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WO2025226813A1 - Prothèses valvulaires à double évasement - Google Patents

Prothèses valvulaires à double évasement

Info

Publication number
WO2025226813A1
WO2025226813A1 PCT/US2025/025964 US2025025964W WO2025226813A1 WO 2025226813 A1 WO2025226813 A1 WO 2025226813A1 US 2025025964 W US2025025964 W US 2025025964W WO 2025226813 A1 WO2025226813 A1 WO 2025226813A1
Authority
WO
WIPO (PCT)
Prior art keywords
frame
prosthetic valve
examples
outflow
tension member
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/US2025/025964
Other languages
English (en)
Inventor
Tamir S. Levi
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 WO2025226813A1 publication Critical patent/WO2025226813A1/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
    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • the present disclosure relates to prosthetic devices, and in particular, to frames of prosthetic valves designed to assume a double-flared configuration in their expanded state.
  • Native heart valves such as the aortic, pulmonary and mitral valves, function to assure adequate directional flow from and to the heart, and between the heart's chambers, to supply blood to the whole cardiovascular system.
  • Various valvular diseases can render the valves ineffective and require replacement with artificial valves.
  • Surgical procedures can be performed to repair or replace a heart valve.
  • Surgeries are prone to an abundance of clinical complications, hence alternative less invasive techniques of delivering a prosthetic heart valve over a catheter and implanting it over the native malfunctioning valve, have been developed over the years.
  • Different types of prosthetic heart valves are known to date, including balloon expandable valve, self-expandable valves and mechanically-expandable valves.
  • Different methods of delivery and implantation are also known, and may vary according to the site of implantation and the type of prosthetic valve.
  • One exemplary technique includes utilization of a delivery assembly for delivering a prosthetic valve in a crimped state, from an incision which can be located at the patient's femoral or iliac artery, towards the native malfunctioning valve. Once the prosthetic valve is properly positioned at the desired site of implantation, it can be expanded against the surrounding anatomy, such as an annulus of a native valve, and the delivery assembly can be retrieved thereafter.
  • Most expandable prosthetic valves comprise a cylindrical metal frame and prosthetic leaflets mounted inside the frame.
  • the leaflets of the prosthetic heart valve are configured to open and close (during systole and diastole, for example), in order to regulate a flow of blood through the prosthetic heart valve.
  • the present disclosure is directed towards prosthetic valves defining two portions that radially flare outwards, in expanded states thereof, at different draft angles.
  • a prosthetic valve comprises a frame defining a first portion configured to flare radially outwards at a first draft angle, and a second portion configured to flare radially outwards at a second draft angle that is greater than the first draft angle.
  • This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and/or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.
  • the frame is configured to transition between a radially expanded and a crimped state, and the first and second portions of the frame are configured to flare radially outwards in the expanded state.
  • the first portion can extend between an inflow end of the frame and a bending region of the frame.
  • the second portion can extend between the bending region and an outflow end of the frame.
  • the prosthetic valve further comprises a valvular structure mounted inside the frame.
  • the valvular structure can comprise a plurality of leaflets configured to regulate flow through the prosthetic valve.
  • each leaflet can comprise a cusp end portion.
  • each two adjacent leaflets can optionally be joined at commissures coupled to the frame.
  • the bending region can be axially defined between the cusp end portions and the commissures.
  • the first draft angle can be in a range of l°-7°, inclusive.
  • the second draft angle can be in a range of 5°-20°, inclusive.
  • the second draft angle can be greater than the first draft angle by at least 3°.
  • the frame optionally defines, in the expanded state, a first diameter at the inflow end, a second diameter between the first portion and the second portion, and a third diameter at the outflow end, such that the second diameter can be greater than the first diameter, and the third diameter can be greater the second diameter.
  • the bending region is distal to the commissures.
  • the prosthetic valve comprises a first flexible tension member optionally disposed around the frame and a second flexible tension member optionally disposed around the frame, wherein the second flexible tension member can be proximal to the first flexible tension member.
  • the first flexible tension member can be disposed around the inflow end of the frame.
  • the second flexible tension member can be disposed around at the bending region.
  • the second flexible tension member can be longer than the first flexible tension member.
  • the prosthetic valve comprises a restriction skirt optionally disposed around the frame, the restriction skirts optionally extending between a distal end and a proximal end thereof.
  • the distal end of the restriction skirt can be disposed around the inflow end of the frame.
  • the proximal end of the restriction skirt can be disposed around at the bending region.
  • the proximal end of the restriction skirt can be longer than the distal end.
  • Fig. 1A is a perspective side view of an exemplary prosthetic valve.
  • Fig. IB is a perspective side view of the prosthetic valve of Fig. 1A without optional skirts thereof.
  • Fig. 1C is a perspective view of the frame of the prosthetic valve of Figs. 1 A-1B.
  • Fig. 2 is a perspective view of an exemplary leaflet comprising two opposing tabs.
  • Fig. 3 shows a flattened view of an exemplary leaflet that includes upper tabs and lower tabs.
  • Fig. 4 is a top plan view of an exemplary prosthetic valve that includes the leaflets of Fig. 3.
  • Fig. 5 shows an exemplary delivery apparatus carrying an exemplary prosthetic valve.
  • Fig. 6 shows a side view of an exemplary double-flared prosthetic valve.
  • Fig. 7 schematically shows a cross-sectional profile of the frame of the prosthetic valve of Fig. 6.
  • Fig. 8 shows an exemplary prosthetic valve that includes two flexible tension members.
  • Fig. 9 shows an exemplary prosthetic valve that includes a restriction skirt.
  • proximal and distal are defined relative to the use position of a delivery apparatus. In general, the end of the delivery apparatus closest to the user of the apparatus is the proximal end, and the end of the delivery apparatus farthest from the user (e.g., the end that is inserted into a patient’s body) is the distal end.
  • proximal when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the proximal end of the delivery apparatus.
  • distal when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the distal end of the delivery apparatus.
  • Figs. 1A-1C illustrate a prosthetic valve 10, according to one example.
  • the term "prosthetic valve”, as used herein, refers to any type of a prosthetic valve deliverable to a patient's target site over a catheter, which is radially expandable and compressible between a radially compressed, or crimped, state, and a radially expanded state.
  • the prosthetic valves can optionally be crimped on or retained by an implant delivery apparatus 52 (see Fig. 5) in the radially compressed state during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site.
  • the expanded state may include a range of diameters to which the valve may expand, between the compressed state and a maximal diameter reached at a fully expanded state.
  • a plurality of partially expanded states may relate to any expansion diameter between radially compressed or crimped state, and maximally expanded state.
  • a prosthetic valve of the current disclosure may include any prosthetic valve configured to be mounted within the native aortic valve, the native mitral valve, the native pulmonary valve, and the native tricuspid valve.
  • 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 US Publication No. 2022/0079749, 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.
  • Balloon expandable valves generally involve a procedure of inflating a balloon within a prosthetic valve, thereby expanding the prosthetic valve within the desired implantation site. Once the valve is sufficiently expanded, the balloon is deflated and retrieved along with a delivery apparatus 52 (see Fig. 5).
  • Self-expandable valves include a frame that is shape-set to automatically expand as soon an outer retaining shaft or capsule (not shown) is withdrawn proximally relative to the prosthetic valve.
  • Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion.
  • the mechanical actuation mechanism usually includes a plurality of expansion and locking assemblies (such as the prosthetic valves described in U.S. Patent No. 10,603,165, International Application No. PCT/US2021/052745, and U.S. Provisional Application Nos. 63/085,947 and 63/209904, each of which is incorporated herein by reference in its entirety), releasably coupled to respective actuation assemblies of a delivery apparatus, controlled via a handle (not shown) for actuating the expansion and locking assemblies to expand the prosthetic valve to a desired diameter.
  • expansion and locking assemblies such as the prosthetic valves described in U.S. Patent No. 10,603,165, International Application No. PCT/US2021/052745, and U.S. Provisional Application Nos. 63/085,947 and 63/209904, each of which is incorporated herein by reference in its entirety
  • the expansion and locking assemblies may optionally lock the valve's diameter to prevent undesired recompression thereof, and disconnection of the actuation assemblies from the expansion and locking assemblies, to enable retrieval of the delivery apparatus once the prosthetic valve is properly positioned at the desired site of implantation.
  • the prosthetic valve 10 comprises a frame 106 movable between a radially compressed state and a radially expanded state, and a valvular structure 140 mounted within the frame 106.
  • the frame extends between an inflow end 104 and an outflow end 102, and defines a central longitudinal axis CA (indicated, for example, in Fig. 7) extending in a direction from the inflow end 104 to the outflow end 102.
  • Fig. 1 A is a perspective view of an exemplary prosthetic valve 10 that can optionally include an inner skirt 156 disposed around an inner surface of the frame 106, an outer skirt 158 disposed around an outer surface of the frame 106, and a valvular structure 140 mounted inside the frame 106, optionally connected to the inner skirt 156.
  • Fig. IB is a perspective side view of the prosthetic valve 10 of Fig. 1 A with the skirts removed from view to expose components of the valvular structure 140.
  • Fig. 1C is a perspective view of the frame 106 of the prosthetic valve 10 of Fig. 1A.
  • proximal generally refers to a position, direction, or portion of a device or a component of a device, which is closer to the user (for example, during an implantation procedure) and further away from the implantation site.
  • distal generally refers to a position, direction, or portion of a device or a component of a device, which is further away from the user and closer to the implantation site.
  • outflow refers to a region of the prosthetic valve through which the blood flows through and out of the prosthetic valve.
  • inflow refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve.
  • the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow”, respectively.
  • the lower end of the prosthetic valve is its inflow end and the upper end of the prosthetic valve is its outflow end.
  • the frame 106 can be made of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol).
  • a plastically-expandable material e.g., stainless steel, etc.
  • self-expanding materials e.g., Nitinol.
  • the frame 106 (and thus the valve 10, 100) can be crimped to a radially compressed state on a delivery catheter (e.g., balloon catheter 60 shown in Fig. 5) and then expanded inside a patient by an inflatable balloon (e.g., balloon 62 shown in Fig. 5) or equivalent expansion mechanism.
  • the frame 106 When constructed of a self-expandable material, the frame 106 (and thus the valve 10, 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.
  • Suitable plastically-expandahle materials that can optionally be used to form the frames disclosed herein (e.g., the frame 106) include metal alloys, polymers, or combinations thereof.
  • Example metal alloys can optionally comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal.
  • the frame 106 comprises stainless steel.
  • the frame 106 comprises cobalt-chromium.
  • the frame 106 comprises nickel-cobalt-chromium.
  • the frame 106 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 R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.
  • the frame 106 is an annular, stent-like structure comprising a plurality of intersecting struts 108 which form multiple rows 130 of cells 128 between the outflow end 102 and the inflow end 104 of the frame 106.
  • strut encompasses vertical struts, angled or curved struts, support posts, commissure windows, and any similar structures described by U.S. Pat. Nos. 7,993,394 and 9,393,110, which are incorporated herein by reference.
  • a strut 108 may be any elongated member or portion of the frame 106.
  • the frame 106 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 104 to the outflow end 102 as shown, or the frame can vary in diameter along the height of the frame, as disclosed in US Pat. No. 9,155,619, which is incorporated herein by reference.
  • the interconnected struts 108 include a plurality of angled struts 110 arranged in a plurality of rungs 112 of circumferentially extending rungs of angled struts, with the strut rungs 112 being arrayed along the length of the frame 106 between the outflow end 102 and the inflow end 104.
  • Struts 108 of the frame 106 can optionally further include a plurality of axial frame members 114.
  • axial frame member refers to a strut or a component of the frame 106 that generally extends in an axial direction
  • angled strut generally refers to a strut that can extend at an angle relative to an axial line intersecting therewith along a plane defined by the frame 106. It is to be understood that the term “angled strut” encompasses both linear angled struts and curved struts.
  • Two or more struts 108 can intersect at junctions 132, which can be equally or unequally spaced apart from each other.
  • the frame 106 can further comprise a plurality of outflow apices 134 at the outflow end 102 of the frame, and a plurality of inflow apices 136 at the inflow end 104 of the frame.
  • the struts 108 may be pivotable or bendable relative to each other, so as to permit frame expansion or compression.
  • the frame 106 can be optionally formed from a single piece of material, such as a metal tube, via various processes such as, but not limited to, laser cutting, electroforming, and/or physical vapor deposition, while retaining the ability to collapse/expand radially in the absence of hinges and like.
  • the valvular structure 140 can comprise a plurality of leaflets 142 (e.g., three leaflets), positioned at least partially within the frame 106, and configured to regulate flow of blood through the prosthetic valve 100 from the inflow end 104 to the outflow end 102. While three leaflets 142 arranged to collapse in a tricuspid arrangement, are shown in the example illustrated in Figs. 1A-1C, it will be clear that a prosthetic valve 10 can include any other number of leaflets 142. Adjacent leaflets 142 can be arranged together to form commissures 154 that are coupled (directly or indirectly) to respective portions of the frame 106, thereby securing at least a portion of the valvular structure 140 to the frame 106.
  • leaflets 142 e.g., three leaflets
  • Fig. 2 shows a perspective view of an exemplary leaflet 142.
  • each leaflet 142 can optionally comprise opposing commissure attachment members, which can be optionally in the form of tabs 150 as shown, for example, in Fig. 2.
  • each tab 150 can be secured to an adjacent tab 150 of an adjacent leaflet 142 to form a commissure 154 that is secured to the frame 106.
  • Each leaflet 142 can further include a free edge portion 144 on a portion of the leaflet 142 between the two tabs 150 and closest to the outflow end 102 of the frame 106, and a cusp end portion 146 extending between the two tabs 150 opposite to the free edge portion 144.
  • the cusp end portion 146 can optionally have an undulating, curved scalloped shape.
  • a leaflet inflow end portion 148 is defined as the distal-most portion of the leaflet 142 along the cusp end portion 146. In some examples, the leaflet inflow end portion 148 can optionally be defined at the middle of the cusp end portion 146.
  • the leaflets 142 can optionally define a non-planar coaptation plane (not annotated) when the free edge portions 144 of the leaflets coapt or mate with each other to seal blood flow through the prosthetic valve 10.
  • a non-planar coaptation plane not annotated
  • the adjacent free edge portions 144 should coapt with each other to prevent retrograde blood from flowing between the free edge portions 144.
  • the adjacent free edge portions 144 will separate from each other and allow antegrade blood to flow between free edge portions 144.
  • the leaflets 142 can optionally be made from, in whole or part, biological material (e.g., pericardium), bio-compatible synthetic materials, or other such materials.
  • biological material e.g., pericardium
  • bio-compatible synthetic materials e.g., bio-compatible materials
  • transcatheter prosthetic heart valves including the manner in which the valvular structure 140 can be coupled to the frame 106 of the prosthetic valve 10, can be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,652,202, and 1 1 , 135,056, all of which are incorporated herein by reference in their entireties.
  • the frame 106 includes an outflow cell row 1300, an inflow cell row 1301, and optionally (but not necessarily) one or more subsequent cell rows 130S therebetween.
  • the frame 106 is shown to comprises four cell rows 130, each row comprising a plurality of cells 128 extending circumferentially such that each cell 128 is directly coupled to two circumferentially adjacent cells 128 on both sides thereof within the same row of cells.
  • the outflow cell row 1300 disposed at the outflow end 102, comprises outflow cells 1280 that are elongated in an axial direction (relative to the central longitudinal axis CA), compared to cells 128 in the remaining cell rows 130, which can include a first subsequent cell row 130S1, a second subsequent cell row 130S2, and the inflow cell row 1301.
  • each cell row 130 comprises twelve cells 128.
  • the frame 106 can be referred to as a twelve-cell frame.
  • the frame 106 can have a greater or fewer number of circumferentially extending cell rows 130 and/or a greater or fewer number of cells 128 in each cell row.
  • cells 128 are coupled to adjacent cells 128 within the same row, such as within the outflow (or proximal-most) cell row 1300, via axial frame members 114.
  • Axial frame members 114 include, in some examples, commissure support members 122 and non-commissural axial struts 120.
  • a commissure support member 122 is configured to support a corresponding commissure 154 of the valvular structure 140.
  • the axial frame members 114, including non-commissural axial struts 120 and commissure support members 122, can optionally be parallel to each other and/or to the central longitudinal axis CA of the frame 106.
  • a commissure support member 122 can optionally comprise a commissure window opening 124 defined between two axially-extending commissure sidewalls 126. While commissure support members 122 that include commissure window openings 124 are illustrated and described herein, it is to be understood that a frame 106 can include other types of commissure support members configured to mount a commissure 154 in any other suitable manner, such as by supporting portions of the valvular structure 140 that can be wrapped therearound, can include apertures through which sutures for attaching the commissures can be passed, and the like.
  • non-commissural axial strut and “axial strut”, as used herein, are interchangeable, and refer to an axial frame member configured to remain unattached to the valvular structure 140. That is to say, an axial struts 120 is not configured to mount a commissure, and may be devoid of a window opening 124.
  • the frame 106 includes an outflow rung 1 120, an inflow rung 1 121, and one or more subsequent rungs 112S therebetween, which can be also referred to as intermediate rungs.
  • the frame 106 is shown to comprise five rungs 112 of angled struts 110, including the outflow rung 1120 of angled outflow struts 110O which is closer to the outflow end 102 relative to other rungs of struts, a first subsequent rung 112S1 of angled struts 110S1 which is distal to the outflow rung 1120, a second subsequent rung 112S2 of angled struts 110S2 which is distal to the first subsequent rung 112S 1, a third subsequent rung 112S3 of angled struts 110S3 which is distal to the second subsequent rung 112S2, and the inflow rung 1121, which includes angled inflow struts 1101 that are
  • One or more (for example, two, as shown in Figs. 1A-1C) axial struts 120 can be positioned between, in the circumferential direction, two commissure support members 122.
  • each axial strut 120 can have a width that is larger than a width of the angled struts 110.
  • a “width” of a strut is measured between opposing locations on opposing surfaces of a strut that extend between the radially facing inner and outer surfaces of the strut (relative to the central axis CA).
  • a “thickness” of a strut is measured between opposing locations on the radially facing inner and outer surfaces of a strut and is perpendicular to the width of the strut.
  • the width of the axial struts 120 is 50-200%, 75-150%, or at least 100% larger than (e.g., double) the width of the angled struts 110 of the frame 106.
  • the axial struts 120 By providing the axial struts 120 with the width that is greater than the width of other, angled struts 110 of the frame 106, a larger contact area is provided for when the leaflets 142 contact the wider axial struts 120 during systole, thereby distributing the stress and reducing the extent to which the leaflets may fold over the axial struts 120, radially outward through the outflow cells 1280. As a result, a long-term durability of the leaflets can be increased.
  • the outflow cells 1280 of the outflow cell row 1300 of the exemplary frame 106 illustrated in Figs. 1A-1C are shown to be generally hexagonal, each cell defined between two outflow angled struts HOO of the outflow rung 1120, two angled struts 110S1 of the first subsequent rung 112S 1 , and two axial frame members 114 extending between the outflow rung 1120 and the first subsequent rung 112S 1.
  • Cells of the first subsequent cell row 130S1, second subsequent cell row 130S2, and inflow cell row 1301 can be generally diamond- shaped cells, with the cells 128S1 of the first subsequent cell row 130S 1 defined by two angled struts 110S1 of the first subsequent rung 112S1 and two angled struts 110S2 of the second subsequent rung 112S2, cells 128S2 of the second subsequent cell row 130S2 defined by two angled struts 1 10S2 of the second subsequent rung 1 12S2 and two angled struts 1 10S3 of the third subsequent rung 112S3, and inflow cells 1281 of the inflow cell row 1301 defined by two angled struts 110S3 of the third subsequent rung 112S3 and two angled struts 1101 of the inflow rung 1121.
  • Each rung 112 of angled struts 110 is shown to be circumferentially arranged in a generally zig-zagged pattern.
  • Each axial frame member 114 can have an outflow end portion 116 at which the axial frame member 114 is linked to outflow angled struts 11 OO of the outflow rung 1120, and an inflow end portion 118 at which the axial frame member 114 is linked to angled struts 1 IOS 1 of the first subsequent rung 112S1.
  • any exemplary prosthetic valve disclosed herein can include any other number of cell rows 130 and strut rungs 112.
  • the prosthetic valve 10 can optionally include an inner skirt 156 secured to an inner surface of the frame 106.
  • the inner skirt 156 can function as a sealing member to prevent or decrease perivalvular leakage, to anchor the valvular structure 140 to the frame 106, and/or to protect the leaflets 142 against damage caused by contact with the frame 106 during crimping and during working cycles of the prosthetic valve 10.
  • cusp end portions 146 of the leaflets 142 can be sutured to the inner skirt 156 generally along a scallop-shaped line.
  • the inner skirt 156 can in turn be coupled to the frame 106 by one or more fasteners, such as sutures.
  • an inner skirt 156 comprises a single sheet of material that extends continuously around frame 106.
  • the inner skirt 156 can optionally comprise one or more skirt portions that are connected together and/or individually connected to the frame 106.
  • the prosthetic valve 10 can further include an outer skirt 158 disposed around an outer surface of the frame 106, and configure to function, for example, as a sealing member retained between the frame 106 and the surrounding tissue of the native annulus against which the prosthetic valve is mounted, thereby reducing risk of paravalvular leakage (PVL) past the prosthetic valve 10.
  • the outer skirt 158 comprises a single sheet of material that extends continuously around the frame 106.
  • the outer skirt 158 can optionally comprise one or more skirt portions that are connected together and/or individually connected to the frame 106.
  • an inner skirt 156 and/or outer skirt 158 can optionally comprise various suitable biocompatible materials, such as, but not limited to, natural tissue (e.g., pericardial tissue), a fabric, or polymeric material (such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc.).
  • suitable biocompatible materials such as, but not limited to, natural tissue (e.g., pericardial tissue), a fabric, or polymeric material (such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc.).
  • an inner skirt and an outer skirt are shown and described herein by way of illustration and not limitation.
  • a prosthetic valve 10 can optionally be provided with an inner skirt 156 and without an outer skirt, in which case, the inner skirt 156 further serves as a PVL sealing member of the valve against the surrounding anatomy.
  • a prosthetic valve 10 can optionally be provided with an outer skirt 158 and without an inner skirt, in which case, the leaflet's cusp end portion 146 can be optionally directly coupled (e.g., sutured) to struts 108 of the frame 106, somewhat similar to the manner illustrated, for example, in Fig. IB.
  • a leaflet 142 includes a leaflet body 152 which is the movable and unattached part of the leaflet, defined between a lower cusp end portion 146 and the upper free edge portion 144.
  • the leaflet body 152 can have a three-dimensional and concave shape, thereby resulting in increased mobility of the leaflet when the prosthetic valve is implanted in a patient. As a result, the efficiency of the prosthetic valve including the valvular structure can be improved.
  • the leaflet 142 can comprise shaped tissue material.
  • a leaflet body 152 of leaflet 142 disclosed herein is not flattenable.
  • the term "not flattenable”, as used herein, means that the leaflet body 152 cannot be flattened. That is to say, if an attempt is made to straighten out the curve of a free edge portion 144, the curve will not be able to be completely straightened such that leaflet body 152 becomes flat.
  • leaflets that are cut from a flat patch and are then attached (e.g., sutured) to a frame of a prosthetic valve, wherein upon removal of such leaflets from the frame they can be laid flat on a flattened surface, with their free edge portions being able to completely straighten in their free state.
  • a leaflet body 152 which is not flattenable defines a non- developable surface. Further details regarding leaflets or leaflet bellies thereof, which are three- dimensional or not flattenable, are described in International Application No. PCT/US2022/032303, and U.S. Provisional Application No.
  • a leaflet 142 a illustrated in Fig. 2 is an exemplary implementation of leaflet 142, and thus can include any of the features described for leaflet 142 throughout the current disclosure, except that the commissure attachment members of leaflet 142 a are in the form of opposite tabs 150, such that a single tab 150 is present at each side of the leaflet 142 a .
  • Fig. 3 shows a flattened view of a leaflet 142 b of an exemplary prosthetic valve 10 b .
  • Fig. 4 is a top plan view of an exemplary prosthetic valve 10 b with the valvular structure that includes the leaflets 142 b of Fig. 3, shown in an open state of the valvular structure.
  • the prosthetic valve 10 b is similar to any example described herein for prosthetic valve 10, except that the commissure attachment portions of leaflet 142 b include a lower tab 150L and an upper tab 150U at each side of the leaflet 142 b .
  • the leaflets 142 transition between a closed state in diastole, with their free edge portions 144 coapting against each other, and an open state (see, for example, Fig. 4) allowing blood to flow through the prosthetic valve 10.
  • the outflow orifice through which the blood can flow determines the pressure gradient across the prosthetic valve.
  • Some prosthetic valves can have valvular structures attached to the frame in such a manner that the outflow edge portions of each leaflet are spaced radially inward of the frame to prevent leaflet abrasion when the leaflets open under the flow of blood.
  • the effective outflow orifice (e.g., as determined by the position of the leaflets), also referred to as the geometric orifice area (GOA), can be narrower than the inflow orifice, producing a relatively high pressure gradient across the prosthetic valve.
  • the increased pressure gradient can lead to prosthesis-patient-mismatch (PPM) where the prosthetic valve is essentially undersized for the patient, which has been shown to be associated with worsened hemodynamic function and more cardiac events. This can be worsened when small diameter valves are used. Accordingly, it is desired to provide a large outflow orifice during systole to prevent elevated pressure gradients.
  • the valvular structure 150 of a prosthetic valve 10 can define a relatively large GOA diameter DL when compared to the size of the outflow orifice diameter DF defined by the outflow end 102 of the frame 106.
  • the term “GOA,” as used herein, is defined as the open space through which blood can flow when the valvular structure is in the open state.
  • the GOA diameter DL can be sized to provide a selected pressure gradient across the prosthetic valve 10.
  • each upper tab 150U can be coupled to a lower tab 150L via a respective neck portion 151.
  • each upper tab 150U and neck portion 151 are formed integrally with the leaflet 142 b .
  • the upper tabs 150U and/or neck portions 151 can be formed separately from the leaflet 142 b and coupled to the leaflet 142 b . While the upper tab 150U is shown in the illustrated example to have a substantially rectangular shape, it is to be understood that in some examples, the upper tab 150U can have any of various shapes.
  • each upper tab 150U is folded downward (e.g., toward the inflow end 104 of the frame 106) along the neck portion 151.
  • the neck portion 151 can be sized such that when the upper tab 150U is folded downwards, a rigid portion is formed by the folded neck portion 151 that extends radially into the outflow orifice, so as to prevent the leaflets 142 from hitting the frame 106 (preventing or mitigating abrasion and/or other damage to the leaflets) while maximizing the GOA diameter DL, thereby improving the pressure gradient across the prosthetic valve 10 b while minimizing wear of the leaflets.
  • a draft angle means the degree of taper between two axially spaced levels of the valve, which can be a measure of the angle between the central longitudinal axis CA and a line drawn tangent to the outer surface of the frame between the two axially spaced levels along which the draft angle is defined.
  • the draft angle is about 0 degrees.
  • the draft angle can be, for example, between about 2 degrees and about 15 degrees.
  • FIG. 5 shows a perspective view of an exemplary delivery assembly 50 that includes a delivery apparatus 52 adapted to deliver a prosthetic device, which can be any exemplary prosthetic valve 10 described above, or any exemplary prosthetic valve 100 described below with respect to Figs. 6-9.
  • the delivery apparatus 52 can optionally include a handle 54 and at least one catheter extending therefrom, configured to carry a prosthetic valve 10, 100 in a crimped state through the patient's vasculature.
  • An exemplary delivery assembly 50 comprises an exemplary delivery apparatus 52 configured to carry a balloon expandable prosthetic valve.
  • the delivery apparatus 52 can optionally comprise a balloon catheter 60 having an inflatable balloon 62 mounted on its distal end.
  • a prosthetic device, such as prosthetic valve 10, 100 can be optionally carried in a crimped state over the balloon catheter 60.
  • a delivery apparatus 52 further comprises an outer shaft 58.
  • an outer shaft 58 of a delivery apparatus 52 can concentrically extend over the balloon catheter 60.
  • the outer shaft 58 and the balloon catheter 60 can optionally be configured to be axially movable relative to each other. For example, a proximally oriented movement of the outer shaft 58 relative to the balloon catheter 60, or a distally oriented movement of the balloon catheter 60 relative to the outer shaft 58, can expose the prosthetic valve 10, 100 from the outer shaft 58.
  • a delivery apparatus 52 can optionally further include a nosecone 64 to facilitate advancement of the delivery apparatus 52 through the patient's vasculature to the site of treatment.
  • a nosecone shaft (concealed from view in Fig. 2) can optionally extend proximally from the nosecone 64 through a lumen of the balloon catheter 60, towards the handle 54.
  • a prosthetic valve 10, 100 is mounted on the balloon 62 and is shown in a crimped state, providing prosthetic valve 10, 100 with a reduced diameter for delivery to the heart via the patient’s vasculature. While the prosthetic valve 10, 100 is shown in Fig. 5 as being crimped or mounted on the balloon 62 for delivery to the treatment location, it should be understood that the prosthetic valve can be optionally crimped or mounted at a location different from the location of balloon 62 (e.g., proximal to the balloon 62) and repositioned over the balloon at some time before inflating the balloon and deploying the prosthetic valve.
  • This off-balloon delivery allows the prosthetic valve to be crimped to a lower profile than would be possible if the prosthetic valve was crimped on top of the balloon 62.
  • the lower profile permits the clinician to more easily navigate the delivery apparatus (including the crimped prosthetic valve) through a patient's vasculature to the treatment location.
  • the lower profile of the crimped prosthetic valve can be particularly helpful when navigating through portions of the patient’s vasculature which are particularly narrow, such as the iliac artery.
  • the proximal ends of the balloon catheter 60, the outer shaft 58, and/or the nosecone shaft, can optionally be coupled to the handle 54.
  • the handle 54 can be maneuvered by an operator (e.g., a clinician or a surgeon) to axially advance or retract components of the delivery apparatus 52, such as the nosecone shaft, the outer shaft 58, and/or the balloon catheter 60, through the patient's vasculature and/or along the target site of implantation, as well as to inflate the balloon 62 mounted on the balloon catheter 60, for example to expand a prosthetic valve 10, 100 mounted on the balloon 62, and to deflate the balloon 62 and retract the delivery apparatus 52, for example once the prosthetic valve 10, 100 is mounted in the implantation site.
  • an operator e.g., a clinician or a surgeon
  • the handle 54 can optionally include a steering mechanism configured to adjust the curvature of a distal end portion of the delivery apparatus 52.
  • the handle 54 includes an adjustment member, such as the illustrated rotatable knob 56a, which in turn is operatively coupled to the proximal end portion of a pull wire (not shown).
  • the pull wire can optionally extend distally from the handle 54 through the outer shaft 58 and has a distal end portion affixed to the outer shaft 58 at or near the distal end of the outer shaft 58.
  • Rotating the knob 56a can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 52. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Pat. No. 9,339,384, which is incorporated by reference herein.
  • the handle 54 can include an adjustment member such as the illustrated rotatable knob 56b, configured to adjust the axial position of the balloon catheter 60 relative to the outer shaft 58, for example for fine positioning at the implantation site.
  • the handle can include additional knobs to control additional components of the delivery apparatus 52. Further details on the delivery apparatus 52 can be found in PCT Application No. PCT/US2021/047056, which is incorporated by reference herein.
  • a prosthetic valve 10, 100 can be carried by the delivery apparatus 52 during delivery in a crimped state, and expanded, for example by balloon inflation, to secure it in a native heart valve annulus (such as an aortic annulus) or against a previously implanted prosthetic valve (for example, during valve-in-valve implantation procedures).
  • the balloon 62 is secured to a distal end portion of the balloon catheter 60 at its proximal end, while the balloon's distal end can optionally be coupled, directly or indirectly, to another component of the delivery apparatus 52, such as the nosecone 64 or nosecone shaft.
  • Balloon 62 is configured to transition between a deflated and inflated states. Upon reaching the site of implantation, the balloon 62 can be inflated to radially expand the prosthetic valve 10, 100. Once the prosthetic valve 10, 100 is expanded to its functional diameter within a native annulus, the balloon 62 can be deflated, and the delivery apparatus 52 can be retrieved from the patient's body.
  • the delivery apparatus 52 with the prosthetic valve 10, 100 assembled thereon can be packaged in a sterile package that can be supplied to end users for storage and eventual use.
  • the leaflets of the prosthetic valve when the leaflets of the prosthetic valve are made from, or include at least an inner core made from, bovine pericardium tissue or other natural or synthetic tissues, the leaflets can be treated during the manufacturing process so that they are completely or substantially dehydrated and can be stored in a partially or fully crimped state without a hydrating fluid. In this manner, the package containing the prosthetic valve and the delivery apparatus, can be free of any liquid. Methods for treating tissue leaflets for dry storage are disclosed in U.S. Pat. Nos. 8,007,992 and 8,357,387, both of which documents are incorporated herein by reference.
  • some types of prosthetic valves can assume a tapered configuration in the expanded state, optionally defining a positive draft angle extending from the inflow end 104 to the outflow end 102 of the frame, resulting in a substantially V-shaped expanded configuration.
  • leaflets are coupled to the frame not only along the commissure 154 but rather along their cusp end portions 146 as well, such design may be challenging, resulting in a sub-optimal performance of the leaflet bodies 152 along the height of the cusp end portions 146.
  • prosthetic valves 100 configured to define two draft angles along portions thereof.
  • a prosthetic valve 100 according to any of the examples described below with respect to Figs. 6-9, can be structurally and functionally similar to any exemplary prosthetic valve 10 described above, except that the frame 106 of prosthetic valve 100 defines a first portion 160 configured to taper at a first draft angle a, and a second portion 162 configured to taper at a second draft angle .
  • prosthetic valve 100 including valvular structure 140 with leaflets 142, optional inner skirt 156, and optional outer skirt 158, can be similar to the same components, with the same component numerals, and features thereof, described above with respect to prosthetic valve 10, and in the interest of brevity will not be described further.
  • Fig. 6 shows a side view of a prosthetic valve 100 with valvular structure 140 mounted therein, wherein optional skirts 156 and/or 158 are not shown for the sake of clarity.
  • Fig. 7 schematically shows a cross-sectional profile of the frame 106 of the prosthetic valve 100 of Fig. 6.
  • the prosthetic valve 100 is shown in the expanded state in both of the Figs. 6 and 7.
  • a first portion 160 of the frame 106 of prosthetic valve 100 is defined as the portion that includes the cusp end portions 146 of the leaflets 142 which are coupled (e.g., sutured along a scalloped- line), directly or indirectly, to the frame 106, and does not include the commissures.
  • a second portion 162 of the frame 106 of prosthetic valve 100 is defined as the portion that includes the commissures 154, and is proximal to the first portion 160 of the valve.
  • the expanded configuration shown in Figs. 6-7 can be also referred to herein as a double-flared or doubletapered configuration.
  • the cusp end portions 146 span the height of the frame 106 that includes the inflow rung 1121 and some or all of the subsequent rungs 112S, optionally up to the inflow end portions 118 of the axial frame members 114.
  • the leaflet inflow end portions 148 can be positioned at or proximate to the inflow end 104 of the frame, as illustrated, for example, in Fig. 6.
  • the leaflet inflow end portions 148 can be coupled, directly or indirectly, to inflow apices 136.
  • the first portion 160 of the frame 106 extends proximally from the inflow end 104, so as to include the cusp end portions 146 coupled to the frame 106, optionally along a scalloped line that terminates at the distal end with the leaflet inflow end portions 148. While the leaflet inflow end portions 148 are shown in the example illustrated in Fig. 6 to be at the level of the inflow end 104, it is to be understood that in some examples, the leaflet inflow end portions 148 can be offset from the inflow end 104 of the frame 106.
  • the first portion 160 of the frame 106 can extend proximally from the inflow end 104 even for implementation in which the leaflet inflow end portions 148 are offset from the inflow end 104 of the frame 106, optionally defining a frame portion that can be longer, in the axial direction, than the height of the cusp end portions 146.
  • a height of a component refers to a height of an axial projection of the corresponding component that can be projected on the central longitudinal axis CA, and is measured along the axial direction, such as along the axis CA.
  • the second portion 162 of the frame 106 includes at least part of the height of the axial frame members 114. In some examples, the second portion 162 of the frame 106 includes at least part of the height of the commissure support members 122. In some examples, the second portion 162 of the frame 106 includes the commissure window openings 124.
  • the second portion 162 can define a frame portion that is longer than the portion of the frame to which the commissures 154 are coupled. In some examples, the second portion 162 of the frame 106 extends distally from the outflow end 102. In some examples, the second portion 162 includes the axial frame members 114 and the outflow rung 1120.
  • the first portion 160 defines a first draft angle a, such that the frame 106 outwardly flares from an inflow diameter DI to a larger diameter D2 (D2 > DI), and the second portion 162 defines a second draft angle p, such that the frame 106 outwardly flares from an the diameter D2 to a larger outflow diameter D3 (D3 > D2), wherein second draft angle is larger than the first draft angle a (P > a).
  • the second portion 162 can be continuous with the first portion 160, such that a bending region 164 is defined at the transition between the first portion 160 and the second portion 162. Since the second draft angle P is larger than the first draft angle a, the second portion 162 is outwardly bent, at the bending region 164, relative to the first portion 160.
  • the bending region 164 can be defined at an axial level between the attachment of the cusp end portions 146 to the frame 106 (such as along a scalloped line) and the commissures 154. In some examples, the bending region 164 can be defined between the first subsequent rung 112S1 and the axial frame members 114.
  • the bending region 164 can be defined along inflow end portions 118 of the axial frame members 114. In some examples, the bending region 164 can be defined distal to the axial frame members 114, such as along angled struts 110S1 of the first subsequent rung 112S 1.
  • the first draft angle a can be in a range of about 1 degree to 7 degrees, inclusive (1° ⁇ a ⁇ 7°).
  • the second draft angle P can be in a range of about 5 degrees to 20 degrees, inclusive (5° ⁇ P ⁇ 20°).
  • the second draft angle P is greater than the first draft angle a by at least 3 degrees (P > a+3°).
  • a can be in a range of about 1 degree to 7 degrees, inclusive, and P can be in a range of about 5 degrees to 20 degrees, inclusive, while also being greater than a by at least 3 degrees.
  • first draft angle a can be relatively smaller to enable an inflow portion of the valve to be properly situated against the native annulus
  • a larger outwardly-oriented inclination of the second portion 162 due to the relatively larger second draft angle p will counter to some degree the inwardly-oriented radial force component applied on the commissures, thereby enabling the second portion 162 of the frame to be less rigid, for example relative to cylindrical frame designs.
  • the frame 106 of a prosthetic valve 100 can be designed to define at least two drafts angles in an expanded state thereof in various manners.
  • the frame 106 can include varying strut lengths tailored along the height of the frame 106 to create, upon expansion, the double-flared configuration of Fig. 7.
  • angled struts 110S1 along the first subsequent rung 112S 1 can be longer than the inflow angled struts 1101 of the inflow rung 1121
  • angled outflow struts 110O along the outflow rung 1120 can be longer than the angled struts 110S 1 of the first subsequent rung 112S1.
  • the variation in lengths along different rungs 112 of the frame 106 can be designed to create the first draft angle a and the second draft angle of the first portion 160 and the second portion 162, respectively.
  • one or more restriction member(s) disposed around the frame 106 can be used to create, upon expansion, the double-flared configuration of Fig. 7.
  • the one or more restriction member(s) can optionally include one or more flexible tension member(s) 170.
  • the one or more restriction member(s) can optionally include a restriction skirt 180.
  • Fig. 8 shows an exemplary prosthetic valve 100 c , illustrated without the valvular structure or optional skirts, for clarity.
  • the prosthetic valve 100 c can be structurally and functionally similar to any example of prosthetic valve 100 described above, except for further comprising two flexible tension members 170a and 170b.
  • the first flexible tension member 170a encircles a circumference of the frame 106 proximate inflow end 104, while the second flexible tension member 170b encircles a circumference of the frame 106 at a level that is proximal to the first flexible tension member 170a.
  • Each flexible tension member 170 serves as an expansion restraining mechanism, and can comprise a wire, string, suture, and/or cable.
  • a flexible tension member 170 can be weaved through and/or knotted to struts 108 and/or junctions 132 of the frame 106.
  • a flexible tension member 170 can be extended through eyelets and/or apertures formed in, or connected to, the frame 106.
  • a maximal length of each flexible tension member 170 corresponds to a perimeter of the valve 100 for a maximal expanded diameter at the level or height of the flexible tension member 170.
  • the first flexible tension member 170a is disposed around and/or coupled to the inflow apices 136. In some examples, the first flexible tension member 170a is disposed around and/or coupled to the inflow rung 1121. In some examples, the second flexible tension member 170b is proximal to the first flexible tension member 170a and distal to the commissures 154. In some examples, the second flexible tension member 170b is distal to the commissure window openings 124. In some examples, the second flexible tension member 170b is disposed around and/or coupled to junctions 132 of the frame 106 interconnecting the first subsequent rung 112S1 with the axial frame members 114.
  • the second flexible tension member 170b is disposed around and/or coupled to the first subsequent rung 112S 1. In some examples, the second flexible tension member 170b is disposed around and/or coupled to the inflow end portions 118 of the axial frame members 114.
  • the axial position of the second flexible tension member 170b can define the bending region 164, such that the first portion 160 of the frame 106 extends between the inflow end 104 and the second flexible tension member 170b, such as optionally between the first flexible tension member 170a and the second flexible tension member 170b, and the second portion 162 of the frame 106 extends proximally from the second flexible tension member 170b, such as optionally between the second flexible tension member 170b and the outflow end 102.
  • the first flexible tension member 170a is configured to restrict expansion to a maximal diameter DI
  • the second flexible tension member 170b is configured to restrict expansion to a maximal diameter D2, as shown in Fig. 7. While two flexible tension members 170 are illustrated in Fig. 8, it is to be understood that any other number of flexible tension member/ s) 170 is contemplated.
  • Fig. 9 shows an exemplary prosthetic valve 100 d , illustrated without the valvular structure or optional skirts, for clarity.
  • the prosthetic valve 100 c can be structurally and functionally similar to any example of prosthetic valve 100 described above, except for further comprising a restriction skirt 180.
  • the restriction skirt 180 can extend around a circumference of the frame 106.
  • the restriction skirt 180 axially extends between a distal end 182 and a proximal end 184 thereof, wherein the distal end 182 of the restriction skirt 180 can be proximate inflow end 104 of the frame 106.
  • the restriction skirt 180 can comprise, for example, a resilient cloth, configured to assume an outwardly flared configuration in the expanded state of the prosthetic valve 100 d .
  • the distal end 182 of restriction skirt 180 is disposed around and/or coupled to the inflow apices 136. In some examples, the distal end 182 of restriction skirt 180 is disposed around and/or coupled to the inflow rung 1121. In some examples, the proximal end 184 of restriction skirt 180 is proximal to the distal end 182 and distal to the commissures 154. In some examples, the proximal end 184 of restriction skirt 180 is distal to the commissure window openings 124. In some examples, the proximal end 184 of restriction skirt 180 is disposed around and/or coupled to junctions 132 of the frame 106 interconnecting the first subsequent rung 112S1 with the axial frame members 114.
  • proximal end 184 of restriction skirt 180 is disposed around and/or coupled to the first subsequent rung 112S1. In some examples, the proximal end 184 of restriction skirt 180 is disposed around and/or coupled to the inflow end portions 118 of the axial frame members 114.
  • the axial position of the proximal end 184 of restriction skirt 180 can define the bending region 164, such that the first portion 160 of the frame 106 extends between the inflow end 104 and the second flexible tension member 170b, such as optionally between the distal end 182 and the proximal end 184 of restriction skirt 180, and the second portion 162 of the frame 106 extends proximally from the proximal end 184 of restriction skirt 180, such as optionally between the proximal end 184 of restriction skirt 180 and the outflow end 102.
  • distal end 182 of restriction skirt 180 is configured to restrict expansion to a maximal diameter DI
  • proximal end 184 is configured to restrict expansion to a maximal diameter D2, as shown in Fig. 7.
  • the restriction skirt 180 can be optionally coupled to the prosthetic valve 100 d by suturing the restriction skirt 180 to an inner skirt 156.
  • the restriction skirt 180 can be coupled sutured directly to the frame 106 (e.g., along struts 108 of the frame, and/or at junctions 132 of the frame).
  • the restriction skirt 180 can be optionally coupled to the prosthetic valve 100 d by suturing the restriction skirt 180 to an outer skirt 158.
  • the restriction skirt 180 is further configured to serve as an outer skirt 158 of the prosthetic valve 100 d .
  • a prosthetic valve 100 can optionally be a balloon-expandable valve.
  • Flexible tension member(s) 170 or restriction skirt 180 can optionally can optionally limit the maximal expansion diameters by restricting balloon expansion past corresponding diameters, such as diameter DI at the inflow end 104 and diameter D2 at the bending region 164, while allowing the balloon to further inflate in a relatively unrestricted manner proximal to the bending region 164, enabling the balloon to expand the prosthetic valve 100 at the outflow end 102 to a larger diameter D3, for example.
  • the balloon 62 of a delivery apparatus 52 used for deployment of a prosthetic valve 100 can be pre-shaped to expand to a non-uniform or non-cylindrical configuration that can generally match the double-flared configuration of the prosthetic valve 100.
  • a prosthetic valve 100 can optionally be a self-expandable valve, configured to assume the expanded double-tapered configuration upon release from a sheath and/or capsule in which the valve 100 may be disposed in a crimped state during delivery.
  • a prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state; a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, wherein each leaflet comprises a cusp end portion, and wherein each two adjacent leaflets are joined at commissures coupled to the frame; wherein the frame defines, in the expanded state: a first portion configured to flare radially outwards between an inflow end of the frame and a bending region of the frame, at a first draft angle; and a second portion configured to flare radially outwards between the bending region and an outflow end of the frame, at a second draft angle that is greater than the first draft angle.
  • Example 2 The prosthetic valve of any example herein, particularly of example 1, wherein the bending region is axially defined between the cusp end portions and the commissures.
  • Example 3 The prosthetic valve of any example herein, particularly of any one of examples 1-2, wherein the first portion is outwardly flared relative to a longitudinal central axis of the frame.
  • Example 4 The prosthetic valve of any example herein, particularly of any one of examples 1-3, wherein the first draft angle is in a range of l°-7°, inclusive.
  • Example 5 The prosthetic valve of any example herein, particularly of any one of examples 1-4, wherein the second draft angle is in a range of 5°-20°, inclusive.
  • Example 6 The prosthetic valve of any example herein, particularly of any one of examples 1-5, wherein the second draft angle is greater than the first draft angle by at least 3°.
  • Example 7 The prosthetic valve of any example herein, particularly of any one of examples 1-6, wherein the frame defines, in the expanded state, a first diameter at the inflow end, a second diameter between the first portion and the second portion, and a third diameter at the outflow end, such that the second diameter is greater than the first diameter, and the third diameter is greater the second diameter.
  • Example 8 The prosthetic valve of any example herein, particularly of any one of examples 1-7, wherein the second portion is outwardly bent relative to the first portion.
  • Example 9 The prosthetic valve of any example herein, particularly of any one of examples 1-8, wherein the bending region is distal to the commissures.
  • Example 10 The prosthetic valve of any example herein, particularly of any one of examples 1-9, wherein the frame comprises a plurality of intersecting struts arranged between the inflow end and the outflow end, the plurality of intersecting struts comprising: a plurality of angled struts arranged to form a plurality of circumferentially extending rungs of struts, the rungs comprising: an outflow rung comprising outflow struts, a first subsequent rung distal to the outflow rung, and one or more additional rungs of angled struts; and a plurality of axial frame members extending between the outflow rung and the first subsequent rung, the axial frame members comprising: a plurality of axial struts and a plurality of commissure support members.
  • Example 11 The prosthetic valve of claim 10, wherein the bending region is defined between the axial frame members and the first subsequent rung.
  • Example 12 The prosthetic valve of any example herein, particularly of example 10, wherein the bending region is defined along inflow end portions of the axial frame members.
  • Example 13 The prosthetic valve of any example herein, particularly of example 10, wherein the bending region is defined along the first subsequent rung.
  • Example 14 The prosthetic valve of any example herein, particularly of any one of examples 10-13, wherein the commissure support members comprise window openings.
  • Example 15 The prosthetic valve of any example herein, particularly of example 14, wherein the bending region is distal to the window openings.
  • Example 16 The prosthetic valve of any example herein, particularly of any one of examples 1-15, further comprising a first flexible tension member disposed around the frame and a second flexible tension member disposed around the frame, wherein the second flexible tension member is proximal to the first flexible tension member.
  • Example 17 The prosthetic valve of any example herein, particularly of example 16, wherein the first flexible tension member is disposed around the inflow end of the frame.
  • Example 18 The prosthetic valve of any example herein, particularly of any one of examples 16-17, wherein the second flexible tension member is disposed around at the bending region.
  • Example 19 The prosthetic valve of any example herein, particularly of any one of examples 16-18, wherein the second flexible tension member is longer than the first flexible tension member.
  • Example 20 The prosthetic valve of any one of claims 16-19, wherein any of the first or second tension members comprises at least one of: a suture, a cable, a string, and/or a wire.
  • Example 21 The prosthetic valve of any example herein, particularly of any one of examples 1-15, further comprising a restriction skirt disposed around the frame, the restriction skirts extending between a distal end and a proximal end thereof.
  • Example 22 The prosthetic valve of any example herein, particularly of example 21, wherein the distal end of the restriction skirt is disposed around the inflow end of the frame.
  • Example 23 The prosthetic valve of any example herein, particularly of any one of examples 21-22, wherein the proximal end of the restriction skirt is disposed around at the bending region.
  • Example 24 The prosthetic valve of any example herein, particularly of any one of examples 21-23, wherein the proximal end of the restriction skirt is longer than the distal end.
  • Example 25 The prosthetic valve of any example herein, particularly of any one of examples 21-24, wherein the restriction skirt comprises a resilient cloth.
  • Example 26 The prosthetic valve of any example herein, particularly of any one of examples 1-25, wherein each leaflet comprises a pair of opposing tabs extending from opposite sides of a leaflet body of the leaflet, wherein each tab is paired with an adjacent lower tab of an adjacent leaflet to form a corresponding commissure.
  • Example 27 The prosthetic valve of any example herein, particularly of any one of examples 1-25, wherein each leaflet comprises a pair of opposing lower tabs extending from opposite sides of a leaflet body of the leaflet, and a pair of opposing upper tabs, each upper tab coupled to the respective lower tab via a neck portion.
  • Example 28 The prosthetic valve of any example herein, particularly of example 27, wherein each lower tab is paired with an adjacent lower tab of an adjacent leaflet to form a commissure, and wherein each upper tab is folded over the corresponding lower tab such that the neck portion forms a rigid portion extending radially inwardly from the frame.
  • Example 29 The prosthetic valve of any example herein, particularly of any one of examples 1-28, wherein the frame is balloon-expandable.
  • Example 30 The prosthetic valve of any example herein, particularly of any one of examples 1-28, wherein the frame is self-expandable.

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

Abstract

La présente divulgation concerne des prothèses valvulaires. Dans un exemple, une prothèse valvulaire comprend un cadre conçu pour alterner entre un état radialement déployé et un état resserré, et une structure valvulaire montée à l'intérieur du cadre et comprenant une pluralité de feuillets conçus pour réguler l'écoulement à travers la prothèse valvulaire. Chaque feuillet comprend une partie terminale de cuspide, les feuillets de chaque paire de feuillets adjacents étant joints au niveau de commissures couplées au cadre. Le cadre définit, à l'état déployé, une première partie évasée radialement vers l'extérieur à un premier angle de dépouille, et une seconde partie évasée radialement vers l'extérieur à un second angle de dépouille qui est supérieur au premier angle de dépouille.
PCT/US2025/025964 2024-04-24 2025-04-23 Prothèses valvulaires à double évasement Pending WO2025226813A1 (fr)

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US63/638,170 2024-04-24

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US8007992B2 (en) 2006-10-27 2011-08-30 Edwards Lifesciences Corporation Method of treating glutaraldehyde-fixed pericardial tissue with a non-aqueous mixture of glycerol and a C1-C3 alcohol
US8357387B2 (en) 2007-12-21 2013-01-22 Edwards Lifesciences Corporation Capping bioprosthetic tissue to reduce calcification
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US9155619B2 (en) 2011-02-25 2015-10-13 Edwards Lifesciences Corporation Prosthetic heart valve delivery apparatus
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US20190125534A1 (en) * 2017-10-31 2019-05-02 W. L. Gore & Associates, Inc. Transcatheter deployment systems and associated methods
US10363130B2 (en) 2016-02-05 2019-07-30 Edwards Lifesciences Corporation Devices and systems for docking a heart valve
US10603165B2 (en) 2016-12-06 2020-03-31 Edwards Lifesciences Corporation Mechanically expanding heart valve and delivery apparatus therefor
US11135056B2 (en) 2017-05-15 2021-10-05 Edwards Lifesciences Corporation Devices and methods of commissure formation for prosthetic heart valve
US20220079749A1 (en) 2019-06-07 2022-03-17 Edwards Lifesciences Corporation Systems, devices, and methods for treating heart valves
US11291540B2 (en) 2017-06-30 2022-04-05 Edwards Lifesciences Corporation Docking stations for transcatheter valves

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7393360B2 (en) 2001-10-11 2008-07-01 Edwards Lifesciences Pvt, Inc. Implantable prosthetic valve
US7510575B2 (en) 2001-10-11 2009-03-31 Edwards Lifesciences Corporation Implantable prosthetic valve
US6730118B2 (en) 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US8007992B2 (en) 2006-10-27 2011-08-30 Edwards Lifesciences Corporation Method of treating glutaraldehyde-fixed pericardial tissue with a non-aqueous mixture of glycerol and a C1-C3 alcohol
US8357387B2 (en) 2007-12-21 2013-01-22 Edwards Lifesciences Corporation Capping bioprosthetic tissue to reduce calcification
US7993394B2 (en) 2008-06-06 2011-08-09 Ilia Hariton Low profile transcatheter heart valve
US8652202B2 (en) 2008-08-22 2014-02-18 Edwards Lifesciences Corporation Prosthetic heart valve and delivery apparatus
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US9155619B2 (en) 2011-02-25 2015-10-13 Edwards Lifesciences Corporation Prosthetic heart valve delivery apparatus
US9339384B2 (en) 2011-07-27 2016-05-17 Edwards Lifesciences Corporation Delivery systems for prosthetic heart valve
US10363130B2 (en) 2016-02-05 2019-07-30 Edwards Lifesciences Corporation Devices and systems for docking a heart valve
US10603165B2 (en) 2016-12-06 2020-03-31 Edwards Lifesciences Corporation Mechanically expanding heart valve and delivery apparatus therefor
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US11135056B2 (en) 2017-05-15 2021-10-05 Edwards Lifesciences Corporation Devices and methods of commissure formation for prosthetic heart valve
US11291540B2 (en) 2017-06-30 2022-04-05 Edwards Lifesciences Corporation Docking stations for transcatheter valves
US20190125534A1 (en) * 2017-10-31 2019-05-02 W. L. Gore & Associates, Inc. Transcatheter deployment systems and associated methods
US20220079749A1 (en) 2019-06-07 2022-03-17 Edwards Lifesciences Corporation Systems, devices, and methods for treating heart valves

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