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WO2025250832A1 - Valvule cardiaque prothétique comportant une jupe externe déployable - Google Patents

Valvule cardiaque prothétique comportant une jupe externe déployable

Info

Publication number
WO2025250832A1
WO2025250832A1 PCT/US2025/031493 US2025031493W WO2025250832A1 WO 2025250832 A1 WO2025250832 A1 WO 2025250832A1 US 2025031493 W US2025031493 W US 2025031493W WO 2025250832 A1 WO2025250832 A1 WO 2025250832A1
Authority
WO
WIPO (PCT)
Prior art keywords
frame
shaft
prosthetic heart
heart valve
sealing 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/US2025/031493
Other languages
English (en)
Inventor
Brendan Michael DALBOW
Justin Mark NUBLA
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 WO2025250832A1 publication Critical patent/WO2025250832A1/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
    • 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
    • A61F2/2439—Expansion controlled by filaments
    • 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
    • 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
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0069—Sealing means

Definitions

  • the present application relates to expandable prosthetic heart valves, including outer skirts for 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 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 heart valve reaches the implantation site in the heart.
  • the prosthetic heart 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 heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.
  • prosthetic heart valves Described herein are prosthetic heart valves, delivery apparatus, and methods for implanting prosthetic heart valves.
  • the disclosed prosthetic heart valves, delivery apparatus, and methods can, for example, provide reduced crimp profiles of prosthetic heart valves, for example, by crimping an outer skirt in series with the remainder of the prosthetic valve onto a delivery apparatus.
  • the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatus.
  • a prosthetic heart valve can comprise a frame and a valvular structure coupled to the frame.
  • a prosthetic heart valve can further comprise one or more of the components disclosed herein.
  • a prosthetic heart valve can comprise a sealing member configured to reduce paravalvular leakage.
  • the sealing member has a delivery configuration in which the sealing member extends from an inflow end of the frame in a direction away from an outflow end of the frame, and the sealing member can be transitioned to a pre-deployment configuration in which the sealing is in an everted position extending over the frame.
  • the sealing member has a first end and a second end, wherein the first end is coupled to the inflow end of the frame.
  • the sealing member is folded in the delivery configuration with the second end of the sealing member positioned adjacent the inflow end of the frame.
  • the sealing member comprises a base layer and a sealing layer.
  • the base layer is positioned radially between the sealing layer and an outer surface of the frame when the sealing member is in the everted position.
  • the sealing layer is spaced apart from the first end of the sealing member.
  • the sealing layer is spaced apart from the second end of the sealing member.
  • the base layer is connected to the inflow end of the frame.
  • the base layer comprises a tissue-growth inhibiting material.
  • the base layer comprises TPU.
  • the sealing layer is outside of and axially spaced apart from the frame in the deliver configuration.
  • the sealing layer has a greater thickness than the base layer.
  • the sealing layer comprises a fabric.
  • the base layer comprises a non-fabric material.
  • a prosthetic heart valve can comprise a sealing member having a first end and a second end, the first end of the sealing member being coupled to an inflow end of a frame, wherein the sealing member comprises a base layer and a sealing layer, wherein when the sealing member is collapsed on a delivery apparatus in a delivery configuration, the sealing member extends from the inflow end of the frame in a direction away from an outflow end of the frame, and wherein when the sealing member is transitioned to a predeployment configuration, the sealing member is in an everted position with the second end of the sealing member extending over an outer surface the frame and the base layer positioned radially between the sealing layer and an outer surface of the frame.
  • a prosthetic heart valve can comprise a collapsible and expandable annular frame that is configured to be collapsed to a radially collapsed state for mounting on a delivery apparatus and expanded to a radially expanded state inside the body, the frame having an inflow end and an outflow end; a collapsible and expandable valvular structure mounted within the annular frame; and a collapsible and expandable annular sealing member having a first end and a second end, the first end of the sealing member being coupled to the inflow end of the frame, wherein the sealing member comprises a base layer and a sealing layer, wherein when the sealing member is collapsed on the delivery apparatus in a delivery configuration, the sealing member extends from the inflow end of the frame in a direction away from the outflow end of the frame, and wherein when the sealing member is transitioned to a pre-deployment configuration, the sealing member is in an everted position with the second end of the sealing member extending over an outer surface the frame and
  • a prosthetic heart valve comprises one or more of the components recited in Examples 1-11 below.
  • An assembly can comprise a delivery apparatus and a prosthetic heart valve coupled to the delivery apparatus.
  • an assembly can comprise a delivery apparatus comprising a first shaft and a second shaft positioned radially outwards of the first shaft, wherein the first shaft and the second shaft are configured to translate axially relative to each other; and a prosthetic heart valve mounted in a radially compressed state around the first shaft in a delivery configuration, the prosthetic heart valve comprising a radially expandable frame having an inflow end and an outflow end and an outer skirt having a first end and a second end, wherein the first end of the outer skirt is coupled to the inflow end of the frame, and wherein in the delivery configuration, the outer skirt extends from the inflow end of the frame in a direction away from the outflow end of the frame and the second end of the outer skirt is axially spaced apart from the inflow end of the frame; wherein relative movement between the first shaft and the second shaft in an axial direction is effective to transition the outer skirt to a predeployment configuration, wherein in the pre-deployment configuration, the second end of
  • an assembly comprises one or more of the components recited in Examples 12-19 below.
  • a delivery apparatus for a prosthetic implant can comprise a handle and one or more shafts coupled to the handle.
  • a delivery apparatus can comprise a locking mechanism configured to releasably couple tethers to the delivery apparatus.
  • a delivery apparatus for delivering a prosthetic heart valve can comprise a shaft; and a shaft assembly coupled to the shaft, wherein the shaft and the shaft assembly are configured to translate relative to each other, wherein the shaft assembly comprises an outer shaft and an inner shaft, wherein the outer shaft and the inner shaft are configured to rotate relative to each other, wherein the outer shaft has a first slot extending from a distal end of the outer shaft, wherein the inner shaft has a second slot extending from a distal end of the inner shaft, wherein in a unlocked position at least a portion of the slots are aligned, wherein in a locked position the first slot and the second slot define an opening that is spaced apart from the distal end of the first shaft and the distal end of the second shaft.
  • a delivery apparatus for delivering a prosthetic heart valve can comprise a guide catheter shaft having a plurality of first projections extending radially inwards from an inner surface of the guide catheter shaft; a balloon catheter shaft having a plurality of second projections extending radially outwards from an outer surface of the balloon catheter shaft, wherein the balloon catheter shaft is coaxially disposed within the guide catheter shaft and configured to translate relative to the guide catheter shaft; and a plurality of rods, each rod fixedly coupled to one of the first projections and extending through an opening of one of the second projections, wherein the rods are configured to translate relative to the second projections.
  • a delivery apparatus for delivering a prosthetic heart valve can comprise a guide catheter shaft having a plurality of first projections extending radially inwards from an inner surface of the guide catheter shaft; a balloon catheter shaft having a plurality of second projections extending radially outwards from an outer surface of the balloon catheter shaft, wherein the balloon catheter shaft is coaxially disposed within the guide catheter shaft and configured to translate relative to the guide catheter shaft; and a plurality of rods, each rod fixedly coupled to one of the second projections and extending through an opening of one of the first projections, wherein the rods are configured to translate relative to the first projections
  • a delivery apparatus comprises one or more of the components recited in Examples 20-32 below.
  • a method comprises implanting a prosthetic heart valve in a body of a patient.
  • a method comprises advancing a distal end portion of a delivery apparatus and a prosthetic heart valve through a patient’s vasculature, wherein the prosthetic heart valve is in a radially compressed state on the distal end portion of the delivery apparatus, wherein the prosthetic heart valve comprises a radially collapsible and expandable frame, a valvular structure disposed within the frame, and an annular sealing member comprising a base layer and a sealing layer, wherein the sealing member has a first end fixed relative to the frame and a second end spaced from the frame; transitioning the sealing member to a pre-deployment configuration in which the second end of the sealing member is disposed around the frame; and radially expanding the prosthetic heart valve from the radially compressed state to a radially expanded state in which the sealing layer of the sealing member contacts native tissue surrounding the prosthetic heart valve.
  • a method of implanting a prosthetic heart valve comprises one or more of the acts recited in Examples 34-37 below.
  • a method of implanting a prosthetic heart valve comprises implanting a prosthetic heart valve comprising one or more components recited in Examples 1-11 below.
  • a method of implanting a prosthetic heart valve comprises implanting a prosthetic valve using an assembly of any of Examples 12-19 below.
  • a method of implanting a prosthetic heart valve comprises implanting a prosthetic valve using a delivery apparatus of any of Examples 20-32 below.
  • FIG. 1 is a perspective view of a prosthetic heart valve, according to one example.
  • FIG. 2 is a side view of a delivery apparatus for implanting a prosthetic heart valve, according to one embodiment.
  • FIG. 3A is a cross-sectional view of the handle of the delivery apparatus of FIG. 2.
  • FIG. 3B is another cross-sectional view of the handle of the delivery apparatus of FIG. 2.
  • FIG. 4 is side view of a section of the handle and a section of the distal end portion of the delivery apparatus of FIG. 1.
  • FIG. 5 is a side view of a distal end portion of the delivery apparatus of FIG. 2.
  • FIG. 6A is a cross-sectional view of a prosthetic heart valve, according to one example.
  • FIG. 6B is a perspective view of a prosthetic heart valve, according to another example.
  • FIG. 6C is a cross-sectional view of the prosthetic heart valve of FIG. 6B.
  • FIG. 7 A is a side view of the prosthetic heart valve of FIG. 6A mounted on the delivery apparatus of FIG. 2 at a first stage of an implantation procedure.
  • FIG. 7B is a cross-sectional view of the prosthetic heart valve of FIG. 6A mounted on the delivery apparatus of FIG. 2 at the first stage of an implantation procedure.
  • FIG. 8 is a side view of the prosthetic heart valve of FIG. 6A mounted on the delivery apparatus of FIG. 2 at a second stage of an implantation procedure.
  • FIG. 9 is a side view of the prosthetic heart valve of FIG. 6A mounted on the delivery apparatus of FIG. 2 at a third stage of an implantation procedure in which the outer skirt is partially everted over the frame.
  • FIGS. 10A-10B are side and cross-sectional views of the prosthetic heart valve of FIG. 6A mounted on the delivery apparatus of FIG. 2 at a fourth stage of an implantation procedure in which the outer skirt is fully everted over the frame.
  • FIG. 11 is a side cross-sectional view of the prosthetic heart valve of FIG. 6A mounted on the delivery apparatus of FIG. 2 at a fifth stage of an implantation procedure in which the tethers are removed from the outer skirt.
  • FIG. 12 is a side view of the prosthetic heart valve of FIG. 6 A mounted on the delivery apparatus of FIG. 2 shown with the balloon partially inflated, according to another example.
  • FIG. 13 is a side view of the prosthetic heart valve and the delivery apparatus of FIG. 12 shown with the balloon fully inflated.
  • FIG. 14 is a cross-sectional view of the prosthetic heart valve of FIG. 6A deployed in a native aortic valve.
  • FIGS. 15A-15B are side views of a locking mechanism for releasably coupling tethers to a delivery apparatus, according to one example.
  • FIGS. 16A-16D are side views illustrating operation of the locking mechanism of FIGS. 15A-15B.
  • FIG. 17 is a side view of a locking mechanism for releasably coupling tethers to a delivery apparatus, according to one example.
  • FIGS. 18A-18B are perspective views illustrating a locked and unlocked configuration of the locking mechanism of FIG. 17, respectively.
  • FIG. 19 is a side view of the prosthetic heart valve of FIG. 6 A mounted on a delivery apparatus, according to another example.
  • FIG. 20 is a side view of the delivery apparatus of FIG. 19 showing a capsule of the delivery apparatus covering the prosthetic heart valve.
  • FIG. 21 is a side view of the prosthetic heart valve of FIG. 6 A and the delivery apparatus of FIG. 19 showing the capsule in a retracted position relative to the prosthetic heart valve.
  • FIG. 22 is a side view of the prosthetic heart valve of FIG. 6A and the delivery apparatus of FIG. 19 showing the outer skirt fully everted over the frame.
  • FIG. 23 is a side view of the prosthetic heart valve of FIG. 6A and the delivery apparatus of FIG. 19 after the prosthetic heart valve has been expanded by a balloon.
  • 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).
  • Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state.
  • the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site.
  • the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.
  • FIG. 1 shows an exemplary prosthetic valve 10, according to one example.
  • Any of the prosthetic valves disclosed herein are 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. Publication No. 2017/0231756, 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. Publication No. 2019/0000615, which is incorporated herein by reference.
  • the prosthetic valve 10 can have four main components: a stent or frame 12, a valvular structure 14, an inner skirt 16, and a perivalvular outer sealing member or outer skirt 18.
  • the prosthetic valve 10 can have an inflow end portion 15, an intermediate portion 17, and an outflow end portion 19.
  • the inner skirt 16 can be arranged on and/or coupled to an inner surface of the frame 12 while the outer skirt 18 can be arranged on and/or coupled to an outer surface of the frame 12.
  • the valvular structure 14 can comprise three leaflets 40, collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, although in other examples there can be greater or fewer number of leaflets (e.g., one or more leaflets 40).
  • the leaflets 40 can be secured to one another at their adjacent sides to form commissures 22 of the leaflet structure 14.
  • the lower edge of valvular structure 14 can have an undulating, curved scalloped shape and can be secured to the inner skirt 16 by sutures (not shown).
  • the leaflets 40 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated by reference herein.
  • pericardial tissue e.g., bovine pericardial tissue
  • biocompatible synthetic materials e.g., polystyrene foam
  • 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.
  • the frame 12 can be radially compressible (collapsible) and expandable (e.g., expanded configuration shown in FIG. 1) and comprise a plurality of interconnected struts 24.
  • a plurality of apices 26 that are spaced circumferentially apart are formed at the inflow end portion 15 and the outflow end portion 19 of the frame 12 (only the apices 26 at the outflow end portion 19 are visible in FIG. 1).
  • Each apex 26 is formed at a junction between two angled struts 24 at either the inflow end portion 15 or the outflow end portion 19.
  • FIG. 1 depicts a frame design with apices 26 that form a U-shaped bend between the two angled struts 24.
  • an angle 30 between the two angled struts 24, connected at the apex 26, can be in a range of 90 to 120 degrees.
  • the frame 12 can be formed with a plurality of commissure supports 20 that are adapted to mount the commissures 22 of the valvular structure 14 to the frame.
  • the commissure supports 20 can have respective slots or commissure windows that respective commissures 22.
  • the frame 12 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol) as known in the art.
  • the frame 12 (and thus the valve 10) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism.
  • the frame 12 When constructed of a self-expandable material, the frame 12 (and thus the valve 10) 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 12 can comprise stainless steel.
  • the frame 12 can comprise cobaltchromium.
  • the frame 12 can comprise nickel-cobalt-chromium.
  • the frame 12 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35NTM (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02).
  • MP35NTM/UNS R3OO35 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.
  • the skirts 16, 18 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof.
  • the skirts 16, 18 can comprise a fabric having interlaced yams or fibers, such as in the form of a woven, braided, or knitted fabric.
  • the fabric can have a plush nap or pile.
  • Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc.
  • the skirt 18 can comprise a fabric without interlaced yams or fibers or randomly interlaced yams or fibers, such as felt or an electrospun fabric.
  • Exemplary materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc.
  • the skirts 16, 18 can comprise a non-textile or non- fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc.
  • the skirt can comprise a sponge material or foam, such as polyurethane foam.
  • the skirts can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).
  • FIGS. 2-5 show a delivery apparatus 100, according to an example, that can be used to implant an expandable prosthetic heart valve (for example, the prosthetic heart valve 10 of FIG. 1).
  • the delivery apparatus 100 is specifically adapted for use in introducing a prosthetic valve into a heart.
  • the delivery apparatus 100 generally includes a steerable guide catheter 114, and a balloon catheter 116 extending through the guide catheter 114.
  • the guide catheter 114 can also be referred to as a flex catheter or a main catheter.
  • the use of the term “main catheter” should be understood, however, to include flex or guide catheters, as well as other catheters or shafts that do not have the ability to flex or guide through a patient’ s vasculature.
  • the guide catheter 114 and the balloon catheter 116 in the illustrated example are adapted to slide longitudinally relative to each other to facilitate delivery and positioning of a prosthetic valve 112 (which may be the prosthetic valve 10 of FIG. 1, in some examples) at an implantation site in a patient’s body, as described further below.
  • a prosthetic valve 112 which may be the prosthetic valve 10 of FIG. 1, in some examples
  • the guide catheter 114 includes a handle portion 120 (as shown in FIGS. 2-3B) and an elongated guide tube, or shaft, 122 extending from handle portion 120 (FIG. 3A, 4, and 5).
  • FIG. 2 shows the delivery apparatus without the guide catheter shaft 122 for purposes of illustration.
  • FIG. 4 shows the guide catheter shaft 122 extending from the handle portion 120 over the balloon catheter.
  • the balloon catheter 116 includes a proximal portion 124 in the form of a Y-connector (FIG. 2) adjacent the handle portion 120 and an elongated shaft 126 (referred to herein as the balloon catheter shaft or balloon shaft) that extends from the proximal portion 124 and through handle portion 120 and guide catheter shaft 122 (FIGS. 2, 4, and 5).
  • the handle portion 120 can include a side arm 127 having an internal passage which fluidly communicates with a lumen defined by the handle portion 120.
  • An inflatable balloon 128 is mounted at the distal end of balloon catheter 116.
  • the delivery apparatus 100 is configured to mount the prosthetic valve 112 in a crimped (radially compressed) state proximal to the balloon 128 for insertion of the delivery apparatus 100 and prosthetic valve 112 into a patient’s vasculature, which is described in detail in U.S. Publication No. 2009/0281619, which is incorporated by reference herein.
  • the prosthetic valve 112 is crimped at a location different from the location of balloon 128 (for example, in this case the prosthetic valve 112 is crimped proximal to balloon 128), the prosthetic valve 112 can be crimped to a lower profile than would be possible if prosthetic valve 112 was crimped on top of the balloon 128.
  • This lower profile permits the user to more easily navigate the delivery apparatus (including crimped valve 112) through a patient’s vasculature to the treatment location.
  • the lower profile of the crimped prosthetic valve is particularly helpful when navigating through portions of the patient’s vasculature which are particularly narrow, such as the iliac artery.
  • the lower profile also allows for treatment of a wider population of patients.
  • a nose cone 132 (FIG. 5) can be mounted at the distal end of the delivery apparatus 100 to facilitate advancement of the delivery apparatus 100 through the patient’s vasculature to the implantation site. In some instances, it may be useful to have nose cone 132 connected to a separate elongated shaft so that nose cone 132 can move independently of other elements of delivery apparatus 100.
  • the balloon catheter 116 can include an inner shaft 134 that extends from the proximal portion 124 and coaxially through the outer balloon catheter shaft 126 (which can also be referred to as an “outer shaft’’) and the balloon 128.
  • the nose cone 232 can be mounted on a distal end portion of the inner shaft 134.
  • the balloon 128 can be supported on a distal end portion of inner shaft 134 that extends outwardly from and distal to the outer shaft 126, with a proximal end portion 136 of the balloon 128 secured to the distal end of the outer shaft 126 (FIG. 2).
  • the outer diameter of inner shaft 134 is sized such that an annular space is defined between the inner shaft 134 and the outer shaft 126 along the entire length of the outer shaft 126.
  • the proximal portion 124 of the balloon catheter can be formed with a fluid passageway (not shown) that is fluidly connectable to a fluid source (e.g. , saline) for inflating the balloon.
  • the fluid passageway is in fluid communication with the annular space between inner shaft 134 and outer shaft 126 such that fluid from the fluid source can flow through fluid passageway, through the space between the shafts, and into balloon 128 to inflate the same and deploy prosthetic valve 112.
  • the proximal portion 124 also defines an inner lumen that is in communication with a lumen 138 of the inner shaft 134 that is sized to receive guide wire (not shown) that can extend coaxially through the inner shaft 134 and the nose cone 132.
  • the inner shaft 134 and balloon catheter shaft 126 (or outer shaft) of the balloon catheter can be formed from any of various suitable materials, such as nylon, braided stainless steel wires, or a polyether block amide (commercially available as Pebax®).
  • the shafts 126, 134 can have longitudinal sections formed from different materials in order to vary the flexibility of the shafts along their lengths.
  • the inner shaft 134 can have an inner liner or layer formed of Teflon® to minimize sliding friction with a guide wire.
  • the distal end portion of the guide catheter shaft 122 comprises a steerable section 168 (FIG. 4), the curvature of which can be adjusted by the operator to assist in guiding the apparatus through the patient’s vasculature, and particularly the aortic arch.
  • the handle portion 120 (or handle 120) in the illustrated example comprises a distal handle portion 146 and a proximal handle portion 148.
  • the distal handle portion 146 functions as a mechanism for adjusting the curvature of the distal end portion of the guide catheter shaft 122 and, in some examples, as a flex indicating device that allows a user to measure the relative amount of flex of the distal end of the guide catheter shaft 122.
  • the flex indicating device can provide a visual and tactile response at the handle the device, which provides a user with an immediate and direct way to determine the amount of flex of the distal end of the catheter.
  • the distal handle portion 146 can be operatively connected to the steerable section 168 and functions as an adjustment mechanism to permit operator adjustment of the curvature of the steerable section via manual adjustment of the handle portion.
  • the handle portion 146 can comprise a flex activating member 150, an indicator pin 152, and a cylindrical main body, or housing 154.
  • the flex activating member 150 comprises an adjustment knob 156 and a shaft 158 extending proximally from the knob into the housing 154.
  • a proximal end portion of the guide catheter shaft 122 extends into and is fixed within the central lumen of the housing 154.
  • An inner sleeve 170 surrounds a portion of the guide catheter shaft 122 inside the housing 154.
  • a threaded slide nut 172 is disposed on and is slidable relative to the sleeve 170.
  • the slide nut 172 is formed with external threads that mate with internal threads 160 of the shaft 158.
  • the slide nut 172 can be formed with two slots formed on the inner surface of the nut and extending the length thereof.
  • the sleeve 170 can be formed with longitudinally extending slots that are aligned with the slots of the slide nut 172 when the slide nut is placed on the sleeve.
  • Disposed in each slot is a respective elongated nut guide, which can be in the form of an elongated rod or pin 176.
  • the pins 176 extend radially into respective slots in the slide nut 172 to prevent rotation of the slide nut 172 relative to the sleeve 170.
  • One or more pull wires 178 couple the adjustment knob 156 to the steerable section 168 to adjust the curvature of the steerable section upon rotation of the adjustment knob.
  • the proximal end portion of the pull wire 178 can extend into and can be secured to a retaining pin, such as by crimping the pin around the proximal end of the pull wire, which pin is disposed in a slot in the slide nut 172.
  • the pull wire can extend from the pin, through the slot in the slide nut, a slot in the sleeve 170, and into and through a pull wire lumen in the shaft 122.
  • the distal end portion of the pull wire is secured to the distal end portion of the steerable section 168.
  • the pin which retains the proximal end of the pull wire 178, is captured in the slot in the slide nut 172.
  • the pull wire also is moved in the proximal direction.
  • the pull wire pulls the distal end of the steerable section 168 back toward the handle portion, thereby bending the steerable section and reducing its radius of curvature.
  • the friction between the adjustment knob 156 and the slide nut 172 is sufficient to hold the pull wire taut, thus preserving the shape of the bend in the steerable section if the operator releases the adjustment knob 156.
  • the steerable section 168 in its non-deflected shape is slightly curved and in its fully curved position, the steerable section generally conforms to the shape of the aortic arch. In other embodiments, the steerable section can be substantially straight in its non-deflected position.
  • the distal handle portion 146 can have other configurations that are adapted to adjust the curvature of the steerable section 168.
  • One such alternative handle configuration is shown in U.S. Publication No. 2007/0005131, which is incorporated by reference herein in its entirety. Additional details relating to the steerable section and handle configuration discussed above can be found in U.S. Patent Publication No. US2008/0065011, which is incorporated by reference herein in its entirety.
  • the shaft 158 can also include an externally threaded surface portion 162. As shown in FIG. 3B, a base portion 164 of the indicator pin 152 mates with the externally threaded surface portion 162 of the shaft 158.
  • the shaft 158 extends into the housing 154 and the indicator pin 152 is trapped between the externally threaded surface portion 162 and the housing 154, with a portion of the indicator pin 152 extending into a longitudinal slot 166 of the handle.
  • the knob 156 rotated to increase the curvature of the distal end of the guide catheter shaft 122, the indicator pin 152 tracks the external threaded portion 162 of the flex activating member and moves in the proximal direction inside of the slot 166.
  • the outer surface of the housing 154 of the distal handle portion 146 can include visual indicia adjacent the slot 166 that indicate the amount of flex of the distal end of the guide catheter shaft 122, based on the position of the indicator pin 152 relative to the visual indicia.
  • Such indicia can identify the amount of flex in any of a variety of manners.
  • the outer surface of the housing 154 can include a series of numbers (for example, 0 to 10) adjacent the slot that indicate the amount of curvature of the guide catheter shaft 122 based on the position of the indicator pin 152 relative to the number scale.
  • a crimped (or radially compressed) prosthetic valve 112 is positioned proximal to the balloon 128 (FIG. 5). Prior to expansion of the balloon 128 and deployment of prosthetic valve 112 at the treatment site, the prosthetic valve 112 is moved axially relative to the balloon (or vice versa) to position the crimped prosthetic valve on the balloon 128 for deploying (expanding) the prosthetic valve.
  • the proximal handle portion 148 can serve as an adjustment device that can be used to move the balloon 128 proximally into position within the frame of prosthetic valve 112, and further to accurately position the balloon and the prosthetic valve at the desired deployment location.
  • the proximal handle portion 148 comprises an outer housing 180 and an adjustment mechanism 182.
  • the adjustment mechanism 182 which is configured to adjust the axial position of the balloon catheter shaft 126 relative to the guide catheter shaft 122, comprises an adjustment knob 184 and a shaft 186 extending distally into the housing 180.
  • Mounted within the housing 180 on the balloon catheter shaft 126 is an inner support 188, which in turn mounts an inner shaft 190 (also referred to as a slider or sliding mechanism).
  • the inner shaft 190 has a distal end portion 192 formed with external threads that mate with internal threads 194 that extend along the inner surface of the adjustment mechanism 182.
  • the inner shaft 190 further includes a proximal end portion 196 that mounts a securement mechanism 198, which is configured to retain the position of the balloon catheter shaft 126 relative to the proximal handle portion 148 for use of the adjustment mechanism 182, as further described below.
  • the inner shaft 190 can be coupled to the inner support 188 such that rotation of shaft 186 causes the inner shaft 190 to move axially within the handle.
  • the inner support 188 can have an axially extending rod or rail that extends into slot formed in the inner surface of the inner shaft 190. The rod or rail prevents rotation of the inner shaft 190 but allows it to move axially upon rotation of the shaft 186.
  • the securement mechanism 198 includes internal threads that mate with external threads of the proximal end portion 196 of the inner shaft.
  • a pusher element 110 mounted within the proximal end portion 196 on the balloon catheter shaft 126 is a pusher element 110 and a shaft engagement member in the form of a collet 102.
  • the collet 102 is configured to be manipulated by the securement mechanism between a first state in which collet allows the balloon catheter shaft to be moved freely in the longitudinal and rotational directions and a second state in which the collet frictionally engages the balloon catheter shaft and prevents rotational and longitudinal movement of the balloon catheter shaft relative to the inner shaft 190.
  • the securement mechanism 198 is operable to restrain movement of the balloon catheter shaft 126 (in the axial and rotational directions) relative to the proximal handle portion 148.
  • the securement mechanism 198 is movable between a proximal position (shown in FIGS. 3A and 3B) and a distal position closer to the adjacent end of the knob 184. In the proximal position, the collet 102 applies little, if any, force against the balloon catheter shaft 126, which can slide freely relative to the collet 102, the entire handle portion 120, and the guide catheter shaft 122.
  • the securement mechanism 198 When the securement mechanism 198 is rotated so as to move to its distal position closer to knob 184, the securement mechanism urges pusher element 110 against the proximal end of the collet 102. The holding force of the collet 102 against the balloon catheter shaft 126 locks the balloon catheter shaft 126 relative to the inner shaft 190. In the locked position, rotation of the adjustment knob 184 causes the inner shaft 190 and the balloon catheter shaft 126 to move axially relative to the guide catheter shaft 122 (either in the proximal or distal direction, depending on the direction the knob 184 is rotated).
  • the adjustment knob 184 can be utilized to position the prosthetic valve 112 on the balloon 128 and/or once the prosthetic valve 112 is on the balloon 128, to position the prosthetic valve and the balloon at the desired deployment site within the native valve annulus.
  • the prosthetic valve 112 initially can be crimped on a mounting region (FIG. 5) of the delivery apparatus that is axially offset from the working portion of the balloon 128 (the working portion being the intermediate portion of the balloon that is used to deploy the prosthetic valve).
  • the prosthetic valve is initially crimped immediately adjacent the proximal end of the balloon 128, such as on a crimp balloon (not shown), which is a thin layer of polymer that extends over the inner shaft 134 from the proximal end of the balloon 128 to the balloon shaft 126.
  • the proximal end of the prosthetic valve can abut the distal end 123 of the guide catheter shaft 122 (FIG. 5), which keeps the prosthetic valve in place on the balloon catheter shaft or crimp balloon as the delivery apparatus and prosthetic valve are inserted through an introducer sheath.
  • the prosthetic valve 112 can be delivered in a transfemoral procedure by first inserting an introducer sheath into the femoral artery and pushing the delivery apparatus through the introducer sheath into the patient’s vasculature.
  • the prosthetic valve 112 can be moved onto the balloon 128.
  • a convenient location for moving the prosthetic valve onto the balloon is the descending aorta.
  • the prosthetic valve can be moved onto the balloon, for example, by holding the handle portion 146 steady (which retains the guide catheter shaft 122 in place) and moving the balloon catheter shaft 126 in the proximal direction relative to the guide catheter shaft 122.
  • the distal end 123 of the guide catheter shaft pushes against the prosthetic valve, allowing the balloon 128 to be moved proximally through the prosthetic valve in order to center the prosthetic valve on the balloon 128.
  • the balloon catheter shaft can include one or more radiopaque markers to assist the user in positioning the prosthetic valve at the desired location on the balloon.
  • the balloon catheter shaft 126 can be moved in the proximal direction by simply sliding/pulling the balloon catheter shaft in the proximal direction if the securement mechanism 198 is not engaged to retain the shaft 126.
  • the securement mechanism 198 can be engaged to retain the shaft 126, in which case the adjustment knob 184 is rotated to effect movement of the shaft 126 and the balloon 128.
  • the axial position of the balloon shaft 126 can be fixed relative to the inner shaft 134, such that axial movement of the balloon shaft 126 relative to the guide catheter shaft 122 produces axial movement of the balloon shaft 126, the inner shaft 134, and the balloon 128 relative to the guide catheter shaft 122.
  • repositioning of the prosthetic valve can be accomplished by moving the guide catheter shaft 122 distally relative to the balloon shaft 126, the inner shaft 134, and the balloon 128.
  • Most prosthetic heart valves include an outer skirt disposed around an outer surface of an annular frame of the prosthetic heart valve.
  • the outer skirt can be configured to form a seal against native tissue upon implantation of the prosthetic heart valve, thereby reducing paravalvular leakage (PVL) past the prosthetic heart valve when expanded against the native anatomy.
  • PVL paravalvular leakage
  • portions of the outer skirt that are configured to extend radially outward can increase the overall crimp profile of the prosthetic heart valve, thereby causing a user advancing the prosthetic heart valve through the patient’s vasculature to experience increased push forces.
  • outer skirts typically are secured to a frame of a prosthetic valve with a plurality of stitches. The assembly of the outer skirt on the frame can be time consuming due to the number of stitches that may be required. The stitches, depending on their locations, can cause abrasion of the prosthetic leaflets from repeated contact with the leaflets during valve cycling.
  • FIG. 6A illustrates a prosthetic heart valve 200 that has an outer skirt 208 that is configured to reduce the overall crimp profile of the prosthetic heart valve 200.
  • the outer skirt 208 can also reduce the number of stitches that are required to assemble the skirt to the frame, thereby simplifying the assembly process and reducing leaflet abrasion caused by contact with stitches.
  • the prosthetic valve 200 includes a frame 202 and a valvular structure 204 disposed within the frame 202.
  • the valvular structure 204 can include a plurality of leaflets 240 (e.g., three leaflets 240) that are configured to regulate the flow of blood through the prosthetic valve 200.
  • the frame 202 can have an inflow end portion 205, an intermediate portion 207, and an outflow end portion 209.
  • the prosthetic valve 200 can include an inner skirt (e.g., similar to inner skirt 16) that can be arranged on and/or coupled to an inner surface of the frame 202.
  • FIG. 6 A show the outer skirt 208 in a delivery configuration extending from the frame, prior to being deployed around the frame during an implantation procedure.
  • the delivery configuration of the outer skirt can be referred to as a non-deployed configuration.
  • the outer skirt 208 has a first end 210 that is coupled to or fixed relative to the frame 202 and a second end 212 that is not fixed to the frame and is spaced axially from the frame 202 in the delivery configuration.
  • the first end 210 of the outer skirt 208 is coupled to the inflow end portion 205 of the frame 202 (such as by stitching the first end 210 to the frame and/or an inner skirt of the prosthetic valve) and the outer skirt 208 can extend away from the inflow end portion 205 in a direction away from the inflow end portion 205 and the outflow end portion 209 of the frame 202 in the delivery configuration.
  • the first end 210 of the outer skirt 208 can be coupled to an inner surface of the prosthetic heart valve 200 within the frame 202, for example, to an inner surface of the frame and/or an inner skirt (e.g., inner skirt 16) that is located inside of the frame.
  • the outer skirt 208 can be referred to as a detached skirt because only one end of the outer skirt 208 is coupled to the frame 202.
  • the outer skirt 208 comprises a first layer 214 (also referred to as an “attachment layer” or a “base layer”) and a second layer 216 (also referred to as a “sealing layer”) that is coupled to the first layer 214.
  • the base layer 214 can comprise a tissue-growth inhibiting material or a thromboresistant material, or a material having a thromboresistance greater than a fabric.
  • the first layer 214 has an outer surface that is smoother or less-abrasive than an outer surface of the second layer 216.
  • the first layer 214 comprises a polymer, such as thermoplastic polyurethane (TPU), or polytetrafluoroethylene, etc., and has a non-textile construction (that is, the layer 214 is a non-fabric).
  • the sealing layer 216 can comprise a material that encourages or promotes tissue ingrowth and/or endothelialization.
  • the sealing layer 216 can comprise a textile or fabric material, such as a fabric having interlaced yams or fibers, for example, in the form of a woven, braided, or knitted fabric.
  • the fabric can have a plush nap or pile.
  • the sealing layer 216 can comprise any of the materials described above in connection with skirt 18.
  • the sealing layer 216 has a greater thickness than the base layer 214, such that the sealing layer 216 has a greater crimp profile than the base layer 214.
  • the first and second layers 214, 216 can be secured to each other using various techniques or mechanisms, such as with stitches, bonding (e.g., adhesive bonding or chemical bonding), welding, etc.
  • the layers 214, 216 can be bonded to each other by applying heat and/or pressure to the layers 214, 216 so as to cause the material of the first layer 214 to bond to the fibers of the second layer 216. Further details regarding skirts having a fabric layer bonded to a non-fabric layer are disclosed in WIPO Publication No. 2023/244612, which is incorporated herein by reference.
  • the base layer 214 is coupled to an inner surface of the prosthetic valve 200 within the frame 202, for example, to an inner skirt of the prosthetic heart valve 200, directly to the frame 202, etc.
  • the base layer 214 is an extension of an inner skirt of the prosthetic heart valve 200.
  • the inner skirt can extend beyond the inflow end portion 205 and the sealing layer 216 can be coupled to the portion of the inner skirt that extends beyond the inflow end portion 205.
  • the sealing layer 216 can be disposed entirely outside the frame and axially adjacent the frame such that no portion of the sealing layer 216 covers or overlaps an inner surface or outer surface of the frame.
  • the base layer 214 and the sealing layer 216 can have different axial lengths.
  • the base layer 214 has a greater axial length than the sealing layer 216.
  • the base layer 214 when formed from a non-fabric material, can be relatively stiffer than the sealing layer 216 and help maintain the shape of the outer skirt after the prosthetic valve is crimped onto the delivery apparatus.
  • the sealing layer 216 is spaced apart from the first end 210 and the second end 212 of the outer skirt 208, such that the first end 210 and the second end 212 of the outer skirt 208 include only the base layer 214, while an intermediate region of the outer skirt 208 include both the base layer 214 and the sealing layer 216.
  • FIGS. 6B and 6C illustrate a prosthetic heart valve 200’, according to one example.
  • the prosthetic heart valve 200’ is generally similar to prosthetic heart valve 200 apart from outer skirt 208’.
  • the outer skirt 208’ includes a sealing layer 216’ comprising a first portion 216a and a second portion 216b.
  • the first portion 216a functions to attach the sealing layer 216’ to the frame 202.
  • the first portion 216a is coupled to an inner surface of the prosthetic valve 200’, for example, to an inner surface of the frame 202 with sutures 217.
  • the first portion 216a can he stitched directly to struts of the frame 202.
  • the first portion 216a can be coupled to an inner skirt of the prosthetic valve 200’, such as by stitching the first portion 216a to the inner skirt.
  • the second portion 216b functions to seal against native anatomy to reduce PVL past the prosthetic heart valve 200’.
  • the second portion 216b is thicker than the first portion 216a.
  • the second portion 216b is spaced apart from the first end 210 of the outer skirt 208, such that only the thinner first portion 216a slightly overlaps with the inflow end portion 205 of the frame 202.
  • the second portion 216b which has a greater crimp profile than the first portion 216a, to be axially spaced apart from the frame 202 such that the second portion 216b does not add to the overall crimp profile of the prosthetic valve 200’.
  • first portion 216a and the second portion 216b can comprise different materials.
  • first portion 216a can comprise a plain woven fabric and the second portion 216b can comprise a plush fabric having a nap or pile.
  • first and second portions 216a, 216b can comprise any of the materials described above in connection with skirts 16, 18.
  • the prosthetic heart valve 200’ can include a base layer 214’ that is configured to inhibit tissue ingrowth on the leaflets.
  • the prosthetic heart valve 200’ include a tissue-growth inhibiting coating forming a base layer 214’ that is applied to an outer surface of the sealing layer 216’.
  • the coating comprises a TPU coating or other materials described above for base layer 214.
  • the coating is applied only to the second portion 216b of the sealing layer 216’.
  • the coating can be applied to the entirety of the second portion 216b or to less than the entirety of the second portion 216b.
  • the coating can give the outer skirt 208’ a semi-rigid structure to retain a low profile after crimping.
  • the sealing layer 216 is coupled to an inner surface of the base layer 214.
  • the sealing layer 216 is initially radially inwards of the base layer 214, as shown in FIG. 7A.
  • the second end 212 of the outer skirt 208 can be coupled to one or more sutures or tethers 218, which can be coupled to the balloon catheter shaft, as further described below.
  • the outer skirt 208 is folded such that the second end 212 of the outer skirt 208 extends towards the frame 202, as shown in FIG. 7B.
  • FIG. 7A illustrates the outer skirt 208 in an unfolded configuration
  • FIG. 7A illustrates the outer skirt 208 in an unfolded configuration
  • FIG. 7B illustrates the outer skirt 208 in a folded configuration.
  • the outer skirt 208 is coupled to the tethers 218 and is folded with a portion of the sealing layer 216 facing outwards.
  • the first end 210 of the outer skirt 208 is positioned radially inwards of the frame 202 and the second end 212 of the outer skirt 208 is positioned radially outwards of the frame 202.
  • the balloon 128 is omitted from FIG. 7B for purposes of illustration.
  • FIGS. 7-13 proceeds with reference to implanting the prosthetic valve 200. It should be understood that the prosthetic valve 200’ can be implanted in the same manner. [0121] As shown in FIG.
  • the first and second ends 210, 212 of the base layer 214 slightly overlap the frame 202, whereas the entirety of the sealing layer 216 is axially spaced apart from the inflow end portion 205 of the frame.
  • the majority of the outer skirt 208 desirably is positioned to extend beyond one end of the frame 202 (e.g., the inflow end portion 205 of the frame in the illustrated embodiment) such that there is no overlap, or very little overlap, between the sealing layer 216 and the frame 202 in the axial direction. In this manner, the thickness of the outer skirt 208 does not contribute to the overall crimped profile of the valve 200 in its radially compressed state.
  • the prosthetic valve 200 can be crimped proximal to the balloon 128 in some examples to further reduce the overall crimped profile, as depicted in FIG. 7A.
  • the prosthetic valve 200 can be advanced through a patient’s vasculature in the delivery configuration shown in FIGS. 7A-7B.
  • the distal end 123 of the outer shaft 122 can abut a proximal end of the prosthetic valve 200 as the prosthetic valve and the delivery apparatus are inserted through an introducer sheath and into the patient’s vasculature.
  • the outer shaft 122 can serve as a pusher member to resist proximal movement of the prosthetic valve relative to the delivery apparatus as they are inserted into and advanced through the patient’s vasculature.
  • the prosthetic valve 200 can be crimped at a location spaced distally from the distal end of the outer shaft 122 (and proximal to the balloon).
  • the prosthetic valve 200 can be moved onto the balloon 128 and the outer skirt 208 can be moved onto the outer surface of the frame 202.
  • a convenient location for moving the prosthetic valve onto the balloon is the ascending aorta.
  • the prosthetic valve can be moved onto the balloon, for example, by holding the handle 120 steady (which retains the guide catheter shaft 122 in place), and moving the balloon catheter shaft 126 and the inner shaft 134 in the proximal direction relative to the guide catheter shaft 122.
  • Retraction of the balloon catheter shaft 126 and the inner shaft 134 in the proximally direction moves the balloon 128 proximally through the prosthetic valve while the guide catheter shaft 122 pushes against and prevents movement of the prosthetic valve 200 in the proximal direction.
  • the balloon catheter shaft 126, the inner shaft 134 and the balloon 128 are retracted proximally until the prosthetic valve 200 is centered on the balloon 128. If the prosthetic valve 200 is initially spaced from the distal end 123 of the guide catheter shaft 122 (FIG.
  • the balloon catheter shaft 126 and the inner shaft 134 are retracted until the distal end 123 of the guide catheter shaft 122 comes into contact with the prosthetic valve 200, and continued retraction of the balloon catheter shaft 126 and the inner shaft 134 moves the balloon through the prosthetic valve 200.
  • the prosthetic valve 200 can be positioned on the balloon 128 by moving the guide catheter shaft 122 distally relative to the balloon catheter shaft 126, the inner shaft 134 and the balloon 128 such that the prosthetic valve is pushed distally onto the balloon 128.
  • the tethers 218 (which are coupled to the shaft 126) begin to pull the outer skirt 208 over the outer surface of the frame 202 in a proximal direction, as shown in FIG. 9.
  • the tethers 218 are attached at one end to the balloon catheter shaft 126, the movement of the balloon catheter shaft 126 in the proximal direction causes the tethers 218 to likewise move in the proximal direction.
  • the prosthetic valve 200 is pushed and/or the balloon catheter shaft 126 is pulled proximally until the outer skirt 208 is fully pulled over the outer surface of the frame 202, as shown in FIGS. 10A-10B (the balloon 128 is omitted in FIG. 10B for purposes of illustration).
  • This causes the outer skirt 208 to assume an everted position in which the second end 212 is positioned around an outer surface of the frame 202 and the outer surface of the outer skirt 208 in FIG. 6A is turned inside out and faces the outer surface of the frame 202.
  • the outer skirt 208 is transitioned to an everted, pre-expanded configuration as shown in FIGS.
  • the outer skirt 208 covers a portion of the outer surface of the frame 202 such that the base layer 214 is positioned against the outer surface of the frame 202 and the sealing layer 216 is positioned radially outwards of the base layer 214 and faces the native anatomy.
  • the guide catheter shaft 122 can be moved proximally relative to the balloon catheter shaft 126, so that the guide catheter shaft 122 is not covering the inflatable portion of the balloon 128, and therefore will not interfere with inflation of the balloon.
  • the tethers 218 can be detached from the second end 212 of the outer skirt 208 prior to inflation of the balloon 128 and expansion of the valve 200.
  • the balloon 128 is omitted from FIG. 11 for purposes of illustration.
  • the tethers 218 can be detached from the balloon catheter shaft 126, as further described below in connection with FIGS. 15-18.
  • the tethers 218 can remain attached to the second end 212 of the outer skirt 208 during inflation of the balloon 128 and deployment of the prosthetic valve 200, as shown in FIGS. 12-13. After the balloon 128 is fully inflated and the prosthetic valve 200 is fully expanded (deployed) at the implantation location, as shown in FIG. 13, the tethers 218 can be detached from the second end 212 of the outer skirt 208.
  • the sealing layer 216 is positioned radially outwards of the base layer 214 and contacts the native anatomy 300 (such as the native aortic annulus and/or the native aortic leaflets), as shown in FIG. 14. In this way, the sealing layer 216 can seal against the native anatomy 300 to reduce PVL past the prosthetic heart valve 200.
  • the base layer 214 is positioned radially between the sealing layer 216 and the outer surface of the frame 202. In this way, the base layer 214 can limit the amount of tissue ingrowth on the leaflets 240 of the prosthetic valve 200.
  • the outer skirt 208 is pulled over the frame 202 during delivery of the prosthetic heart valve 200, there are no sutures used to couple the second end 212 of the outer skirt 208 to the frame 202, such that the second end 212 is not fixed to the frame 202.
  • no stitches for connecting the outer skirt to the frame are present along the length of the frame, except for those securing the outer skirt to the inflow end of the frame, thereby reducing the potential for suture-caused abrasions in the leaflets 240 during valve cycling.
  • the substantial reduction in the number of stitches required to the assemble the outer skirt to the frame can simplify and reduce the assembly time of the prosthetic valve.
  • each tether 218 can form a loop that extends through the outer skirt 208 and has a proximal end coupled to the balloon shaft 126.
  • the balloon catheter shaft 126 includes a pair of interlocking shafts that are configured to releasably hold the tethers 218 in place relative to the balloon catheter shaft 126.
  • the interlocking shafts can function as a locking mechanism to lock the tethers 218 in place relative to the balloon catheter shaft 126 while the prosthetic valve 200 is transitioned from the delivery configuration (FIGS. 7A-7B) to the pre-deployment configuration (FIGS. 10A-10B).
  • the locking mechanism can be configured to release the tethers 218 after the outer skirt 208 is positioned around the frame 202, for example, before or after deployment of the prosthetic valve 200.
  • the balloon catheter shaft 126 can include an outer shaft 340 and an inner shaft 342.
  • the outer shaft 340 and the inner shaft 342 are shown separately for purposes of illustration, and in FIGS. 16A- 16D, the inner shaft 342 is disposed within the outer shaft 340.
  • the outer shaft 340 and the inner shaft 342 are configured to rotate relative to each other in the circumferential direction.
  • the outer shaft 340 can include an L-shaped slot 344 extending proximally from the distal end 346 of the outer shaft 340.
  • the slot 344 includes a first portion 344a extending proximally from the distal end 346 and a second portion 344b that is perpendicular to the first portion 344a.
  • the inner shaft 342 also includes an L-shaped slot 348 extending proximally from the distal end 350 of the inner shaft 342.
  • the slot 348 includes a first portion 348a extending proximally from the distal end 346 and a second portion 348b that is perpendicular to the first portion 348a.
  • the L-shaped slots 344, 348 are oriented in opposite directions, such that the second portions 344b, 348b of the slots 344, 348 extend circumferentially in opposite directions from their respective first portions 344a, 348a. As such, when the outer shaft 340 and the inner shaft 342 are rotated relative to each other, the slots 344, 348 can only partially align.
  • FIG. 16A illustrates the outer shaft 340 and inner shaft 342 in an open or unlocked position.
  • the first portions 344a, 348a are circumferentially aligned such that the two first portions 344a, 348a together form a straight slot that extends from the distal ends 346, 350 of the outer shaft 340 and the inner shaft 342, respectively.
  • the second portions 344b, 348b of both slots 344, 348 are inaccessible from the distal ends 346, 350 of the shafts 340, 342.
  • a proximal end of the loop formed by the tether 218 can be inserted into the slots 344, 348, as shown in FIG. 16B.
  • the outer shaft 340 and inner shaft 342 can be rotated relative to each other such that the second portions 344b, 348b of the slots 344, 348 are circumferentially aligned, as shown in FIG. 16C.
  • the locked position neither of the first portions 344a, 348a are accessible, such that the tether 218 cannot be removed from the second portions 344b, 348b of the slots 344, 348.
  • the second portions 344b, 348b of the slots 344, 348 form an opening that is entirely spaced apart from the distal ends 346, 350 of the shafts 340, 342, such that the tether 218 cannot be removed from the slots 344, 348.
  • the outer shaft 340 and the inner shaft 342 can be returned to the open position. To do so, the outer shaft 340 and the inner shaft 342 can be rotated relative to each other such that the first portions 344a, 348a of the slots 344, 348 are circumferentially aligned, as shown in FIG. 16D. Thereafter, the tether 218 can be removed from the slots 344, 348. The tether 218 can be released from the slots 344, 348, thereby releasing the tether from the delivery apparatus, prior to expanding the prosthetic valve or after expanding the prosthetic valve.
  • each tether 218 can be retained in the slots 344, 348.
  • the shafts 340, 342 can be formed with multiple pairs of slots 344, 348 spaced circumferentially around the shaft, wherein each tether 218 can be retained in a pair of cooperating slots 344, 348.
  • the tethers 218 can be coupled at their proximal ends to the balloon catheter shaft 126 without the use of interlocking shafts.
  • the guide catheter shaft 122 and the balloon catheter shaft 126 include a plurality of projections through which rods extend, and the rods are configured to releasably hold the tethers 218 in place relative to the balloon catheter shaft 126.
  • the projections and rods can function to hold the tethers 218 in place relative to the balloon catheter shaft 126 while the prosthetic valve 200 is transitioned from the delivery configuration (FIGS. 7A-7B) to the pre-deploy ment configuration (FIGS. 10A-10B) and release the tethers 218 after the outer skirt 208 is positioned around the frame 202, for example, in the pre-deployment configuration.
  • a plurality of projections 352 extend inwards in a radial direction from an inner surface of the guide catheter shaft 122 and a plurality of projections 354 extend outwards in a radial direction from an outer surface of the balloon catheter shaft 126.
  • the projections 352 can be located distal to the projections 354.
  • the projections 352, 354 are arranged in pairs of projections 352, 354, with the projections 352, 354 of each pair being circumferentially aligned with each other along an imaginary line that extends parallel to the shafts 122, 126.
  • Each projection 352, 354 includes an opening configured to receive a rod 356.
  • Each rod 356 is fixedly coupled to a respective projection 352 of the guide catheter shaft 122.
  • the rods 356 are configured to translate in an axial direction relative to the projections 354 of the balloon catheter shaft 126.
  • Each rod 356 can receive a respective tether 218.
  • FIGS. 18A-18B illustrate one pair of projections 352, 354 separate from the guide catheter shaft 122 and the balloon catheter shaft 126, respectively, for purposes of illustration.
  • FIG. 18A illustrates the projections 352, 354 and rod 356 in a delivery configuration (such as shown in FIGS. 7A-7B) and
  • FIG. 18B illustrates the projections 352, 354 and rod 356 after the delivery apparatus 100 has been transitioned to the pre-deployment configuration (FIGS. 10A-10B).
  • the rod 356 extends proximally from a proximal end 358 of the projection 354.
  • proximal end of tether 218 is looped around the proximal end portion 356p of the rod 356 and extends distally towards the prosthetic heart valve 200 where the tether 218 is coupled to the outer skirt 208.
  • the length of the rod 356 is selected such that the tether 218 remains looped around the proximal end portion 356p as the prosthetic valve 200 is repositioned onto the balloon and the outer skirt 208 is deployed into its everted configuration. In this manner, the tethers 218 remain coupled to the rod 356 and remain in tension at least until the outer skirt reaches its everted configuration.
  • the guide catheter shaft 122 and the projection 352 move distally, as indicated by arrow 360, relative to the balloon catheter shaft 126 and the projection 354. Because the rod 356 is fixedly coupled to the projection 352, the rod 356 also moves distally in direction 360 until the proximal end of the rod 356 no longer extends proximally beyond the proximal end of the projection 354. This releases the proximal end of the tether 218 from the rod, as indicated by arrow 362, thereby releasing the tether from the delivery apparatus.
  • the length of the rod 356 is selected such that the tether 218 remains looped around the proximal end portion 356p as the prosthetic valve 200 is repositioned onto the balloon and the outer skirt 208 is deployed into its everted configuration. In this manner, the tethers 218 remain coupled to the rod 356 and remain in tension at least until the outer skirt reaches its everted configuration, at which point the proximal end of the rod 356 is distal to the proximal end 358 of the projection 354.
  • a pair of projections 352, 354 can be provided for each tether 218 that is coupled to the outer skirt (e.g., three pairs of projections for three tethers), although a greater or fewer number of pairs of projections can be provided.
  • more than one tether 218 can be releasably coupled to a single rod 356.
  • the prosthetic valve 200 can be crimped proximal to the balloon 128 in some examples, as depicted in FIG. 7A.
  • an implantation procedure is described above in connection with FIGS. 7A-14 in which the prosthetic heart valve 200 is initially crimped proximal to the balloon 128 and subsequently translated axially over the balloon 128 during the procedure.
  • the prosthetic heart valve 200 can be crimped on the balloon 128 itself for an on-balloon delivery of the prosthetic heart valve 200. As such, the prosthetic heart valve 200 does not move axially relative to the balloon 128 prior to inflation of the balloon 128 and deployment of the prosthetic heart valve 200.
  • the guide catheter shaft 122 can be retracted axially relative to the balloon 128 to allow the balloon 128 to inflate.
  • Such axial movement of the guide catheter shaft 122 relative to the balloon 128 and the prosthetic valve 200 can be used to evert the outer skirt 208 over the frame 202, as described in more detail below.
  • FIG. 19 shows a delivery apparatus 300 that can be used for on-balloon delivery of a prosthetic heart valve, according to one example.
  • the delivery apparatus 300 can include an outer shaft 122 (which optionally can be a steerable guide catheter shaft), an intermediate shaft 126, an inner shaft 134, a balloon 128 mounted around the inner shaft 134, a nose cone 132 connected to a distal end of the inner shaft 134, and any or all of the components of the delivery apparatus 100 shown and described above.
  • the delivery apparatus 300 can include an optional capsule 125 formed as the distal end portion of the guide catheter shaft 122, such that the capsule 125 forms the distal end 123 of the guide catheter shaft 122.
  • the capsule 125 can have a larger diameter than the portion of the guide catheter shaft that extends proximally from the capsule.
  • the capsule 125 is configured to surround or encapsulate the prosthetic heart valve 200 and balloon 128, for example, as the prosthetic heart valve 200 is advanced through the patient’s vasculature.
  • the capsule 125 is configured to translate along with the guide catheter shaft 122 relative to the prosthetic heart valve 200 and balloon 128, for example, to unsheathe the prosthetic heart valve 200 and balloon 128 prior to expansion of the prosthetic heart valve 200 and balloon 128.
  • one or more tethers 218 are coupled to the second end 212 of the outer skirt 208.
  • the tether 218 is looped through the second end 212 of the outer skirt 208, such that a distal end portion 218d and a proximal end portion 218p of the tether 218 extend into the guide catheter shaft 122, radially between the guide catheter shaft 122 and the balloon catheter shaft 126.
  • the distal end portion 218d of the tether 218 is releasably coupled to the guide catheter shaft 122 adjacent to the proximal end of the capsule 125.
  • the proximal end portion 218p extends proximally through the guide catheter shaft 122 to a handle of the delivery apparatus 300 (for example, handle 120).
  • the terminal end of the proximal end portion 218p can be located inside the handle where it can be operatively coupled to an actuator of the handle, or alternatively, the terminal end of the proximal end portion 218p can be located outside of the handle for manipulation by a user.
  • FIG. 19 only one tether 218 is shown for purposes of illustration. Where multiple tethers 218 are used, each tether 218 can be spaced apart in the circumferential direction around the prosthetic heart valve 200 and the balloon catheter shaft 126 within the guide catheter shaft 122.
  • WIPO Publication No. 2022/046585 Another example of a delivery apparatus for delivering a prosthetic heart valve in an on-balloon orientation is disclosed in WIPO Publication No. 2022/046585, which is incorporated herein by reference.
  • the delivery apparatus disclosed in WIPO Publication No. 2022/046585 can be used to delivery and implant any of the prosthetic heart valves disclosed herein.
  • the delivery apparatus disclosed in WIPO Publication No. 2022/046585 can be modified to include the capsule 125 and to incorporate the tethers 218.
  • the distal end portion 218d of the tether 218 can be coupled to the guide catheter shaft 122 using the locking mechanisms described above in connection with FIGS. 15A-18B.
  • the locking mechanisms can be modified to account for the tethers 218 being coupled to the guide catheter shaft 122, rather than the balloon catheter shaft 126.
  • the guide catheter shaft 122 can include interlocking shafts 340, 342, instead of the balloon catheter shaft 126, and the distal end portion 218d of the tether can be looped through the interlocking shafts 340, 342.
  • the projections 354 can extend from the guide catheter shaft 122 and the projections 352 can extend from the balloon catheter shaft 126.
  • the distal end portion 218d of the tether 218 can be fixed to the guide catheter shaft 122, such as to an inner surface of the guide catheter shaft 122 at a convenient location (for example, at or near the proximal end of the capsule 125).
  • the proximal end portion 218p of the tether 218 can be releasably connected to a suture release mechanism on or adjacent the handle of the delivery apparatus.
  • FIGS. 19-22 The description of FIGS. 19-22 proceeds with reference to implanting the prosthetic valve 200. It should be understood that the prosthetic valve 200’ can be implanted in the same manner. Initially, the prosthetic valve 200 is crimped onto the balloon 218 with the outer skirt 298 extending distally from the frame 202, as shown in FIG. 19. In this manner, the majority of the outer skirt 208 desirably is positioned to extend beyond one end of the frame 202 such that there is no overlap, or very little overlap, between the sealing layer 216 and the frame 202 in the axial direction. In this manner, the thickness of the outer skirt 208 does not contribute to the overall crimped profile of the valve 200 in its radially compressed state.
  • FIG. 20 illustrates a delivery configuration of the delivery apparatus 300, after the balloon catheter shaft 126 and the inner shaft 134 have been retracted until the capsule 125 is advanced over the prosthetic heart valve 200 and the distal end 123 of the guide catheter shaft 122 comes into contact with the nose cone 132.
  • the guide catheter shaft 122 can be advanced distally over the balloon and the prosthetic valve.
  • the prosthetic valve 200 can be advanced through a patient’ s vasculature in the delivery configuration shown in FIG. 20.
  • the balloon catheter shaft 126 and the inner shaft 134 can be retracted until the distal end 123 of the guide catheter shaft 122 comes into contact with the prosthetic valve 200.
  • the guide catheter shaft 122 can be moved proximally relative to the balloon catheter shaft 126, so that the capsule 125 is no longer covering the prosthetic valve 200 and the inflatable portion of the balloon 128, and therefore will not interfere with inflation of the balloon.
  • the tethers 218 (which are coupled to the shaft 122) begin to pull the outer skirt 208 over the outer surface of the frame 202 in a proximal direction, as shown in FIG. 21.
  • the tethers 218 are attached at one end portion 218d to the guide catheter shaft 122, the movement of the guide catheter shaft 122 in the proximal direction causes the tethers 218 to likewise move in the proximal direction.
  • the balloon catheter shaft 126 is advanced distally and/or the guide catheter shaft 122 is pulled proximally until the outer skirt 208 is fully pulled over the outer surface of the frame 202, as shown in FIG. 22.
  • This causes the outer skirt 208 to assume an everted position in which the second end 212 is positioned around an outer surface of the frame 202 and the outer surface of the outer skirt 208 in FIG. 6A is turned inside out and faces the outer surface of the frame 202.
  • the outer skirt 208 is transitioned to an everted, preexpanded configuration as shown in FIG.
  • the outer skirt 208 covers a portion of the outer surface of the frame 202 such that the base layer 214 is positioned against the outer surface of the frame 202 and the sealing layer 216 is positioned radially outwards of the base layer 214 and faces the native anatomy.
  • the balloon 128 can be inflated to expand the prosthetic valve 200.
  • the balloon 128 can be deflated, as shown in FIG. 23, and the distal ends 218d of the tethers 218 can be uncoupled from the guide catheter shaft 122 to allow removal of the delivery apparatus 300.
  • the tethers 218 can be detached from the second end 212 of the outer skirt 208 when the delivery apparatus 300 is removed from the patient.
  • the distal end portions 218d of the tethers are pulled through the second end 212 of the skirt 208 as the delivery apparatus 100 is being removed from the patient.
  • the distal end portions 218d of the tethers 218 can be fixed to the guide catheter shaft 122, such as to an inner surface of the guide catheter shaft 122 at a convenient location (for example, at or near the proximal end of the capsule 125).
  • the proximal end portions 218p of the tethers 218 can be releasably connected to a suture release mechanism on or adjacent the handle of the delivery apparatus.
  • the proximal end portions 218p are released from the suture release mechanism, after which the delivery apparatus is retracted from the patient’s body, which causes the proximal end portions 218p to be pulled through the skirt 208.
  • 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.
  • the prosthetic valve For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is 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 are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta.
  • the prosthetic valve is 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 self-expand).
  • 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) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve.
  • a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.
  • the prosthetic valve is 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 are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (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) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.
  • the prosthetic valve For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is 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 are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is 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 is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve/pulmonary artery.
  • Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is 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 transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is 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 prosthetic heart valve comprising: a collapsible and expandable annular frame that is configured to be collapsed to a radially collapsed state for mounting on a delivery apparatus and expanded to a radially expanded state inside the body, the frame having an inflow end and an outflow end; a collapsible and expandable valvular structure mounted within the annular frame; and a collapsible and expandable annular sealing member having a first end and a second end, the first end of the sealing member being coupled to the inflow end of the frame, wherein the sealing member comprises a base layer and a sealing layer, wherein when the sealing member is collapsed on the delivery apparatus in a delivery configuration, the sealing member extends from the inflow end of the frame in a direction away from the outflow end of the frame, and wherein when the sealing member is transitioned to a pre-deployment configuration, the sealing member is in an everted position with the second end of the sealing member extending over an outer surface the frame and the base
  • Example 2 The prosthetic heart valve of any example herein, particularly example 1 , wherein the base layer is coupled to the inflow end of the frame.
  • a prosthetic heart valve comprising: a collapsible and expandable annular frame that is configured to be collapsed to a radially collapsed state for mounting on a delivery apparatus and expanded to a radially expanded state inside the body, the frame having an inflow end and an outflow end; a collapsible and expandable valvular structure mounted within the annular frame; and a collapsible and expandable annular sealing member having a first end and a second end, the first end of the sealing member being coupled to the inflow end of the frame, wherein the sealing member comprises a base layer and a sealing layer, wherein when the sealing member is collapsed on the delivery apparatus in a delivery configuration, the sealing member extends from the inflow end of the frame in a direction away from the outflow end of the frame, and wherein when the sealing member is transitioned to a pre-deployment configuration, the sealing member is in an everted position with the second end of the sealing member extending over an outer surface the frame and the base
  • Example 2 The prosthetic heart valve of any example herein, particularly example 1, wherein the base layer is coupled to the inflow end of the frame.
  • Example 3 The prosthetic heart valve of any example herein, particularly either example 1 or example 2, wherein the base layer comprises a tissue-growth inhibiting material.
  • Example 4 The prosthetic heart valve of any example herein, particularly any one of examples 1-3, wherein the base layer comprises TPU.
  • Example 5 The prosthetic heart valve of any example herein, particularly any one of examples 1-4, wherein in the delivery configuration the sealing layer is outside of and axially spaced apart from the frame.
  • Example 6 The prosthetic heart valve of any example herein, particularly any one of examples 1-5, wherein the sealing layer has a greater thickness than the base layer.
  • Example 7 The prosthetic heart valve of any example herein, particularly any one of examples 1-6, wherein the sealing layer is spaced apart from the first end of the sealing member.
  • Example 8 The prosthetic heart valve of any example herein, particularly any one of examples 1-7, wherein the sealing layer is spaced apart from the second end of the sealing member.
  • Example 9 The prosthetic heart valve of any example herein, particularly any one of examples 1-8, wherein in the delivery configuration, the sealing member is folded and the second end of the sealing member is positioned adjacent to the inflow end of the frame.
  • Example 10 The prosthetic heart valve of any example herein, particularly any one of examples 1-9, wherein the sealing layer comprises a fabric.
  • Example 11 The prosthetic heart valve of any example herein, particularly example 10, wherein the base layer comprises a non-fabric material.
  • Example 12 An assembly comprising: a delivery apparatus comprising a first shaft and a second shaft positioned radially outwards of the first shaft, wherein the first shaft and the second shaft are configured to translate axially relative to each other; and a prosthetic heart valve mounted in a radially compressed state around the first shaft in a delivery configuration, the prosthetic heart valve comprising a radially expandable frame having an inflow end and an outflow end and an outer skirt having a first end and a second end, wherein the first end of the outer skirt is coupled to the inflow end of the frame, and wherein in the delivery configuration, the outer skirt extends from the inflow end of the frame in a direction away from the outflow end of the frame and the second end of the outer skirt is axially spaced apart from the inflow end of the frame; wherein relative movement between the first shaft and the second shaft in an axial direction
  • Example 13 The assembly of any example herein, particularly example 12, wherein in the delivery configuration, the outer skirt is folded and the second end of the outer skirt is positioned adjacent to the inflow end of the frame.
  • Example 14 The assembly of any example herein, particularly either example 12 or example 13, further comprising one or more tethers coupled to the second end of the outer skirt and to a third shaft of the delivery apparatus that extends over the first shaft and through the second shaft.
  • Example 15 The assembly of any example herein, particularly either example 12 or example 13, further comprising one or more tethers coupled to the second end of the outer skirt and to the second shaft.
  • Example 16 The assembly of any example herein, particularly example 15, wherein the second shaft comprises a capsule at a distal end portion of the second shaft, wherein the prosthetic heart valve is positioned radially and axially within the capsule in the delivery configuration, and wherein the capsule is spaced apart from the prosthetic heart valve in the pre-deployment configuration.
  • Example 17 The assembly of any example herein, particularly any one of examples 12-16, wherein the outer skirt comprises a base layer and a sealing layer, wherein the sealing layer is configured to reduce paravalvular leakage past the prosthetic heart valve when the prosthetic heart valve is deployed at a target location in a patient, and wherein in the predeployment configuration the sealing layer is positioned radially outwards of the base layer.
  • Example 18 The assembly of any example herein, particularly example 17, wherein the base layer comprises a tissue-growth inhibiting material.
  • Example 19 The assembly of any example herein, particularly either example 17 or example 18, wherein the base layer is coupled to an inner surface of the prosthetic heart valve.
  • Example 20 A delivery apparatus for delivering a prosthetic heart valve, the delivery apparatus comprising: a shaft; and a shaft assembly coupled to the shaft, wherein the shaft and the shaft assembly are configured to translate relative to each other, wherein the shaft assembly comprises an outer shaft and an inner shaft, wherein the outer shaft and the inner shaft are configured to rotate relative to each other, wherein the outer shaft has a first slot extending from a distal end of the outer shaft, wherein the inner shaft has a second slot extending from a distal end of the inner shaft, wherein in a unlocked position at least a portion of the slots are aligned, wherein in a locked position the first slot and the second slot define an opening that is spaced apart from the distal end of the first shaft and the distal end of the second shaft.
  • Example 21 The delivery apparatus of any example herein, particularly example 20, wherein the first slot is an L-shaped slot, and wherein the second slot is an L-shaped slot.
  • Example 22 The delivery apparatus of any example herein, particularly either example 20 or example 21, wherein the first and second slots are configured to retain a tether coupled to a prosthetic heart valve in the locked position.
  • Example 23 The delivery apparatus of any example herein, particularly any one of examples 20-22, wherein the shaft assembly is positioned radially inwards of the shaft.
  • Example 24 The delivery apparatus of any example herein, particularly any one of examples 20-22, wherein the shaft is positioned radially inwards of the shaft assembly.
  • Example 25 A delivery apparatus for delivering a prosthetic heart valve, the delivery apparatus comprising: a guide catheter shaft having a plurality of first projections extending radially inwards from an inner surface of the guide catheter shaft; a balloon catheter shaft having a plurality of second projections extending radially outwards from an outer surface of the balloon catheter shaft, wherein the balloon catheter shaft is coaxially disposed within the guide catheter shaft and configured to translate relative to the guide catheter shaft; and a plurality of rods, each rod fixedly coupled to one of the first projections and extending through an opening of one of the second projections, wherein the rods are configured to translate relative to the second projections.
  • Example 26 The delivery apparatus of any example herein, particularly example 25, wherein the first projections are positioned distal to the second projections.
  • Example 27 The delivery apparatus of any example herein, particularly either example 25 or example 26, wherein an end of the rod extends beyond an end of the second projection in a first position, and wherein the end of the rod is within the opening of the second projection in a second position.
  • Example 28 The delivery apparatus of any example herein, particularly example 27, wherein the rods are configured to retain a tether coupled to a prosthetic heart valve in the first position, and wherein the rods are configured to release the tether in the second position.
  • Example 29 A delivery apparatus for delivering a prosthetic heart valve, the delivery apparatus comprising: a guide catheter shaft having a plurality of first projections extending radially inwards from an inner surface of the guide catheter shaft; a balloon catheter shaft having a plurality of second projections extending radially outwards from an outer surface of the balloon catheter shaft, wherein the balloon catheter shaft is coaxially disposed within the guide catheter shaft and configured to translate relative to the guide catheter shaft; and a plurality of rods, each rod fixedly coupled to one of the second projections and extending through an opening of one of the first projections, wherein the rods are configured to translate relative to the first projections.
  • Example 30 The delivery apparatus of any example herein, particularly example 29, wherein the first projections are positioned proximal to the second projections.
  • Example 31 The delivery apparatus of any example herein, particularly either example 29 or example 30, wherein an end of the rod extends beyond an end of the first projection in a first position, and wherein the end of the rod is within the opening of the first projection in a second position.
  • Example 32 The delivery apparatus of any example herein, particularly example 31, wherein the rods are configured to retain a tether coupled to a prosthetic heart valve in the first position, and wherein the rods are configured to release the tether in the second position.
  • Example 33 The delivery apparatus of any example herein, particularly example 31, wherein the rods are configured to retain a tether coupled to a prosthetic heart valve in the first position, and wherein the rods are configured to release the tether in the second position.
  • a method of implanting a prosthetic heart valve comprising: advancing a distal end portion of a delivery apparatus and a prosthetic heart valve through a patient’ s vasculature, wherein the prosthetic heart valve is in a radially compressed state on the distal end portion of the delivery apparatus, wherein the prosthetic heart valve comprises a radially collapsible and expandable frame, a valvular structure disposed within the frame, and an annular sealing member comprising a base layer and a sealing layer, wherein the sealing member has a first end fixed relative to the frame and a second end spaced from the frame; transitioning the sealing member to a pre-deploy ment configuration in which the second end of the sealing member is disposed around the frame; and radially expanding the prosthetic heart valve from the radially compressed state to a radially expanded state in which the sealing layer of the sealing member contacts native tissue surrounding the prosthetic heart valve.
  • Example 34 The method of any example herein, particularly example 33, wherein the sealing layer does not overlap the frame prior to the act of transitioning the sealing member to the pre-deployment configuration.
  • Example 35 The method of any example herein, particularly example 33 or example 34, wherein sealing layer is radially inward of the base layer during the act of advancing the distal end portion of the delivery apparatus and the prosthetic heart valve through a patient’s vasculature and radially outward of the base layer in the pre-deployment configuration.
  • Example 36 The method of any example herein, particularly, any one or examples 33-35, wherein the delivery apparatus comprises one or more tethers coupled to the second end of the sealing member and to a shaft of the delivery apparatus, wherein transitioning the sealing member to a pre-deployment configuration comprises moving the shaft relative to the prosthetic heart valve to pull the sealing member over the frame with the one or more tethers.
  • Example 37 The method of any example herein, particularly any of examples 33-36, wherein the base layer comprises a non-fabric material and the sealing layer comprises a fabric.
  • any one or more of the features of one outer skirt can be combined with any one or more features of another outer skirt.
  • any one or more features of one prosthetic valve can be combined with any one or more features of another prosthetic valve.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial 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

L'invention concerne des valvules cardiaques prothétiques et des appareils de pose pour valvules cardiaques prothétiques. Dans un exemple, une valvule cardiaque prothétique comprend un cadre annulaire; une structure valvulaire montée à l'intérieur du cadre annulaire ; et un élément d'étanchéité annulaire présentant une première extrémité couplée à une extrémité d'entrée du cadre, l'élément d'étanchéité comprenant une couche de base et une couche d'étanchéité, lorsque l'élément d'étanchéité est plié dans une configuration de pose, l'élément d'étanchéité s'étend à partir de l'extrémité d'entrée du cadre dans une direction s'éloignant d'une extrémité de sortie du cadre, et lorsque l'élément d'étanchéité passe dans une configuration de pré-déploiement, l'élément d'étanchéité est dans une position retournée avec une seconde extrémité de l'élément d'étanchéité s'étendant sur au moins une partie du cadre et la couche de base positionnée radialement entre la couche d'étanchéité et une surface externe du cadre.
PCT/US2025/031493 2024-05-30 2025-05-29 Valvule cardiaque prothétique comportant une jupe externe déployable Pending WO2025250832A1 (fr)

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US202463653503P 2024-05-30 2024-05-30
US63/653,503 2024-05-30
US202463687894P 2024-08-28 2024-08-28
US63/687,894 2024-08-28

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