein, particularly of any one of examples 201 to 205, wherein each outflow cell is defined by two of the outflow angled struts, two of the axial frame members, and two of the first subsequent angled struts.
  • Example 207 The prosthetic valve of any example herein, particularly of any one of examples 192 to 206, wherein each outflow cell spans a width of two of the first subsequent cells.
  • Example 208 The prosthetic valve of any example herein, particularly of any one of examples 192 to 207, wherein each outflow cell spans a width of two of the second subsequent cells.
  • Example 209 The prosthetic valve of any example herein, particularly of any one of examples 192 to 208, wherein the outflow cells are axially longer than the first subsequent cells.
  • Example 210 The prosthetic valve of any example herein, particularly of any one of examples 192 to 209, further comprising a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.
  • Example 211 The prosthetic valve of any example herein, particularly of example 210, wherein the valvular structure comprises a plurality of commissure attachment regions defined between adjacent leaflets, the commissure attachment regions forming commissures coupled to the commissure posts.
  • Example 212 The prosthetic valve of any example herein, particularly of example 211, wherein the commissures terminate proximal to the outflow apices.
  • Example 213 The prosthetic valve of any example herein, particularly of any one of examples 210 to 212, wherein the valvular structure is a one-piece material.
  • Example 214 The prosthetic valve of any example herein, particularly of any one of examples 192 to 213, wherein the plurality of axial frame members comprises a plurality of axial post struts and a plurality of axial support members, and wherein the axial post struts are circumferentially aligned with the commissure posts.
  • Example 215. The prosthetic valve of any example herein, particularly of example 214, wherein the axial post struts and the axial support members are alternately arranged around the circumference of the frame.
  • Example 216 The prosthetic valve of any example herein, particularly of example 214 or 215, wherein the plurality of axial post struts comprises three axial post struts, and wherein the plurality of axial support members comprises three axial support members.
  • Example 217 The prosthetic valve of any example herein, particularly of any one of examples 192 to 216, wherein the plurality of commissure posts comprises three commissure posts.
  • Example 218 The prosthetic valve of any example herein, particularly of any one of examples 192 to 217, wherein each commissure post comprises a slot.
  • a prosthetic valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame comprising: an outflow rung comprising outflow angled struts defining a plurality of outflow apices; a plurality of subsequent rungs distal to the outflow rung, each subsequent rung comprising a plurality of subsequent angled struts, wherein a first subsequent rung of the plurality of subsequent rungs defines a plurality of free apices aligned with the outflow apices; a plurality of axial frame members extending between the outflow rung and the first subsequent rung; and a plurality of commissure posts extending proximally from the outflow rung; wherein each of the outflow angled struts comprises an inflection point separating between a proximally convex segment and a proximally concave segment thereof.
  • Example 220 The prosthetic valve of any example herein, particularly of example 219, wherein the proximally convex segment of the outflow angled strut extends from a lower junction of the outflow angled strut to the inflection point.
  • Example 221 The prosthetic valve of any example herein, particularly of example 220, wherein the inflection point is positioned mid-way between the lower junction of the outflow angled strut and the corresponding outflow apex.
  • Example 222 The prosthetic valve of any example herein, particularly of any one of examples 219 to 221, wherein the proximally concave segment of the outflow angled strut extends from the inflection point to the corresponding outflow apex.
  • Example 223 The prosthetic valve of any example herein, particularly of any one of examples 219 to 222, wherein the outflow angled struts are devoid of linear strut segments.
  • Example 224 The prosthetic valve of any example herein, particularly of any one of examples 219 to 223, further comprising a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.
  • Example 225 The prosthetic valve of any example herein, particularly of example 224, wherein the valvular structure comprises a plurality of commissure attachment regions defined between adjacent leaflets, the commissure attachment regions forming commissures coupled to the commissure posts.
  • Example 226 The prosthetic valve of any example herein, particularly of example 225, wherein the commissures terminate proximal to the outflow apices.
  • Example 227 The prosthetic valve of any example herein, particularly of any one of examples 224 to 226, wherein the valvular structure is a one-piece material.
  • Example 228 The prosthetic valve of any example herein, particularly of any one of examples 219 to 227, wherein the outflow angled struts are longer than any of the subsequent angled struts.
  • Example 229. The prosthetic valve of any example herein, particularly of any one of examples 219 to 228, further comprising an outflow cell row comprising a plurality of outflow cells proximal to the rungs of angled struts, and a plurality of subsequent cell rows comprising a plurality of diamond-shaped subsequent cells distal to the outflow cell row.
  • Example 230 The prosthetic valve of any example herein, particularly of example 229, wherein each outflow cell spans a width of two of the subsequent cells.
  • Example 23 The prosthetic valve of any example herein, particularly of example 229 or 230, wherein each of the outflow cells is coupled to adjacent outflow cells via the axial frame members.
  • Example 232 The prosthetic valve of any example herein, particularly of any one of examples 219 to 227, wherein the axial frame members comprise a plurality of axial post struts and a plurality of axial support members, and wherein the axial post struts are circumferentially aligned with commissure posts extending proximally from an outflow rung of the frame.
  • Example 233 The prosthetic valve of any example herein, particularly of example 232, wherein the axial post struts and the axial support members are alternately arranged around the circumference of the frame.
  • Example 234 The prosthetic valve of any example herein, particularly of example 232 or 233, wherein the plurality of axial post struts comprises three axial post struts, and wherein the plurality of axial support members comprises three axial support members.
  • Example 235 The prosthetic valve of any example herein, particularly of any one of examples 232 to 234, wherein the frame further comprises a plurality of commissure posts extending proximally from the axial post struts.
  • Example 236 The prosthetic valve of any example herein, particularly of example 235, wherein the plurality of commissure posts comprises three commissure posts.
  • a prosthetic valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame comprising: an outflow rung comprising outflow angled struts defining a plurality of outflow apices; a plurality of subsequent rungs distal to the outflow rung, each subsequent rung comprising a plurality of subsequent angled struts; a plurality of axial frame members extending between the outflow rung and a first subsequent rung of the plurality of subsequent rungs; a plurality of commissure posts extending proximally from the outflow rung; and a plurality of pairs of curved stabilization struts, each pair of curved stabilization stmts diverging from an upper junction of a first subsequent rung of the plurality of subsequent rungs, towards axial frame members at both sides of the corresponding upper junction; wherein the upper junctions from which the pairs of curved stabilization stmts diverge,
  • Example 241 The prosthetic valve of any example herein, particularly of any one of examples 238 to 240, wherein the frame further comprises a plurality of first outflow sub-cells and a plurality of second outflow sub-cells, disposed between the outflow rung and the first subsequent rung.
  • Example 242 The prosthetic valve of any example herein, particularly of example 241 , wherein each first outflow sub-cell is defined between a pair of outflow angled strut and a pair of curved stabilization struts.
  • Example 243 The prosthetic valve of any example herein, particularly of example 241 or 242, wherein each second outflow sub-cell is defined by a pair of first subsequent angled struts, one curved stabilization strut, and at least a portion of an axial frame member extending proximally from the first subsequent rung.
  • Example 244 The prosthetic valve of any example herein, particularly of any one of examples 241 to 243, wherein each first outflow sub-cell spans a width of two of the second outflow sub-cells.
  • Example 245. The prosthetic valve of any example herein, particularly of any one of examples 241 to 244, wherein the frame further comprises a plurality of first subsequent cells defined between the first subsequent rung and a second subsequent rung of the plurality of subsequent rungs.
  • Example 246 The prosthetic valve of any example herein, particularly of example 245, wherein each first subsequent cell is a diamond- shaped cell defined between two subsequent angled struts of the first subsequent rung and two subsequent angled struts of the second subsequent rung.
  • Example 247 The prosthetic valve of any example herein, particularly of example 245 or 246, wherein each first outflow sub-cell spans a width of two of the first subsequent cells.
  • Example 248 The prosthetic valve of any example herein, particularly of any one of examples 238 to 247, further comprising a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.
  • Example 249. The prosthetic valve of any example herein, particularly of example 248, wherein the valvular structure comprises a plurality of commissure attachment regions defined between adjacent leaflets, the commissure attachment regions forming commissures coupled to the commissure posts.
  • Example 250. The prosthetic valve of any example herein, particularly of example 249, wherein the commissures terminate proximal to the outflow apices.
  • Example 251 The prosthetic valve of any example herein, particularly of any one of examples 248 to 250, wherein the valvular structure is a one-piece material.
  • Example 252 The prosthetic valve of any example herein, particularly of any one of examples 238 to 251, wherein the plurality of axial frame members comprises a plurality of axial post struts and a plurality of axial support members, and wherein the axial post struts are circumferentially aligned with the commissure posts.
  • Example 253 The prosthetic valve of any example herein, particularly of example 252, wherein the axial post struts and the axial support members are alternately arranged around the circumference of the frame.
  • Example 254 The prosthetic valve of any example herein, particularly of example 252 or 253, wherein the plurality of axial post struts comprises three axial post struts, and wherein the plurality of axial support members comprises three axial support members.
  • Example 255 The prosthetic valve of any example herein, particularly of any one of examples 238 to 254, wherein the plurality of commissure posts comprises three commissure posts.
  • Example 256 The prosthetic valve of any example herein, particularly of any one of examples 238 to 255, wherein each commissure post comprises a slot.
  • a prosthetic valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame comprising: an outflow rung comprising outflow angled struts defining a plurality of outflow apices; a plurality of subsequent rungs distal to the outflow rung, each subsequent rung comprising a plurality of subsequent angled struts, wherein a first subsequent rung of the plurality of subsequent rungs defines a plurality of proximally -oriented free apices aligned with the outflow apices; a plurality of axial frame members extending between the outflow rung and the first subsequent rung; a plurality of commissure posts extending proximally from the outflow rung; a plurality of struts extending from intermediate junctions of first subsequent angled struts of the first subsequent rung; wherein the struts extending from first subsequent angled struts are disposed between the first subsequent a
  • Example 258 The prosthetic valve of any example herein, particularly of example 257, wherein at least some of the distally-oriented free apices are circumferentially aligned with the proximally-oriented free apices.
  • Example 259 The prosthetic valve of any example herein, particularly of example 257 or 258, wherein at least some of the distally-oriented free apices are circumferentially aligned with the axial frame members.
  • Example 260 The prosthetic valve of any example herein, particularly of any one of examples 257 to 259, wherein the frame further comprises a plurality of first subsequent minor sub-cell and a plurality of a first subsequent major sub-cell, disposed between the first subsequent rung and the second subsequent rung.
  • Example 261 The prosthetic valve of any example herein, particularly of example 260, wherein the first subsequent major sub-cell are distal to the first subsequent minor sub-cell.
  • Example 263 The prosthetic valve of any example herein, particularly of any one of examples 260 to 262, wherein the first subsequent minor sub-cell are circumferentially spaced from each other.
  • Example 264 The prosthetic valve of any example herein, particularly of any one of examples 260 to 263, wherein the frame further comprises an outflow cell row comprising a plurality of outflow cells, and wherein each outflow cell spans a width of two first subsequent major sub-cells.
  • Example 265. The prosthetic valve of any example herein, particularly of any one of examples 260 to 264, wherein the plurality of struts extending from the intermediate junctions comprises a plurality of arched struts, and the plurality of distally-oriented free apices comprises a plurality of inner arcuate regions.
  • Example 266 The prosthetic valve of any example herein, particularly of example 265, wherein the arched struts are proximally concaved.
  • Example 267 The prosthetic valve of any example herein, particularly of example 265 or 266, wherein each first subsequent minor sub-cell is defined between an arched strut and portions of two first subsequent angled struts extending between the upper junction and the corresponding intermediate junctions.
  • Example 268 The prosthetic valve of any example herein, particularly of any one of examples 265 to 267, wherein each first subsequent major sub-cell is defined between an arched strut is defined by two second subsequent angled struts, portions of two first subsequent angled struts extending from corresponding lower junctions and intermediate junctions of the first subsequent rung, and a corresponding arched strut.
  • Example 269. The prosthetic valve of any example herein, particularly of any one of examples 260 to 264, wherein the plurality of struts extending from the intermediate junctions comprises a plurality of angled struts, each extending from a corresponding one of the intermediate junctions to a corresponding one of the distally-oriented free apices.
  • Example 270 The prosthetic valve of any example herein, particularly of example 269, wherein each first subsequent minor sub-cell is defined between two angled struts that extend from corresponding intermediate junctions, and portions of two first subsequent angled struts extending between the upper junction and the corresponding intermediate junctions.
  • Example 271 The prosthetic valve of any example herein, particularly of example 269 or 270, wherein each first subsequent major sub-cell is defined by two second subsequent angled struts, portions of two first subsequent angled struts extending from corresponding lower junctions and corresponding intermediate junctions of the first subsequent rung, and two angled struts that extend from the corresponding intermediate junctions.
  • Example 272 The prosthetic valve of any example herein, particularly of any one of examples 257 to 271, further comprising a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.
  • Example 273 The prosthetic valve of any example herein, particularly of example 272, wherein the valvular structure comprises a plurality of commissure attachment regions defined between adjacent leaflets, the commissure attachment regions forming commissures coupled to the commissure posts.
  • Example 274 The prosthetic valve of any example herein, particularly of example 273, wherein the commissures terminate proximal to the outflow apices.
  • Example 275 The prosthetic valve of any example herein, particularly of any one of examples 272 to 274, wherein the valvular structure is a one-piece material.
  • Example 276 The prosthetic valve of any example herein, particularly of any one of examples 257 to 275, wherein the plurality of axial frame members comprises a plurality of axial post struts and a plurality of axial support members, and wherein the axial post struts are circumferentially aligned with the commissure posts.
  • Example 277 The prosthetic valve of any example herein, particularly of example 276, wherein the axial post struts and the axial support members are alternately arranged around the circumference of the frame.
  • Example 278 The prosthetic valve of any example herein, particularly of example 276 or 277, wherein the plurality of axial post struts comprises three axial post struts, and wherein the plurality of axial support members comprises three axial support members.
  • Example 279. The prosthetic valve of any example herein, particularly of any one of examples 257 to 278, wherein the plurality of commissure posts comprises three commissure posts.
  • Example 280 The prosthetic valve of any example herein, particularly of any one of examples 257 to 279, wherein each commissure post comprises a slot.
  • Example 281 A prosthetic valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame comprising: an outflow rung comprising outflow angled struts defining a plurality of outflow apices; a first subsequent rung distal to the outflow rung and comprising first subsequent angled struts; a second subsequent rung distal to the first subsequent rung and comprising second subsequent angled struts; a plurality of axial frame members extending between the outflow rung and the first subsequent rung; and a plurality of commissure posts extending proximally from the outflow rung; wherein the first subsequent angled struts are wider than the second subsequent angled struts.
  • Example 282 The prosthetic valve of any example herein, particularly of example 281, wherein the frame further comprises a third subsequent rung distal to the second subsequent rung and comprising third subsequent angled struts, and wherein the first subsequent angled struts are wider than the third subsequent angled struts.
  • Example 283 The prosthetic valve of any example herein, particularly of example 281 or 282, wherein a width of the first subsequent angled struts is at least 25% larger than a width of the second subsequent angled struts.
  • Example 284 The prosthetic valve of any example herein, particularly of example 281 or 282, wherein a width of the first subsequent angled struts is at least 50% larger than a width of the second subsequent angled struts.
  • Example 285. The prosthetic valve of any example herein, particularly of example 281 or 282, wherein a width of the first subsequent angled struts is at least 75% larger than a width of the second subsequent angled struts.
  • Example 286 The prosthetic valve of any example herein, particularly of example 281 or 282, wherein a width of the first subsequent angled struts is at least 100% larger than a width of the second subsequent angled struts.
  • Example 287 The prosthetic valve of any example herein, particularly of any one of examples 281 to 286, wherein the outflow angled struts are longer than the first subsequent angled struts.
  • Example 288 The prosthetic valve of any example herein, particularly of any one of examples 281 to 287, wherein the frame further comprises an outflow cell row comprising a plurality of outflow cells defined between the outflow rung and the first subsequent rung, and a first subsequent cell row comprising a plurality of first subsequent cells defined between the first subsequent rung and the second subsequent rung, and wherein each outflow cell spans a width of two of the first subsequent cells.
  • Example 289. The prosthetic valve of any example herein, particularly of example 288, wherein the outflow cells are axially longer than the first subsequent cells.
  • Example 291 The prosthetic valve of any example herein, particularly of example 290, wherein the valvular structure comprises a plurality of commissure attachment regions defined between adjacent leaflets, the commissure attachment regions forming commissures coupled to the commissure posts.
  • Example 292. The prosthetic valve of any example herein, particularly of example 291, wherein the commissures terminate proximal to the outflow apices.
  • Example 293 The prosthetic valve of any example herein, particularly of any one of examples 290 to 292, wherein the valvular structure is a one-piece material.
  • Example 295. The prosthetic valve of any example herein, particularly of example 294, wherein the axial post struts and the axial support members are alternately arranged around the circumference of the frame.
  • Example 296 The prosthetic valve of any example herein, particularly of example 294 or 295, wherein the plurality of axial post struts comprises three axial post struts, and wherein the plurality of axial support members comprises three axial support members.
  • Example 297 The prosthetic valve of any example herein, particularly of any one of examples 281 to 296, wherein the plurality of commissure posts comprises three commissure posts.
  • Example 298 The prosthetic valve of any example herein, particularly of any one of examples 281 to 297, wherein each commissure post comprises a slot.
  • a first subsequent rung comprising a plurality of first subsequent angled struts defining a plurality of free apices; and an inflow rung comprising a plurality of inflow angled struts defining a plurality of inflow apices; a plurality of axial frame members extending between the outflow rung and the inflow rung, the plurality of axial frame members comprising a plurality of axial post struts and a plurality of axial support members; and a plurality of commissure posts extending proximally from the outflow rung; wherein the axial post struts are circumferentially aligned with the commissure posts.
  • Example 300 The prosthetic valve of any example herein, particularly of example 299, wherein the axial frame members are connected to the outflow rung and all of the subsequent rungs.
  • Example 301 The prosthetic valve of any example herein, particularly of example 299 or 300, wherein the plurality of free apices of the first subsequent rung comprises two free apices disposed between each two circumferentially adjacent axial frame members.
  • Example 302. The prosthetic valve of any example herein, particularly of any one of examples 299 to 301, wherein the outflow angled struts are longer than the first subsequent angled struts.
  • Example 303 The prosthetic valve of any example herein, particularly of any one of examples 299 to 302, wherein the frame further comprises an outflow cell row comprising a plurality of outflow cells, each outflow cell defined between two outflow angled struts, portions of two axial frame members extending between the outflow rung and the first subsequent rung, and four first subsequent angled struts.
  • Example 304 The prosthetic valve of any example herein, particularly of example 303, wherein the plurality of subsequent rungs further comprises a second subsequent rung comprising a plurality of second subsequent angled struts, wherein the frame further comprises a first subsequent cell row comprising a plurality of first subsequent cells defined between the first subsequent rung and the second subsequent rung, and wherein each outflow cell spans a width of two of the first subsequent cells.
  • Example 305 The prosthetic valve of any example herein, particularly of example 304, wherein each first subsequent cell is a diamond-shaped cell defined between two first subsequent angled struts and two second subsequent angled struts.
  • Example 306 The prosthetic valve of any example herein, particularly of example 304 or 305, wherein the inflow angled struts are longer than any of the first subsequent angled struts and the second subsequent angled struts.
  • Example 307. The prosthetic valve of any example herein, particularly of any one of examples 304 to 306, wherein the inflow angled struts and the outflow angled struts have equal lengths.
  • Example 308 The prosthetic valve of any example herein, particularly of any one of examples 304 to 307, wherein the frame further comprises an inflow cell row comprising a plurality of inflow cells, and wherein each inflow cell spans a width of two of the first subsequent cells.
  • Example 310 The prosthetic valve of any example herein, particularly of example 308 or 309, wherein each inflow cell is defined between two inflow angled struts, portions of two axial frame members extending between the inflow rung and the second subsequent rung, and four second subsequent angled struts.
  • Example 311 The prosthetic valve of any example herein, particularly of example 304 or 305, wherein the plurality of subsequent rungs further comprises a third subsequent rung comprising a plurality of third subsequent angled struts which are distally spaced from the second subsequent rung.
  • Example 312 The prosthetic valve of any example herein, particularly of example 311, wherein all of the subsequent angled struts have equal lengths.
  • Example 315 The prosthetic valve of any example herein, particularly of example 313 or 314, wherein the second subsequent rung and the third subsequent ruing are parallel to each other.
  • Example 316 The prosthetic valve of any example herein, particularly of any one of examples 313 to 315, wherein the third subsequent rung and the inflow rung are parallel to each other.
  • Example 317 The prosthetic valve of any example herein, particularly of any one of examples 313 to 316, wherein the frame further comprises an inflow cell row comprising a plurality of inflow cells, and wherein each inflow cell spans a width of two of the first subsequent cells.
  • Example 318 The prosthetic valve of any example herein, particularly of example 317, wherein each inflow cell is defined between four third subsequent angled struts, portions of two axial frame members extending between the third subsequent rung and the inflow rung, and four inflow angled struts.
  • Example 32 The prosthetic valve of any example herein, particularly of any one of examples 299 to 320, further comprising a valvular structure coupled to the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.
  • Example 322 The prosthetic valve of any example herein, particularly of example 321, wherein the valvular structure comprises a plurality of commissure attachment regions defined between adjacent leaflets, the commissure attachment regions forming commissures coupled to the commissure posts.
  • Example 323 The prosthetic valve of any example herein, particularly of example 322, wherein the commissures terminate proximal to the outflow apices.
  • Example 324 The prosthetic valve of any example herein, particularly of any one of examples 321 to 323, wherein the valvular structure is a one-piece material.
  • Example 325 The prosthetic valve of any example herein, particularly of any one of examples 299 to 324, wherein the axial post struts and the axial support members are alternately arranged around the circumference of the frame.
  • Example 326 The prosthetic valve of any example herein, particularly of any one of examples 299 to 325, wherein the plurality of axial post struts comprises three axial post struts, and wherein the plurality of axial support members comprises three axial support members.
  • Example 327 The prosthetic valve of any example herein, particularly of any one of examples 299 to 326, wherein the plurality of commissure posts comprises three commissure posts.
  • Example 328 The prosthetic valve of any example herein, particularly of any one of examples 299 to 327, wherein each commissure post comprises a slot.
  • a prosthetic valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame comprising: an outflow rung comprising outflow angled struts defining a plurality of outflow apices; a plurality of subsequent rungs distal to the outflow rung, each subsequent rung comprising a plurality of subsequent angled struts; a plurality of axial frame members extending between the outflow rung and a first subsequent rung of the plurality of subsequent rungs, each axial frame member defining outer edges on circumferential sides thereof, wherein the plurality of axial frame members comprises a plurality of axial post struts and a plurality of axial support members; and a plurality of commissure posts extending proximally from the outflow rung, wherein the commissure posts are circumferentially aligned with the axial post struts; and a valvular structure coupled to the frame and comprising a
  • Example 330 The prosthetic valve of any example herein, particularly of example 329, wherein the groove is sized to receive the suture extending therealong in a manner that prevents axial displacement of the suture out of the groove.
  • Example 3 The prosthetic valve of any example herein, particularly of example 329 or 330, wherein corresponding grooves on both sides of the axial post struts are axially aligned with each other.
  • Example 332 The prosthetic valve of any example herein, particularly of any one of examples 329 to 331, wherein the one or more grooves comprise a plurality of grooves formed on each outer edge of the axial post strut.
  • Example 333 The prosthetic valve of any example herein, particularly of example 332, wherein portions of the one or more sutures passed between the grooves cross each other on an outer surface of the axial post strut.
  • Example 334 The prosthetic valve of any example herein, particularly of any one of examples 329 to 333, wherein each axial support member further comprises one or more grooves on each of its outer edges.
  • Example 335 The prosthetic valve of any example herein, particularly of any one of examples 329 to 334, wherein the valvular structure is a one-piece material.
  • Example 336 The prosthetic valve of any example herein, particularly of any one of examples 329 to 335, wherein the axial post struts and the axial support members are alternately arranged around the circumference of the frame.
  • Example 337 The prosthetic valve of any example herein, particularly of any one of examples 329 to 335, wherein the plurality of axial post struts comprises three axial post struts, and wherein the plurality of axial support members comprises three axial support members.
  • Example 338 The prosthetic valve of any example herein, particularly of any one of examples 329 to 337, wherein the plurality of commissure posts comprises three commissure posts.
  • Example 339 The prosthetic valve of any example herein, particularly of any one of examples 329 to 338, wherein the frame further comprises an outflow cell row comprising a plurality of outflow cells coupled to each other via the axial frame members.
  • Example 340 The prosthetic valve of any example herein, particularly of example 339, wherein the frame further comprises a plurality of subsequent cell rows distal to the outflow cell row, each of the subsequent cell rows comprising a plurality of subsequent cells.
  • Example 34 The prosthetic valve of any example herein, particularly of example 340, wherein each of the subsequent cells is diamond-shaped.
  • Example 342 The prosthetic valve of any example herein, particularly of example 340 or 341, wherein each outflow cell spans a width of two of the subsequent cells.
  • Example 343 The prosthetic valve of any example herein, particularly of any one of examples 329 to 342, wherein first subsequent rung defines a plurality of free apices.
  • Example 344 The prosthetic valve of any example herein, particularly of example 343, wherein the free apices are circumferentially disposed between the axial frame members.
  • Example 345 The prosthetic valve of any example herein, particularly of example 343 or 344, wherein the free apices are aligned with the outflow apices.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente divulgation concerne des prothèses valvulaires et des structures valvulaires associées. Dans un exemple, une prothèse valvulaire peut comprendre un cadre formé à un diamètre de coupe de cadre et mobile entre le diamètre de coupe de cadre et une configuration radialement comprimée définissant un diamètre inférieur au diamètre de coupe de cadre, et de la configuration comprimée à une configuration radialement étendue, définissant un diamètre qui est supérieur au diamètre de coupe de cadre. Le cadre peut comprendre une pluralité d'échelons d'entretoises inclinées, définissant une pluralité de rangées de cellules. Chaque rangée de cellules peut comprendre une pluralité de cellules en forme de diamant. Dans certains exemples, un angle défini entre des entretoises inclinées de l'une quelconque des cellules en forme de diamant, dans le diamètre de coupe de cadre, n'est pas supérieur à 120°.
PCT/US2025/019926 2024-03-15 2025-03-14 Prothèses valvulaires Pending WO2025194032A1 (fr)

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Application Number Priority Date Filing Date Title
US202463566127P 2024-03-15 2024-03-15
US63/566,127 2024-03-15
US202463657638P 2024-06-07 2024-06-07
US63/657,638 2024-06-07

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6730118B2 (en) 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US7993394B2 (en) 2008-06-06 2011-08-09 Ilia Hariton Low profile transcatheter heart valve
US8652202B2 (en) 2008-08-22 2014-02-18 Edwards Lifesciences Corporation Prosthetic heart valve and delivery apparatus
US9155619B2 (en) 2011-02-25 2015-10-13 Edwards Lifesciences Corporation Prosthetic heart valve delivery apparatus
US9393110B2 (en) 2010-10-05 2016-07-19 Edwards Lifesciences Corporation Prosthetic heart valve
US10603165B2 (en) 2016-12-06 2020-03-31 Edwards Lifesciences Corporation Mechanically expanding heart valve and delivery apparatus therefor
US11135056B2 (en) 2017-05-15 2021-10-05 Edwards Lifesciences Corporation Devices and methods of commissure formation for prosthetic heart valve
WO2023225236A1 (fr) * 2022-05-19 2023-11-23 Edwards Lifesciences Corporation Valve prothétique avec barreaux d'éléments de support

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6730118B2 (en) 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US7393360B2 (en) 2001-10-11 2008-07-01 Edwards Lifesciences Pvt, Inc. Implantable prosthetic valve
US7510575B2 (en) 2001-10-11 2009-03-31 Edwards Lifesciences Corporation Implantable prosthetic valve
US7993394B2 (en) 2008-06-06 2011-08-09 Ilia Hariton Low profile transcatheter heart valve
US8652202B2 (en) 2008-08-22 2014-02-18 Edwards Lifesciences Corporation Prosthetic heart valve and delivery apparatus
US9393110B2 (en) 2010-10-05 2016-07-19 Edwards Lifesciences Corporation Prosthetic heart valve
US9155619B2 (en) 2011-02-25 2015-10-13 Edwards Lifesciences Corporation Prosthetic heart valve delivery apparatus
US10603165B2 (en) 2016-12-06 2020-03-31 Edwards Lifesciences Corporation Mechanically expanding heart valve and delivery apparatus therefor
US11135056B2 (en) 2017-05-15 2021-10-05 Edwards Lifesciences Corporation Devices and methods of commissure formation for prosthetic heart valve
WO2023225236A1 (fr) * 2022-05-19 2023-11-23 Edwards Lifesciences Corporation Valve prothétique avec barreaux d'éléments de support

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