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WO2025217496A1 - Valves cardiaques prothétiques - Google Patents

Valves cardiaques prothétiques

Info

Publication number
WO2025217496A1
WO2025217496A1 PCT/US2025/024244 US2025024244W WO2025217496A1 WO 2025217496 A1 WO2025217496 A1 WO 2025217496A1 US 2025024244 W US2025024244 W US 2025024244W WO 2025217496 A1 WO2025217496 A1 WO 2025217496A1
Authority
WO
WIPO (PCT)
Prior art keywords
skirt
frame
edge
inner skirt
commissure
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/US2025/024244
Other languages
English (en)
Inventor
Roy SHITRIT
Michael BUKIN
Giolnara PINHAS
Elena Sherman
Nikolai Gurovich
Bich Hoang PHAM
Christine Uyen Dang
Anastasya DIVILOV
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 WO2025217496A1 publication Critical patent/WO2025217496A1/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
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures

Definitions

  • the present disclosure relates to implantable, radially expandable prosthetic devices, such as prosthetic heart valves, and to methods, assemblies, and apparatuses for delivering, expanding, implanting, and deploying such prosthetic heart valves.
  • the human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve.
  • repair devices for example, stents
  • artificial valves as well as a number of known methods of implanting these devices and valves in humans.
  • Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable.
  • a prosthetic heart valve (or simply “prosthetic valve”) can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient's vasculature (for example, through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart.
  • the prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery apparatus so that the prosthetic valve can self-expand to its functional size.
  • a prosthetic heart valve can include an annular frame comprising an inflow end and an outflow end, and a leaflet structure comprising a plurality of leaflets positioned within the annular frame. The leaflet structure is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end.
  • a prosthetic heart valve can further include one or more of the components disclosed herein.
  • a prosthetic heart valve can include an inner skirt disposed on an inner surface of the annular frame and an outer skirt disposed on an outer surface of the annular frame.
  • the outer skirt can be connected to the inner skirt via one or more stitches which are shielded from the plurality of leaflets when the leaflet structure moves between the open state and the closed state.
  • a prosthetic heart valve can include an inner skirt disposed on an inner surface of the annular frame and an outer skirt disposed on an outer surface of the annular frame.
  • the inner skirt can include one or more folded portions that are concealed from the plurality of leaflets.
  • An outflow end portion of the outer skirt can be connected to the one or more folded portions of the inner skirt via stitches.
  • a prosthetic heart valve can include an inner skirt disposed on an inner surface of the annular frame and an outer skirt disposed on an outer surface of the annular frame.
  • the annular frame can include a first row of angled strut segments defining the outflow end, a second row of angled strut segments immediately upstream of the first row of angled strut segments, and a plurality of axial frame members bridging the first row of angled strut segments and the second row of angled strut segments.
  • the plurality of axial frame members can be connected to the second row of angled strut segments at a plurality of junctions.
  • An outflow end portion of the outer skirt can be attached to the plurality of junctions via stitches which are shielded from the plurality of leaflets by the inner skirt.
  • a prosthetic heart valve can include an inner skirt disposed on an inner surface of the annular frame.
  • Each leaflet can include a main body and two opposing sub-commissure tabs arranged on opposite sides of the main body.
  • Each sub-commissure tab can be paired with and connected to an adjacent sub-commissure tab of an adjacent leaflet. Pairs of sub-commissure tabs can extend through adjacent gaps formed in the inner skirt.
  • a prosthetic heart valve can include an inner skirt disposed on an inner surface of the annular frame.
  • Each leaflet can include a main body and two opposing sub-commissure tabs arranged on opposite sides of the main body.
  • Each sub-commissure tab can be paired with and connected to an adjacent sub-commissure tab of an adjacent leaflet. Pairs of sub-commissure tabs can extend through adjacent openings formed in the inner skirt.
  • a prosthetic heart valve can include an inner skirt disposed on an inner surface of the annular frame.
  • Each leaflet can include a main body and two opposing sub-commissure tabs arranged on opposite sides of the main body.
  • Each sub-commissure tab can be paired with and connected to an adjacent sub-commissure tab of an adjacent leaflet. Pairs of sub-commissure tabs can extend into adjacent pockets of the inner skirt.
  • a prosthetic heart valve including a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration, and a plurality of leaflets mounted on an inside of the frame.
  • Each leaflet can include a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end, two lower tabs disposed on opposite sides of the main body, two upper tabs disposed on opposite sides of the main body, and two sub-commissure tabs disposed on opposite sides of the main body.
  • Lower and upper tabs of adjacent leaflets can be paired to form a commissure that is secured to the frame.
  • Sub-commissure tabs of the adjacent leaflets can be paired and folded to extend from the inside of the frame towards an outside of the frame.
  • a prosthetic heart valve includes an annular frame having an inflow end and an outflow end, and an inner skirt disposed on an inner surface of the annular frame.
  • the frame includes a plurality of apex regions formed at the inflow end, each apex region connecting two angled struts located on opposite sides of the apex region.
  • Each apex region is attached to the inner skirt by a suture forming a plurality of whip stitches alternating with a plurality of locking stitches in a row along the apex region.
  • the whip stitches extend through the inner skirt and around the apex region and the locking stitches extend through the inner skirt and respective whip stitches.
  • a method for assembling a prosthetic heart valve includes identifying apex regions defining an inflow end of an annular frame of the prosthetic valve, each apex region connecting two angled struts located on opposite sides of the apex region, and attaching a skirt to the frame, comprising connecting each apex region to the skirt.
  • Connecting each apex region to the skirt comprises: forming a plurality of whip stitches with a suture, wherein each whip stitch extends through the skirt and around an apex region, and forming a plurality locking stitches that extend through the skirt and through respective whip stitches.
  • a prosthetic heart valve includes an annular frame having an inflow end and an outflow end, a leaflet structure comprising a plurality of leaflets positioned within the annular frame, and an inner skirt disposed on an inner surface of the annular frame.
  • the leaflet structure is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end.
  • the inner skirt includes a plurality of first markings and a plurality of second markings.
  • the plurality of first markings defines a first undulating scallop line and the plurality of the second markings defines a second undulating scallop line.
  • the first and second undulating scallop lines are parallel to each other.
  • the plurality of leaflets is attached to the inner skirt via a first suture extending through the plurality of first markings along the first undulating scallop line. Cusp edges of the leaflets are aligned with the second undulating scallop line.
  • a method for assembling a prosthetic valve includes attaching an inner skirt to a frame of the prosthetic valve, and attaching a plurality of leaflets to the inner skirt.
  • the inner skirt includes a plurality of first markings and a plurality of second markings on the inner skirt.
  • the plurality of first markings defines a first undulating scallop line and the plurality of the second markings defines a second undulating scallop line.
  • the first and second undulating scallop lines are parallel to each other.
  • Attaching the plurality of leaflets to the inner skirt includes aligning cusp edges of the leaflets to the second undulating scallop line and stitching a first suture through the plurality of first markings along the first undulating scallop line.
  • a prosthetic heart valve includes an annular frame having an inflow end, an outflow end, and a plurality of interconnected struts between the inflow end and the outflow end, a leaflet structure including a plurality of leaflets positioned within the annular frame, and an inner skirt disposed on an inner surface of the annular frame.
  • the leaflet structure is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end.
  • the inner skirt includes a plurality of markings defining an undulating scallop line.
  • the plurality of leaflets is attached to the inner skirt via a suture extending along the undulating scallop line. Each marking is positioned offset from and does not overlap with any of the plurality of interconnected struts.
  • a prosthetic heart valve includes an annular frame having an inflow end and an outflow end, a leaflet structure including a plurality of leaflets positioned within the annular frame, and an inner skirt disposed on an inner surface of the annular frame.
  • the leaflet structure is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end.
  • Each leaflet includes an outflow edge, a cusp edge opposite to the outflow edge, and a pair of commissure tabs extending from opposite sides of the leaflet and between the outflow edge and the cusp edge.
  • Each commissure tab is paired with an adjacent commissure tab of an adjacent leaflet to form a commissure of the leaflet structure.
  • the frame includes a first row of angled struts defining the outflow end, a second row of angled struts immediately upstream of the first row of angled struts, and a plurality of axial frame members bridging the first row of angled struts and the second row of angled struts. At least some the axial frame members are axially extending window struts. Each axially extending window strut has a commissure window configured to receive an adjacent commissure of the leaflet structure.
  • the inner skirt includes a plurality of skirt segments, each being connected to a corresponding leaflet.
  • Each skirt segment includes an inflow portion and an outflow portion.
  • Each outflow portion includes two opposing side edge portions. Two adjacent side edge portions of each pair of adjacent skirt segments are connected to form an axial congruent region.
  • Each congruent region is connected to the frame via a suture extending through an aperture on an adjacent axially extending window strut. The aperture is positioned upstream of the commissure window of the axially extending window strut.
  • a prosthetic heart valve includes an annular frame having an inflow end and an outflow end, a leaflet structure including a plurality of leaflets positioned within the annular frame, and a plurality of reinforcement strips, each reinforcement strip being attached to a corresponding leaflet.
  • the leaflet structure is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end.
  • Each leaflet includes two opposing sub-commissure tabs and a cusp edge portion extending from one subcommissure tab to the other sub-commissure tab of the leaflet.
  • Each sub-commissure tab is paired with and connected to an adjacent sub-commissure tab of an adjacent leaflet.
  • Each pair of sub-commissure tabs extend radially outwardly through an adjacent cell of the frame.
  • Each reinforcement strip includes a body portion that is shaped and sized to match the cusp edge portion of the leaflet, two first wing portions that are located at opposite ends of the body portion, and two second wing portions that are respectively connected to and positioned upstream of the two first wing portions. At least a portion of each first wing portion extends radially outwardly and between a corresponding pair of sub-commissure tabs.
  • a method for assembling a prosthetic heart valve includes attaching a leaflet structure to an annular frame, wherein the leaflet structure includes a plurality of leaflets, wherein each leaflet includes two opposing sub-commissure tabs and a cusp edge portion extending from one sub-commissure tab to the other sub-commissure tab of the leaflet; connecting each sub-commissure tab to an adjacent sub-commissure tab of an adjacent leaflet to form a pair of sub-commissure tabs extending radially outwardly through an adjacent cell of the frame; attaching a plurality of reinforcement strips to the leaflet structure, each reinforcement strip being attached to a corresponding leaflet, wherein each reinforcement strip comprises a body portion that is shaped and sized to match the cusp edge portion of the corresponding leaflet and two first wing portions that are located at opposite ends of the body portion; connecting two adjacent first wing portions of two reinforcement strips respectively attached to two adjacent leaflets to form a first wing pair; and inserting the
  • a prosthetic heart valve includes an annular frame having an inflow end and an outflow end, a leaflet structure including a plurality of leaflets positioned within the annular frame, an inner skirt disposed on an inner surface of the annular frame, and an outer skirt disposed on an outer surface of the annular frame.
  • the leaflet structure is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end.
  • An outflow edge of the outer skirt is attached to the inner skirt via a plurality of stitches positioned within a row of cells of the frame. There are less than three stitches within each cell in the row that are exposed to an inner surface of the inner skirt.
  • a prosthetic heart valve includes an annular frame having an inflow end and an outflow end, an inner skirt disposed on an inner surface of the annular frame, and a plurality of leaflets attached to the inner skirt.
  • the plurality of leaflets is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end.
  • the inner skirt includes a plurality of skirt segments. Each leaflet is connected to a corresponding skirt segment.
  • Each skirt segment includes an inflow portion and an outflow portion.
  • Each inflow portion includes two opposing first side edges and an inflow edge extending between the two first side edges.
  • Each outflow portion includes two opposing second side edges and an outflow edge extending between the two second side edges.
  • the two first side edges are parallel to each other and form an oblique angle relative to the inflow edge.
  • the two second side edges are parallel to each other and perpendicular to the inflow edge.
  • a prosthetic heart valve comprises one or more of the components recited in Examples 1-90, 98-103, 106-121, and 128-136 described in the section “Additional Examples of the Disclosed Technology” below.
  • FIG. 1 is a side view of a prosthetic heart valve, according to one example.
  • FIG. 2 is a side view of a frame of the prosthetic heart valve of FIG. 1.
  • FIG. 3 is a side view of a portion of the frame of FIG. 2, showing the portion of the frame in a straightened (non-annular) state.
  • FIG. 4 is a side view of an exemplary delivery apparatus configured to deliver and implant a radially expandable prosthetic valve at an implantation site.
  • FIG. 5 is a flattened view of a leaflet, according to one example.
  • FIG. 6 is a flattened view of an inner skirt, according to one example.
  • FIG. 7 is a flattened view of three skirt segments for an inner skirt, according to one example.
  • FIG. 8 shows a portion of an inner skirt with flaps attached to a frame of a prosthetic heart valve, viewed from inside the frame, according to one example.
  • FIG. 9 shows an outer skirt attached to the flaps folded over strut segments of the prosthetic heart valve of FIG. 8, viewed from outside the frame, according to one example.
  • FIG. 10 is a schematic cross-sectional view of an outer skirt attached to a flap of an inner skirt, according to one example.
  • FIG. 11 is a schematic cross-sectional view of an outer skirt attached to a radial fold of an inner skirt, according to one example.
  • FIG. 12A shows an inner skirt including multiple skirt segments, according to one example.
  • FIG. 12B is a flattened view of one of the skirt segments of FIG. 12A.
  • FIG. 12C shows a pair of flaps of two adjacent skirt segments of FIG. 12B are connected to form a foldable portion extending radially outwardly through a cell of an annular frame.
  • FIG. 12D shows attaching an outflow edge of the skirt segments to a row of angled struts of the annular frame of FIG. 12C.
  • FIG. 13 shows a portion of a prosthetic heart valve in which an outer skirt directly attached to junctions of a frame of the prosthetic heart valve, according to one example.
  • FIG. 14A is a cross-sectional view of a portion of a prosthetic heart valve, showing a pair of sub-commissure tabs of two adjacent leaflets extending radially inwardly and away from of a frame of the prosthetic heart valve, according to one example.
  • FIG. 14B shows the pair of sub-commissure tabs of FIG. 14A viewed from inside the frame.
  • FIG. 15 A is a cross-sectional view of a portion of a prosthetic heart valve, showing a pair of sub-commissure tabs of two adjacent leaflets overlapping one another in a flattened configuration, according to one example.
  • FIG. 15B shows the pair of sub-commissure tabs of FIG. 15A viewed from inside the frame.
  • FIG. 16A is a cross-sectional view of a portion of a prosthetic heart valve, showing a pair of sub-commissure tabs of two adjacent leaflets extending radially outwardly, through an inner skirt, and toward a frame of the prosthetic heart valve, according to one example.
  • FIG. 16B shows the pair of sub-commissure tabs of FIG. 16A viewed from outside the frame.
  • FIG. 16C shows a portion of the prosthetic valve of FIGS. 16A and 16B, as viewed from inside the prosthetic valve at the location of the sub-commissure tabs.
  • FIGS. 16D is a side view of the prosthetic valve of FIGS. 16A-16C.
  • FIG. 17A shows an opening on an inner skirt, according to one example.
  • FIG. 17B shows an opening on an inner skirt, according to another example.
  • FIG. 17C shows an opening adjacent a triangular portion of an inner skirt, according to one example.
  • FIG. 17D shows two split semi-triangular portions of an inner skirt which define an opening of the inner skirt, according to one example.
  • FIG. 18A shows a skirt segment, according to one example.
  • FIG. 18B shows three skirt segments of FIG. 18A attached to one another to form an inner skirt, according to one example.
  • FIG. 18C shows a cross-section of a section of the skirt of FIG. 18B at a location where sub-commissure tabs of leaflets extend through the skirt.
  • FIG. 19A shows a flattened inner skirt with foldable portions, according to one example.
  • FIG. 19B shows the inner skirt of FIG. 19A after folding the foldable portions into radial folds, according to one example.
  • FIG. 20 A shows a flattened inner skirt with foldable flaps, according to one example.
  • FIG. 20B is an enlarged view of a portion of the inner skirt of FIG. 20A, illustrating relative positions of apertures on a flap and apertures adjacent an opening on the inner skirt.
  • FIG. 20C schematically depicts a cross-section of a pair of sub-commissure tabs of leaflets inserted through the opening of the inner skirt and covered by the flap of FIG. 20B.
  • FIG. 21A depicts an inner skirt attached to an annular frame of a prosthetic valve, according to one example.
  • FIG. 21B depicts an enlarged view of an inflow apex region of the frame of FIG. 21A, depicting locking stitches.
  • FIGS. 22A-22I illustrates an example sequence of steps to form the locking stitches of FIG. 21B.
  • FIG. 23 illustrates a skirt segment and a portion of a frame of a prosthetic valve, according to one example.
  • FIG. 24A depicts attachment of a congruent region of two adjacent skirt segments to an axially extending window strut of a frame, according to one example.
  • FIG. 24B depicts attaching a pair of side flaps of two adjacent skirt segments to an axially extending window strut, as viewed from inside the frame, according to one example.
  • FIG. 24C depicts the pair of side flaps of two adjacent skirt segments extending radially outwardly through a cell of the frame, as viewed from outside the frame.
  • FIG. 25A depicts a reinforcement strip attached to a leaflet, according to one example.
  • FIG. 25B is a schematic cross-sectional view (along a central longitudinal axis of the leaflet) of prosthetic valve depicting positions of the leaflet and reinforcement strip of FIG. 25A relative to an inner skirt and a frame of the prosthetic valve.
  • FIG. 26A depicts two reinforcement strips attached to two adjacent leaflets, as viewed from inside a frame, according to one example.
  • FIG. 26B depicts folding first and second wing portions of each reinforcement strip of FIG. 26A, as viewed from inside the frame.
  • FIG. 26C depicts stitching the folded second wing portions of two reinforcement strip of FIG. 26A, as viewed from inside the frame.
  • FIG. 26D depicts folded wing portions extending radially outwardly from the frame, as viewed from outside the frame.
  • FIG. 26E is a schematic cross-sectional view of an example multi-layer structure formed by two reinforcement strips and two sub-commissure tabs extending radially outwardly from the frame.
  • FIG. 27A depicts attaching an outer skirt to an inner skirt via stitches, according to one example.
  • FIG. 27B depicts attaching an outer skirt to a pair of sub-commissure tabs of the leaflets, according to one example.
  • proximal refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site.
  • distal refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site.
  • proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body).
  • FIG. 1 shows a prosthetic heart valve 100 (or simply, “prosthetic valve”), according to one example.
  • Any of the prosthetic valves disclosed herein can be adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves).
  • the disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient.
  • the disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.
  • the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel.
  • the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Patent No. 10,363,130, which is incorporated by reference herein.
  • the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020/247907, which is incorporated herein by reference.
  • the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Patent No. 11,291,540, which is incorporated herein by reference.
  • the prosthetic heart valve 100 can include an annular stent or frame 102, a valvular structure 104, and a perivalvular outer sealing member or outer skirt 106.
  • the frame 102 (and the prosthetic heart valve 100) has an inflow end 108 and an outflow end 110.
  • the frame 102 can have multiple rows of angled struts (also referred to as angled strut segments) circumferentially extending between the inflow end 108 and the outflow end 110, as described further below.
  • the valvular structure 104 can be disposed on an interior of the frame 102 while the outer skirt 106 is disposed around an outer surface of the frame 102.
  • a component of the prosthetic valve 100 (for example, a row of angled struts) is deemed to be upstream of a reference object (for example, another row of angled struts) if the valve component is closer to the inflow end 108 (or farther away from the outflow end 110) than the reference object.
  • a component of the prosthetic valve 100 is deemed to be downstream of a reference object if the frame component is closer to the outflow end 110 (or farther away from the inflow end 108) than the reference object.
  • the valvular structure 104 (which can also be referred to as a “leaflet structure” or a “leaflet assembly”) can comprise a plurality of leaflets 112 (for example, three leaflets, as shown in FIG. 1), which can be arranged to collapse in a tricuspid arrangement.
  • the leaflet structure 104 is movable between an open state which permits blood flow from the inflow end 108 to the outflow end 110 and a closed state which blocks blood fluid flow from the outflow end 110 to the inflow end 108.
  • each leaflet 112 can comprise opposing commissure tabs 115 disposed on opposite sides of the leaflet 112 and a cusp edge portion 113 extending between the opposing commissure tabs.
  • the cusp edge portion 113 of the leaflets 112 can have an undulating, curved scallop shape, and can be secured directly to the frame 102 (for example, by sutures).
  • the cusp edge portion of the leaflets 112 can be secured to an inner skirt (disposed on an inner surface of the frame 102) or a fabric reinforcing member which is then secured to the frame 102.
  • the leaflets 112 can be formed of pericardial tissue (for example, bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated by reference herein. Example structures of leaflets 112 are described more fully below.
  • the outer skirt 106 can be an annular skirt. In some instances, the outer skirt 106 can comprise one or more skirt portions that are connected together and/or individually connected to the frame 102.
  • the outer skirt 106 can comprise a fabric or polymeric material, such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc.
  • the outer skirt 106 instead of having a relatively straight upper edge portion, as shown in FIG. 1, the outer skirt 106 can have an undulating upper edge portion that extends along and is secured to some angled struts (for example, the angled struts 134 of FIG. 2).
  • the frame 102 can be radially compressible and expandable between a radially compressed (or collapsed) configuration and a radially expanded configuration (the expanded configuration is shown in FIG. 1).
  • the frame 102 is shown alone in FIG. 2 and a portion of the frame 102 in a straightened (non-annular) configuration is shown in FIG. 3.
  • the frame 102 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, nickel titanium alloy (NiTi), such as nitinol).
  • plastically-expandable material for example, stainless steel, etc.
  • self-expanding materials for example, nickel titanium alloy (NiTi), such as nitinol.
  • the frame 102 When constructed of a plastically-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.
  • Suitable plastically-expandable materials that can be used to form the frames disclosed herein include, metal alloys, polymers, or combinations thereof.
  • Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal.
  • the frame 102 can comprise stainless steel.
  • the frame 102 can comprise cobalt-chromium.
  • the frame 102 can comprise nickel-cobalt- chromium.
  • the frame 102 comprises a nickel-cobalt-chromium- molybdenum alloy, such as MP35NTM (tradename of SPS Technologies), which is equivalent to UNS R3OO35 (covered by ASTM F562-02).
  • MP35NTM/UNS R3OO35 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.
  • the frame 102 can comprise a plurality of interconnected struts 116 which form multiple rows of cells 118 between the outflow end 110 and the inflow end 108 of the frame 102.
  • the frame 102 can comprise three rows of cells 118 including a first (the upper row in the orientation shown in FIGS. 2-3) row 120 of cells 118 disposed at the outflow end 110, a second row 126 of cells 118 upstream of the first row 120 of cells, and a third row 128 of cells 118 at the inflow end 108 of the frame 102.
  • the first row 120 of cells can also be referred to as “outflow cells” and the third row 128 of cells can also be referred to as “inflow cells.”
  • the first row 120 comprises cells 118 that are elongated in an axial direction (relative to a central longitudinal axis 122 of the frame 102), as compared to cells 118 in the remaining rows of cells.
  • the cells 118 of the first row 120 of cells can have a longer axial length 124 than cells 118 in the second row 126 of cells and the third row 128 of cells.
  • each row of cells comprises nine cells 118.
  • the frame 102 can be referred to as a nine-cell frame.
  • the frame 102 can comprise more than three rows of cells (for example, four or five) and/or more or less than nine cells per row.
  • the cells 118 in the first row 120 of cells may not be elongated compared to cells 118 in the remaining rows of cells of the frame 102 (for example, the second row 126 of cells and the third row 128 of cells).
  • the interconnected struts 116 can include a plurality of angled struts 130, 132, 134, and 136 arranged in a plurality of rows of circumferentially extending rows of angled struts, with the rows being arrayed along the length of the frame 102 between the outflow end 110 and the inflow end 108.
  • the frame 102 can comprise a first row of angled struts 136 arranged end-to-end and extending circumferentially at the outflow end 110 of the frame; a second row of circumferentially extending, angled struts 134; a third row of circumferentially extending, angled struts 132; and a fourth row of circumferentially extending, angled struts 130 at the inflow end 108 of the frame 102.
  • the first row of angled struts 136 is downstream of the second row of angled struts 134, which is downstream of the third row of angled struts 132, which is downstream of the fourth row of angled struts 130.
  • the two rows of angled struts that are closest to the outflow end 110 can be connected by a plurality of axially extending struts, or simply axial struts 140 (which can also be referred to axial frame members).
  • Some of the axial struts 140 can define commissure windows 142 (for example, open windows extending through a thickness of the axial struts).
  • commissure windows 142 for example, open windows extending through a thickness of the axial struts.
  • such axial struts with commissure windows 142 can also be referred to as axially extending window struts 138 (or simply “window struts” or “commissure supports”).
  • Each commissure window 142 can be adapted to receive a pair of commissure tabs of a pair of adjacent leaflets 112 arranged into a commissure (for example, the commissure 114 shown in FIG. 1).
  • the commissure windows 142 and/or the window struts 138 defining the commissure windows 142 can be referred to as commissure features or commissure supports.
  • Each commissure feature or support is configured to receive and/or be secured to a pair of commissure tabs of a pair of adjacent leaflets.
  • One or more (for example, two, as shown in FIGS. 2-3) axial struts 140 without commissure windows 142 can be positioned between, in the circumferential direction, two adjacent commissure supports comprising the commissure windows 142. Since the frame 102 can include fewer cells per row (for example, nine) and fewer axial struts 140 between each pair of window struts 138, as compared to some more traditional prosthetic heart valves, each cell 118 can have an increased width (in the circumferential direction), thereby providing a larger opening for blood flow and/or coronary access.
  • each axial strut 140 (including each window strut 138) can extend from a location defined by the convergence of lower ends (for example, ends arranged downwardly in FIGS. 2-3 and farthest away from the outflow end 110) of two angled struts 136 (which can also be referred to as an upper strut junction) to another location defined by the convergence of the upper ends (for example, ends arranged upwardly in FIGS. 2-3 and closer to the outflow end 110) of two angled struts 134 (which can also be referred to as a lower strut junction).
  • Each axial strut 140 (including each window strut 138) thus forms an axial side of two adjacent cells of the first row 120 of cells 118.
  • each axial strut 140 can have a width 144 that is larger than a width of the angled struts 130, 132, 134, and 136.
  • a “width” of a strut is measured between opposing locations on opposing surfaces of the strut that extend between the radially facing inner and outer surfaces of the strut (relative to the central longitudinal axis 122 of the frame 102).
  • a “thickness” of a strut is measured between opposing locations on the radially facing inner and outer surfaces of the strut and is perpendicular to the width of the strut.
  • the width 144 of the axial struts 140 is 50-200%, 75-150%, or at least 100% larger than (for example, double) the width of the angled struts of the frame 102.
  • the cells 118 of the frame 102 can have a relatively large width compared to alternate prosthetic valves that have more than nine cells per row, the wider axial struts 140 can be more easily incorporated into the frame 102, without sacrificing open space for blood flow and/or coronary access.
  • commissure tabs 115 of adjacent leaflets 112 can be secured together to form commissures 114 (FIG. 1).
  • Each commissure 114 of the prosthetic valve 100 comprises two commissure tabs 115 paired together, one from each of two adjacent leaflets 112, and extending through a commissure window 142 of the frame 102.
  • Each commissure 114 can be secured to a respective window strut 138 forming commissure window 142.
  • each leaflet 112 can be secured to the frame 102 via one or more fasteners (for example, sutures).
  • the cusp edge portion of each leaflet 112 can be secured directly to the struts of the frame 102 (for example, angled struts 130, 132, and 134).
  • the cusp edge portions of the leaflets 112 can be sutured to the angled struts 130, 132, and 134 that generally follow the contour of the cusp edge portions of the leaflets 112.
  • the cusp edge portion of the leaflets 112 can be secured to an inner skirt disposed on an inner surface of the frame, and the inner skirt can then be secured directly to the frame 102.
  • Various methods for securing the leaflets 112 to a frame, such as the frame 102, are disclosed in PCT Application No. PCT/US2022/049666, which is incorporated by reference herein.
  • one or more of or each of the axial struts 140 can comprise an inflow end portion 146 (for example, an end portion that is closest to the inflow end 108) and an outflow end portion 148 that are widened relative to a middle portion 150 of the axial strut 140.
  • the inflow end portion 146 of the axial strut 140 can comprise an aperture 147.
  • the apertures 147 can be configured to receive fasteners (for example, sutures) for attaching soft components of the prosthetic heart valve 100 to the frame 102.
  • the outer skirt 106 can be positioned around the outer surface of the frame 102 and an upper or outflow edge portion of the outer skirt 106 can be secured to the apertures 147 by fasteners 149 (for example, sutures), as shown in FIG. 1.
  • the interconnected struts 116 can also comprise horizontal struts 182 that extend between adjacent cells 118 of a row of cells of the frame 102 (FIGS. 2-3).
  • the horizontal struts 182 can extend in a circumferential direction.
  • the horizontal struts 182 can connect angled struts of two adjacent rows of angled struts of the frame 102 to one another.
  • each horizontal strut 182 can connect to two angled struts of one row of struts (for example, struts 134 shown in FIG. 3) and two angled struts in another, adjacent row of struts (for example, struts 132 shown in FIG. 3).
  • an angled strut 184 extending between a window strut 138 and a horizontal strut 182 and an angled strut 186 extending between the horizontal strut 182 and another horizontal strut 182 disposed adjacent to the inflow end 108 of the frame 102 can be aligned along an angled line that can follow a scallop line of the leaflets (when the leaflets are attached to the frame 102).
  • the horizontal struts 182 can allow the angled struts (for example, angled struts 184, 186) to follow a shape that more closely matches a shape of the scallop line of the leaflets when the frame 102 is in the radially expanded configuration (as shown in FIGS. 2-3). Additionally, the horizontal struts 182 can serve as spacers that can maintain a specified gap between the angled struts when the frame 102 is in the radially compressed configuration, thereby reducing a risk of pinching the leaflets between the struts in the radially compressed configuration.
  • the frame 102 can further comprise a plurality of apex regions 152 formed at the inflow end 108 and the outflow end 110, each apex region 152 extending and forming a junction between two angled struts 130 at the inflow end 108 or two angled struts 136 at the outflow end 110. As such, the apex regions 152 are spaced apart from one another, in a circumferential direction at the inflow end 108 and the outflow end 110.
  • each apex region 152 can comprise an apex 154 (the highest or most outward extending point in an axial direction) and two thinned (or narrowed) strut portions 156, one thinned strut portion 156 extending from either side of the apex 154 to a corresponding, wider, angled strut 136 (at the outflow end 110) or angled strut 130 (at the inflow end 108).
  • each of the apex regions 152 at the outflow end 110 can form a narrowed transition region between and relative to the two angled struts 136 extending from the corresponding apex region 152 and each of the apex regions 152 at the inflow end 108 can form a narrowed transition region between and relative to the two angled struts 130 extending from the corresponding apex region 152.
  • the thinned strut portions 156 of the apex regions 152 can have a width 158 that is smaller than a width 160 of the angled struts 130 or 136 (FIG. 3).
  • the width 158 can be a uniform width (for example, along an entire length of the strut portion 156). In some examples, the width 158 of the thinned strut portions 156 can be from about 0.06-0.15 mm smaller than the width 160 of the angled struts 130 and/or 136.
  • Each of the thinned strut portions 156 of the apex regions 152 can have a length 162 in a range of 0.8- 1.4 mm, 0.9- 1.2 mm, 0.95-1.05 mm, or about 1.0 mm (for example, ⁇ 0.03 mm). In alternate examples, the length 162 is in a range of 0.3-0.7 mm, 0.4-0.6 mm, 0.45- 0.55 mm, or about 0.5 mm (for example, ⁇ 0.03 mm). Because each outflow apex region 152 can include two thinned strut portions 156 having the same length 162, a total length of the apex region 152 can be two times the length 162.
  • Each apex region 152 and two corresponding angled struts 136 at the outflow end 110 can form an outflow strut 166 and each apex region 152 and two corresponding angled struts 130 at the inflow end 108 can form an inflow strut 168.
  • Each outflow strut 166 and inflow strut 168 can have a length that includes an apex region 152 and the two angled struts 136 or 130 (or strut portions), respectively, on either side of the apex region 152.
  • One half the total length of each outflow strut 166 and inflow strut 168 is shown in FIG. 3 as length 170, which extends from an end of one angled strut 136 or 130 to a middle longitudinal axis 164.
  • the length of each outflow strut 166 and inflow strut 168 is two times length 170.
  • the length 170 for half of each inflow strut 168 can be different than the length 170 for half of each outflow strut 166.
  • each thinned strut portion 156 can be at least 25% of the length 170 of the corresponding half outflow strut 166 or inflow strut 168.
  • the length of each apex region 152 (a total length being two times the length 162) can be at least 25% of the total length (two times length 170) of the outflow strut 166 or inflow strut 168.
  • the length of each apex region 152 can be more than 25% of the total length of the corresponding outflow strut 166 or inflow strut 168, such as 25-35%.
  • each apex region 152 can comprise a curved, axially facing outer surface 172 and an arcuate or curved, axially facing inner depression 174 which forms the thinned strut portions 156.
  • the curved inner depression 174 can depress toward the curved outer surface 172 from an inner surface of the angled strut portions 156, thereby forming the smaller width thinned strut portions 156.
  • the curved inner depressions 174 can be formed on a cell side of the apex region 152 (for example, as opposed to the outside of the apex region 152).
  • the curved outer surface 172 of each apex region 152 can form a single, continuous curve from one angled strut portion 156 on a first side of the apex region 152 to another angled strut portion 156 on an opposite, second side of the apex region 152 (for example, the curved outer surface 172 can have a constant curvature).
  • Each apex region 152 can have a radius of curvature 176, along the curved outer surface 172 (for example, in some instances, along an entirety or an entire length of the curved outer surface 172) (FIG. 3).
  • the radius of curvature 176 at the apex 154 and/or along the entire curved outer surface 172 of the apex region 152 can be greater than 1 mm.
  • the radius of curvature 176 can be in a range of 1-20 mm, 3- 16 mm, or 8-14 mm. In some instances, the radius of curvature 176 can be greater than 10 mm.
  • the radius of curvature 176 can be dependent on (and thus change due to changes in) the width 158 (for example, the amount of reduction in width from the angled struts 130 or 136) and the length 162 of the thinned strut portions 156.
  • a height (an axial height) 178 of the apex regions 152 which can be defined in the axial direction from an outer surface of the two angled struts 130 or 136 to the curved outer surface 172 of the apex region 152 at the apex 154, can be the width 158 of the thinned strut portions 156 (FIG. 3).
  • the height 178 of the apex regions 152 can be relatively small and not add much to the overall axial height of the radially expanded frame 102.
  • the leaflets 112 secured to the frame 102 (FIG. 1) can be disposed close to the inflow end 108, thereby leaving a larger open space at the outflow end 110 of the frame 102 that is not blocked by the leaflets 112.
  • each of the apex region 152 can form an angle 180 between the two angled struts 130 or 136 extending from either side of the corresponding apex region 152 (FIG. 3).
  • the angle 180 can be in a range of 120 (not inclusive) to 140 degrees (for example, such that the angle 180 is greater than 120 degrees and less than or equal to 140 degrees).
  • FIG. 4 shows a delivery apparatus 200, according to an example, that can be used to implant an expandable prosthetic valve (for example, the prosthetic valve 100 and/or any of the other prosthetic valves described herein).
  • the delivery apparatus 200 can be specifically adapted for use in introducing a prosthetic valve into a heart.
  • the delivery apparatus 200 in the illustrated example of FIG. 4 is a balloon catheter comprising a handle 202 and a steerable, outer shaft 204 extending distally from the handle 202.
  • the delivery apparatus 200 can further comprise an intermediate shaft 206 (which also may be referred to as a balloon shaft) that extends proximally from the handle 202 and distally from the handle 202, the portion extending distally from the handle 202 also extending coaxially through the outer shaft 204. Additionally, the delivery apparatus 200 can further comprise an inner shaft 208 extending distally from the handle 202 coaxially through the intermediate shaft 206 and the outer shaft 204 and proximally from the handle 202 coaxially through the intermediate shaft 206.
  • an intermediate shaft 206 which also may be referred to as a balloon shaft
  • the outer shaft 204 and the intermediate shaft 206 can be configured to translate (for example, move) longitudinally, along a central longitudinal axis 220 of the delivery apparatus 200, relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a patient’s body.
  • the intermediate shaft 206 can include a proximal end portion 210 that extends proximally from a proximal end of the handle 202, to an adaptor 212.
  • a rotatable knob 214 can be mounted on the proximal end portion 210 and can be configured to rotate the intermediate shaft 206 around the central longitudinal axis 220 and relative to the outer shaft 204.
  • the adaptor 212 can include a first port 238 configured to receive a guidewire therethrough and a second port 240 configured to receive fluid (for example, inflation fluid) from a fluid source.
  • the second port 240 can be fluidly coupled to an inner lumen of the intermediate shaft 206.
  • the intermediate shaft 206 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 204 when a distal end of the outer shaft 204 is positioned away from an inflatable balloon 218 of the delivery apparatus 200.
  • a distal end portion of the inner shaft 208 can extend distally beyond the distal end portion of the intermediate shaft 206.
  • the balloon 218 can be coupled to the distal end portion of the intermediate shaft 206.
  • a distal end of the balloon 218 can be coupled to a distal end of the delivery apparatus 200, such as to a nose cone 222, or to an alternate component at the distal end of the delivery apparatus 200 (for example, a distal shoulder).
  • An intermediate portion of the balloon 218 can overlay a valve mounting portion 224 of a distal end portion of the delivery apparatus 200 and a distal end portion of the balloon 218 can overlie a distal shoulder 226 of the delivery apparatus 200.
  • the valve mounting portion 224 and the intermediate portion of the balloon 218 can be configured to receive a prosthetic valve in a radially compressed state.
  • a prosthetic device such as the prosthetic valve 100, can be mounted around the balloon 218, at the valve mounting portion 224 of the delivery apparatus 200.
  • the balloon shoulder assembly including the distal shoulder 226, can be configured to maintain the prosthetic valve 100 (or other medical device) at a fixed position on the balloon 218 during delivery through the patient’s vasculature.
  • the outer shaft 204 can include a distal tip portion 228 mounted on its distal end.
  • the outer shaft 204 and the intermediate shaft 206 can be translated axially relative to one another to position the distal tip portion 228 adjacent to a proximal end of the valve mounting portion 224, when the prosthetic valve 100 is mounted in the radially compressed state on the valve mounting portion 224 and during delivery of the prosthetic valve to the target implantation site.
  • the distal tip portion 228 can be configured to resist movement of the prosthetic valve 100 relative to the balloon 218 proximally, in the axial direction, relative to the balloon 218, when the distal tip portion 228 is arranged adjacent to a proximal side of the valve mounting portion 224.
  • An annular space can be defined between an outer surface of the inner shaft 208 and an inner surface of the intermediate shaft 206 and can be configured to receive fluid from a fluid source via the second port 240 of the adaptor 212.
  • the annular space can be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 208 and an inner surface of the balloon 218. As such, fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the balloon 218 and radially expand and deploy the prosthetic valve 100.
  • An inner lumen of the inner shaft can be configured to receive a guidewire therethrough, for navigating the distal end portion of the delivery apparatus 200 to the target implantation site.
  • the handle 202 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 200.
  • the handle 202 includes an adjustment member, such as the illustrated rotatable knob 260, which in turn can be operatively coupled to the proximal end portion of a pull wire.
  • the pull wire can extend distally from the handle 202 through the outer shaft 204 and has a distal end portion affixed to the outer shaft 204 at or near the distal end of the outer shaft 204.
  • Rotating the knob 260 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 200.
  • the handle 202 can further include an adjustment mechanism 261 including an adjustment member, such as the illustrated rotatable knob 262, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 278.
  • the adjustment mechanism 261 can be configured to adjust the axial position of the intermediate shaft 206 relative to the outer shaft 204 (for example, for fine positioning at the implantation site). Further details on the delivery apparatus 200 can be found in PCT Application No. PCT/US2021/047056, which is incorporated by reference herein.
  • the delivery apparatus 200 depicted in FIG. 4 is specifically adapted to deliver a balloon expandable prosthetic valve, it is to be understood that variants of the delivery apparatus 200 can be adapted for delivery of self-expandable prosthetic valves and/or mechanically expandable prosthetic valves, as described in references incorporated above.
  • the prosthetic valve for example, the prosthetic valve 100
  • the prosthetic valve can be mounted in a radially compressed state along the distal end portion of a delivery apparatus (for example, the delivery apparatus 200).
  • the prosthetic valve and the distal end portion of the delivery apparatus can be inserted into a femoral artery and then advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta.
  • the prosthetic valve can be positioned within the native aortic valve and radially expanded (for example, by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to selfexpand).
  • a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) can be introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve can be positioned within the native aortic valve.
  • a prosthetic valve (on the distal end portion of the delivery apparatus) can be introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-stemotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.
  • the prosthetic valve can be mounted in a radially compressed state along the distal end portion of a delivery apparatus.
  • the prosthetic valve and the distal end portion of the delivery apparatus can be inserted into a femoral vein and then advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (for example, through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve.
  • a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) can be introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve can be positioned within the native mitral valve.
  • the prosthetic valve For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve can be mounted in a radially compressed state along the distal end portion of a delivery apparatus.
  • the prosthetic valve and the distal end portion of the delivery apparatus can be inserted into a femoral vein and then advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve can be positioned within the native tricuspid valve.
  • a similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve can be advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve/pulmonary artery.
  • Another delivery approach is a trans-atrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) can be inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a trans-ventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) can be inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.
  • the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature.
  • the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.
  • a leaflet 300 for a prosthetic heart valve (for example, the prosthetic heart valve 100 of FIG. 1) is shown in a flattened configuration in FIG. 5.
  • the leaflet 300 can be formed of pericardial tissue (for example, bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118.
  • a plurality of the leaflets 300 can be assembled together into a leaflet assembly or valvular structure (for example, the valvular structure 104 of FIG. 1) and then secured to a frame of a prosthetic heart valve, such as the frame 102 of the prosthetic valve 100 shown in FIGS. 1-3.
  • the leaflet 300 has a main body 302 with an outflow edge 304 and a cusp edge portion 306.
  • the cusp edge portion 306 has a curved contour defined by its outermost edge 305 (also referred to as “cusp edge” hereinafter) which is opposite to the outflow edge 304 and symmetric about an apex 301 (the most outward extending point in an axial direction) of the leaflet.
  • the cusp edge portion 306 can be attached (such as via stitching) to struts of a frame of a prosthetic heart valve and/or to an inner skirt that is attached to the struts of the frame.
  • the cusp edge portions 306 of the multiple leaflets can define an undulating scallop line.
  • the outflow edge 304 can be configured to move and contact respective outflow edges of the other leaflets of a leaflet assembly during closure of the leaflets (for example, during diastole during operation of the prosthetic heart valve).
  • the leaflet 300 can include two sets of opposing tabs disposed on opposite sides of the leaflet 300.
  • the leaflet 300 includes a pair of upper tabs 308 disposed on opposite sides of the leaflet 300 and a pair of lower tabs 310 disposed on opposite sides of the leaflet 300.
  • the lower tabs 310 are disposed closer to the cusp edge portion 306 than the upper tabs 308.
  • the lower tabs 310 can also be referred to as commissure tabs.
  • the upper tabs 308 can be optional.
  • Both the upper tabs 308 and lower tabs 310 extend laterally outward from the main body 302 of the leaflet 300, relative to a central longitudinal axis 312 of the leaflet 300.
  • an outer edge 314 of each upper tab 308 extends farther laterally outward, away from the main body 302 of the leaflet 300, than an outer edge 316 of the respective lower tab 310.
  • an axial direction can be a direction parallel to the central longitudinal axis 312 and a lateral direction can be perpendicular to the central longitudinal axis 312 (for example, from one side of the leaflet to the opposite side of the leaflet, across the central longitudinal axis 312).
  • each upper tab 308 can be axially and laterally offset from the outflow edge 304 of the leaflet 300 by an offsetting portion 326 (which can also be referred to as a neck, neck portion, or connecting portion).
  • the offsetting portion 326 extends between the lower tab 310 and the upper tab 308 on each side of the leaflet 300.
  • An upper edge 318 of each lower tab 310 can be positioned at an angle relative to the central longitudinal axis 312. In some examples, the angle can be 90 degrees. In some examples, such as when the frame to which the leaflet 300 is to be attached is non-cylindrical (such as tapered, frustoconical, V-shaped, or Y-shaped), the angle measured between the upper edge 318 of each lower tab 310 and the central longitudinal axis 312 can be less than 90 degrees, such as 80 to 88 degrees.
  • the angle measured between the upper edge 318 of each lower tab 310 and the central longitudinal axis 312 can be selected based on a draft angle of the frame to which the leaflet 300 is to be attached, as described in PCT Publication No. WO 2022/026351, which is incorporated herein by reference.
  • each lower tab 310 of a leaflet can be paired with an adjacent lower tab 310 of an adjacent leaflet to form a commissure (for example, the commissure 114 of FIG. 1) that is coupled to the frame.
  • the upper tabs 308 of the two adjacent leaflets 300 can be folded downward at their offsetting portions 326 such that the lower tabs 310 or the commissure are disposed between the pair of upper tabs 308.
  • the lower tabs 310 or the commissure can then be inserted through a commissure window (for example, the commissure window 142 of FIGS. 2-3) in the frame.
  • Each lower tab 310 can be coupled to a respective upper tab 308 via sutures. Further details on forming the commissures are described in PCT Application No. PCT/US2023/030530, which is incorporated by reference herein.
  • the leaflet 300 can include a pair of sub-commissure tabs 320 arranged on opposite sides of the main body 302 and below the lower tabs 310.
  • the sub-commissure tabs 320 can extend laterally outward from the main body 302 of the leaflet 300, relative to the central longitudinal axis 312.
  • the sub-commissure tab 320 can be separated from the lower tab 310 by a recessed region 322.
  • the outer edge 316 of each lower tab 310 extends farther laterally outward, away from the main body 302 of the leaflet 300, than an outer edge 324 of the respective sub-commissure tab 320.
  • Each sub-commissure tab 320 of a leaflet can be paired with and connected to an adjacent sub-commissure tab 320 of an adjacent leaflet to form a wing member, which can be oriented in different directions, as described more fully below.
  • the cusp edge portion 306 can terminate at its upper ends at the sub-commissure tabs 320.
  • the cusp edge portion 306 can extend from one sub-commissure tab 320 to the other sub-commissure tab 320 of the leaflet 300.
  • the sub-commissure tabs 320 of the multiple leaflets are positioned right above the highest point of the scallop line defined by the cusp edge portions 306.
  • leaflet 300 Additional details of the leaflet 300 are described in U.S. Provisional Application No. 63/553,275, filed February 14, 2024, which is incorporated by reference herein.
  • a prosthetic heart valve can have an inner skirt disposed on an inner surface of an annular frame of the prosthetic heart valve.
  • the inner skirt can serve several functions.
  • the inner skirt can function as a seal member to prevent or decrease perivalvular leakage, to anchor the leaflets to the frame, and/or to protect the leaflets against damage caused by contact with the frame during crimping and during working cycles of the prosthetic heart valve.
  • the inner skirt can comprise a tough, tear resistant material such as polyethylene terephthalate (PET), although various other synthetic or natural materials can be used.
  • FIG. 6 shows an inner skirt 400 which can be mounted on an inner surface of a frame of a prosthetic heart valve (for example, the frame 102), according to one example.
  • the inner skirt 400 has an inflow edge 402 and an outflow edge 404.
  • the inflow edge 402 can be straight or substantially straight.
  • the outflow edge 404 can have a zigzagged pattern that aligns with and generally corresponds to the shape of a row of angled strut (for example, the angled struts 184 of FIG. 3) of the annular frame.
  • the outflow edge 404 can define a plurality of triangular edge portions 406 which are situated downstream of a body portion 414 of the inner skirt 400.
  • the inner skirt 400 is shown in a flattened configuration, for example, before mounting the inner skirt 400 to the frame.
  • the inner skirt 400 can have two opposing side edges 408.
  • Each side edge 408 can form an oblique angle relative to the inflow edge 402.
  • One side edge 408 forms an acute Al that can range between 30 and 60 degrees, or between 40 and 50 degrees. In one specific example, the angle Al can be about 45 degrees.
  • the opposing side edges 408 can be affixed together (for example, via stitches, glues, or any other attachment means) so that the inner skirt 400 has a generally cylindrical shape.
  • the inner skirt 400 can be woven from two sets of fibers (or yams, strands, etc.) that are perpendicular to one another.
  • the inner skirt 400 can have a first set of fibers oriented in a first direction and a second set of fibers oriented in a second direction, and the first direction can be generally perpendicular to the second direction.
  • one set of the fibers can form an angle between 30 and 60 degrees (for example, about 45 degrees) relative to the inflow edge 402.
  • one set of the fibers can be parallel or substantially parallel to the side edges 408. As such, when the frame is radially expanded, the fibers of the inner skirt 400 can extend parallel or substantially parallel to angled struts of the frame.
  • the inner skirt 400 can have a plurality of axially extending openings 410 (for example, longitudinal slits). Three openings 410 are shown in FIG. 6, while the number of openings 410 can be two or more than three.
  • Each opening 410 has an upper end 410a and a lower end 410b. The lower end 410b is closer to the inflow edge 402 than the upper end 410a.
  • the axially extending openings 410 can be positioned in or below (for example, upstream of) selected triangular edge portions 406. For example, both the upper end 410a and lower end 410b of an opening can be located in a selected triangular edge portion 406.
  • the upper end 410a of an opening can be located in a selected triangular edge portion 406 and the lower end 410a of the opening can be located in the body portion 414.
  • a pair of sub-commissure tabs (for example, the sub-commissure tabs 320 of FIG. 5) of the leaflet structure can extend radially outwardly through an adjacent opening 410 on the inner skirt 400, as described more fully below.
  • the inner skirt 400 can also include a plurality of preformed markings 412 (which can also be referred to as “markers”) on the body portion 414 of the inner skirt 400.
  • the plurality of preformed markings 412 can define an undulating scallop line 416.
  • the scallop line 416 can extend between each two immediately adjacent openings 410.
  • the scallop line 416 can include multiple cusp-shaped curves 418 formed by separate groups of the preformed markings 412, each group comprising preformed markings 412 located between two immediately adjacent openings 410.
  • Three cusp-shaped curves 418 are shown in FIG. 6, while the number of cusp-shaped curves 418 can be two or more than three, depending on the number of leaflets present.
  • Each cusp-shaped curve 418 can generally match the contour of the cusp edge portion (for example, the cusp edge portion 306 of FIG. 5) of a leaflet.
  • the scallop line 416 can be used as an alignment feature.
  • the cusp edge portion of each leaflet can be coupled to the inner skirt 400 via at least one suture extending along the scallop line 416.
  • the preformed markings 412 can be preformed apertures, such that the suture can extend through those apertures. These apertures (and any other apertures on various inner skirts disclosed herein) can be formed by means of laser drilling or cutting or other drilling or cutting mechanisms. In some examples, the preformed markings 412 may not perforate the inner skirt 400. For instance, the preformed markings 412 can be nonperforating visual markers featuring different colors (colors different than that of the skirt) or other visually perceptible indicators to guide the attachment of the leaflets to the inner skirt 400.
  • these visual markers can be formed by using ultraviolet (UV) light to selectively expose and alter the material properties of the inner skirt 400 at the corresponding locations.
  • UV light can be used to discolor the surface of the skirt at locations exposed to the UV light such that the discolored areas on the skirt can serve as markings.
  • the markings 412 can be formed by applying (e.g., printing) ink or paint to a skirt. These visual markers can be used to guide the precise placement of the suture. Additionally, the markings 412 (whether preformed apertures or other types of visual markings) can be a plurality of discrete, spaced apart markings, or a continuous line.
  • the scallop line 416 can be defined by a continuous, undulating line formed by exposure to UV light or applying ink or paint to the skirt.
  • the types of and techniques for forming markings 412 or a continuous marking line can be applied to any of the skirts or other components described herein that include preformed markings.
  • the uppermost markings are positioned adjacent to the lower ends 410b of the openings 410.
  • a pair of uppermost markings 412a, 412b can be positioned on opposite sides of each opening 410 and slightly below the lower end 410b of the opening 410.
  • the distance between the uppermost markings 412a, 412b and the opening 410 can be configured to be greater than a predefined distance to prevent merging of the uppermost markings 412a, 412b with the opening 410 caused by the tearing or stress induced by the commissure inserted through the opening 410 and/or suture extending through the uppermost markings 412a, 412b.
  • the distance between the uppermost markings 412a, 412b and the opening 410 can be about the same as two immediately adjacent markings 412 located on a cusp-shaped curves 418.
  • the lower ends 410b of the openings 410 can be positioned at or close to the highest points of the scallop line 416.
  • the multiple cusp-shaped curves 418 can be joined together at locations close to the lower ends 410b of the openings 410 to form the scallop line 416.
  • FIG. 7 shows an inner skirt 500 in a flattened configuration, according to another example.
  • the inner skirt 500 has multiple skirt segments 520.
  • the number of skirt segments 520 is equal to the number of leaflets present.
  • Three skirt segments 520 are shown in FIG. 7, although the number of skirt segments 520 can be two or more than three.
  • Each skirt segment 520 has an inflow portion 522 and an outflow portion 524.
  • the inflow portion 522 of each skirt segment 520 has two opposing lower side edges 508 and an inflow edge 502 extending between the two lower side edges 508.
  • the outflow portion 524 of each skirt segment 520 has two upper side edges 510 and an outflow edge 504 extending between the two upper side edges 510.
  • Two adjacent lower side edges 508 of a pair of adjacent skirt segments 520 can be connected (for example, via stitches, glues, or any other attachment means) so that the inflow portions 522 of the multiple skirt segments 520 can form a continuous surface or edge forming a lower portion (or inflow portion) of the inner skirt 500.
  • two adjacent upper side edges 510 of a pair of adjacent skirt segments 520 can be connected (for example, via stitches, glues, or any other attachment means) so that the outflow portions 524 of the multiple skirt segments 520 can form a continuous surface or edge forming an upper portion (or outflow portion) of the inner skirt 500.
  • the inner skirt 500 can have a generally cylindrical shape and be mounted to an inner surface of the annular frame.
  • the inflow edge 502 of each skirt segment 520 can be substantially straight, and the outflow edge 504 of each skirt segment 520 can have a zigzagged pattern to define a plurality of triangular edge portions 506.
  • the outflow edges 504 of the multiple skirt segments 520 can form a continuous outflow edge similar to the outflow edge 404 of FIG. 6, which can align with and generally correspond to the shape of a row of angled strut (for example, the angled struts 184 of FIG. 3) of the annular frame.
  • the inflow edges 502 of the multiple skirt segments 520 can form a continuous inflow edge similar to the inflow edge 402 of FIG. 6.
  • a lower side edge 508 of each skirt segment 520 can form an oblique angle relative to the inflow edge 502.
  • one side edge 508 forms an acute angle A2 that can range between 30 and 60 degrees, or between 40 and 50 degrees. In one specific example, the angle A2 can be about 45 degrees.
  • the upper side edges 510 of each skirt segment 520 can be perpendicular to the inflow edge 502.
  • each skirt segment 520 can be woven from two sets of fibers (or yams, strands, etc.) that are perpendicular to one another.
  • each skirt segment 520 can have a first set of fibers oriented in a first direction and a second set of fibers oriented in a second direction that is perpendicular to the first direction.
  • one set of the fibers can form an angle between 30 and 60 degrees (for example, about 45 degrees) relative to the inflow edge 502.
  • one set of the fibers can be parallel or substantially parallel to the lower side edges 508. As such, when the frame is radially expanded, the fibers of the inner skirt 500 can extend parallel or substantially parallel to angled stmts of the frame.
  • each skirt segment 520 can have a plurality of preformed markings 512 extending from one upper side edge 510 to the other upper side edge 510. Similar to the markings 412, the markings 512 can be apertures for a suture to extend therethrough and/or non-perforating visual markers to guide stitch placement.
  • the plurality of preformed markings 512 on each skirt segment 520 can define a cusp-shaped curve 518 that substantially matches the contour of the cusp edge portion (for example, the cusp edge portion 306 of FIG. 5) of a leaflet.
  • each leaflet can be coupled to an adjacent skirt segment 520, for example, via at least one suture extending through the plurality of preformed markings 512.
  • the cusp-shaped curves 518 defined by the plurality of preformed markings 512 on each skirt segment 520 can be joined together to form an undulating scallop line similar to the scallop line 416 of FIG. 6.
  • the leaflet structure and the inner skirt 500 can be pre-assembled together before mounting the inner skirt and the leaflet structure to the frame.
  • the leaflets can be attached to the corresponding skirt segments 520 in the flattened configuration. Then, the skirt segments 520 can be connected to one another to form the cylindrically shaped inner skirt 500, which is then attached to the frame.
  • each skirt segment 520 two uppermost markings 512a, 512b that are closest to the outflow edge 504 can be adjacent to respective upper ends 510a, 510b of the two upper side edges 510.
  • the uppermost markings 412a, 412b are close to the lower ends 410b of the openings 410 (thus, they are spaced apart from the outflow edge 404 by at least an axial length of the openings 410)
  • the uppermost markings 512a, 512b in each skirt segment 520 can be much closer to the outflow edge 504.
  • inner skirts 700, 800, and 900 are described further below.
  • a prosthetic heart valve can have an outer skirt (for example, the outer skirt 106 of FIG. 1) disposed on an outer surface of an annular frame of the prosthetic heart valve.
  • the outer skirt can cooperate with the inner skirt to further reduce or avoid perivalvular leakage after implantation of the prosthetic heart valve.
  • the outer skirt can be attached to the inner skirt.
  • an outflow end portion of the outer skirt can be sutured to the inner skirt via stitches.
  • those stitches may extend through the inner skirt and be exposed to leaflets of the prosthetic heart valve. As a result, abrasion to the leaflets and/or the stitches may occur when the leaflets contact those stitches during working cycles of the prosthetic heart valve.
  • the outer skirt can be attached to the inner skirt via stitches which are shielded from the leaflets when the leaflet structure moves between the open state and the closed state. As a result, abrasion to the leaflets and/or the stitches can be prevented or reduced.
  • FIGS. 8-10 illustrates one example method of attaching an outer skirt to an inner skirt via concealed stitches.
  • FIG. 8 shows a portion of a prosthetic heart valve 600 having a frame 602 and an inner skirt 610 disposed on an inner surface of the frame 602.
  • the inner skirt 610 can be constructed from a single, unitary or continuous piece of material as the inner skirt 400 of FIG. 6 or can comprise multiple skirt segments as the inner skirt 500 of FIG. 7.
  • FIG. 8 shows only one skirt segment of the inner skirt 610 while other skirt segments are removed for clarity.
  • the frame 602 can be the same or similar to the frame 102 of FIGS. 1-3.
  • FIG. 8 shows the frame 602 has a first row 622 of angled struts defining an outflow end 620 of the frame and a second row 624 (FIG. 9) of angled struts immediately upstream of the first row 622 of angled struts.
  • the frame 602 also has a plurality of axial struts or axial frame members 608 bridging the first row 622 and second row 624 of the angled strut.
  • the first row 622 of angled struts, the second row 624 of angled struts, and the axial frame members 608 can define a plurality of outflow cells 626.
  • the prosthetic heart valve 600 has an outer skirt 630 disposed on an outer surface of the frame 602.
  • the outer skirt 630 has an outflow end portion 632 (FIG. 9), which can be straight or substantially straight.
  • the outflow end portion 632 of the outer skirt 630 can be attached to the inner skirt 610 via stitches that are concealed from the leaflets, as described further below.
  • the inner skirt 610 has a plurality of preformed markings 612 following a scallop line (similar to the inner skirt 500 of FIG. 7).
  • the leaflets can be attached to the inner skirt 610, for example, by a suture forming a plurality stitches extending along the scallop line aligned with the cusp edge portions of the leaflets (for example, cusp edge portions 306 of leaflets 300).
  • the inner skirt 610 can have an outflow edge 604 which has a zigzagged pattern. When mounted on the frame 602, the outflow edge 604 can align with a row of angled struts of the frame 602.
  • FIG. 8 shows the outflow edge 604 is attached to and aligned with the second row 624 of angled struts 614 (the angled struts are hidden from view in FIG. 8 but are visible in FIG. 9).
  • the inner skirt 610 also includes one or more flaps 606 along at least portions of the outflow edge 604, extending from a main body 618 of the inner skirt 610.
  • the outflow edge 404 can include two angled edge portions 604a, 604b between each two immediately adjacent axial frame members 608.
  • each angled edge portion 604a or 604b can have one flap 606.
  • a pair of flaps 606 can extend from two angled edge portions 604a and 604b, which respectively align with two angled struts 614 (in the second row 624) connecting two adjacent axial frame members 608.
  • only selected angled edge portions have flaps 606.
  • the one or more flaps 606 can extend upwardly toward the outflow end 620 of the frame. As shown in FIGS. 9-10, the one or more flaps 606 can be folded over adjacent angled struts 614 to form one or more folded portions 616 on the outside of the frame. The folded portions 616 can extend downwardly or away from the outflow end 620. The folded portions 616 can slightly overlap with the outflow end portion 632 of the outer skirt 630 on the outside of the frame. Thus, the outflow end portion 632 of the outer skirt 630 can be connected to the one or more folded portions 616 via stitches 634.
  • FIG. 11 shows another example method of attaching an outer skirt to an inner skirt via concealed stitches.
  • an inner skirt 640 of a prosthetic heart valve can have one or more folded portion 642 extending in a radial direction.
  • Each folded portion 642 can be configured as a double layer, including an upper layer 644 and a lower layer 646 overlapping one another.
  • Each folded portion 642 can extend radially outwardly through an adjacent cell 645 of the frame 602. The folded portions 642 can be aligned with the outflow end portion 632 of the outer skirt 630.
  • the outflow end portion 632 of the outer skirt 630 can be connected to the one or more folded portions 642 via stitches 648.
  • the cells 645 through which the folded portions 642 extend can be any cells of the frame, and in some examples, the cells can be any cells that are upstream of the outflow cells 626, depending on the vertical height of the outer skirt 630. Because the folded portions 642 extend outside the frame 602, the stitches 648 are concealed from the leaflets.
  • FIGS. 12A-12D show another example inner skirt 500’ which can be connected to an outer skirt via stitches while shielding the stitches from leaflets of a prosthetic heart valve 600’.
  • the inner skirt 500’ includes a plurality of skirt segments 520’ for example, three segments 520’).
  • FIGS. 12A and 12C show two inner skirt segments 520A’ and 520B’ connected to one another.
  • FIG. 12B shows one example skirt segment 520’, which can be substantially similar to the skirt segment 520 of FIG. 7.
  • each skirt segment 520’ has an inflow portion 522 and an outflow portion 524.
  • the inflow portion 522 of each skirt segment 520’ has two opposing lower side edges 508 and an inflow edge 502 extending between the two lower side edges 508.
  • the outflow portion 524 of each skirt segment 520’ has two upper side edges 510 and an outflow edge 504 extending between the two upper side edges 510.
  • Two adjacent lower side edges 508 of a pair of adjacent skirt segments 520’ can be connected so that the inflow portions 522 of the multiple skirt segments 520’ can form a continuous surface or edge forming a lower portion (or inflow portion) of the inner skirt 500’.
  • two adjacent upper side edges 510 of a pair of adjacent skirt segments 520’ can be connected so that the outflow portions 524 of the multiple skirt segments 520 can form a continuous surface or edge forming an upper portion (or outflow portion) of the inner skirt 500.
  • the skirt segment 520’ additionally includes two flaps 530 located at opposing ends of the outflow portion 524.
  • Each flap 530 is foldable relative the outflow portion 524 along a corresponding folding line 544.
  • the corresponding folding line 544 can define a part of the outflow edge 504 of the skirt segment 520’.
  • the outflow edge 504 can have a zigzagged pattern aligned with a row of angled strut segments 614 of an annular frame 602 of the prosthetic heart valve 600’.
  • FIG. 12D shows the outflow edge 504 of each skirt segment 520’ (including the folding line 544) can be connected to the row of angle strut segments 614 via a plurality of whip stitches 548.
  • each flap 530 has a first edge 532, a second edge 534, a third edge 536, and a fourth edge 538.
  • the first edge 532 extends further downstream of the outflow edge 504 of the skirt segment 520’.
  • the second edge 534 is substantially parallel to the third edge 536. Additionally, the second edge 534 is slightly shorter and located more laterally than the third edge 536.
  • the first edge 532 extends between the second edge 534 and the third edge 536.
  • the fourth edge 538 can be substantially parallel to an adjacent segment of the outflow edge 504 (for example, an adjacent side of a triangular edge portion 506) and define a gap 540 therebetween.
  • the folding line 544 can extend from an end of the second edge 534 to an end of the fourth edge 538.
  • each flap 530 can be paired with and connected to an adjacent flap of an adjacent skirt segment to form a folded portion 550, to which an outflow end portion of an outer skirt optionally can be connected.
  • the outflow end portion 632 of the outer skirt 630 depicted in FIGS. 9-11 can be connected to the folded portion 550 via stitches.
  • each folded portion 550 can extend radially outwardly through an adjacent cell 626 of the annular frame 602. As a result, the stitches connecting the outer skirt 630 to the folded portion 550 are concealed from the leaflets of the prosthetic heart valve 600’.
  • each folded portion 550 can be formed by joining first edges 532 of a pair of flaps 530 of two adjacent skirt segments 520’.
  • the second edge 534 of the flap can align with an end segment 546 of the outflow edge 504, and the first edge 532 of the flap can extend along (for example, parallel to) the adjacent upper side edge 510 of the skirt segment 520’.
  • the first edge 532 of the folded flap can extend slightly farther laterally outward than the adjacent upper side edge 510.
  • the first edge 532 of the flap and the side edge 510 can be folded along a vertical fold line so as to extend radially outward into an adjacent cell of the frame.
  • each skirt segment 520’ can have a plurality of preformed markings 512 defining a cusp-shaped curve, which generally matches the contour of the cusp edge portion of a leaflet. As shown in FIGS.
  • each flap 530 can include one or more apertures 542 configured to align with selected preformed markings 512 (for example, one or more preformed markings 512 closest to the outflow edge 504) on the cuspshaped curve when the flap 530 is folded over the outflow portion 524 (FIG. 12A).
  • these apertures 542 on the folded flap can define an upper end portion of the scallop line, along which the inner skirt 500’ can be connected to the leaflets via at least one suture extending through the preformed markings 512 and the aligned markings 542 (for example, stitches extending through the markings 512, 542 and the leaflet cusp edge portions).
  • a pair of sub-commissure tabs of adjacent leaflets can extend through an opening or gap between a first pair of folded edges 532, 510 and a second pair of folded edges 532, 510 and stitched thereto, as described below with respect to FIGS. 18A-18C.
  • FIG. 13 shows an alternative example where the outer skirt 630 is directly attached to the frame 602. In this example, the leaflet structure and the inner skirt of the prosthetic heart valve are removed for clarity. As shown in FIG. 13, the plurality of axial frame members 608 are connected to the second row 624 of angled struts at a plurality of junctions 628.
  • the outflow end portion 632 of the outer skirt 630 can be attached to the plurality of junctions 628 via stitches 636, for example, that extend through the skirt 630 and through apertures 638 located at the junctions 628.
  • the inner skirt can shield the stitches 636 from the leaflets.
  • the outflow end portion 632 of the outer skirt 630 is connected to the frame 602 solely at the junctions 628 such that portions of the outflow end portion 632 of the outer skirt between each pair of immediately adjacent junctions 628 are detached from the frame 602.
  • the unattached sections of the outflow end portion 632 of the outer skirt allow for the formation of pockets into which retrograde blood can flow during working cycles of the prosthetic valve. Blood filling these pockets can push the outer skirt 630 radially outwards against the native anatomy, thereby potentially improving the sealing of the prosthetic heart valve and reducing the likelihood of paravalvular leakage.
  • each commissure tab for example, the lower tabs 310 of FIG. 5
  • each sub-commissure tab for example, the sub- commissure tab 320 of FIG. 5
  • the pairs of sub-commissure tabs can be arranged in different configurations.
  • FIG. 14A depicts a prosthetic heart valve comprising the frame 602 and multiple leaflets 650 forming a leaflet structure.
  • the prosthetic heart valve can also have an inner skirt 660 (which can be any one of the inner skirts described herein) disposed on an inner surface 602a of the frame 602.
  • FIG. 14B shows that a pair of commissure tabs 652 of two adjacent leaflets 650 can form a commissure which can be inserted into a commissure window 654 (similar to the commissure window 142 of FIGS. 2-3) of the frame 602.
  • the cusp edge portions of the leaflets 650 can be sutured to the inner skirt 660 along a scallop line 662.
  • 14A-14B also depict a pair of sub-commissure tabs 656 of the two adjacent leaflets 650, which are positioned below or upstream of the pair of commissure tabs 652.
  • the pair of sub-commissure tabs 656 can be coupled together, for example, via stitches 658, glues, or other attachment means.
  • the pair of sub-commissure tabs 656, when coupled together, can also be referred to as a wing member.
  • the pair of sub-commissure tabs 656 or the wing member extends radially inwardly and away from of the frame 602 (that is, the wing member is oriented toward the center of the lumen of the prosthetic heart valve). Additional examples of orienting the pair of sub-commissure tabs or the wing member radially inwardly and away from the frame are described in PCT Publication WO 2022/072442, which is incorporated by reference herein.
  • the sub-commissure tabs or wing members extending radially inwardly may create an inward-oriented bulging tissue at the upper ends of the scallop line along which the cusp edge portions of the leaflets are sutured to the inner skirt.
  • avoiding the inner protrusions of the sub-commissure tabs may also lead to more symmetric closure of the leaflets.
  • FIGS. 15A-15B show a prosthetic valve comprising the frame 602, the inner skirt 660 disposed on the inner surface 602a of the frame 602, and multiple leaflets 650 (which, in some examples, comprise leaflets 300) sutured to the inner skirt 660 along the scallop line 662.
  • leaflets 650 which, in some examples, comprise leaflets 300 sutured to the inner skirt 660 along the scallop line 662.
  • each pair of sub-commissure tabs 656 of two adjacent leaflets 650 are arranged in a flat (non- folded) configuration, extending in a circumferential direction along the inner surface 602a of the frame 602.
  • a sub-commissure tab 656a of one leaflet 650a can lie flat against the inner skirt 660, and an adjacent sub-commissure tab 656b of an adjacent leaflet 650b can be placed over the sub-commissure tab 656a.
  • the overlapping pair of sub-commissure tabs 656a, 656b can then be coupled together, for example, via stitches 658, glues, or other attachment means, to form a circumferentially oriented and flattened wing member.
  • the length of the stitches 658 are exaggerated in FIG. 15 A for purposes of illustration, but it should be understood that the stitches tightly secure the tabs 656a, 656b to each other and optionally to the inner skirt 660.
  • an optional reinforcing member 661 such as in the form of a strip comprising a fabric or anther tear-resistant material, can be secured to the inner surface of the cusp edge portions of the leaflets 650.
  • the reinforcing member 661 covers the overlapping sub-commissure tabs 656a, 656b and provides a generally smooth and flat inner surface.
  • the cusp edge portions of the leaflets 650 can be stitched to the inner skirt with stitches 663 along a scallop line.
  • the stitches 663 can comprises, for example, a plurality of in-and-out stitches that extend through the reinforcing member 661 (if present), the leaflet cusp edge portions, and the inner skirt 660 along the scallop line.
  • the leaflet cusp edge portions optionally can be further secured to the reinforcing member 661 and/or the inner skirt 660 with blanket stitches 665. Further details regarding the stitching of the leaflet cusp edge portions to the reinforcing member and the inner skirt are disclosed in U.S. Patent No. 9,393,110, which is incorporated herein by reference.
  • pairs of sub-commissure tabs or wing members can be configured to extend through adjacent gaps formed on the inner skirt, thereby avoiding the formation of inner protrusions.
  • FIGS. 16A-16D show a prosthetic valve 600’ comprising the frame 602, the inner skirt 660 disposed on the inner surface 602a of the frame 602, and multiple leaflets 650 (which, in some examples, comprise leaflets 300) sutured to the inner skirt 660 along the scallop line 662.
  • the lower and upper commissure tabs of adjacent leaflets can be assembled together as previously described to form commissures 651 connected to respective commissure supports 609 (similar to commissure supports 138).
  • each pair of sub-commissure tabs 656 of two adjacent leaflets 650 are oriented radially outwardly toward the frame 602.
  • the pair of sub-commissure tabs 656 optionally can be coupled together, for example, via stitches 658, glues, or other attachment means, to form a wing member.
  • the pair of sub-commissure tabs 656 or the wing member can extend through an adjacent opening 664 (which can be similar to the openings 410 of FIG. 6) in the inner skirt 660, and at least partially through a cell 666 of the frame 602.
  • each opening 664 defines a gap through which an adjacent pair of sub-commissure tabs 656 can extend radially outwardly.
  • the cells 666 into which the pairs of sub-commissure tabs 656 extend can be any cells of the frame, and in some examples, the cells can be any cells upstream of the outflow cells 626, depending on the vertical height of the inner skirt 660 and positions of the openings 664 on the inner skirt 660.
  • each pair of sub-commissure tabs 656 or the wing member extending into an adjacent cell 666 does not extend beyond an outer surface 602b of the frame 602.
  • the radial length (L) of the wing member can be configured to be larger than a thickness (Tl) of the inner skirt 660, but is similar to, or slightly less than, Tl plus a thickness (T2) of the struts defining edges of the cells 666.
  • Tl thickness
  • T2 a thickness
  • the wing member can extend through the inner skirt 660 and into the adjacent cell 666 without protruding beyond the outer surface 602b of the frame 602.
  • the tabs 656 can extend completely through a cell such that an outer edges of the tabs 656 are located outside the frame.
  • FIG. 16B illustrates a radially outward facing portion of the prosthetic valve 600’ at a location where the sub-commissure tabs 656 extend outwardly at least partially through a cell 666 of the frame 602 that is directly adjacent to and circumferentially aligned with a commissure support 609.
  • the commissure 651 formed by a pair of adjacent leaflets 650 and the sub-commissure tabs 656 of the pair of adjacent leaflets 650 both extend radially outwards through the frame 602 at locations that are circumferentially aligned and axially spaced apart.
  • the adjacent sub-commissure tabs 656 optionally can be connected to each other, such as with stitches 658.
  • FIG. 16C illustrates a radially inward facing portion of the prosthetic valve 600’ at a location 653 corresponding to skirt opening 664 where the sub-commissure tabs 656 extend outwardly toward the frame 602. Because the sub-commissure tabs 656 are folded such that their outer edges 657 extend through the opening 664 of the inner skirt 660 and into a cell 666 of the frame 602, the leaflets 650 are generally smooth at location 653. For example, there is no radially inward protuberance at location 653 that can restrict opening and closing movements of the leaflets 650 or decrease the flow orifice of the leaflets.
  • the cusp edge portions 655 can be secured to the inner skirt 660 with stitches 663 that extend along the scallop line.
  • an optional reinforcing member 661 can be secured to the inner surfaces of the cusp edge portions 655, such as with the stitches 663, such that the cusp edge portions 655 are sandwiched between the inner skirt 660 and the reinforcing member 661.
  • the stitches 663 can comprise in-and-out stitches that extend through the inner skirt 660, the cusp edge portion 655 of each leaflet, and the reinforcing member 661. As best shown in FIG.
  • the stitches 663 can extend through the tabs 656 and optionally through skirt flaps covering the tabs 656 (such as flaps 730, described below). In this manner, the stitches 663, and therefore the scallop line, can extend along the sub-commissure tabs 656 and form a peak at the upper edges of the tabs 656.
  • the suture forming the stitches 663 optionally can extend over the upper edges of the tabs 656, as shown.
  • the scallop line formed by the stitches 663 can be a continuous stitch line formed by a single suture that is situated on an inner surface of the frame 602 and extends around an entirety of the inner skirt 660 and all of the leaflets. In some examples, more than one suture can be used to form the scallop line.
  • the stitch line or scallop line can be formed by forming a first stitch path in a first circumferential direction around the inner skirt and the leaflets to form a plurality of first stitches 663 and then forming a second stitch path in a second circumferential direction, opposite the first circumferential direction, around the inner skirt and the leaflets to form a plurality of second stitches 663.
  • first and second stitch paths can be formed by a single suture.
  • the frame 602 shown in FIG. 16D is similar to the frame 102 of FIG. 2, except that it includes an additional row of angled struts (for a total of four rows of struts upstream of the axial struts 608, 609.
  • the frame 602 can be identical to the frame 102.
  • the inner skirt 660 can be attached to the frame 602, such as along an outflow edge of the inner skirt and a fourth row of angled struts 614 of the frame 602, for example with a plurality of whip stitches 659a.
  • the inner skirt 660 can further be attached adjacent an inflow edge of the inner skirt to a first row of angled struts 614 that define the inflow end of the frame 602, for example with a plurality of whip stitches 659b.
  • the sub-commissure tabs 656 of adjacent leaflets 656 are folded such that the subcommissure tabs 656 extend radially outwards through the opening 664 of the inner skirt 660 (FIG. 16 A) and at least partially through a cell 666 of the frame 602 that is defined by a third row of angled struts 614 and the fourth row of angled struts 614.
  • the sub-commissure tabs 656 can extend through a cell 666 that is spaced apart from the inflow end of the prosthetic valve 600’.
  • the opening 664 in the inner skirt 660 can have any of various shapes.
  • FIG. 17A shows an opening 664a comprising a longitudinal slit 668 and two horizontal slits 670 connected to two opposing ends of the longitudinal slit 668.
  • the axial length of the longitudinal slit 668 can be about the same as the axial length or vertical height of a pair of sub-commissure tabs 656, and the width of the longitudinal slit 668 can be less than the thickness of the pair of sub-commissure tabs 656.
  • the pair of sub-commissure tabs 656 can be inserted through the longitudinal slits 668 by pushing aside skirt material located between the two horizontal slits 670 and on opposite sides of the longitudinal slits 668.
  • FIG. 17B shows an opening 664b which is configured as a rectangular window extending in the axial direction.
  • the axial length of the opening 664b can be about the same as the axial length of a pair of sub-commissure tabs 656, and the width of the opening 664b can be about the same as the thickness of the pair of sub-commissure tabs 656.
  • the pair of sub-commissure tabs 656 can be inserted through the opening 664b.
  • the opening 664b can be configured to have non-rectangular shapes, such as a window with an elliptical shape, a square shape, a circular shape, a window with concave or convex side edges, etc.
  • any of the openings 664 described above can be formed by cutting the inner skirt 660, for example, using scissors, laser, or any other cutting means.
  • the openings 664 can be located upstream of an outflow edge of the inner skirt 660.
  • FIG. 17C shows the inner skirt 660 has a zigzagged outflow edge 672 which can be aligned with a row of angled struts of the frame, as described above.
  • the outflow edge 672 can define a plurality of triangular edge portions 674 of the inner skirt 660.
  • the openings 664 (which can be openings 664a or 664b) can be positioned in selected triangular edge portions 674.
  • FIG. 17D illustrates another method of forming openings in an inner skirt.
  • the outflow edge 672 of the inner skirt 660 also has a zigzagged pattern defining a plurality of triangular edge portions 674.
  • Selected triangular edge portions 674 can be split apart or separated into pairs of smaller triangular portions.
  • FIG. 17D shows a pair of triangular portions 676 that are separated by a wedge-shaped gap 678 defined by two adjacent side edges 680 of the two triangular portions 676 and an open space between the two side edges 680.
  • the gap 678 can serve as an opening through which an adjacent pair of sub- commissure tabs 656 can extend.
  • a pair of sub-commissure tabs 656 can be positioned across the inner skirt 660 through the gap 678. Then, upper ends 682 of the pair of triangular portions 676 can be joined together (for example, via stitches, glues, or other attachment means), as indicated by the dashed line. As a result, the pair of smaller triangular portions 676 can form a larger triangular edge portion 674, and the gap 678 is closed at the upper ends 682 to define an opening receiving the pair of sub-commissure tabs 656.
  • the openings in the inner skirt can affect creating preformed apertures at locations adjacent to the openings.
  • FIG. 6 shows the inner skirt 400 having a plurality of axially extending opening 410 and a plurality of preformed markings 412 defining the scallop line 416. As described above, these preformed markings 412 can be preformed apertures.
  • the highest points 430 of the scallop line 416 can be positioned above the lower ends 410b of the openings 410. In such circumstances, because of the presence of the opening 410, it may not be possible to preform apertures at locations corresponding to or close to the highest points 430 of the scallop line 416.
  • the preformed apertures at those locations would merge or intersect with or risk merging with the openings 410, for example, due to tearing or stress induced by the subcommissure tabs inserted through the openings 410 and/or suture extending through the uppermost apertures.
  • those preformed apertures or other markings at or near the highest points 430 of the scallop line 416 it may be difficult to identify the upper end portions 432 of the scallop line 416 during assembly. For example, when attaching the leaflets to the inner skirt, it may be difficult to ensure that the cusp edge portions of the leaflets are stitched precisely along the scallop line 416, especially at the upper end portions 432 of the scallop line 416.
  • inner skirts are described below which have gaps configured to receive sub-commissure tabs of the leaflet structure which extend outwardly (thus avoiding inner protrusions), while preserving adequate marking or visibility of preformed markings, such as apertures, at upper ends of the scallop line to facilitate leaflet assembling process.
  • FIGS. 18A-18B One example inner skirt 700 is shown in FIGS. 18A-18B. Like the inner skirt 500 of FIG. 7, the inner skirt 700 has multiple skirt segments 720. Three skirt segments 720 are shown in FIG. 18B, although the number of skirt segments 720 can be two or more than three. [0210] Like the skirt segment 520 of FIG. 7, each skirt segment 720 has an inflow portion 722 and an outflow portion 724. The inflow portion 722 of each skirt segment 720 has two opposing side edges 708 and an inflow edge 702 extending between the two side edges 708. A side edge 708 can form an oblique angle A3 relative to the inflow edge 702. In some examples, the angle A3 can range between 30 and 60 degrees, or between 40 and 50 degrees.
  • the angle A3 can be about 45 degrees.
  • Two adjacent side edges 708 of each pair of adjacent skirt segments 720 can be connected (for example, via stitches, glues, or any other attachment means) so that the inflow portions 722 of the skirt segments 720 can form a continuous surface or edge forming a lower portion (or inflow portion) of the inner skirt 700.
  • each skirt segment 720 can be woven from two sets of fibers (or yams, strands, etc.) that are perpendicular to one another.
  • each skirt segment 720 can have a first set of fibers oriented in a first direction and a second set of fibers oriented in a second direction that is generally perpendicular to the second direction.
  • one set of the fibers can form an angle between 30 and 60 degrees (for example, about 45 degrees) relative to the inflow edge 702.
  • one set of the fibers can be parallel or substantially parallel to the side edges 708.
  • each skirt segment 720 can have a zigzagged outflow edge 704 which aligns with a row of angled stmts of the frame. Additionally, the outflow portion 724 of each skirt segment 720 can also have two opposing side flaps 730 arranged on opposite ends of the outflow edge 704. Each flap 730 can be defined by two horizontal slits 714 and a lateral edge 710 connecting the two horizontal slits 714. The lateral edge 710 can be perpendicular or substantially perpendicular to the inflow edge 702.
  • FIG. 18B shows three skirt segments 720 connected to each other along adjacent side edges 708 with stitching 709.
  • each flap 730 overlaps an adjacent flap 730 of another skirt segment 720 and each pair of overlapping flaps 730 are not connected to each other.
  • each pair of adjacent flaps 730 of adjacent skirt segments 720 can be folded radially outwardly toward the frame so as to form an opening or pocket 706 .
  • Each pocket 706 defines a gap through which an adjacent pair of sub-commissure tabs (for example, the sub-commissure tabs 656) can extend such that the pair of tabs 656 are “sandwiched” or positioned between the flaps 730.
  • each skirt segment 720 can have a plurality of preformed markings 712 which defines a cusp- shaped curve 718 which generally matches the contour of the cusp edge portions 655 of the leaflets 650.
  • the multiple cusp-shaped curves 718 of the multiple skirt segments 720 can be joined together to define an undulating scallop line for receiving stitches 663.
  • each leaflet can be sutured to an adjacent skirt segment 720 with stitches 663 along the scallop line defined by the plurality of preformed markings 712.
  • the preformed markings 712 can be preformed apertures for a suture to pass through and/or non-perforating visual markers to guide stitch placement.
  • each skirt segment 720 the plurality of preformed markings 712 can be located in both the inflow portion 722 and the outflow portion 724.
  • each flap 730 can have one or more preformed markings 712.
  • the one or more preformed markings 712 on one flap 730 are configured to align with the one or more preformed markings 712 on the other flap 730.
  • stitches 663 can extend along the cusp-shaped curve 718 defined by those preformed markings 712, all the way to the flaps 730. For example, FIG.
  • each flap 730 has one uppermost marking 712a which is located in the highest position or farthest away from the inflow edge 702 among all preformed markings 712.
  • the uppermost marking 712a on one flap 730 can align with the uppermost marking 712a on the other flap 730 so that a stitch 663 can extend through the markings 712a and the tabs 656 positioned between the flaps 730.
  • the preformed markings 712 can be apertures extending all the way up to or immediately adjacent the highest points (or peaks) of the scallop line.
  • the uppermost markings 712a on the flaps 730 can define the locations along the scallop line just prior to the suture extending over the upper edges of the tabs 656 (see FIG. 16B). In some examples, the markings 712a can define the uppermost locations of the scallop line.
  • FIGS. 19A andl9B show another inner skirt 800 in a flattened configuration and a cylindrical configuration, respectively.
  • the inner skirt 800 has an inflow edge 802 and an outflow edge 804.
  • the inner skirt 800 In the flattened configuration (for example, pre-assembly), the inner skirt 800 has two opposing side edges 808 connecting the inflow edge 802 and the outflow edge 804.
  • a side edge 808 can form an oblique angle A4 relative to the inflow edge 802.
  • the angle A4 can range between 30 and 60 degrees, or between 40 and 50 degrees. In one specific example, the angle A4 can be about 45 degrees.
  • the opposing side edges 808 can be affixed together (for example, via stitches, glues, or any other attachment means) so that the inner skirt 800 has a generally cylindrical shape.
  • the inner skirt 800 can be woven from two sets of fibers (or yams, strands, etc.) that are perpendicular to one another.
  • the inner skirt 800 can have a first set of fibers oriented in a first direction and a second set of fibers oriented in a second direction that is generally perpendicular to the second direction.
  • one set of the fibers can form an angle between 30 and 60 degrees (for example, about 45 degrees) relative to the inflow edge 802.
  • one set of the fibers can be parallel or substantially parallel to the side edges 808.
  • the inner skirt 800 in the cylindrical configuration can have a plurality of radially extending folds 830 (referred to as “radial folds”).
  • the number of radial folds 830 can match the number of leaflets (three radial folds 830 are shown in FIG. 19B), and the radial folds 830 are positioned to align with corresponding pairs of sub-commissure tabs (for example, the sub-commissure tabs 656).
  • the radial folds 830 can have a tapered shape. For example, the width of each radial fold 830 (measured in the radial direction) can progressively increase from the inflow edge 802 to the outflow edge 804.
  • each radial fold 830 extends radially outwardly toward the frame.
  • each radial fold 830 can extend through an adjacent cell of the frame.
  • Each radial fold 830 has two opposing folded sides 830a, 830b, which can define a gap or pocket 806 therebetween.
  • An adjacent pair of sub-commissure tabs can extend into the pocket 806.
  • the pairs of sub-commissure tabs instead of having openings in the inner skirt to allow pairs of sub-commissure tabs to pass through (as the example depicted in FIGS. 16A-16D), the pairs of sub-commissure tabs, which extend radially outwardly, can be inserted into the pockets 806 formed by the radial folds 830.
  • the radial folds 830 can be created by having excess skirt material in selected parts of the inner skirt 800.
  • an outflow end portion 824 of the inner skirt 800 can have a larger circumferential length than an inflow end portion 822 of the inner skirt 800 when the radial folds 830 are unfolded.
  • the outflow end portion 824 can be configured to have more slack or excess material compared to the inflow end portion 822. This additional material allows for the creation of the radial folds 830.
  • the inner skirt 800 has a plurality of first portions 814 (nonfold portions) and a plurality of second, foldable portions 816 positioned between adjacent first portions 814. When the inner skirt 800 is in the cylindrical configuration, as shown in FIG. 19B, each foldable portion 816 is folded radially outwardly to form a corresponding radial fold 830 and the first portions 814 are joined together to form a substantially continuous cylindrical surface.
  • the inflow edge 802 can be substantially straight in both the first portions 814 and the foldable portions 816.
  • the outflow edge 804 can have a zigzagged pattern in the first portions 814 to define a plurality of triangular edge portions 810 (similar to the triangular edge portions 406 and 674 described above).
  • the outflow edge 804 in each foldable portion 816 can have a trapezoidal shape, defined by two sloped side segments 826 and a flat or substantially flat top segment 820.
  • Each foldable portion 816 can be folded along a midline 828 of the foldable portion 816 which bifurcates the top segment 820 to form a corresponding radial fold 830. Such folding can cause the two sloped side segments 826 to be joined together at the radial fold 830 to form a corresponding triangular edge portion 810.
  • the cusp edge portion of each leaflet can be sutured to the inner skirt 800 (such as with stitches 663) along a cusp-shaped curve defined by a group of preformed markings on the inner skirt 800.
  • the inner skirt 800 can have multiple groups of preformed markings 812 respectively defining multiple cusp-shaped curves 818 (three groups of preformed markings 812 defining three cusp-shaped curves 818 are shown in FIG. 19A).
  • the multiple cusp-shaped curves 818 can be aligned with cusp edge portions of corresponding leaflets.
  • the multiple groups of preformed markings 812 can be separated from one another at the foldable portions 816.
  • two adjacent uppermost markings 812a, 812b of two adjacent groups of preformed markings can be separated by a lateral distance D.
  • upper end portions of the multiple cusp-shaped curves 818 are disjointed at the foldable portions 816 when the inner skirt 800 is in the flattened configuration.
  • the inner skirt 800 is in the cylindrical configuration, as shown in FIG.
  • the plurality of radial folds 830 can join the multiple cusp-shaped curves 818 into an undulating scallop line, along which the cusp edge portions of the leaflets can be sutured.
  • the preformed markings 812 can be preformed apertures extending all the way up to or immediately adjacent the highest points of the scallop line.
  • the uppermost markings 812a, 812b can define the locations along the scallop line just prior to the suture extending over the upper edges of the tabs 656 (see FIG. 16B).
  • the markings 812a, 812b can define the uppermost locations of the scallop line.
  • each group of preformed markings 812 can extend from an upper end (adjacent the outflow edge 804) of a foldable portion 816 downwardly (toward the inflow edge 802) to an adjacent first portion 814, and then upwardly to the upper end of another foldable portion 816.
  • Each foldable portion 816 includes one or more pairs of preformed markings 812 defining upper end portions of two adjacent cusp-shaped curves 818. For example, FIG.
  • a foldable portion 816 have preformed markings 812a, 812c, and 812e defining the upper end portion of one cusp-shaped curve and preformed markings 812b, 812d, and 812f defining the upper end portion of an adjacent cusp-shaped curve.
  • These preformed markings in two different groups can be arranged symmetric about the midline 828 of the foldable portion 816 so that when the foldable portion 816 is folded along the midline 828 to form the radial fold 830, these preformed markings in two different groups can be located on two opposing folded sides 830a, 830b of the radial fold 830 and overlap or align with one another.
  • markings 812a, 812c, and 812e can respectively overlap or align with markings 812b, 812d, and 812f in the corresponding radial fold 830.
  • markings 812a, 812c, and 812e can respectively overlap or align with markings 812b, 812d, and 812f in the corresponding radial fold 830.
  • each radial fold 830 can have at least one pair of folding apertures 832 located on the two opposing folded sides 830a, 830b.
  • the pair of folding apertures 832 can align with one another so that a suture 834 can extend therethrough to couple the folded sides 830a, 830b together, thus maintaining the radial fold 830 in a folded configuration.
  • the pair of folding apertures 832 can be positioned between two adjacent cuspshaped curves 818.
  • FIG. 20A shows yet another inner skirt 900 in a flattened configuration. Similar to the inner skirt 400 of FIG. 6, the inner skirt 900 has an inflow edge 902 which is straight or substantially straight and an outflow edge 904 which has a zigzagged pattern defining a plurality of triangular edge portions 906 situated downstream of a body portion 914 of the inner skirt 900.
  • the inner skirt 900 has two opposing, diagonally extending side edges 908, one of which forms an oblique angle A5 relative to the inflow edge 902.
  • the angle A5 can range between 30 and 60 degrees, or between 40 and 50 degrees. In one specific example, the angle A5 can be about 45 degrees.
  • the opposing side edges 908 can be affixed together (for example, via stitches, glues, or any other attachment means) so that the inner skirt 900 has a generally cylindrical shape.
  • the inner skirt 900 can be woven from two sets of fibers (or yams, strands, etc.) that are perpendicular to one another.
  • the inner skirt 900 can have a first set of fibers oriented in a first direction and a second set of fibers oriented in a second direction that is generally perpendicular to the second direction.
  • one set of the fibers can form an angle between 30 and 60 degrees (for example, about 45 degrees) relative to the inflow edge 902.
  • one set of the fibers can be parallel or substantially parallel to the side edges 908.
  • the inner skirt 900 has a plurality of a plurality of axially extending slits or openings 910 positioned in or below of selected triangular edge portions 906.
  • Each pair of sub-commissure tabs (for example, the sub-commissure tabs 320 of FIG. 5 or the sub-commissure tabs 656 of FIGS. 16A-16D) of the leaflet structure can extend radially outwardly through an adjacent opening 910.
  • the inner skirt 900 also has a plurality of preformed markings 912 on the body portion 914 of the inner skirt 900.
  • the plurality of preformed markings 912 can define an undulating scallop line 916, extending between each two immediately adjacent openings 910.
  • the markings 912 can be preformed apertures for a suture to pass through and/or non-perforating visual markers to guide stitch placement.
  • the cusp edge portions of the leaflets can be coupled to the inner skirt 900, for example, via at least one suture extending along the scallop line 916 defined by the preformed markings 912.
  • stitches 663 can extend through the apertures and the leaflet cusp edge portions.
  • Each opening 910 has an upper end 910a and a lower end 910b.
  • the highest points 930 of the scallop line 916 can be positioned above the lower ends 910b of the openings 910.
  • the highest points 930 of the scallop line 916 may be located within the openings 910, with a height (or axial distance) H measured from the inflow edge 902.
  • uppermost markings 912a, 912b on the scallop line 916 may be located below or upstream of the highest points 930 of the scallop line 916.
  • upper end portions 932 of the scallop line 916 may not be identified only by those preformed markings 912.
  • the inner skirt 900 further includes a plurality of flaps 920 connected to and downstream of the selected triangular edge portions 906 corresponding to the openings 910.
  • Each flap 920 is configured to be foldable relative to the body portion 914, for example, along a line 918 that connects the flap 920 and the corresponding triangular edge portion 906.
  • each folded flap 920 is configured to cover at least a portion of the corresponding opening 910. In some examples, each folded flap 920 can completely cover the corresponding opening 910.
  • each flap 920 can have a plurality of apertures 922, including one or more central apertures located adjacent the center of the flap 920 and one or more side apertures located on lateral sides of the central apertures.
  • each flap has three central apertures 922e, 922f, and 922g, and four side apertures 922a, 922b, 922c, and 922d.
  • the number of central apertures and side apertures can vary.
  • the number of central apertures can be less than three or more than three, and the number of side apertures can be less than four or more than four.
  • Both the central apertures and the side apertures can be positioned symmetric about a midline 928 of the flap 920, which can also define a longitudinal axis of the adjacent opening 910.
  • the one or more central apertures are positioned downstream of the preformed markings 912 on the body portion 914.
  • FIG. 20B shows that, after folding the flap 920, the central apertures 922e, 922f, and 922g align with the locations marked by ‘x’, which are positioned on the scallop line 916 and above the uppermost markings 912a, 912b.
  • a suture can extend through the preformed markings 912 on the body portion 914 and the central apertures 922e, 922f, and 922g on the flap 920 while following the scallop line 916.
  • the central apertures 922e, 922f, and 922g on the folded flap 920 can define upper end portions 932 of the scallop line 916.
  • the central aperture 922e can mark the highest point 930 of the scallop line 916. Because the central apertures 922e, 922f, and 922g are on the flap 920 which is spaced apart from the opening 910, the upper end portions of the scallop line 916 can be visualized to facilitate assembly while the risk of merging those apertures with the opening 910 is reduced.
  • the inner skirt 900 can also have one or more folding apertures 924 positioned adjacent each opening 910.
  • the folding apertures 924 can be located on selected triangular edge portions 906 and/or the body portion 914.
  • FIG. 20B shows four folding apertures 924a, 924b, 924c, and 924d, which are positioned symmetrically on opposite sides of the opening 910 and mirror corresponding side apertures 922a, 922b, 922c, and 922d.
  • the four folding apertures 924a, 924b, 924c, and 924d are configured to respectively align with the four side apertures 922a, 922b, 922c, and 922d.
  • a suture or stitches can extend through the folding apertures 924a, 924b, 924c, and 924d and the side apertures 922a, 922b, 922c, and 922d to affix the flap 920 to the body portion 914 and/or the triangular edge portion 906 of the inner skirt 900.
  • FIG. 20C schematically depicts an arrangement of a pair of sub-commissure tabs 940 (which can be the sub-commissure tabs 320 of FIG. 5 or the sub-commissure tabs 656 of FIGS. 16A-16D) of a leaflet structure relative to the inner skirt 900.
  • the pair of sub-commissure tabs 940 can be inserted radially outwardly through an opening 910 located on a triangular edge portion 906 (and/or the body portion 914) of the inner skirt 900.
  • end portions 942 of the pair of sub-commissure tabs 940 can be split apart from one another in opposite directions so that the end portions 942 overlie respective parts of the triangle edge portion 906 (and/or the body portion 914) of the inner skirt 900.
  • the flap 920 connected to the triangular edge portion 906 can be folded downwardly so as to cover the end portions 942 of the sub-commissure tabs 940. In other words, the end portions 942 can be sandwiched between the flap 920 and the triangular edge portion 906.
  • the flap 920, the end portions 942, and the triangular edge portion 906 can be coupled together, for example, by stitches 944 extending through one or more of the folding apertures (for example, apertures 924a, 924b, 924c, and 924d) and corresponding aligned side apertures (for example, 922a, 922b, 922c, and 922d).
  • the length of the stitches 944 are exaggerated in FIG. 20C for purposes of illustration, but it should be understood that the stitches tightly secure the flap 920, the triangular edge portion 906, and the pair of subcommissure tabs 940.
  • an inner skirt can be mounted on an inner surface of a frame of a prosthetic valve, and a plurality of leaflets can be attached to the inner skirt.
  • an inner skirt 1000 can be directly attached to the frame 102 of FIGS. 1-3 via one or more sutures 1002.
  • the sutures 1002 can extend along multiple rows of angled struts of the frame 102, forming a plurality of whip stitches 1004 that securely connect the inner skirt 1000 to the frame 102.
  • the suture 1002 can extend from a first side of the inner skirt 1000 to a second, opposite side of the inner skirt 1000, then go back to the first side, looping around a strut segment before running to the opposite side again, thus forming a loop around the strut segment.
  • one suture can run continuously along an angled strut to form multiple whip stitches 1004 on that angled strut.
  • the stitching technique described below with respect to inner skirt 1000 can be applied to any of the inner skirts or inner skirt segments disclosed herein.
  • the inner skirt 1000 in FIGS. 21A-21B extends beyond the inflow end of the frame.
  • the inflow end portion of the skirt 1000 can be trimmed such that the inflow end of the skirt is aligned with the inflow apices 152.
  • the frame 102 can have a plurality of apex regions 152 formed at an inflow end 108 of the frame, and each apex region 152 extends and forms a junction between two angled struts 130 at the inflow end 108.
  • each apex region 152 is narrower than the two angled struts 130 located on opposite sides of the apex region 152.
  • each apex region 152 can be attached to the inner skirt 1000 by a suture forming a plurality of whip stitches 1005 alternating with a plurality of locking stitches 1006.
  • whip stitches 1005 combined with the locking stitches 1006 are configured to more securely fasten the inner skirt 1000 (and the leaflets attached thereto) to the frame 102, thereby reducing relative movement between the inner skirt 1000 and the frame 102 at the apex regions 152.
  • the plurality of whip stitches 1005 and locking stitches 1006 are configured to extend over an entire length of an apex region 152.
  • the suture forming the plurality of whip stitches 1005 and locking stitches 1006 at each apex region 152 extends continuously beyond the apex region 152 to form a plurality of whip stitches 1004 circling around the two angled struts 130 located on opposite sides of the apex region 152.
  • the whip stitches 1005 and locking stitches 1006 can extend along the entire extent of a pair of thinned strut portions 156 forming an apex region 152.
  • the number of pairs of whip stitches 1005 and locking stitches 1006 connecting each apex region 152 to the inner skirt 1000 can be in a range of two to eight, or three to seven, or four to six. In one specific example, there are five whip stitches 1005 and five locking stitches 1006 connecting each apex region 152 to the inner skirt 1000. In some examples, there can be one pair of a whip stitch 1005 and a locking stitch 1006.
  • the whip stitches 1005 located at each apex region 152 can be arranged much closer to one another compared to whip stitches 1004 around the two angled struts 130 located on opposite sides of the apex region 152. In other words, the spacing between adjacent whip stitches 1005 is much smaller than the spacing between two adjacent whip stitches 1004. In some examples, no gap is formed between two adjacent whip stitches 1005 (as shown in FIG. 21B), which would otherwise expose the apex region 152. In other examples, there can be a small gap between two adjacent whip stitches 1005 (as shown in FIG. 22H).
  • FIGS. 22A-22G illustrates an example method of using a suture 1002 to form multiple whip and locking stitches at an apex region 152 of the frame 102 to secure a skirt to the apex region.
  • FIG. 22A shows two regular whip stitches 1004a, 1004b formed around an angled strut 130 located on one side of the apex region 152.
  • the frame 102 is shown above the inner skirt 1000 (viewed from outside the frame).
  • the suture 1002 is shown extending outwardly from the inner skirt 1000 to begin forming the first whip stitch 1005 at the apex region.
  • the first whip stitch 1005 can be a special type of whip stitch, which can also be referred to as an inter-locking stitch.
  • the first whip stitch pierces through filaments of the suture 1002 forming the previous whip stitch 1004b, as depicted in FIG. 22B.
  • FIG. 22B shows that a needle 1008 connected to the suture 1002 pierces through a portion of the suture forming the second whip stitch 1004b.
  • the suture 1002 is pulled in a direction from outside the skirt 1000 to the inside of the skirt 1000.
  • the needle 1008 can split those filaments into two sets of strands, allowing the needle 1008 (and the suture 1002 connected thereto) to extend between the two sets of strands before piercing through the inner skirt 1000. Piercing through both the suture 1002 and the underlying inner skirt 1000 affixes the suture 1002 to the inner skirt 1000, preventing relative movement of the suture 1002 at the apex region 152.
  • FIG. 22C shows the first whip stitch 1005 being formed around the strut segment, as the needle 1008 moves from outside of the inner skirt 1000 to inside of the inner skirt, thereby pulling the suture 1002 around the strut segment and forming the whip stitch 1005.
  • the needle 1008 is threaded back through the skirt 1000 from the inside to the outside of the skirt 1000.
  • FIG. 22D shows the suture 1002 being pulled back through the inner skirt 1000 by the needle 1008 from the inside of the skirt 1000 to the outside of the skirt 1000 and then the suture 1002 being pulled taught so that the first whip stitch fits tightly around the strut segment.
  • FIG. 22E shows the formation of the first locking stitch 1006 by threading the needle 1008 through the first whip stitch 1005 on the outside of the strut segment.
  • the suture 1002 is pulled through the whip stitch 1005 along the strut segment via the needle 1008.
  • the locking stitch 1006 extends along an inflow edge 151 of the apex region 152 outside of the frame (as best shown in FIG. 22H and 221).
  • FIG. 22F shows the locking stitch 1006 being tightened by pulling the suture 1002 away from the frame. As shown, after forming the first locking stitch 1006, the suture 1002 is on the outside of the inner skirt 1000.
  • the whip stitch 1005 in combination with the locking stitch 1006 creates a locking effect that prevents movement of the inner skirt 1000 relative to the frame 102.
  • This locking effect occurs because the locking stitch, by passing through the loop of the whip stitch, creates a frictional engagement of the suture 1002 that resists loosening, while the interlocking nature of the stitches further secures the inner skirt 1000 in place and reduce the potential for relative movement.
  • FIG. 22G shows the needle 1008 threading the suture 1002 through the skirt 1000 from the outside to the inside of the skirt to form a second whip stitch 1005 encircling the strut.
  • the second whip stitch along the apex region can passes directly through the inner skirt 1000 without penetrating the suture material of the first whip stitch 1005 on the apex region.
  • the needle 1008 and the suture 1002 are then threaded back through the inner skirt from the inside to the outside of the skirt and then threaded through the second whip stitch 1005.
  • FIG. 22H is a schematic cross-section of the apex region 152 showing a whip stitch 1005 and a locking stitch 1006 extending through the whip stitch 1005.
  • the stitching technique described above with respect to FIGS. 21A-21B and 22A-22G can be used to attach the inflow end of an outer skirt (e.g., outer skirt 106) to the inflow apices 152 of a frame (e.g., frame 102).
  • an outer skirt e.g., outer skirt 106
  • a frame e.g., frame 102
  • leaflets of a prosthetic valve can be attached to an inner skirt which is secured to a frame of the prosthetic valve.
  • FIG. 6 shows that the inner skirt 400 has a plurality of preformed markings 412 defining an undulating scallop line 416.
  • the cusp edge portions of the leaflets can be attached to the inner skirt 400 by a suture extending through the plurality of preformed markings 412.
  • the inner skirt can have two parallel rows of preformed markings, one of which can be used for receiving a suture for attachment of the leaflets to the skirt, and the other to assist in alignment of the leaflets over the inner skirt.
  • FIG. 23 shows an inner skirt segment 1100 (or simply “skirt segment”) which can be attached to the frame 102 of FIGS. 1-3.
  • the inner skirt segment 1100 has a plurality of first markings 1102 and a plurality of second markings 1104.
  • the plurality of second markings 1104 is located upstream of the plurality of first markings 1102.
  • the plurality of first markings 1102 can define a first undulating scallop line 1112
  • the plurality of the second markings 1104 can define a second undulating scallop line 1114.
  • the first and second undulating scallop lines 1112, 1114 are substantially parallel to each other, that is, they can have the same curvature. In some examples, there are more first markings 1102 than the second markings 1104.
  • An inner skirt can include a plurality of inner skirt segments 1100 wherein the number of inner skirt segments can be equal to the number of the leaflets, such as three inner skirt segments for three leaflets, similar to the skirt 500 of FIG. 7.
  • both the first markings 1102 and second markings 1104 can be preformed apertures.
  • the first markings 1102 can be preformed apertures and the second markings 1104 can be non-perforating visual markers.
  • both the first markings 1102 and second markings 1104 can be non-perforating visual markers.
  • the cusp edge 305 of the leaflet can be first aligned with the second undulating scallop line 1114. Then, the leaflet 300 can be stitched to the inner skirt segment 1100 via a suture extending through the leaflet and the skirt segment 1100 along the first undulating scallop line 1112 (e.g., when the first markings 1102 are preformed apertures, the suture can extend through those apertures).
  • an apex 1118 of the second undulating scallop line 1114 is configured to axially align with an apex 154 of the frame that defines the inflow end 108 of the frame 102. As such, when the leaflet is attached to the inner skirt segment 1100, the apex of the leaflet is axially aligned with the inflow end of the frame.
  • those apertures 1104 can be filled with another suture that is detached from the leaflets.
  • blanket stitches can be threaded through those apertures 1104 after securing the leaflet to the inner skirt segment 1100.
  • a suture can be used to form in-and-out stitches that pass through those apertures 1104 (without extending through the leaflet).
  • a leaflet 300 can be stitched to each inner skirt segment 1100 of the inner skirt in the same manner.
  • the inner skirt segments 1100 can be attached to the frame 102, such as by stitching the inner skirt segments to the frame (e.g., as shown in FIG. 21A) and the leaflets can be stitched to the inner skirt segments 1100 after the inner skirt segments have been attached to the frame.
  • the leaflets can be stitched to the inner skirt segments prior to attaching the inner skirt segments to the frame.
  • first and second sets of markings 1102 and 1104 can be formed in a skirt that comprises a unitary piece of material, such as the inner skirt 400 of FIG. 6.
  • the inner skirt segment has an inflow portion 1122 and an outflow portion 1124.
  • the inflow portion 1122 has two opposing lower side edges 1108 and an inflow edge 1106 extending between the two lower side edges 1108.
  • the outflow portion 1124 has two opposing upper side edges 1110 and an outflow edge 1116 extending between the two upper side edges 1110.
  • the two lower side edges 1108 are oblique to the inflow edge 1106, and the two upper side edges 1110 are perpendicular to the inflow edge 1106.
  • each upper side edge 1110 can be separated from a corresponding lower side edge 1110 by a horizontal slit 1126.
  • the outflow portion 1124 of each skirt segment has two side flaps 1120 (similar to the side flaps 730 of FIG. 18A).
  • Each side flap 1120 can have a substantially rectangular shape defined by four sides: a horizontal slit 1126, a portion of the outflow edge 1116, an upper side edge 1110, and a fold line 1130 that is parallel to the upper side edge 1110 and passes through an end 1128 of the horizontal slit 1126.
  • the two side flaps 1120 can be folded along respective fold lines 1130, allowing the side flaps 1120 to extend radially outwardly relative to the frame 102.
  • two adjacent side flaps 1120 from neighboring skirt segments can combine to form a pair of side flaps that extend radially outwardly through a cell of the frame 102, as described further below.
  • At least two upper-most second markings 1104 are located on each of the two side flaps 1120, respectively.
  • the row of second markings 1104 can extend from one upper side edge 1110 of the outflow portion 1124, along the inflow portion 1122, and to another upper side edge 1110 of the outflow portion 1124.
  • the leaflets can be attached to the inner skirt segments 1100 after the inner skirt segments are attached to the frame.
  • each first marking 1102 is positioned offset from and does not overlap with any of the plurality of interconnected struts 116 forming the frame 102. This positioning helps avoid accidentally passing a needle into a strut of the frame when stitching the leaflets to the inner skirt segments 1100 through the first markings 1102.
  • cusp edges 305 of the leaflets can be aligned with other forms of alignment markers on the inner skirt.
  • the second undulating scallop line 1114 can be marked by printed guide lines, or the like.
  • FIG. 24A depicts an inner skirt 1200 attached to the frame 102 of FIGS. 1-3, according to one example.
  • the frame 102 has a plurality of axial frame members 140 bridging the first row of angled struts 136 defining the outflow end 110 and the second row of angled struts 134 immediately upstream of the first row of angled struts 136.
  • Some of the axial frame members 140 are axially extending window struts 138, each of which has a commissure window 142 configured to receive an adjacent commissure (for example, the commissure 114 of FIG. 1) of the leaflets.
  • each skirt segment 1201 can have an inflow portion 1222 and an outflow portion 1224.
  • Each outflow portion 1224 can have two opposing upper side edge portions 1210 (similar to side edge portions 1110) extending in axial direction.
  • Each inflow portion 1222 has two opposing lower side edge portions 1208 (similar to side edge portions 1108) which are angled relative to the upper side edge portions 1210.
  • Two adjacent upper side edge portions 1210 of each pair of adjacent skirt segments 1201 can be connected to form an upper, axial congruent region 1216. Additionally, two adjacent lower side edge portions 1208 of each pair of adjacent skirt segments can overlap each other to form a lower, oblique congruent region 1218 which is angled relative to the upper, axial congruent region 1216. The two overlapping side edge portions 1208 of adjacent skirt segments 1201 can be attached to each other with stitching, such as with in-and-out stitches that extend along the length of the congruent region 1218.
  • each upper congruent region 1216 can be connected to the frame 102 via a suture 1202 extending through the aperture 147 on an adjacent axially extending window strut 138.
  • an upper end 1226 of the upper congruent region 1216 can be axially aligned with the aperture 147, and the suture 1202 passing through the aperture 147 can extend through the upper end 1226 of the upper congruent region 1216 to stitch together the two adjacent upper side edge portions 1210.
  • the suture 1202 can further extend through a lower end of the commissure window 142 of the axially extending window strut 138 to reinforce the stitch that couples the two adjacent upper side edge portions 1210 to each other.
  • each skirt segment 1201 can be side flaps, similar to the side flaps 1120 of FIG. 23. As described above, each side flap can be folded along its fold line. As a result, a pair of side flaps from two adjacent skirt segments 1201 can be combined to form an axial congruent region extending radially outwardly relative to the frame 102.
  • FIG. 24B depicts attaching a pair of side flaps of two adjacent skirt segments 1201 to the axially extending window strut 138 of the frame 102, as viewed from inside the frame (thus the pair of side flaps are hidden behind the skirt segments 1201). Leaflets are omitted in FIG. 24B for clarity.
  • FIG. 24C depicts a pair of side flaps 1220 forming the axial congruent region 1216, which extends radially outwardly through a cell 118 of the frame 102 that is immediately below or upstream of the axially extending window strut 138 (as viewed from outside the frame).
  • an upper end 1226 of the axial congruent region 1216 can be axially aligned with the aperture 147 located at the lower end of the axially extending window strut 138.
  • a suture 1202 can extend through the aperture 147 to stitch the pair of side flaps 1220 together and connect the upper end 1226 of the axial congruent region 1216 to the frame 102.
  • the suture 1202 can further extend through a lower end of the commissure window 142 of the axially extending window strut 138 to reinforce the stitch that couples the pair of side flaps 1220 to each other.
  • each leaflet can have two opposing sub-commissure tabs (for example, the sub-commissure tabs 320 of FIG. 5) and a cusp edge portion extending from one sub-commissure tab to the other sub-commissure tab of the leaflet.
  • Each subcommissure tab can be paired with and connected to an adjacent sub-commissure tab of an adjacent leaflet.
  • each pair of sub-commissure tabs can extend radially outwardly through an adjacent cell of the frame. Specifically, after attaching each leaflet to a corresponding skirt segment, each pair of sub-commissure tabs of two adjacent leaflets can extend radially outwardly and be sandwiched between a corresponding pair of side flaps of the two adjacent skirt segments.
  • FIG. 24C shows a pair of sub-commissure tabs 320 of two adjacent leaflets 300 that are respectively attached to the two adjacent skirt segments 1201.
  • FIG. 24C also shows a portion of a commissure 114 formed by the two adjacent leaflets 300 and extending through the commissure window 142.
  • the pair of sub-commissure tabs 320 are oriented radially outwardly and inserted between the pair of side flaps 1220 that extend through the cell 118.
  • the pair of side flaps 1220 can define a gap or opening through which the pair of sub-commissure tabs 320 can extend through.
  • the pair of side flaps 1220 and the pair of sub-commissure tabs 320 inserted therebetween can be stitched together by a suture 1204.
  • leaflets of a prosthetic valve can have a reinforcement structure configured to reinforce the cusp edge portions of the leaflets when the leaflets are stitched to an inner skirt and/or a frame of the prosthetic valve.
  • the reinforcement structure can include a plurality of reinforcement strips, each being attached to a corresponding leaflet.
  • the reinforcement strips can comprise natural or synthetic fabric materials such as a woven, braided or knitted fabric, such as a PET, PTFE, or UHMW fabric.
  • the reinforcement strip can comprise non-fabric polymeric materials such as silicone or polyurethane, or natural tissue such as pericardium.
  • FIG. 25 A depicts an example reinforcement strip 1300, which can be attached to the inner surface of a cusp edge portion 306 of the leaflet 300 of FIG. 5.
  • FIG. 25 A depicts an example reinforcement strip 1300, which can be attached to the inner surface of a cusp edge portion 306 of the leaflet 300 of FIG. 5.
  • FIG. 25 A depicts an example reinforcement strip 1300, which can
  • 25B schematically depicts the reinforcement strip 1300 attached to the inner surface of the leaflet 300, which is further attached to an inner skirt 1200 or skirt segment 1201, for example, using one or more sutures 1322.
  • the inner skirt 1200 or skirt segment 1201 can be further attached to the frame 102 of FIGS. 1-3, for example, via additional sutures (e.g., sutures 1002 or 1202).
  • the leaflet 300 has two opposing sub-commissure tabs 320, and the cusp edge portion 306 extends from one sub-commissure tab 320 to the other subcommissure tab 320 of the leaflet.
  • Each sub-commissure tab 320 can be paired with and connected to an adjacent sub-commissure tab of an adjacent leaflet.
  • each pair of sub-commissure tabs 320 can extend radially outwardly through an adjacent cell of the frame, as illustrated in FIG. 24C.
  • the reinforcement strip 1300 includes a body portion 1302 that is shaped and sized to match the cusp edge portion 306 of the leaflet 300, two first wing portions 1304 that are located at opposite ends 1305 of the body portion 1302, and two second wing portions 1306 that are respectively connected to and positioned upstream of the two first wing portions 1304.
  • both the first wing portions 1304 and the second wing portions 1306 are wider than the body portion 1302.
  • the reinforcement strip 1300 can have a plurality of apertures 1308 extending along the body portion 1302, for example, along a midline of the body portion 1302.
  • the plurality of apertures 1308 can be formed in the second wing portions 1306 and the first wing portions 1304.
  • the reinforcement strip 1300 can be attached to the leaflet 300 with a suture extending through the plurality of apertures 1308.
  • Both the second wing portions 1306 and the body portion 1302 of the reinforcement strip can be positioned on an interior side of the leaflet 300. As shown in FIG. 25 A, the body portion 1302 of the reinforcement strip has an inner edge 1310 and an outer edge 1312.
  • each second wing portion 1306 of the reinforcement strip is connected to one end 1305 of the body portion 1302 and extends sideway from the inner edge 1310.
  • each first wing portion 1304 includes an angled, first side edge 1314, an angled, second side edge 1316, and a V-shaped end edge 1318 connecting the first side edge 1314 and the second side edge 1316.
  • the first wing portion 1304 can be folded along an axis 1320 bisecting the V-shaped end edge 1318 such that the second side edge 1316 aligns with the first side edge 1314 to form a double layer.
  • each second wing portion 1306 can also be folded along the axis 1320 over the corresponding end 1305 of the body portion 1302.
  • Each folded second wing portion 1306 can conceal some of the stitches located at the end 1305 of the body portion (for example, the stitches through apertures 1308a, 1308b, 1308c, and 13O8d), thereby reducing the risk of abrasion to the leaflet by those stitches.
  • each first wing portion 1304 can extend radially outwardly through a cell of the frame and between a corresponding pair of subcommissure tabs 320 when the leaflets are assembled onto the frame.
  • each first wing portion 1304 of a reinforcement strip attached to a leaflet can be connected to an adjacent first wing portion 1304 of another reinforcement strip attached to an adjacent leaflet to form a pair of first wing portions.
  • the pair of first wing portions can extend radially outwardly through an adjacent cell of the frame and be sandwiched between the corresponding pair of sub-commissure tabs 320, as further described below.
  • FIG. 26A depicts two reinforcement strips 1300 attached to corresponding cusp edge portions of two adjacent leaflets 300 via one or more sutures forming stitches 1322, as viewed from an interior side of the frame 102.
  • the stitches 1322 can also extend through respective skirt sections 1201 of the inner skirt 1200 and can form a scalloped stitch line, similar to stitches 663.
  • the cusp edges 305 of the two adjacent leaflets 300 define an undulating scallop line.
  • the pair of sub-commissure tabs 320 formed by the two leaflets 300 extend radially outwardly through a cell 118 of the frame 102, as depicted in FIG. 26D.
  • the cell 118 is located immediately below an axially extending window strut 138 having a commissure window configured to receive a commissure 114 of the prosthetic valve.
  • FIG. 26A the body portions 1302 of the two reinforcement strips 1300 can be joined at their adjacent ends.
  • the respective first and second wing portions 1304, 1306 of the two reinforcement strips 1300 are connected to each other, forming a butterfly- shaped wing structure.
  • a portion of each first wing portion 1304 is inserted between the pair of sub-commissure tabs 320 and hides behind the leaflets 300 in FIG. 26A.
  • FIG. 26B depicts folding the first and second wing portions 1304, 1306 of each reinforcement strip, as indicated by the arrows 1324.
  • the folded first wing portion 1304 of each reinforcement strip can form a double layer (including an outer layer 1304a and an inner layer 1304b), which can be inserted between the pair of sub-commissure tabs 320.
  • each folded first wing portion 1304 (as a double layer) extends radially outwardly and is sandwiched between the pair of sub-commissure tabs 320, as illustrated in FIGS. 26D and 26E.
  • the folded second wing portions 1306 of each reinforcement strip can cover nearby stitches formed by the suture 1322 located at respective ends of the body portions 1302, as depicted in FIG. 26C.
  • the folded second wing portions 1306 of the two adjacent reinforcement strips can be affixed together, for example, by a stitch 1326.
  • each leaflet 300 can be connected to a skirt segment 1201 that is part of an inner skirt disposed on an inner surface of the frame 102.
  • each skirt segment 1201 can have two opposing side flaps 1220, and a pair of side flaps 1220 from two adjacent skirt segments 1201 can extend radially outwardly through the cell 118 of the frame 102, as shown in FIG. 26D.
  • the pair of side flaps 1220, the pair of sub-commissure tabs 320, and the two folded first wing portions 1304 can form a multi-layer structure 1330 extending radially outwardly from the frame 102, as illustrated in FIG. 26E.
  • two folded first wing portions 1304 (each forming a double layer) of the two adjacent reinforcement strips 1300 can be sandwiched between the pair of sub-commissure tabs 320 of the two adjacent leaflets 300, which are further sandwiched between the pair of side flaps 1220 of the two adjacent skirt segments 1201.
  • the pair of side flaps 1220, the pair of sub-commissure tabs 320, and the two folded first wing portions 1304 can be affixed together, for example, by a suture 1328 that can be used to form multiple stitches extending through the multilayer structure (similar to stitches 658 of FIG. 16B).
  • the two folded first wing portions 1304 can be axially aligned. In some examples, these two folded first wing portions 1304 can be utilized as an alignment feature, for height alignment between the reinforcement strips 1300, the leaflets 300, and the skirt segments 1201.
  • FIGS. 27A-27B depict another example prosthetic valve including the frame 102 of FIGS. 1-3, a plurality of leaflets 300 positioned with the frame, the inner skirt 1200 of FIG. 24A disposed on an inner surface of the frame, and the outer skirt 106 of FIG. 1 disposed on an outer surface of the frame.
  • the outer skirt 106 can be attached to the inner skirt 1200 using one or more sutures forming a plurality of stitches 103.
  • the stitches 103 can extend along an outflow end portion of the outer skirt 106.
  • the outer skirt 106 has an outflow edge 107, which is depicted as a dashed line in FIG. 27A for purposes of illustration.
  • the number of stitches exposed on the inner surface of the inner skirt 1200 and facing the leaflets 300 can be minimized or reduced to decrease the risk of leaflet abrasion.
  • the stitches 103 can be positioned within the cells 118 of the frame just below the commissures (e.g., the second row 126 of cells of FIG. 2).
  • each stitch 103 are discrete stitches that are spaced apart from each other and extend through the inner skirt 1200 and the outer skirt 106.
  • each stitch 103 can form a loop, which can extend over the outflow edge 107 of the outer skirt 106.
  • the stitches 103 can be continuous or interconnected stitches.
  • each leaflet 300 can have two opposing sub-commissure tabs 320, and a pair of sub-commissure tabs 320 of two adjacent leaflets can extend radially outwardly through an adjacent cell 118, such as one of the cells that is immediately below or upstream of an axially extending window struts 138.
  • Side flaps 1220 from adjacent inner skirt sections 1201 can extend alongside the sub-commissure tabs 320.
  • the folded wing portions 1304 can be positioned between the sub-commissure tabs 320, as described above.
  • the outflow edge portion of the outer skirt 106 can be attached to each pair of sub-commissure tabs 320 and/or side flaps 1220 with a suture forming at least one reinforcement stitch 105.
  • the stitch 105 can form a loop that extends through the outer skirt 106, the tabs 320, the side flaps 1220 and the wing portions 1304.
  • the stitch 105 can extend through one or both of the tabs 320, one of both of the side flaps 1220, and/or one or both of the wing portions 1304.
  • any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat/thermal, pressure, steam, radiation, and/or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method.
  • heat/thermal sterilization include steam sterilization and autoclaving.
  • radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam.
  • chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. Additional Examples of the Disclosed Technology
  • a prosthetic heart valve comprising: an annular frame comprising an inflow end and an outflow end; a leaflet structure comprising a plurality of leaflets positioned within the annular frame, wherein the leaflet structure is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end; an inner skirt disposed on an inner surface of the annular frame; and an outer skirt disposed on an outer surface of the annular frame; wherein the outer skirt is connected to the inner skirt via one or more stitches, wherein the one or more stitches are shielded from the plurality of leaflets when the leaflet structure moves between the open state and the closed state.
  • Example 2 The prosthetic heart valve of any example herein, particularly example 1, wherein the leaflet structure is connected to the inner skirt, wherein the inner skirt is fixedly attached to the annular frame.
  • Example 3 The prosthetic heart valve of any example herein, particularly example 1, wherein the leaflet structure is directly attached to the annular frame.
  • Example 4 The prosthetic heart valve of any example herein, particularly any one of examples 1-3, wherein the inner skirt comprises one or more folded portions that are concealed from the plurality of leaflets, wherein the one or more stitches connect an outflow end portion of the outer skirt to the one or more folded portions of the inner skirt.
  • Example 5 The prosthetic heart valve of any example herein, particularly example 4, wherein the inner skirt has an outflow edge which aligns with a row of angled strut segments of the annular frame, wherein the inner skirt comprises one or more flaps along at least portions of the outflow edge, wherein the one or more flaps are configured to be folded over adjacent angled strut segments of the annular frame to form the one or more folded portions.
  • Example 6 The prosthetic heart valve of any example herein, particularly example 4, wherein the inner skirt has an outflow edge which aligns with a row of angled strut segments of the annular frame, wherein the inner skirt comprises one or more flaps along at least portions of the outflow edge, wherein the one or more flaps are configured to be folded over adjacent angled strut segments of the annular frame to form the one or more folded portions.
  • Example 7 The prosthetic heart valve of any example herein, particularly example 4, wherein the one or more folded portions extend radially outwardly through adjacent cells of the annular frame.
  • a prosthetic heart valve comprising: an annular frame comprising an inflow end and an outflow end; a leaflet structure comprising a plurality of leaflets positioned within the annular frame, wherein the leaflet structure is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end; an inner skirt disposed on an inner surface of the annular frame; and an outer skirt disposed on an outer surface of the annular frame; wherein the inner skirt comprises one or more folded portions that are concealed from the plurality of leaflets, wherein an outflow end portion of the outer skirt is connected to the one or more folded portions of the inner skirt via stitches.
  • Example 9 The prosthetic heart valve of any example herein, particularly example 8, wherein the inner skirt has an outflow edge which aligns with a row of angled strut segments of the annular frame, wherein the inner skirt comprises one or more flaps along at least portions of the outflow edge, wherein the one or more folded portions are formed by folding the one or more flaps over adjacent angled strut segments of the annular frame.
  • Example 10 The prosthetic heart valve of any example herein, particularly example 8, wherein a selected folded portion comprises a double layer extending radially outwardly through an adjacent cell of the annular frame, wherein the double layer comprises an upper layer and a lower layer overlapping one another.
  • Example 11 The prosthetic heart valve of any example herein, particularly example 8, wherein the inner skirt comprises a plurality skirt segments, wherein each skirt segment comprises an inflow portion and an outflow portion, wherein each inflow portion comprises two opposing side edges and an inflow edge extending between the two side edges, wherein two adjacent side edges of each pair of adjacent skirt segments are connected so that the inflow portions of the skirt segments form a continuous surface.
  • Example 12 The prosthetic heart valve of any example herein, particularly example
  • each skirt segment further comprises two flaps located at opposing ends of the outflow portion, wherein each flap is foldable relative the outflow portion along a corresponding folding line, wherein when each flap is folded relative to the outflow portion, the corresponding folding line defines a part of an outflow edge of the skirt segment.
  • Example 13 The prosthetic heart valve of any example herein, particularly example
  • each skirt segment has a zigzagged pattern which is aligned with a row of angled strut segments of the annular frame.
  • Example 14 The prosthetic heart valve of any example herein, particularly any one of examples 12-13, wherein each flap is paired with and connected to an adjacent flap of an adjacent skirt segment to form a folded portion, to which the outflow end portion of the outer skirt is connected.
  • Example 15 The prosthetic heart valve of any example herein, particularly any one of examples 12-14, wherein each skirt segment comprises a plurality of preformed markings defining a cusp-shaped curve, wherein each flap comprises one or more apertures configured to align with selected preformed markings on the cusp-shaped curve when the flap is folded over the outflow portion.
  • Example 16 The prosthetic heart valve of any example herein, particularly any one of examples 11-15, wherein each folded portion extends radially outwardly through an adjacent cell of the annular frame.
  • Example 17 The prosthetic heart valve of any example herein, particularly any one of examples 11-16, wherein each folded portion extends in an axial direction.
  • a prosthetic heart valve comprising: an annular frame comprising an inflow end and an outflow end; a leaflet structure comprising a plurality of leaflets positioned within the annular frame, wherein the leaflet structure is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end; an inner skirt disposed on an inner surface of the annular frame; and an outer skirt disposed on an outer surface of the annular frame; wherein the annular frame comprises: a first row of angled strut segments defining the outflow end; a second row of angled strut segments immediately upstream of the first row of angled strut segments; and a plurality of axial frame members bridging the first row of angled strut segments and the second row of angled strut segments, wherein the plurality of axial frame members are connected to the second row of angled strut segments at a plurality of junctions, wherein an
  • Example 19 The prosthetic heart valve of any example herein, particularly example 18, wherein the outflow end portion of the outer skirt is connected to the annular frame solely at the plurality of junctions such that portions of the outflow end portion of the outer skirt between each pair of immediately adjacent junctions are detached from the annular frame. [0312] Example 20.
  • a prosthetic heart valve comprising: an annular frame comprising an inflow end and an outflow end; a leaflet structure comprising a plurality of leaflets positioned within the annular frame, wherein the leaflet structure is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end; and an inner skirt disposed on an inner surface of the annular frame, wherein each leaflet comprises a main body and two opposing sub-commissure tabs arranged on opposite sides of the main body, wherein each sub-commissure tab is paired with and connected to an adjacent sub-commissure tab of an adjacent leaflet, wherein pairs of sub-commissure tabs extend through adjacent gaps formed in the inner skirt.
  • the inner skirt comprises a plurality of longitudinal slits defining the gaps.
  • Example 22 The prosthetic heart valve of any example herein, particularly example
  • Example 23 The prosthetic heart valve of any example herein, particularly any one of examples 21-22, wherein each leaflet has a cusp edge portion extending from one subcommissure tab to the other sub-commissure tab of the leaflet, wherein the cusp edge portion of each leaflet is coupled to the inner skirt via at least one suture extending through preformed markings on a body portion of the inner skirt.
  • Example 24 The prosthetic heart valve of any example herein, particularly example
  • Example 25 The prosthetic heart valve of any example herein, particularly example
  • Example 26 The prosthetic heart valve of any example herein, particularly any one of examples 23-25, wherein the inner skirt comprises a plurality of flaps extending downstream of the body portion, wherein the plurality of flaps are foldable relative to the body portion so as to cover at least portions of the plurality of longitudinal slits, wherein each flap comprises at least one aperture that is positioned downstream of the preformed markings on the body portion when the flap is folded relative to the body portion.
  • Example 27 The prosthetic heart valve of any example herein, particularly example 26, wherein when folded, the at least one suture extends through the at least one aperture on each flap for coupling the cusp edge portion of each leaflet to the inner skirt.
  • Example 28 The prosthetic heart valve of any example herein, particularly example 20, wherein the inner skirt comprises a plurality skirt segments, wherein each skirt segment comprises an inflow portion and an outflow portion, wherein each inflow portion comprises two opposing side edges and an inflow edge extending between the two side edges, wherein two adjacent side edges of each pair of adjacent skirt segments are connected so that the inflow portions of the skirt segments form a continuous surface.
  • Example 29 The prosthetic heart valve of any example herein, particularly example 28, wherein each side edge forms an oblique angle relative to the inflow edge.
  • Example 30 The prosthetic heart valve of any example herein, particularly any one of examples 28-29, wherein the outflow portion of each skirt segment comprises a zigzagged outflow edge and two opposing flaps arranged on opposite ends of the outflow edge.
  • Example 31 The prosthetic heart valve of any example herein, particularly example
  • Example 32 The prosthetic heart valve of any example herein, particularly example
  • each leaflet has a cusp edge portion extending from one sub-commissure tab to the other sub-commissure tab of the leaflet, wherein the cusp edge portion of each leaflet is coupled to an adjacent skirt segment via at least one suture extending through preformed markings on the adjacent skirt segment.
  • Example 33 The prosthetic heart valve of any example herein, particularly example
  • each flap of a skirt segment comprises at least one preformed aperture, wherein when overlapped with an adjacent flap of an adjacent skirt segment to form the pocket, the preformed apertures on the overlapped flaps align with one another so that the at least one suture can extend therethrough.
  • Example 34 The prosthetic heart valve of any example herein, particularly example 20, wherein the inner skirt comprises a plurality of radial folds extending outwardly toward the annular frame, wherein each radial fold defines a gap through which an adjacent pair of sub-commissure tabs can extend.
  • Example 35 The prosthetic heart valve of any example herein, particularly example 34, wherein the inner skirt comprises an inflow end portion and an outflow end portion, wherein the outflow end portion has a larger circumferential length than the inflow end portion when the radial folds are unfolded.
  • Example 36 The prosthetic heart valve of any example herein, particularly any one of examples 34-35, wherein each radial fold has a width that progressively increases from an inflow edge of the inner skirt to an outflow edge of the inner skirt.
  • Example 37 The prosthetic heart valve of any example herein, particularly any one of examples 34-36, wherein each leaflet has a cusp edge portion extending from one subcommissure tab to the other sub-commissure tab of the leaflet, wherein the cusp edge portion of each leaflet is coupled to the inner skirt via at least one suture extending through preformed markings on the inner skirt.
  • Example 38 The prosthetic heart valve of any example herein, particularly example 37, wherein the preformed markings are arranged in multiple marking groups, each marking group defines a cusp-shaped curve aligned with the cusp edge portion of a corresponding leaflet.
  • Example 39 The prosthetic heart valve of any example herein, particularly any one of examples 34-38, wherein each radial fold comprises two opposing folded sides, wherein a pair of folding apertures are positioned on the two opposing folded sides, wherein the pair of folding apertures are aligned with each other so that a suture can extend therethrough to maintain the radial fold in a folded configuration.
  • Example 40 A prosthetic heart valve, comprising: an annular frame comprising an inflow end and an outflow end; a leaflet structure comprising a plurality of leaflets positioned within the annular frame, wherein the leaflet structure is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end; and an inner skirt disposed on an inner surface of the annular frame, wherein each leaflet comprises a main body and two opposing sub-commissure tabs arranged on opposite sides of the main body, wherein each sub-commissure tab is paired with and connected to an adjacent sub-commissure tab of an adjacent leaflet, wherein pairs of sub-commissure tabs extend through adjacent openings formed in the inner skirt.
  • Example 41 The prosthetic heart valve of any example herein, particularly example
  • each leaflet has a cusp edge portion extending from one sub-commissure tab to the other sub-commissure tab of the leaflet, wherein the cusp edge portion of each leaflet is sutured to the inner skirt along a scallop line defined by a plurality of preformed markings on a body portion of the inner skirt.
  • Example 42 The prosthetic heart valve of any example herein, particularly example
  • Example 43 The prosthetic heart valve of any example herein, particularly any one of examples 41-42, wherein the plurality of preformed markings are positioned upstream of the openings.
  • Example 44 The prosthetic heart valve of any example herein, particularly any one of examples 41-43, wherein the inner skirt comprises a plurality of flaps configured to fold over respective openings.
  • Example 45 The prosthetic heart valve of any example herein, particularly example 44, wherein each flap comprises one or more first apertures, wherein when the flap is folded over a corresponding opening, the one or more first apertures are positioned on the scallop line and downstream of the plurality of preformed markings on the body portion of the inner skirt.
  • Example 46 The prosthetic heart valve of any example herein, particularly example 45, wherein each flap comprises one or more second apertures adjacent the first apertures, wherein the inner skirt comprises one or more side apertures adjacent each opening, the side apertures being spaced apart from the plurality of preformed markings on the body portion of the inner skirt, wherein when the flap is folded over the corresponding opening, the one or more second apertures align with the one or more side apertures adjacent the corresponding opening so that a suture can extend therethrough to affix the flap to the body portion of the inner skirt.
  • Example 47 The prosthetic heart valve of any example herein, particularly any one of examples 44-46, wherein the inner skirt has an outflow edge which aligns with a row of angled strut segments of the annular frame, wherein the outflow edge of the inner skirt defines a plurality of triangular edge portions, wherein the plurality of openings are positioned in selected triangular edge portions, wherein the plurality of flaps are connected to and downstream of the selected triangular edge portions.
  • Example 48 The prosthetic heart valve of any example herein, particularly any one of examples 40-47, wherein each pair of sub-commissure tabs extend into an adjacent cell of the annular frame, wherein the pair of sub-commissure tabs do not extend beyond an outer surface of the annular frame.
  • Example 49 The prosthetic heart valve of any example herein, particularly any one of examples 40-48, wherein each opening comprises a longitudinal slit and two horizontal slits connected to opposing ends of the longitudinal slit.
  • Example 50 The prosthetic heart valve of any example herein, particularly any one of examples 40-48, wherein each opening comprises a rectangular window extending in an axial direction.
  • Example 51 The prosthetic heart valve of any example herein, particularly any one of examples 40-48, wherein an outflow edge of the inner skirt defines a plurality of triangular edge portions, wherein selected triangular edge portions are formed by suturing pairs of semi- triangular portions, wherein before suturing, each pair of semi-triangular portions are split apart to define an opening through which an adjacent pair of sub-commissure tabs can extend.
  • Example 52 The prosthetic heart valve of any example herein, particularly any one of examples 40-48, wherein an outflow edge of the inner skirt defines a plurality of triangular edge portions, wherein selected triangular edge portions are formed by suturing pairs of semi- triangular portions, wherein before suturing, each pair of semi-triangular portions are split apart to define an opening through which an adjacent pair of sub-commissure tabs can extend.
  • a prosthetic heart valve comprising: an annular frame comprising an inflow end and an outflow end; a leaflet structure comprising a plurality of leaflets positioned within the annular frame, wherein the leaflet structure is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end; and an inner skirt disposed on an inner surface of the annular frame, wherein each leaflet comprises a main body and two opposing sub-commissure tabs arranged on opposite sides of the main body, wherein each sub-commissure tab is paired with and connected to an adjacent sub-commissure tab of an adjacent leaflet, wherein pairs of sub-commissure tabs extend into adjacent pockets of the inner skirt.
  • Example 53 The prosthetic heart valve of any example herein, particularly example
  • the inner skirt comprises a plurality skirt segments, wherein each skirt segment comprises an inflow portion and an outflow portion, wherein each inflow portion comprises two opposing side edges and an inflow edge extending between the two side edges, wherein two adjacent side edges of each pair of adjacent skirt segments are connected so that the inflow portions of the skirt segments form a continuous surface.
  • Example 54 The prosthetic heart valve of any example herein, particularly example
  • each side edge forms an angle that is between 30 and 60 degrees relative to the inflow edge.
  • Example 55 The prosthetic heart valve of any example herein, particularly any one of examples 53-54, wherein the outflow portion of each skirt segment comprises an outflow edge and two opposing flaps arranged on opposite ends of the outflow edge, wherein two adjacent flaps of each pair of adjacent skirt segments overlap one another to form one of the pockets into which an adjacent pair of sub-commissure tabs can extend.
  • Example 56 The prosthetic heart valve of any example herein, particularly example 55, wherein the outflow edge of each skirt segment has a zigzagged pattern which aligns with a row of angled strut segments of the annular frame.
  • Example 57 The prosthetic heart valve of any example herein, particularly any one of examples 55-56, wherein each leaflet has a cusp edge portion extending from one subcommissure tab to the other sub-commissure tab of the leaflet, wherein the cusp edge portion of each leaflet is sutured to an adjacent skirt segment along a scallop line defined by a plurality of preformed markings on the adjacent skirt segment.
  • Example 58 The prosthetic heart valve of any example herein, particularly example
  • each flap of each skirt segment comprises one or more of the preformed markings that define the scallop line.
  • Example 59 The prosthetic heart valve of any example herein, particularly example
  • Example 60 The prosthetic heart valve of any example herein, particularly any one of examples 53-59, wherein the inner skirt comprises exactly three skirt segments.
  • Example 61 The prosthetic heart valve of any example herein, particularly any one of examples 52-60, wherein each pocket is oriented in a circumferential direction.
  • Example 62 The prosthetic heart valve of any example herein, particularly example 52, wherein the inner skirt comprises a plurality of radial folds extending outwardly toward the annular frame, wherein each radial fold defines a pocket into which an adjacent pair of sub-commissure tabs can extend.
  • Example 63 The prosthetic heart valve of any example herein, particularly example 62, wherein the inner skirt comprises an inflow end portion and an outflow end portion, wherein the outflow end portion has a larger circumferential length than the inflow end portion when the radial folds are unfolded.
  • Example 64 The prosthetic heart valve of any example herein, particularly any one of examples 62-63, wherein each radial fold has a width that progressively increases from an inflow edge of the inner skirt to an outflow edge of the inner skirt.
  • Example 65 The prosthetic heart valve of any example herein, particularly any one of examples 62-64, wherein each leaflet has a cusp edge portion extending from one subcommissure tab to the other sub-commissure tab of the leaflet, wherein the cusp edge portion of each leaflet is sutured to the inner skirt along a cusp-shaped curve defined by a group of preformed markings on the inner skirt.
  • Example 66 The prosthetic heart valve of any example herein, particularly example
  • the inner skirt comprises multiple groups of preformed markings respectively defining multiple cusp-shaped curves, wherein the plurality of radial folds join the multiple cusp-shaped curves into a scallop line.
  • Example 67 The prosthetic heart valve of any example herein, particularly example
  • the inner skirt comprises a plurality of non- fold portions and a plurality of foldable portions positioned between adjacent non-fold portions, wherein each foldable portion is folded radially outwardly to form a corresponding radial fold.
  • Example 68 The prosthetic heart valve of any example herein, particularly example 67, wherein each foldable portion comprises one or more pairs of preformed markings defining upper end portions of two adjacent cusp-shaped curves, wherein after folding the foldable portion into a radial fold, each pair of the preformed markings are aligned with one another so that the two adjacent cusp-shaped curves are joined at their upper end portions.
  • Example 69 The prosthetic heart valve of any example herein, particularly example 67, wherein each foldable portion comprises one or more pairs of preformed markings defining upper end portions of two adjacent cusp-shaped curves, wherein after folding the foldable portion into a radial fold, each pair of the preformed markings are aligned with one another so that the two adjacent cusp-shaped curves are joined at their upper end portions.
  • each foldable portion comprises a pair of folding apertures positioned between two adjacent cusp-shaped curves, wherein after folding the foldable portion into a radial fold, the pair of folding apertures are aligned with one another so that a suture can extend therethrough to maintain the radial fold in a folded configuration.
  • Example 70 The prosthetic heart valve of any example herein, particularly any one of examples 62-69, wherein the inner skirt has an outflow edge which aligns with a row of angled strut segments of the annular frame.
  • Example 71 The prosthetic heart valve of any example herein, particularly any one of examples 62-70, wherein the inner skirt comprises exactly three radial folds.
  • Example 72 A prosthetic heart valve comprising: a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration; and a plurality of leaflets mounted on an inside of the frame, wherein each leaflet comprises a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end, two lower tabs disposed on opposite sides of the main body, two upper tabs disposed on opposite sides of the main body, and two sub-commissure tabs disposed on opposite sides of the main body, wherein lower and upper tabs of adjacent leaflets are paired to form a commissure that is secured to the frame, and wherein sub-commissure tabs of the adjacent leaflets are paired and folded to extend from the inside of the frame towards an outside of the frame.
  • Example 73 The prosthetic heart valve of any example herein, particularly example 72, wherein the sub-commissure tabs are disposed closer to the cusp edge portion of the leaflet than the lower tabs.
  • Example 74 The prosthetic heart valve of any example herein, particularly any one of examples 72-73, wherein the free edge is spaced apart in an axial direction from an outflow edge of each lower tab.
  • Example 75 The prosthetic heart valve of any example herein, particularly any one of examples 72-74, further comprising two offsetting portions, each offsetting portion extending between a respective lower tab and upper tab and offsetting the respective upper tab axially and laterally away from the free edge of the main body.
  • Example 76 The prosthetic heart valve of any example herein, particularly any one of examples 72-75, further comprising an inner skirt disposed around an inner surface of the frame and secured to the cusp edge portion of each leaflet, wherein the inner skirt includes an opening, and wherein the sub-commissure tabs of adjacent leaflets extend through the opening.
  • Example 77 The prosthetic heart valve of any example herein, particularly any one of examples 72-76, wherein the frame comprises a plurality of interconnected struts including a plurality of rows of angled struts and a plurality of axially extending window strut portions defining a plurality of circumferentially spaced apart commissure windows, and wherein the commissures of the adjacent leaflets are secured to a respective commissure window of the frame.
  • Example 78 The prosthetic heart valve of any example herein, particularly example 77, wherein the plurality of interconnected struts forms a plurality of rows of cells, wherein the sub-commissure tabs extend at least partially through a cell of the plurality of cells that is circumferentially aligned with a respective commissure window.
  • Example 79 The prosthetic valve of any example herein, particularly example 78, wherein the plurality of rows of cells includes a first row of cells disposed at an inflow end of the frame, a second row of cells disposed at an outflow end of the frame, and a third row of cells disposed axially between the first and second rows of cells, wherein the sub-commissure tabs extends at least partially through a cell of the third row of cells.
  • Example 80 The prosthetic valve of any example herein, particularly example 79, wherein the third row of cells is positioned adjacent to the second row of cells.
  • Example 81 The prosthetic valve of any example herein, particularly any one of examples 72-80, wherein an outer edge of each sub-commissure tab is positioned radially between an inner surface of the frame and an outer surface of the frame.
  • Example 82 The prosthetic valve of any example herein, particularly any one of examples 72-80, wherein an outer edge of each sub-commissure tab extends radially beyond an outer surface of the frame.
  • a prosthetic heart valve comprising: an annular frame comprising an inflow end and an outflow end; and an inner skirt disposed on an inner surface of the annular frame, wherein the frame comprises a plurality of apex regions formed at the inflow end, each apex region connecting two angled struts located on opposite sides of the apex region, wherein each apex region is attached to the inner skirt by a suture forming a plurality of whip stitches alternating with a plurality of locking stitches in a row along the apex region, wherein the whip stitches extend through the inner skirt and around the apex region and the locking stitches extend through the inner skirt and respective whip stitches.
  • Example 84 The prosthetic heart valve of any example herein, particularly example 83, wherein no gap is formed between two adjacent whip stitches.
  • Example 85 The prosthetic heart valve of any example herein, particularly any one of examples 83-84, wherein each apex region is narrower than the two angled struts located on opposite sides of the apex region, wherein the plurality of whip stitches and the plurality of locking stitches extend over an entire length of the apex region.
  • Example 86 The prosthetic heart valve of any example herein, particularly example 85, wherein the suture forming the plurality of whip and locking stitches at each apex region extends continuously beyond the apex region to form a plurality of whip stitches circling around the two angled struts located on opposite sides of the apex region.
  • Example 87 The prosthetic heart valve of any example herein, particularly any one of examples 83-86, wherein there are two to eight pairs of whip and locking stitches connecting each apex region to the inner skirt.
  • Example 88 The prosthetic heart valve of any example herein, particularly example 87, wherein there are five pairs of whip and locking stitches connecting each apex region to the inner skirt.
  • Example 89 The prosthetic heart valve of any example herein, particularly any one of examples 83-88, wherein at least one of the whip stitches is an inter-locking stitch which extends through filaments of an adjacent stitch.
  • Example 90 The prosthetic heart valve of any example herein, particularly example 89, wherein the inner skirt is attached to each apex region by two inter-locking stitches which define both ends of the row.
  • Example 91 A method for assembling a prosthetic heart valve, the method comprising: identifying apex regions defining an inflow end of an annular frame of the prosthetic valve, each apex region connecting two angled struts located on opposite sides of the apex region; and attaching a skirt to the frame, comprising connecting each apex region to the skirt, wherein connecting each apex region to the skirt comprises: forming a plurality of whip stitches with a suture, wherein each whip stitch extends through the skirt and around an apex region; and forming a plurality locking stitches that extend through the skirt and through respective whip stitches.
  • Example 92 The method of any example herein, particularly example 91, wherein the whip stitches are formed side-by-side along an apex region without any gaps between adjacent whip stitches.
  • Example 93 The method of any example herein, particularly any one of examples 91-
  • each apex region is narrower than the two angled struts located on opposite sides of the apex region, wherein connecting each apex region to the skirt comprises forming the plurality of whip stitches and the plurality of locking stitches over an entire length of the apex region.
  • Example 94 The method of any example herein, particularly any one of examples 91-
  • attaching the skirt to the frame further comprises forming a plurality of additional whip stitches using the suture, wherein the additional whip stitches surround the two angled struts located on both sides of the apex region.
  • Example 95 The method of any example herein, particularly any one of examples 91-
  • the attaching comprises forming two to eight whip stitches and two to eight locking stitches on each apex region.
  • Example 96 The method of any example herein, particularly example 95, wherein the attaching comprises forming five whip stitches and five locking stitches on each apex region.
  • Example 97 The method of any example herein, particularly any one of examples 91- 96, wherein at least one of the locking stitches is an inter-locking stitch, wherein the first stitch of the inter-locking stitch pierces through filaments of the suture.
  • a prosthetic heart valve comprising: an annular frame comprising an inflow end and an outflow end; a leaflet structure comprising a plurality of leaflets positioned within the annular frame, wherein the leaflet structure is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end; and an inner skirt disposed on an inner surface of the annular frame, wherein the inner skirt comprises a plurality of first markings and a plurality of second markings, wherein the plurality of first markings defines a first undulating scallop line and the plurality of the second markings defines a second undulating scallop line, wherein the first and second undulating scallop lines are parallel to each other, wherein the plurality of leaflets is attached to the inner skirt via a first suture extending along the first undulating scallop line, wherein cusp edges of the leaflets are aligned with the second undulating scallop line.
  • Example 100 The prosthetic heart valve of any example herein, particularly any one of examples 98-99, wherein there are more first markings than the second markings.
  • Example 101 The prosthetic heart valve of any example herein, particularly any one of examples 98-100, wherein the plurality of second markings is located upstream of the plurality of first markings.
  • Example 102 The prosthetic heart valve of any example herein, particularly any one of examples 98-101, wherein the inner skirt comprises a plurality of skirt segments, each being connected to a corresponding leaflet, wherein each skirt segment comprises an inflow portion and an outflow portion, wherein each inflow portion comprises two opposing lower side edges and an inflow edge extending between the two lower side edges, wherein each outflow portion comprises two opposing upper side edges and an outflow edge extending between the two upper side edges, wherein the two lower side edges are oblique to the inflow edge, wherein the two upper side edges are perpendicular to the inflow edge, wherein the second markings on each skirt segment extend from one of the upper side edges of the outflow portion, through the inflow portion, and to another one of the upper side edges of the outflow portion.
  • Example 103 The prosthetic heart valve of any example herein, particularly any one of examples 98-102, wherein apices of the leaflets are axially aligned with the inflow end of the frame.
  • Example 104 A method for assembling a prosthetic valve, the method comprising: attaching an inner skirt to a frame of the prosthetic valve; and attaching a plurality of leaflets to the inner skirt, wherein the inner skirt comprises a plurality of first markings and a plurality of second markings on the inner skirt, wherein the plurality of first markings defines a first undulating scallop line and the plurality of the second markings defines a second undulating scallop line, wherein the first and second undulating scallop lines are parallel to each other, wherein attaching the plurality of leaflets to the inner skirt comprises aligning cusp edges of the leaflets to the second undulating scallop line and stitching a first suture through the plurality of first markings along the first undulating scallop line.
  • Example 105 The method of any example herein, particularly example 104, further comprising extending a second suture through the plurality of second markings, wherein the second suture does not extend through the leaflets.
  • Example 106 A prosthetic heart valve comprising: an annular frame comprising an inflow end, an outflow end, and a plurality of interconnected struts between the inflow end and the outflow end; a leaflet structure comprising a plurality of leaflets positioned within the annular frame, wherein the leaflet structure is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end; and an inner skirt disposed on an inner surface of the annular frame, wherein the inner skirt comprises a plurality of markings defining an undulating scallop line, wherein the plurality of leaflets is attached to the inner skirt via a suture extending along the undulating scallop line, wherein each marking is positioned offset
  • Example 107 The prosthetic heart valve of any example herein, particularly example 106, wherein the plurality of markings are first markings and the undulating scallop line is a first scallop line, wherein the inner skirt further comprises a plurality of second markings defining a second scallop line, wherein the second scallop line is parallel to and located upstream of the first scallop line.
  • a prosthetic heart valve comprising: an annular frame comprising an inflow end and an outflow end; a leaflet structure comprising a plurality of leaflets positioned within the annular frame, wherein the leaflet structure is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end; and an inner skirt disposed on an inner surface of the annular frame, wherein each leaflet comprises an outflow edge, a cusp edge opposite to the outflow edge, and a pair of commissure tabs extending from opposite sides of the leaflet and between the outflow edge and the cusp edge, wherein each commissure tab is paired with an adjacent commissure tab of an adjacent leaflet to form a commissure of the leaflet structure, wherein the frame comprises a first row of angled struts defining the outflow end, a second row of angled struts immediately upstream of the first row of angled struts
  • Example 109 The prosthetic heart valve of any example herein, particularly example 108, wherein an upper end of the congruent region is aligned with the aperture, wherein the suture extends through the upper end of the congruent region.
  • Example 110 The prosthetic heart valve of any example herein, particularly any one of examples 108-109, wherein the suture further extends through the commissure window of the axially extending window strut.
  • a prosthetic heart valve comprising: an annular frame comprising an inflow end and an outflow end; a leaflet structure comprising a plurality of leaflets positioned within the annular frame, wherein the leaflet structure is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end; and a plurality of reinforcement strips, each reinforcement strip being attached to a corresponding leaflet, wherein each leaflet comprises two opposing sub-commissure tabs and a cusp edge portion extending from one sub-commissure tab to the other sub-commissure tab of the leaflet, wherein each sub-commissure tab is paired with and connected to an adjacent subcommissure tab of an adjacent leaflet, wherein each pair of sub-commissure tabs extend radially outwardly through an adjacent cell of the frame, wherein each reinforcement strip comprises a body portion that is shaped and sized to match the cusp edge portion
  • Example 112 The prosthetic heart valve of any example herein, particularly example 111, wherein each first wing portion of a reinforcement strip attached to a leaflet is connected to an adjacent first wing portion of another reinforcement strip attached to an adjacent leaflet to form a first wing pair, wherein the first wing pair extends radially outwardly and is sandwiched between the corresponding pair of sub-commissure tabs.
  • Example 113 The prosthetic heart valve of any example herein, particularly any one of examples 111-112, wherein both the first wing portions and the second wing portions are wider than the body portion.
  • Example 114 The prosthetic heart valve of any example herein, particularly any one of examples 111-113, wherein each reinforcement strip comprises a plurality of apertures extending along the body portion, through the second wing portions, and onto the first wing portions, wherein the reinforcement strip is attached to the corresponding leaflet through a suture extending through the plurality of apertures.
  • Example 115 The prosthetic heart valve of any example herein, particularly any one of examples 111-114, wherein each first wing portion includes a first side edge, a second side edge, and a V-shaped end edge connecting the first side edge and the second side edge, wherein the first wing portion is folded along an axis bisecting the V-shaped end edge such that the first side edge aligns with the second side edge to form a double layer, wherein a portion of the double layer including the first side edge and the second side edge extends radially outwardly and is sandwiched between the corresponding pair of sub-commissure tabs.
  • Example 116 The prosthetic heart valve of any example herein, particularly any one of examples 111-115, wherein the body portion of each reinforcement strip comprises an inner edge and an outer edge, wherein when the reinforcement strip is attached to a corresponding leaflet, the outer edge aligns with a cusp edge of the cusp edge portion of the leaflet, wherein the inner edge is positioned downstream of the outer edge, wherein each second wing portion of the reinforcement strip is connected to one end of the body portion and extends sideway from the inner edge.
  • Example 117 The prosthetic heart valve of any example herein, particularly example 116, wherein each second wing portion is folded over the corresponding end of the body portion.
  • Example 118 The prosthetic heart valve of any example herein, particularly any one of examples 111-117, wherein both the second wing portions and the body portion of each reinforcement strip are positioned on an interior side of the corresponding leaflet.
  • Example 119 The prosthetic heart valve of any example herein, particularly any one of examples 111-118, further comprising an inner skirt disposed on an inner surface of the frame, wherein the inner skirt comprises a plurality of skirt segments, each being connected to a corresponding leaflet, wherein each skirt segment comprises an inflow portion and an outflow portion, wherein each outflow portion comprises two opposing side flaps, wherein two adjacent side flaps of each pair of adjacent skirt segments are configured to extend radially outwardly through an adjacent cell of the frame.
  • Example 120 The prosthetic heart valve of any example herein, particularly example
  • Example 121 The prosthetic heart valve of any example herein, particularly example
  • Example 122 A method for assembling a prosthetic heart valve, the method comprising: attaching a leaflet structure to an annular frame, wherein the leaflet structure comprises a plurality of leaflets, wherein each leaflet comprises two opposing subcommissure tabs and a cusp edge portion extending from one sub-commissure tab to the other sub-commissure tab of the leaflet; connecting each sub-commissure tab to an adjacent subcommissure tab of an adjacent leaflet to form a pair of sub-commissure tabs extending radially outwardly through an adjacent cell of the frame; attaching a plurality of reinforcement strips to the leaflet structure, each reinforcement strip being attached to a corresponding leaflet, wherein each reinforcement strip comprises a body portion that is shaped and sized to match the cusp edge portion of the corresponding leaflet and two first wing portions that are located at opposite ends of the body portion; connecting two adjacent first wing portions of two reinforcement strips respectively attached to two adjacent leaflets to form a first wing pair; and insert
  • Example 123 The method of any example herein, particularly example 122, further comprising folding each first wing portion to form a double layer.
  • Example 124 The method of any example herein, particularly any one of examples 122-123, wherein each reinforcement strip further comprises two second wing portions that are respectively connected to and positioned upstream of the two first wing portions, the method further comprising folding each second wing portion over the body portion of the reinforcement strip.
  • Example 125 The method of any example herein, particularly any one of examples 122-124, further comprising attaching the plurality of leaflets to an inner skirt disposed on an inner surface of the frame.
  • Example 126 The method of any example herein, particularly example 125, wherein the inner skirt comprises a plurality of skirt segments, each being connected to a corresponding leaflet, wherein each skirt segment comprises an inflow portion and an outflow portion, wherein each outflow portion comprises two opposing side flaps, the method further comprising extending two adjacent side flaps of each pair of adjacent skirt segments radially outwardly through the adjacent cell of the frame, wherein the corresponding pair of sub-commissure tabs are sandwiched between the two adjacent side flaps.
  • Example 127 The method of any example herein, particularly example 126, further comprising stitching the two adjacent side flaps and the corresponding pair of subcommissure tabs sandwiched therebetween together.
  • a prosthetic heart valve comprising: an annular frame comprising an inflow end and an outflow end; a leaflet structure comprising a plurality of leaflets positioned within the annular frame, wherein the leaflet structure is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end; an inner skirt disposed on an inner surface of the annular frame; and an outer skirt disposed on an outer surface of the annular frame; wherein an outflow edge of the outer skirt is attached to the inner skirt via a plurality of stitches positioned within a row of cells of the frame, wherein there are less than three stitches within each cell in the row that are exposed to an inner surface of the inner skirt.
  • Example 129 The prosthetic heart valve of any example herein, particularly example 128, wherein there are exactly two stitches within each cell in the row that are exposed to the inner surface of the inner skirt.
  • Example 130 The prosthetic heart valve of any example herein, particularly any one of examples 128-129, wherein each leaflet comprises two opposing sub-commissure tabs and a cusp edge portion extending from one sub-commissure tab to the other sub-commissure tab of the leaflet, wherein each sub-commissure tab is paired with and connected to an adjacent sub-commissure tab of an adjacent leaflet, wherein each pair of sub-commissure tabs extend radially outwardly through an adjacent cell in the row, wherein each pair of sub-commissure tabs is stitched to the outer skirt via a suture.
  • a prosthetic heart valve comprising: an annular frame comprising an inflow end and an outflow end; an inner skirt disposed on an inner surface of the annular frame; and a plurality of leaflets attached to the inner skirt, wherein the plurality of leaflets is movable between an open state which permits blood flow from the inflow end to the outflow end and a closed state which blocks blood fluid flow from the outflow end to the inflow end, wherein the inner skirt comprises a plurality of skirt segments, wherein each leaflet is connected to a corresponding skirt segment, wherein each skirt segment comprises an inflow portion and an outflow portion, wherein each inflow portion comprises two opposing first side edges and an inflow edge extending between the two first side edges, wherein each outflow portion comprises two opposing second side edges and an outflow edge extending between the two second side edges, wherein the two first side edges are parallel to each other and form an oblique angle relative to the inflow edge, wherein the two second side edges are parallel to each other and perpendic
  • Example 132 The prosthetic heart valve of any example herein, particularly example 131, wherein in each skirt segment, the two first side edges are separated from corresponding two second side edges by two slits that are parallel to the inflow edge.
  • Example 133 The prosthetic heart valve of any example herein, particularly any one of examples 131-132, wherein each first side edge overlaps an adjacent first side edge of an adjacent skirt segment.
  • Example 134 The prosthetic heart valve of any example herein, particularly any one of examples 131-133, wherein there are exactly three leaflets and exactly three skirt segments.
  • Example 135. The prosthetic heart valve of any example herein, particularly any one of examples 131-134, wherein each skirt segment comprises two opposing side flaps defining the second side edges, wherein each side flap is paired with a side flap of an adjacent skirt segment to form a pair of side flaps that extend through an opening in the frame.
  • Example 136 The prosthetic heart valve of any example herein, particularly example 135, wherein each leaflet comprises two opposing sub-commissure tabs, each subcommissure being paired with a sub-commissure tab of an adjacent leaflet to form a pair of sub-commissure tabs that extends through a respective opening in the frame and between a respective pair of side flaps.

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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)
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  • Prostheses (AREA)

Abstract

Une valve cardiaque prothétique est composée d'une armature annulaire présentant une extrémité d'entrée et une extrémité de sortie, une structure de feuillet comprenant une pluralité de feuillets positionnés à l'intérieur de l'armature annulaire, et une collerette interne disposée sur une surface interne de l'armature annulaire. La structure de feuillet est mobile entre un état ouvert qui permet un écoulement sanguin de l'extrémité d'entrée à l'extrémité de sortie et un état fermé qui bloque l'écoulement fluidique sanguin de l'extrémité de sortie à l'extrémité d'entrée. Chaque feuillet comporte un corps principal et deux languettes sous-commissurales opposées disposées sur des côtés opposés du corps principal. Chaque languette sous-commissurale est appariée et connectée à une languette sous-commissurale adjacente d'un feuillet adjacent. Des paires de languettes sous-commissurale traversent des espaces adjacents formés dans la collerette interne.
PCT/US2025/024244 2024-04-12 2025-04-11 Valves cardiaques prothétiques Pending WO2025217496A1 (fr)

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US63/633,610 2024-04-12
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US63/719,811 2024-11-13

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