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WO2025088515A1 - Prothèse de valvule cardiaque transcathéter comprenant une jupe de pont - Google Patents

Prothèse de valvule cardiaque transcathéter comprenant une jupe de pont Download PDF

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Publication number
WO2025088515A1
WO2025088515A1 PCT/IB2024/060429 IB2024060429W WO2025088515A1 WO 2025088515 A1 WO2025088515 A1 WO 2025088515A1 IB 2024060429 W IB2024060429 W IB 2024060429W WO 2025088515 A1 WO2025088515 A1 WO 2025088515A1
Authority
WO
WIPO (PCT)
Prior art keywords
skirt
bridge
fixation
heart valve
valve prosthesis
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/IB2024/060429
Other languages
English (en)
Inventor
Amanda Margaret Barnes
Tasha Ann Cheshko MEZIERE
Milad SAMAEE
Luke LEHMANN
Matthew E. GENOVESE
David A. Grossman
Mustafa Ertan TASKIN
Kelly T. TRAN
Lijin Rajendran NANU
Mina SHAFIEI
Sachin JOSE
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.)
Medtronic Inc
Original Assignee
Medtronic Inc
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 Medtronic Inc filed Critical Medtronic Inc
Publication of WO2025088515A1 publication Critical patent/WO2025088515A1/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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • 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 technology is related generally to transcatheter heart valve prostheses, and more specifically to transcatheter heart valve prostheses a bridge skirt extending between an inner frame and an outer frame of the transcatheter heart valve prosthesis.
  • the human heart is a four chambered, muscular organ that provides blood circulation through the head during a cardiac cycle.
  • the four main chambers include the right atrium and right ventricle which supplies the pulmonary circulation, and the left atrium and left ventricle which supplies oxygenated blood received from the lungs to the remaining head.
  • atrioventricular valves tricuspid and mitral valves
  • semi-lunar valves pulmonary valve and aortic valve
  • valves contain leaflets or cusps that open and shut in response to blood pressure changes caused by the contraction and relaxation of the heart chambers.
  • the leaflets move apart from each other to open and allow blood to flow downstream of the valve, and coapt to close and prevent backflow or regurgitation in an upstream manner.
  • Diseases associated with heart valves can include stenosis and valvular insufficiency or regurgitation.
  • valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve.
  • Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient.
  • a diseased or damaged valve which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency.
  • Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots, which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and/or life threatening.
  • Heart valve prostheses have been developed for repair and replacement of diseased and/or damaged heart valves. Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based systems. Heart valve prostheses can be delivered while in a low profile or compressed/collapsed arrangement so that the heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the heart valve prosthesis can be expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.
  • LVOTO left ventricular outflow tract obstruction
  • TMVR transcatheter mitral valve replacement
  • the techniques and devices of this disclosure generally relate to heart valve prostheses with a bridge skirt configured to bridge an inner frame and a fixation frame of the heart valve prosthesis. Bridging of the inner frame and the fixation frame by the bridge skirt permits removal of material at the outflow ends of either an inner skirt or an outer skirt that can extend therefrom and restrict blood flow to downstream heart valves.
  • the present disclosure relates to a heart valve prosthesis having a radially expanded configuration and a radially compressed configuration.
  • the heart valve prosthesis includes an inner frame, a fixation frame coupled to and radially surrounding the inner frame, an inner skirt coupled to a surface of the inner frame, a fixation skirt coupled to a surface of the fixation frame, a bridge skirt, and a prosthetic valve component disposed within and coupled to the inner frame.
  • Each of the inner frame and the fixation frame includes a plurality of side openings.
  • the bridge skirt includes an inner edge coupled to the inner skirt and an outer edge coupled to the fixation skirt.
  • the bridge skirt is torus shaped.
  • the bridge skirt is frustonically shaped.
  • the outer edge of the bridge skirt is coupled to an inflow end of the fixation skirt.
  • the outer edge of the bridge skirt is coupled to a brim at the inflow end of the fixation skirt.
  • the inner edge of the bridge skirt is coupled to an inflow end of the inner skirt.
  • the inner edge of the bridge skirt is coupled to an outflow end of the inner skirt.
  • the outer edge of the bridge skirt is coupled to an outflow end of the fixation skirt.
  • the inner edge of the bridge skirt is coupled to an inflow end of the inner skirt.
  • the fixation frame in another example hereof, in the heart valve prosthesis of any of the preceding or following examples, includes a fixation ring extending from an inflow end of the fixation frame in a downstream direct to an elbow, and a tapered portion extending in a downstream direction and radially inwardly from the elbow to an outflow end of the fixation frame.
  • downstream end of the fixation skirt is upstream of the elbow of the fixation frame.
  • the downstream end of the fixation skirt is scalloped.
  • downstream end of the inner skirt is scalloped, wherein the downstream end of the inner skirt is coupled to an upstream end of the plurality of leaflets along a margin of attachment.
  • the inner skirt does not extend downstream of the margin of attachment.
  • the bridge skirt is a fabric material and includes a support configured to provide support and structure to the bridge skirt.
  • the support is a fabric quilting structure formed by stitching the bridge skirt in a pattern.
  • the pattern comprises a plurality of circumferential sinusoid patterns, plurality of radial stitching lines, a zig-zag pattern, or a plurality of radial zig-zags.
  • the support comprises a suture support coupling the bridge skirt to at least one of inner frame, the fixation frame, or the brim around at least a portion of the circumference of the bridge skirt.
  • the suture support couples the bridge skirt to at least one of the inner fame or the fixation frame downstream of the bridge skirt.
  • the suture support couples the bridge skirt to at least one of the inner fame, the fixation frame, or the brim upstream of the bridge skirt.
  • the support comprises a plurality of wires extend radially along and coupled to the bridge skirt, wherein each wire is configured to preferentially bend the bridge skirt in an upstream direction when the heart valve prosthesis is in the radially compressed configuration.
  • the support comprises a fabric layer attached to the bridge skirt.
  • the fabric layer includes an inner ring, an outer ring, and a circumferential gap between the inner ring and the outer ring, the circumferential gap configured to enable the bridge skirt to preferentially bend in an upstream direction when the heart valve prosthesis is in the radially compressed configuration.
  • the present disclosure relates to a heart valve prosthesis having a radially expanded configuration and a radially compressed configuration.
  • the heart valve prosthesis includes an inner frame, an inner frame including a plurality side openings, an inner skirt coupled to a surface of the inner frame, a prosthetic valve component including a plurality of leaflets disposed within and coupled to the inner frame, a fixation frame coupled to and radially surrounding the inner frame, the fixation frame including a plurality of side openings, and a bridge skirt having an outer edge coupled to the fixation frame adjacent an inflow end of the fixation frame and an inner edge coupled to the inner skirt distal of plurality of leaflets.
  • the prosthetic valve component is configured to block blood flow in one direction to regulate blood flow through a central lumen of the inner frame.
  • the bridge skirt is frustonically shaped.
  • the fixation frame does not include a skirt.
  • the fixation frame in the heart valve prosthesis of any of the preceding or following examples, includes a fixation ring extending from an inflow end of the fixation frame in a downstream direction to an elbow, and a tapered portion extending in a downstream direction and radially inwardly from the elbow to an outflow end of the fixation frame.
  • the heart valve prosthesis of any of the preceding or following examples further comprises a fixation skirt coupled to a surface of the fixation ring, wherein a distal end of the fixation skirt is proximal of the elbow of the fixation frame.
  • the fixation skirt is scalloped.
  • the outer edge of the bridge skirt is coupled to a brim at an inflow end of the fixation frame.
  • the support is a wire mesh.
  • a heart valve prosthesis having a radially expanded configuration and a radially compressed configuration comprises: an inner frame including a plurality side openings; a fixation frame coupled to and radially surrounding the inner frame, the fixation frame including a plurality of side openings; a prosthetic valve component including a plurality of leaflets, wherein the prosthetic valve component is disposed within and coupled to the inner frame, the prosthetic valve component being configured to block blood flow in one direction to regulate blood flow through a central lumen of the inner frame; and a plurality of leaflet hooks extending from the fixation frame, the plurality of leaflet hooks having a compressed state and an expanded state, wherein in the expanded state the plurality of leaflet hooks extend radially outwardly and proximally and are configured to capture native valve leaflets of a heart valve.
  • the fixation frame in the heart valve prosthesis of any of the preceding or following examples, with the heart valve prosthesis in the radially expanded configuration, includes a fixation ring extending from an inflow end of the fixation frame in a downstream direction to an elbow, and a tapered portion extending in a downstream direction and radially inwardly from the elbow to an outflow end of the fixation frame, and wherein the leaflet hooks extends from the elbow of the fixation frame.
  • each leaflet hook of the plurality of leaflet hooks includes a first arm, a second arm, and a head.
  • the first arm is coupled to a first node at the elbow
  • the second arm is coupled to a second node at the elbow adjacent the first node
  • the head is coupled to the first arm and the second arm.
  • the plurality of leaflet hooks are integrally formed with the fixation frame.
  • the tapered portion of the fixation frame comprises a plurality of connectors extending from the elbow to the outflow end of the fixation frame, wherein with the leaflet hooks in the compressed stated, the plurality of connectors and the leaflet hooks alternate around a circumference of the fixation frame in the tapered portion.
  • the leaflet hooks in the expanded state, extend radially outwardly and proximally from the elbow such that gaps are formed between circumferentially adjacent connectors of the tapered portion where the leaflet hooks were located in the compressed state.
  • the plurality of leaflet hooks are formed separate from the fixation frame and are coupled to the fixation frame.
  • FIG. 1 depicts a perspective view of an example heart valve prosthesis.
  • FIG. 2 depicts a perspective view of an inner frame and prosthetic valve of the heart valve prosthesis of FIG. 1.
  • FIG. 3A depicts a side view of an inner skirt for the heart valve prosthesis of FIG. 1, according to an embodiment hereof.
  • FIG. 3B depicts a perspective view of an inner frame of a heart valve prosthesis with the skirt of FIG. 3 A and a prosthetic valve.
  • FIG. 4 depicts a perspective view of the attachment of the inner skirt of FIG. 3 A to the leaflets of the heat valve prosthesis of FIG. 1.
  • FIG. 5A depicts a fixation skirt according to embodiments hereof.
  • FIG. 5B depicts a perspective view of a heart valve prosthesis with the fixation skirt of FIG. 5A.
  • FIG. 6 depicts a fixation skirt according to embodiments hereof.
  • FIG. 7 depicts a side view of a heart valve prosthesis with the fixation skirt of
  • FIG. 6 disposed thereon.
  • FIG. 8 depicts a perspective view of a heart valve prosthesis with a bridge skirt coupled thereto.
  • FIG. 9 depicts apian view of the bridge skirt of FIG. 8 according to embodiments hereof.
  • FIG. 10 depicts a cross-sectional view of the heart valve prosthesis of FIG. 8 in a radially expanded configuration.
  • FIG. 11 depicts a double whip stitch sewing pattern for coupling a bridge skirt to an inner skirt according to embodiments hereof.
  • FIG. 12 depicts a double running stitch sewing pattern for coupling a bridge skirt to an inner skirt according to embodiments hereof.
  • FIG. 13 depicts coupling of the bridge skirt to an inner skirt according to embodiments hereof.
  • FIG. 14 depicts coupling of the bridge skirt to the fixation skirt according to embodiments hereof.
  • FIG. 15 depicts coupling of the bridge skirt to a brim of a heart valve prosthesis according to embodiments hereof.
  • FIG. 16 depicts a bridge skirt including patterned stitching for bridge skirt support according to embodiments hereof.
  • FIG. 17 depicts a bridge skirt including patterned stitching for bridge skirt support according to embodiments hereof.
  • FIG. 18 depicts a bridge skirt including patterned stitching for bridge skirt support according to embodiments hereof.
  • FIG. 19 depicts a bridge skirt including patterned stitching for bridge skirt support according to embodiments hereof.
  • FIG. 20 depicts a bridge skirt including patterned stitching for bridge skirt support according to embodiments hereof.
  • FIG. 21 depicts a cross sectional view of a heart valve prosthesis including a bridge skirt and a bridge skirt suture support at the fixation frame according to embodiments hereof.
  • FIG. 22 depicts a cross sectional view of a heart valve prosthesis including a bridge skirt and a bridge skirt suture support at the inner frame according to embodiments hereof.
  • FIG. 23 depicts a cross sectional view of a heart valve prosthesis including a bridge skirt and a bridge skirt suture support at the inner frame according to embodiments hereof.
  • FIG. 24 depicts a cross sectional view of a heart valve prosthesis including a bridge skirt and a bridge skirt suture support at the brim according to embodiments hereof.
  • FIG. 25 depicts a cross sectional view of a heart valve prosthesis including a bridge skirt and a bridge skirt wire support according to embodiments hereof.
  • FIG 26A-26B depict the heart valve prosthesis of FIG. 25 with a bridge skirt wire support of FIG. 25 disposed within a delivery capsule.
  • FIG. 27A-27D depict various views of a bridge skirt with a fabric layering support according to embodiments hereof.
  • FIG. 28 depicts a cross-sectional view of a heart valve prosthesis with an angled bridge skirt according to embodiments hereof.
  • FIGS. 29A-29C depict coupling profiles for the angled bridge skirt of FIG. 28.
  • FIG. 30 depicts a cross-sectional view of a heart valve prosthesis with an angled bridge skirt according to embodiments hereof.
  • FIG. 31 depicts a cross-sectional view of a heart valve prosthesis with a bridge skirt disposed downstream of the prosthetic valve leaflets according to embodiments hereof.
  • FIGS . 32A-32C depict coupling profiles for the bridge skirt of FIG. 31.
  • FIG. 33A-33B depict a cross-sectional view and a top view, respectively, of a heart valve prosthesis including a bridge skirt with a brim wire according to embodiments hereof.
  • FIG. 34 depicts a cross-sectional view of a heart valve prosthesis with a bridge skirt including a vertical bridge according to embodiments hereof.
  • FIG. 35 depicts a cross-sectional view of a heart valve prosthesis with an angled bridge skirt according to embodiments hereof.
  • FIG. 36 depicts the heart valve prosthesis of FIG. 35, in situ, at the site of a native mitral valve.
  • FIG. 37 depicts a fixation frame of a heart valve prosthesis in a radially expanded configuration with a plurality of leaflet hooks according to embodiments hereof.
  • FIG. 38 depicts the fixation frame of FIG. 37 in a radially collapsed configuration.
  • FIG. 39A depicts a perspective view of a portion of the fixation frame of FIG. 37 showing a leaflet hook thereof according to embodiments hereof.
  • FIG. 39B depicts a side view a portion of the fixation frame of FIG. 37 showing a leaflet hook thereof according to embodiments hereof.
  • FIG. 39C depicts a bottom, perspective view of the fixation frame of FIG. 37 in the radially expanded configuration.
  • FIG. 40 depicts the fixation frame and the leaflet hooks of FIG. 37 in an as-cut, laid-open flat view.
  • FIG. 41 depicts a cross-sectional view of a heart valve prosthesis with the fixation frame of FIG. 37 according to embodiments hereof.
  • FIG. 42 depicts a fixation frame of a heart valve prosthesis in a radially expanded configuration with a plurality of leaflet hooks according to embodiments hereof.
  • FIG. 43 depicts the fixation frame of FIG. 42 in a radially collapsed configuration.
  • FIG. 44A depicts a perspective view of a portion of the fixation frame of FIG. 46 showing a leaflet hook thereof according to embodiments hereof.
  • FIG. 44B depicts a side view of a portion of the fixation frame of FIG. 46 showing a leaflet hook thereof according to embodiments hereof.
  • FIG. 45 depicts the fixation frame of FIG. 46 in an as-cut, laid-open flat view.
  • FIG. 46 depicts a leaflet hook according to embodiments hereof.
  • FIG. 47 depicts a view of the leaflet hook of FIG. 50 engaged with a heart valve leaflet.
  • FIGS. 48-51 depict steps in a method of deploying a heart valve prosthesis including leaflet hooks, in situ, at the site of a native mitral valve.
  • distal and proximal when used in the following description to refer to a native vessel, native valve, or a device to be implanted into a native vessel or native valve, such as a heart valve prosthesis, are with reference to the direction of blood flow.
  • distal and distal refer to positions in a downstream direction with respect to the direction of blood flow
  • proximal and proximally refer to positions in an upstream direction with respect to the direction of blood flow.
  • Embodiments disclosed herein are directed to bridge skirts extending between an inner frame and an outer or fixation frame of a transcatheter heart valve prosthesis.
  • the bridge skirts in combination with reduced length inner and/or outer skirts reduce the risks of left ventricular outflow tract obstruction (LVOTO) and improve patient eligibility for transcatheter mitral valve replacement.
  • LVOTO left ventricular outflow tract obstruction
  • FIGS. 1-2 illustrate a heart valve prosthesis 100 upon which the embodiments of bridge skirts described herein may be utilized.
  • the heart valve prosthesis 100 is illustrated herein to facilitate description of the present disclosure.
  • the following description of the heart valve prosthesis 100 is merely exemplary in nature and is not intended to limit the disclosure or the application and uses of the disclosure. It is understood that any number of alternate heart valve prostheses can be used with the bridge skirts described herein.
  • Other non-limiting examples of heart valve prostheses that can be used with the bridge skirts described herein are described in U.S. Patent No. 11,318,013 to Medtronic, Inc., U.S. Patent No. 9,034,032 to Twelve, Inc., International Patent Application No.
  • FIG. 1 is a perspective view of the heart valve prosthesis 100 in accordance with an embodiment hereof.
  • the heart valve prosthesis 100 is configured with a radially compressed configuration for delivery within a vasculature (not shown) and to return to a radially expanded configuration when deployed, as shown in FIG. 1.
  • the heart valve prosthesis 100 when the heart valve prosthesis is in the radially compressed configuration, the heart valve prosthesis 100 has a low profile suitable for delivery to and deployment within a native heart valve via a suitable delivery catheter that may be tracked to the deployment site of the native heart valve of a heart via any one of a transseptal, retrograde, or transapical approach.
  • the heart valve prosthesis 100 includes an inner frame 102 surrounded by and coupled to a fixation frame 104.
  • a prosthetic valve component 106 is disposed within and coupled to the inner frame 102.
  • the prosthetic valve component 106 includes at least one valve leaflet 108 disposed within and secured to the inner frame 102 and an inner skirt 116, as described in greater detail below.
  • the inner frame 102 and the fixation frame 104 described herein as elements of the heart valve prosthesis 100 may be made from any number of suitable biocompatible materials, e.g., stainless steel, nickel titanium alloys such as NitinolTM, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials.
  • suitable biocompatible materials e.g., stainless steel, nickel titanium alloys such as NitinolTM, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials.
  • the inner frame 102 may be a tubular stent-like structure that defines a lumen 110 from an inflow end 112 of the inner frame 102 to an outflow end 114 of the inner frame 102, as best shown in FIG. 2.
  • the inner frame 102 is configured to support the prosthetic valve component 106 therein, described in more detail below.
  • the inner frame 102 has a substantially cylindrical shape in which the outflow end 114 of the inner frame 102 has a diameter that is substantially the same as a diameter of the inflow end 112 of the inner frame 102.
  • the inner frame 102 includes a plurality of crowns 122 and a plurality of struts 124 with each crown 122 being formed between a pair of opposing struts 124.
  • Each crown 122 is a curved segment or bend extending between opposing struts 124.
  • the inner frame 102 is tubular, with a plurality of side openings 126 being defined by edges of the plurality of crowns 122 and the plurality of struts 124. In an embodiment, the plurality of side openings 126 may be substantially diamond-shaped.
  • the inner frame 102 includes a plurality of nodes 128.
  • a node 128 is defined as a region where two crowns 122 of the plurality of crowns 122 within the inner frame 102 meet or connect.
  • the inner frame 102 includes an inner skirt 116 coupled to a surface thereof. More particularly, the inner skirt 116 includes an inflow end 160 and an outflow end 162 and is coupled to an inner surface of the inner frame 102 to line a portion thereof. In the embodiment of FIG. 2, the outflow end 162 of the inner skirt 116 extends at least to the commissures 109A-109C of the valve leaflets 108 or the outflow end of the valve leaflets 108. In other words, the skirt 116 extends in the outflow direction beyond the margin of attachment between the valve leaflets 108 and the skirt 116, as shown in FIG. 2.
  • the inner skirt 116 includes an outflow end 162 with three (3) scallops 164.
  • Each scallop 164 corresponds to a first end 166 of a valve leaflet 108 of the prosthetic valve component 106 and is coupled thereto.
  • the inner skirt 116 is attached to an inner surface 132 of the inner frame 102 around a circumference thereof, and lines a portion off the inner surface 132 of the inner frame 102 above a margin of attachment, or MOA, of the valve leaflets 108 and spans across or extends over each adjacent side opening 126 of the plurality of side openings 126.
  • the inner skirt 116 may span or cover only a portion of each adjacent side opening 126.
  • the outflow end 162 of the inner skirt 116 does not extend in the outflow direction beyond the MOA of the valve leaflets 108, and thus does not extend into the left ventricular outflow tract, thereby reducing obstruction thereof and improving blood flow through the left ventricular outflow tract and to an aortic valve. Additionally, reducing the amount of material required for the inner skirt 116 reduces the profile of the inner frame 102 when the heart valve prosthesis 100 is in the radially compressed configuration.
  • the inner skirt 116 may be a natural or biological material such as pericardium or another membranous tissue such as intestinal submucosa.
  • the inner skirt 116 may be a low-porosity woven fabric, such as polyester, Dacron fabric, or PTFE, which creates a one-way fluid passage when attached to the stent.
  • the inner skirt 116 may be a knit or woven polyester, such as a polyester or PTFE knit, which can be utilized when it is desired to provide a medium for tissue ingrowth and the ability for the fabric to stretch to conform to a curved surface.
  • Polyester velour fabrics may alternatively be used, such as when it is desired to provide a medium fortissue ingrowth on one side and a smooth surface on the other side.
  • the prosthetic valve component 106 of the heart valve prosthesis 100 is capable of regulating flow therethrough via the valve leaflets 108 that may form a replacement valve .
  • FIGS. 1-4 illustrate an exemplary prosthetic valve component having three (3) leaflets, although a single leaflet or bicuspid leaflet configuration may alternatively be used in embodiments hereof.
  • the prosthetic valve component 106 in a closed state is configured to block blood flow in one direction to regulate blood flow through the lumen 110 of the inner frame 102.
  • FIG. 3B depicts a perspective view of the inner frame 102 with a prosthetic valve component 106 secured therein, the inner frame 102 being shown in FIG. 3B removed from the remainder of the heart valve prosthesis 100 shown in FIG. 1 for ease of illustration.
  • the prosthetic valve component 106 includes valve leaflets 108, e.g., three valve leaflets 108, that are disposed to couple to the outflow end 162 of the inner skirt 116 with leaflet commissures 109A, 109B, 109C of the valve leaflets 108 being secured within a downstream portion of the inner frame 102, such that the valve leaflets 108 open during diastole.
  • Valve leaflets 108 are attached to the inner skirt 116 and to the inner frame 102 as described above, for example, using sutures or a suitable biocompatible adhesive.
  • the MOA is formed at the junction of the valve leaflets 108 to the outflow end 162 of the inner skirt 116.
  • Adjoining pairs of valve leaflets 108 are attached to one another at their lateral ends to form leaflet commissures 109A, 109B, 109C.
  • the orientation of the valve leaflets 108 within the inner frame 102 depends upon which end of the heart valve prosthesis 100 is the inflow end and which end of the heart valve prosthesis 100 is the outflow end, thereby ensuring one-way flow of blood through the heart valve prosthesis 100.
  • the valve leaflets 108 may be formed of various flexible materials including, but not limited to natural pericardial material such as tissue from bovine, equine or porcine origins, or synthetic materials such as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolytic carbon, or other biocompatible materials. With certain prosthetic leaflet materials, it may be desirable to coat one or both sides of the replacement valve leaflet with a material that will prevent or minimize overgrowth. It is further desirable that the prosthetic leaflet material is durable and not subject to stretching, deforming, or fatigue.
  • the fixation frame 104 is a stent-like structure that functions as an anchor for the heart valve prosthesis 100 to secure its deployed position within a native annulus.
  • the fixation frame 104 includes an inflow end 148 and an outflow end 142.
  • the fixation frame 104 includes a fixation ring 169 extending in a downstream direction from the inflow end.
  • the fixation ring 169 is generally cylindrical in shape.
  • a tapered portion 170 of the fixation frame 104 extends from the fixation ring 169 at an elbow 171, and tapers inwardly toward the outflow end 142, where the fixation frame 104 is coupled to the inner frame 102.
  • the fixation frame 104 is configured to engage heart tissue at or below an annulus of a native heart valve, such as an annulus of a native mitral valve. At the inflow end 112 of the inner frame 102, the fixation frame 104 is radially spaced from the inner frame 102 to mechanically isolate the inflow end 112 of the inner frame 102 from the fixation frame 104. As shown in FIG. 1, the fixation frame 104 includes a plurality of crowns 134 and a plurality of struts 136 with each crown 134 being formed between a pair of opposing struts 136. Each crown 134 is a curved segment or bend extending between opposing struts 136.
  • the fixation frame 104 is generally tubular, with a plurality of side openings or cells 138 being defined by edges of the plurality of crowns 134 and the plurality of struts 136.
  • the plurality of side openings 138 may be substantially diamond-shaped.
  • the fixation frame 104 includes a plurality of nodes 140, wherein each node 140 is defined as a region where two crowns 134 of the plurality of crowns 134 within the fixation frame 104 meet or connect.
  • crowns 134 and nodes 140 may also be used interchangeably.
  • an outflow end 142 of the fixation frame 104 is coupled to the outflow end 114 of the inner frame 102 by, for example, and not by way of limitation, rivets, sutures, soldering, welding, staples, or other fasteners, mechanical interlocking, snap fit, friction or interference fit, or any combination thereof.
  • the fixation frame 104 includes one or more cleats or prongs 118 that extend outward from an exterior side thereof to engage heart tissue.
  • the fixation frame 104 may employ barbs, spikes, or other tissue fixation mechanisms for engaging heart tissue.
  • the prongs 118, or any of the other various fixation features may be formed integrally with the fixation frame 104 or may be coupled to the fixation frame 104 by, for example, and not by way of limitation, rivets, sutures, soldering, welding, staples, or other fasteners, mechanical interlocking, snap fit, friction or interference fit, or any combination thereof.
  • the fixation frame 104 further includes a fixation skirt 146 with an inflow end 156 and an outflow end 158.
  • the fixation skirt 146 is attached to and lines an inner surface 172 of the fixation frame 104 around a circumference thereof.
  • the fixation skirt 146 extends to the outflow end 142 of the fixation frame 104, or at least into the tapered portion 170 of the fixation frame 104, such that the outflow end 158 of the fixation skirt 146 is adjacent the outflow end 142 of the fixation frame 104.
  • the fixation skirt 146 is shortened relative to the fixation skirt 146 of FIG.
  • the fixation skirt 146 terminates upstream of the tapered portion 170, at or upstream of the elbow 171.
  • the fixation skirt 146 has a substantially rectangular shape.
  • the fixation skirt 146 is attached to and lines an inner surface 172 of the fixation frame 104 around a circumference thereof.
  • the fixation skirt 146 may be a natural or biological material such as pericardium or another membranous tissue such as intestinal submucosa, or may be a low-porosity woven fabric, such as polyester, Dacron fabric, or PTFE.
  • a fixation skirt 246 includes an inflow end 256 and an outflow end 258 with a plurality of scallops 268.
  • Each scallop 268 is of a generally triangular shape to correspond to an adjacent side opening 138 of the fixation frame 104.
  • the outflow end 256 of the fixation skirt 246 is coupled to the fixation frame 104 proximal of, or upstream of, the tapered portion 170 of the fixation frame 104.
  • the fixation skirt 246 is attached around an inner circumference thereof, and lines a portion off the fixation frame 104 above the tapered portion 170.
  • the outflow end 258 of the fixation skirt 246 does not extend into the left ventricular outflow tract. Ventricular outflow tract obstruction is therefore reduced, and blood flow through the left ventricular outflow tract to an aortic valve is improved. As described above, the reduction in the amount of material in the fixation skirt 246 also reduces the profile of the of the heart valve prosthesis 100 when in the radially compressed configuration, making delivery of the heart valve prosthesis 100 easier for the clinician. [00118] Referring back to FIG.
  • the heart valve prosthesis 100 further includes a brim or rim element 120 that extends outwardly from the inflow end 148 of the fixation frame 104.
  • the brim 120 includes overlapping, 180 degree out of phase sinusoidal wire forms 121 that are attached and hinged to the fixation frame 104 by a suitable biocompatible low-profile fabric used in bioprosthetic implants to promote bio-integration, such as woven polyethylene terephthalate (PET) fabric.
  • PET polyethylene terephthalate
  • the brim 120 may act as an atrial retainer, if present, and to serve such a function the brim 120 may be configured to engage tissue above a native annulus, such as a supra-annular surface or some other tissue in the left atrium, to thereby inhibit downstream migration of the heart valve prosthesis 100, for e.g., during atrial systole.
  • a bridge skirt 150 extends between the inner frame 102 and the fixation frame 104.
  • the bridge skirt 150 has an annular shape with an outer edge 152, an inner edge 154, and a central opening 155.
  • the shape of the bridge skirt 150 may also be described as donut or torus shaped. In an embodiment best shown in FIG.
  • the outer edge 152 of the bridge skirt 150 is disposed at and coupled to the inflow end 156 of the fixation skirt 146 and the inner edge 154 of the bridge skirt 150 is disposed at and coupled to the inflow end 160 of the inner skirt 116.
  • the bridge skirt 150 prevents blood flow in the upstream direction (up in FIG. 10) between the inner frame 102 and the fixation frame 104 proximal (upstream) of the bridge skirt 150.
  • the bridge skirt 150 may be formed of a low-porosity woven fabric, such as polyester, Dacron fabric, or PTFE, or may be formed of tissue, such as pericardial tissue.
  • the inner edge 154 of the bridge skirt 150 is coupled to the inflow end 160 of the inner skirt 116 in an edge-to-edge configuration by sewing with a double whip stitch 191, as shown in FIG. 11.
  • the inner edge 154 of the bridge skirt 150 may be coupled to the inflow end 160 of the inner skirt 116 in an edge-to-edge seam by sewing with a double running stitch 193, as shown in FIG. 12.
  • the bridge skirt 150 may be coupled to the inner skirt 116, and moreover to other components in other embodiments described herein by thread or filament of any suitable suture material, such as, but not limited to silk, nylon, polypropylene, polyester, polytetrafluoroethylene, or other materials suitable for the purposes described herein.
  • the inner edge 154 of the bridge skirt 150 is folded towards the outflow end 162 of the inner skirt 116 and coupled to the inner skirt 116 above the MOA of the valve leaflets 108 by sewing with a double run stitch 193.
  • the outer edge 152 of the bridge skirt 150 is folded toward the outflow end 158 of the fixation skirt 146 and is coupled to the fixation skirt 146 near the inflow end 156 with a double running stitch 193.
  • the outer edge 152 of the bridge skirt 150 is coupled to an inner portion 168 of the brim 120.
  • the outer edge 152 of the bridge skirt 150 is layered over an inner portion 168 of the brim 120 and coupled thereto with a double running stitch 193.
  • FIGS. 11-15 are examples of connections between the bridge skirt 150 and the inner and fixation frames 102, 104, and are not meant to be limiting.
  • the bridge skirt 150 may be coupled to the inner and fixation frames 102, 104 in other suitable ways as known to those skilled in the art.
  • FIGS. 16-27D illustrate various support components implemented with and configured to provide support and structure for embodiments of the bridge skirts 150 described herein.
  • Each support component described herein is configured to improve durability of the fabric of the bridge skirt 150 and can be configured to influence the direction of folding when the heart valve prosthesis 100 transitions to the radially compressed configuration to thereby improve packing density and making delivery of the heart valve prosthesis 100 easier for the clinician.
  • the support components can promote folding of the bridge skirt 150 in desired locations and discourage folding of the bridge skirt 150 in between the fixation frame 104 and the inner frame 102. While the various support components are described separately, this is not meant to be limiting, and one or more of the various support components may be combined in any combination.
  • Fabric quilting structures are described with references to FIGS. 16-20.
  • Fabric quilting is the stitching of the bridge skirt 150, wherein the stitches are in particular patterns such that the stitches add support to the unsupported fabric of the bridge skirt 150, as described below.
  • the bridge skirt 150 is supported and reinforced with a plurality of stitched offset sinusoids 180.
  • a centerline of each sinusoid 180 of the plurality of sinusoids is same radial distance from the inner edge 154 of the bridge skirt 150.
  • a first contiguous sinusoid 180A and a second contiguous sinusoid 180B are stitched into the bridge skirt 150 with a sine wave geometric waveform that oscillates, or travels radially inward towards the inner edge 154 and radially outward towards the outer edge 152 of the bridge skirt 150, periodically, forming peaks 182 and valleys 184.
  • each peak 182 extends radially outward direction and each valley extends in a radially inward direction.
  • each sinusoid is an s-shaped wave traveling circumferentially around the bridge skirt 150.
  • the sinusoids 180 are offset from each other such that each peak 182A and each valley 184A of the first sinusoid 180A are offset from the adjacent peaks 182B and valleys 184B of the second sinusoid 180B.
  • FIG. 16 shows two sinusoids 180 and a specific number of peaks 182 and valleys 184. This is not meant to limit the invention, more than two sinusoids are possible, with each sinusoid having more or fewer peaks 182 and valleys 184.
  • FIG. 17 shows the bridge skirt 150 with another embodiment of quilting support, wherein the bridge skirt 150 is supported and reinforced with a plurality of stitched straight lines 186.
  • Each stitch straight line 186 extends radially outward from a point at or near the inner edge 154 of the bridge skirt 150 to a point at or near the outer edge 152 of the bridge skirt 150. While illustrated in FIG. 17 with a specific number of radial stitched straight lines 186, more or fewer are possible.
  • the bridge skirt 150 is supported and reinforced with a continuous zig-zag stitching pattern 188.
  • the zig-zag stitching pattern 188 extends from adjacent the inner edge 154 of the bridge skirt 150 to adjacent the outer edge 152 at a first angle, then returns back to the inner edge 154 at a second angle.
  • FIG. 18 is a bottom view of heart valve prosthesis 100 such that the zig-zag stitching pattern 188 is on the outflow side of the bridge skirt 150. Further, in the embodiment shown, the zig-zag stitching pattern 188 extends only partially around the circumference of the bridge skirt 150.
  • the zig-zag stitching pattern 188 may extend only around the portion of the bridge skirt 150 configured to be adjacent the native aortic valve (i.e., the anterior side). However, this is not meant to be limiting, and the zigzag stitching pattern 188 may extend around the entire circumference of the bridge skirt 150. While illustrated in FIG. 18 with specific and generally consistent first and second angles, in alternative embodiments the angle of each radial section may be the same, different, or combined in any combination.
  • quilting support of the bridge skirt 150 utilizes a plurality of stitched radial zig-zag sections 190.
  • Each stitched radial zig-zag section 190 is substantially a zig-zag segment with stitching beginning at a first end 192 at or near the inner edge 154 of the bridge skirt 150, and continuing radially outward in a back and forth, or clockwise-counterclockwise zig-zag pattern to a second end 194 at or near the outer edge 152 of the bridge skirt 150. While shown herein with a specific number of stitched radial zig-zag sections 190, this is not meant to limit the design, and more or fewer stitched radial zig-zag sections 190 may be utilized.
  • the bridge skirt 150 is supported and reinforced with a plurality of stitched circumferential sinusoids 196.
  • a centerline of each circumferential sinusoid 196 of the plurality of circumferential sinusoids 196 is at a different radial distance from the inner edge 154 of the bridge skirt 150.
  • a first contiguous sinusoid 196A and a second contiguous sinusoid 196B are each stitched into the bridge skirt 150 with a sine wave geometric waveform that oscillates, or travels radially inward towards the inner edge 154 and radially outward towards the outer edge 152 of the bridge skirt 150, periodically, in an s-shape traveling circumferentially around the bridge skirt 150.
  • Each circumferential sinusoid 196 is radially aligned such that each peak 198A and each valley 200A of the first sinusoid 196A is substantially radially aligned with a corresponding peak 198B and valley 200Bof the second sinusoid 196B. Accordingly, each circumferential sinusoid 196 of the plurality of circumferential sinusoids 196 has an equivalent number of peaks 198 and valleys 200. Each peak 198 and each valley 1200 of the plurality of circumferential sinusoids 196 extends radially outward or inward for a portion of the bridge skirt 150 between the inner edge 154 and the outer edge 152.
  • each circumferential sinusoid While illustrated with two circumferential sinusoids 196 and a specific number of peaks 198 and valleys 200, it will be understood that more or fewer than two circumferential sinusoids are possible, with each circumferential sinusoid having more or fewer peaks 198 and valleys 200.
  • FIGS. 21-24 describe embodiments of suture or tether support components for use with the bridge skirt 150.
  • Each suture support couples the unsupported fabric of the bridge skirt 150 to a structural component of the heart valve prosthesis 100 to provide support to the unsupported fabric of the bridge skirt 150 when the heart valve prosthesis 100 is in the radially expanded configuration.
  • Each suture support described herein may be formed of any thread or filament of suitable suture material, for example silk, nylon, polypropylene, polyester, polytetrafluoroethylene, or other materials suitable for the purposes described herein.
  • Each suture support in embodiments herein may be coupled to the bridge skirt 150 and the structural component of the heart valve prosthesis 100 by adhesives, knots, or any other suitable material.
  • embodiments of suture supports described herein may be used together in any combination to support the bridge skirt 150.
  • FIG. 21 shows a suture support 202 for supporting the bridge skirt 150 according to an embodiment hereof.
  • the suture support 202 has a first end 204 coupled to the bridge skirt 150 at a point between the inner edge 154 and the outer edge 152.
  • a second end 206 of the suture support 202 is coupled to the fixation frame 104 below or on an outflow side 226 of the bridge skirt 150.
  • the suture support 202 may be coupled to the fixation skirt 146 and/or the fixation frame 104. Although described as “ends” of the suture support 202, the “ends” may be considered “ends” in the cross-sectional view as the suture support may continue around the circumference of the bridge skirt 150, as explained below.
  • suture support 202 is shown only in two locations (left and right).
  • the suture support 202 can extend around the entire circumference of the bridge skirt 150, extending back and forth between the bridge skirt 150 and the fixation frame 104 at spaced intervals. In other embodiments, the suture support 202 may extend around only a portion of the circumference of the bridge skirt 150.
  • a suture support 208 has a first end 210 coupled to the bridge skirt 150 at a point between the inner edge 154 and the outer edge 152 and a second end 212 coupled to the inner frame 102 below or on an outflow side 226 of the bridge skirt 150.
  • FIG. 22 is a cross-sectional view such that the suture support 202 is shown only in two locations (left and right).
  • the suture support 208 can extend around the entire circumference of the bridge skirt 150, extending back and forth between the bridge skirt 150 and the fixation frame 104 at spaced intervals. In other embodiments, the suture support 208 may extend around only a portion of the circumference of the bridge skirt 150.
  • a suture support 214 has a first end 216 coupled to the bridge skirt 150 at a point between the inner edge 154 and the outer edge 152 and a second end 218 coupled to the inner frame 102 above, or on the inflow side 228 of the bridge skirt 150.
  • FIG. 23 is a cross-sectional view such that the suture support 214 is shown only in two locations (left and right).
  • the suture support 214 can extend around the entire circumference of the bridge skirt 150, extending back and forth between the bridge skirt 150 and the fixation frame 104 at spaced intervals. In other embodiments, the suture support 214 may extend around only a portion of the circumference of the bridge skirt 150.
  • a suture support 220 is attached between the bridge skirt 150 and the brim 120 to support the bridge skirt 150.
  • the suture support 220 includes a first end 222 coupled to the bridge skirt 150 at a point between the inner edge 154 and the outer edge 152 thereof, and a second end 224 coupled to the brim 120.
  • FIG. 24 is a cross-sectional view such that the suture support 214 is shown only in two locations (left and right).
  • the suture support 214 can extend around the entire circumference of the bridge skirt 150, extending back and forth between the bridge skirt 150 and the brim 120 at spaced intervals. In other embodiments, the suture support 214 may extend around only a portion of the circumference of the bridge skirt 150.
  • a support component for the bridge skirt 150 includes a wire 230 supporting the bridge skirt 150.
  • the wire 230 is coupled to an outflow side of the bridge skirt 150, but this is not meant to be limiting, and the wire 230 may instead be coupled to an inflow side of the bridge skirt 150.
  • the wire 230 extends radially from a first end 232 adjacent to the inner frame 102 and a second end 234 adjacent to the fixation frame 104.
  • Each wire 230 is configured to support the bridge skirt 150 when the heart valve prosthesis is in the radially expanded configuration.
  • FIG. 25 is a cross-sectional view such that only two wires 230 are shown.
  • wires 230 may be positioned radially around the entire circumference of the bridge skirt 150, similar to the radial stitched straight line sutures 186 shown in FIG. 17.
  • Each wire 230 may be coupled to the bridge skirt 150 by stitching, adhesives, or other mechanical connections, or may be woven into the fabric of the bridge skirt.
  • the ends 232, 234 of wires 230 may also be attached to the inner and fixation frames 102, 104, respectively.
  • each wire 230 includes a fold point 238 between the first end 232 and the second end 234 configured to promote folding of the wire 230 at the fold point 238 in a direction towards the inflow side 228 of the bridge skirt 150 when the heart valve prosthesis 100 transitions to the radially compressed configuration, such as when compressing the heart valve prosthesis 100 into a capsule of a delivery system.
  • Folding of each wire 230 as described above, and shown in FIGS . 26A-26B reduces the overall profile of the heart valve prosthesis 100 in the radially compressed configuration by locating the folded bridge skirt 150 with the wires 230 attached thereto away from the portion of the heart valve prosthesis 100 where the inner frame 102 and the fixation frame 104 radially overlap.
  • FIG. 26A shows the heart valve prosthesis 100 as it is being radially compressed into a delivery capsule DC of a delivery device DD, showing the bridge skirt 150 being folded in the upstream direction.
  • FIG. 26B shows the heart valve prosthesis within the delivery capsule DC with an inflow portion of the heart valve prosthesis extending from an end of the delivery capsule DC, showing the folded bridge skirt 150.
  • each fold point 238 may be formed with a bend imparted at the factory disposed to fold the desired direction. In another embodiment, each fold point 238 may be formed by weakening the wire structure at the fold point 238.
  • the wire 230 may be made from any number of suitable biocompatible materials, e.g., stainless steel, nickel titanium alloys such as NitinolTM, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials.
  • suitable biocompatible materials e.g., stainless steel, nickel titanium alloys such as NitinolTM, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials.
  • ELGILOY® Elgin, Ill.
  • the bridge skirt 150 includes multiple fabric layers.
  • the support for the bridge skirt 150 is provided by at least one fabric support layer.
  • FIG. 27A-27D shows a fabric support layer 242 that includes an inner ring 241 and an outer ring 243, both disposed on an inflow facing surface 228 of the bridge skirt 150.
  • the inner ring 241 and the outer ring 243 are separated by a circumferential gap 253.
  • the inner ring 241 has an inner edge 245 defining a first inner diameter ID 1 and outer edge 247 defining a first outer diameter OD 1.
  • the outer ring 243 has an inner edge 249 defining a second inner diameter ID2 and an outer edge 251 defining a second outer diameter OD2.
  • the first outer diameter GDI of inner ring 241 is smaller than the second inner diameter ID2 of the outer ring 243.
  • the inner ring 241 is disposed on and coupled to an inner radial portion of the inflow facing surface 228 of the bridge skirt 150 such that the inner edge 245 is disposed adjacent the inner edge 154 of the bridge skirt 150.
  • the outer ring 243 is disposed on and coupled to an outer radial portion of the inflow facing surface 228 of the bridge skirt 150, with the outer edge 251 disposed adjacent the outer edge 152 of the bridge skirt 150.
  • the first outer diameter OD 1 of the inner ring 241 and the second inner diameter ID2 of the outer ring 243 are sized such that when disposed on the inflow facing surface 228 of the bridge skirt 150 as described above, the outer edge 247 of the inner ring 241 does not meet the inner edge 249 of the outer ring 243, thereby defining the circumferential gap 253 between the inner ring 241 and the outer ring 243.
  • the inner and outer rings 241, 243 are configured to support the bridge skirt 150 when the heart valve prosthesis 100 is in the radially expanded configuration.
  • the circumferential gap 253 is configured to promote folding of the bridge skirt 150 in a direction towards the inflow facing surface 228 when the heart valve prosthesis 100 is in the radially compressed configuration.
  • FIGS. 27C-27D reduces the overall profile of the heart valve prosthesis 100 in the radially compressed configuration and promotes ease of delivery to a target deployment annulus.
  • the inner and outer rings 241, 243 of the fabric support layer 242 may each be formed of a low-porosity woven fabric, such as polyester, Dacron fabric, or PTFE, or may be formed of tissue, such as pericardial tissue.
  • the inner and outer rings 241, 243 may each be coupled to the bridge skirt 150 by adhesives, thread or filament, or any other suitable method.
  • FIGS. 28-34 show additional embodiments of bridge skirts for use with heart valve prostheses.
  • each embodiment will be described in greater detail below as part of a heart valve prosthesis, similar to the heart valve prosthesis 100 described above, except for the bridge skirt. Accordingly, other parts of the heart valve prosthesis 100 will use the same reference numerals, such as, but not limited to, the inner frame 102, the fixation frame 104, prosthetic valve component 106, the inner skirt 116, and the fixation skirt 146. Thus, these parts need not be described again.
  • Each of the embodiments is configured to permit removal of skirt material at an outflow end of the respective inner frame and/or fixation frame, as described above, and in any combination, to minimize or eliminate heart valve prosthesis obstruction within the left ventricular outflow tract to improve blood flow therethrough to the aortic valve and to increase the number of patients eligible for transcatheter mitral valve replacement.
  • FIG. 28 illustrates a cross sectional view of the heart valve prosthesis 100 with an angled bridge skirt 1150.
  • the angled bridge skirt 1150 is frustoconically shaped.
  • the angled bridge skirt 1150 is coupled to the inner and fixation skirts 116, 146 such that the angled bridge skirt 1150 is angled in an outflow direction from the inner skirt 116 to the fixation skirt 146.
  • an inner edge 1154 of the bridge skirt 1150 is coupled to the inner skirt 116 at or above the MOA of the inner skirt 116 with the plurality of valve leaflets 108.
  • An outer edge 1152 of the angled bridge skirt 1150 is coupled to the fixation skirt 146 at or near the outflow end 158 thereof, which is adjacent the elbow 171 of the fixation frame 104.
  • the outer edge 1152 may be coupled directly to the fixation skirt 146 at the outflow end 158, as shown in FIG. 29A.
  • an outer portion of the angled bridge skirt 1150 can be folded in the inflow direction at the elbow 171 and the outer edge 1152 can be coupled to the outer surface of to the fixation skirt 146, as shown in FIG. 29B or to the inner surface of the fixation skirt 146, as shown in FIG. 29C.
  • the angled bridge skirt 1150 of this embodiment can be used with a scalloped inner skirt 116 as described above.
  • the various supports described above with respect to the bridge skirt 150 may also be used with this embodiment.
  • the fixation skirt 146 can extend to the elbow 171 of the fixation frame 104, or to a point upstream of the elbow 171.
  • the angled bridge skirt 1150 may be used with the scalloped fixation skirt 146, as described above.
  • FIG. 30 shows another embodiment of an angled bridge skirt 2150.
  • the angled bridge skirt 2150 is similar to the angled bridge skirt 1150 except that the angled bridge skirt 2150 is angled in an outflow direction from the fixation skirt 146 to the inner skirt 116.
  • the angled bridge skirt 2150 is also frustoconically shaped, but is upside down as compared to the angled bridge skirt 1150.
  • an outer edge 2152 of the angled bridge skirt 2150 is coupled to the fixation skirt 146 at or near the inflow end 156.
  • An inner edge 2154 of the bridge skirt 2150 is coupled to the inner skirt 116 at or near the commissures 109 of the valve leaflets 108 thereof.
  • FIG. 31 shows another embodiment of a bridge skirt 3150.
  • the bridge skirt 3150 shown in FIG. 31 is disposed at the outflow end 158 of the fixation skirt 146 (adjacent the elbow 171 of the fixation frame 104) and at the outflow end 162 of the inner skirt 116.
  • the bridge skirt 3150 extends generally perpendicular to the central longitudinal axis of the heart valve prosthesis 100.
  • an outer edge 3152 of the bridge skirt 3150 is coupled to the fixation skirt 146 at the outflow end 158 thereof, which is at or near the elbow 171 of the fixation frame 104.
  • An inner edge 3154 of the bridge skirt 3150 is coupled to the inner skirt 116 at the outflow end 162 thereof, which is at or near the commissures 109 of the valve leaflets 3108.
  • the outer edge 3152 may be coupled to the outflow end 158 of the fixation skirt 146 in an edge-to-edge configuration, as shown in FIG. 32A.
  • the outer edge 3152 of the bridge skirt 3150 can be folded in the inflow direction at the outflow end 158 of the fixation skirt 146 the outer edge 3152 can be coupled to an outer surface of to the fixation skirt 146, as shown in FIG. 32B or to an inner surface of the fixation skirt 146, as shown in FIG. 32C.
  • the various supports described above with respect to the bridge skirt 150 may also be used with the angled bridge skirt 3150.
  • the bridge skirt 3150 may be used with the scalloped fixation skirt 146, as described above, but a scalloped inner skirt 116 is unlikely to be used with this embodiment.
  • FIGS. 33A-33B show another embodiment of a bridge skirt 4150.
  • the bridge skirt 4150 may essentially be an extension of the brim 120 described above.
  • the brim 120 instead of terminating at the inflow end 156 of the fixation skirt 146, the brim 120 would continue across the space between the fixation frame 104 and the inner frame 102 to form the bridge skirt 4150.
  • the bridge skirt 4150 may be separate from and coupled to the brim 120, such that the bridge skirt 4150 includes an inner edge 4154 coupled to the inflow end 160 of the inner skirt 116 (i.e., above the MOA) and an outer edge 4152 coupled to the inflow end 156 of the fixation skirt 146.
  • the outer edge 4152 of the bridge skirt 4150 may be coupled to the brim 120.
  • the bridge skirt 4150 includes at least one circumferential sinusoidal wire 4121.
  • the bridge skirt 4150 includes two overlapping, 180 degree out of phase sinusoidal wires 4121, as shown in FIG. 33B.
  • the bridge skirt 4150 of this embodiment can be used with a scalloped inner skirt 116 and/or a scalloped fixation skirt 146, as described above.
  • FIG. 34 shows another embodiment of a bridge skirt 5150.
  • the bridge skirt 5150 includes a bridge portion 5151 , a brim portion 5120, and a vertical bridge portion 5153.
  • An inner edge 5154 of the bridge portion 5151 is coupled to the inner skirt 116 above the MOA of the plurality of valve leaflets 108 to the inner skirt 116.
  • the brim portion 5120 extends radially outwardly from the bridge portion 5150.
  • the vertical bridge 5153 extends from the brim portion 5120 to the upstream or inflow end 156 of the fixation skirt 146. As shown, the upstream end of the fixation frame 104 extends to the brim portion 5120. In other embodiments, the vertical bridge 5153 may be an extension of the fixation skirt 146.
  • the bridge skirt 4150 of this embodiment can be used with a scalloped inner skirt 116 and/or a scalloped fixation skirt 146, as described above. Further, the various supports described above with respect to the bridge skirt 150 may also be used with the bridge skirt 4150.
  • FIGS. 35-36 show another embodiment of an angled bridge skirt 6150.
  • the angled bridge skirt 6150 is similar to the angled bridge skirt 2150 except that heart valve prosthesis 100 does not include a fixation skirt.
  • the angled bridge skirt 6150 is frustoconically shaped.
  • An outer edge 6152 of the angled bridge skirt 6150 is coupled to the inflow end 148 of the fixation frame 104.
  • the outer edge 6152 may be coupled to the fixation frame 104 and an inner edge of the brim 120.
  • an inner edge 6154 of the bridge skirt 6150 is coupled to the outflow end 162 of the inner skirt 116 and the outflow end 114 of the inner frame 102.
  • this is not meant to be limiting.
  • the inner edge 6154 of the angled bridge skirt 6150 may be coupled to the just the inner frame 102 at or near the outflow end 114 of the inner frame 102. In another embodiment the inner edge 6154 of the angled bridge skirt 6150 may be coupled to the just the outflow end 162 of the inner skirt 116. In embodiments herein, the inner skirt 116 should extend distally to at least the longitudinal location where the inner edge 6154 of the angled bridge skirt 6150 meets the inner frame 102 and/or the inner skirt 116.
  • the bridge skirt 6150 may be coupled to the inner frame 102, the fixation frame 104, the inner skirt 116, and/or the brim 120 by thread or filament of any suitable suture material, such as, but not limited to silk, nylon, polypropylene, polyester, polytetrafluoroethylene, or other materials suitable for the purposes described herein.
  • the bridge skirt 6150 may be formed of any suitable material as described above.
  • the bridge skirt 6150 may include various support structures including, but not limited to, a wire mesh material, or any of the bridge skirt support structures described above.
  • FIG. 36 shows the heart valve prosthesis 100, in situ, at a native mitral valve MV.
  • the fixation frame 104 does not include a fixation skirt, blood flow to the left ventricular outflow tract (LVOT) is enabled through the fixation frame 104.
  • the shaded area IA illustrates the increased area for blood flow through the left ventricular outflow tract (LVOT) provided by embodiments of the angled bridge skirt 6150.
  • the fixation frame 104 may have a shortened fixation skirt (i.e., extending shorter in the distal direction) to provide some of the increased area for blood flow indicated in FIG. 36.
  • the shortened fixation skirt may extend from the proximal end of the fixation frame to a location proximal of the elbow 171 of the fixation frame.
  • the shortened fixation skirt may be scalloped as described above.
  • FIGS. 37-51 are directed a transcatheter heart valve prosthesis including leaflet hooks extending from the fixation frame thereof.
  • the leaflet hooks are configured to capture native valve leaflets of a native atrio-ventricular valve, such as a native mitral valve or native tricuspid valve.
  • the leaflet hooks are configured to capture native mitral valve leaflets to move the mitral valve leaflets in an upstream, proximal, or atrial direction to reduce the risks of left ventricular outflow tract obstruction (LVOTO) and improve patient eligibility for transcatheter mitral valve replacement.
  • LVOTO left ventricular outflow tract obstruction
  • FIGS. 37-41 show a fixation frame of a heart valve prosthesis 100 with a plurality of leaflet hooks 302 coupled to the fixation frame 300 according to embodiments hereof.
  • the heart 100 is similar to the heart valve prosthesis 100 shown in FIGS. 1-2 and FIG. 5B except as described herein. Therefore, all of the details described above are incorporated into the description of FIGS. 37-41 and the same reference numerals are used.
  • the inner frame 102 may be the same as the embodiments described above, and thus is not shown in many of the figures of the heart valve prosthesis. As noted above, the difference between the heart valve prosthesis 100 of FIGS.
  • the heart valve prosthesis 100 includes the inner frame 102, the fixation frame 300, and the prosthetic valve component 106.
  • the inner frame 102 further includes any of the embodiments of the inner skirt 116.
  • the fixation frame 300 may include the prongs 118, the brim 120, the outflow end 142, the tapered portion 170, the plurality of crowns 134, the plurality of struts 136, the plurality of side openings 138, and the fixation skirt 146, as described above.
  • the fixation frame 300 differs from the fixation frame 104 in that the fixation frame 300 further includes the plurality of leaflet hooks 302 extending from the fixation frame 300.
  • the embodiment of FIGS. 37-41 is generally directed to reducing LVOTO. Therefore, the transcatheter heart valve prosthesis 100 of FIGS. 37-41 may include any of the bridge skirt, fixation skirt, and inner skirt embodiments described above. However, this is not meant to be limiting, and the heart valve prosthesis 100 of FIGS. 37-41 may include other skirt arrangements.
  • FIGS. 37-38 show the fixation frame 300 separate from the inner frame 102, the prosthetic valve component 106, and the skirts for clarity. It shall be understood that the fixation frame 300 is configured to be coupled to the inner frame 102, the prosthetic valve component 106, skirts (e.g. inner skirts, fixation skirts), and other components described to form the heart valve prosthesis 100.
  • skirts e.g. inner skirts, fixation skirts
  • each leaflet hook 302 includes a head 304, a first arm 320, and a second arm 340, as best shown in FIG. 39A.
  • the head 304 of the leaflet hook 302 includes a first end 306 and a second end 308.
  • the head 304 is generally teardrop-shaped, such that the first end 306 of the head 304 is generally smaller in width, as measured circumferentially, than the second end 308. The first end 306 is coupled to both the first arm 320 and the second arm 340, as described below.
  • each leaflet hook 302 extends from the elbow 171 wherein the fixation ring 169 and the tapered portion 170 of the fixation frame 300 meet.
  • the tapered portion 170 of the fixation frame 300 extends from the fixation ring 169 at the elbow 171, and tapers inwardly toward the outflow end 142.
  • fixation ring 169 and the tapered portion 170 may be formed of a plurality of rows of the struts 136 and nodes 140 forming the side openings or cells 138 of the fixation frame 300. In the example shown in FIGS.
  • the fixation frame 300 starting at the inflow end 148 of the fixation frame 300, a first row of first angled outer struts 136A, wherein adjacent proximal ends of the first angled outer struts 138A are connected to each other at first outer nodes 140A and adjacent distal ends of the first angled struts 138A are connected to each other at second outer nodes MOB.
  • the fixation frame 300 includes a second row of second angled outer struts 136B, wherein adjacent proximal ends of the second angled struts are connected to each other and to the distal ends of the first angled outer struts 136A at the second outer nodes 140B.
  • a third row of third angled outer struts 136C are connected to each other at their proximal ends and to the distal ends of the second outer struts 136B at third outer nodes 140C. Adjacent distal ends of the third angled struts 138C are connected to each other at fourth outer nodes MOD.
  • the fourth outer nodes MOD define the elbow 171. Extending distally from each of the fourth outer nodes MOD is a single fourth angled outer strut 136D of a fourth row of fourth angled outer struts 136D. Distal ends of adjacent fourth angled outer struts 136D are connected to each other and to one outer connector arm 136F of a plurality of outer connector arms 138F at fifth outer node MOE.
  • Each outer connector arm 136F extends distally from a respective fifth outer node MOE to a distal end of each connector arm 136F coupled to distal ends of adjacent pairs of fifth angled outer struts 136E at seventh outer nodes MOG disposed at the outflow end 142 of the fixation frame 300.
  • Each pair of adjacent fifth outer struts 136E are connected to each other at their proximal ends at sixth outer nodes 140F, as shown in FIGS. 37 and 40.
  • the sixth outer nodes 140F are not attached to struts proximal of the sixth outer nodes 140F.
  • the leaflet hooks 302 are coupled to the elbow 171 which is formed at the fourth outer nodes MOD.
  • the leaflet hooks 302 are formed integrally with the struts 136 and nodes 140 of the fixation frame 300.
  • the fixation frame 300 may be formed by removed material from a tube, such as by laser etching, chemical etching, or similar methods.
  • alternating (or every other) pair of fourth angled outer struts 136D and connectors 136F are removed to create room for the leaflet hooks 302.
  • Each leaflet hook 302 is similar to the combination of the fourth outer struts 136D, fifth outer nodes 140E, and the connector arms 136F (collectively referred to as “connectors 173”), except that the distal ends of the leaflet hooks 302 are not coupled to the seventh outer nodes 140G.
  • proximal ends 322, 342 of the first arm 320 and the second arm 340 of each leaflet hook 302 are coupled to (i.e. formed integrally with) adjacent fourth outer nodes 140D, as shown in FIG. 39A and 40.
  • the first and second arms 320, 340 extend distally from the fourth outer nodes MOD to respective second ends 324, 344 of the first and second arms 320, 340.
  • each leaflet hook 302 extends distally from the first end 306 to a second end 308, which is disposed adjacent the seventh outer nodes MOG with the fixation frame 300 and the leaflet hooks 302 in the radially compressed configuration, as best shown in FIGS. 38 and 40.
  • the leaflet hooks 302 extend generally parallel to the central longitudinal axis of the fixation frame 300.
  • the fixation frame 300 and/or the leaflet hooks 302 are released from the sheath or capsule of the delivery device (or other restraining device), the leaflet hooks 302 curve radially outwardly and proximally, as best shown in FIGS. 37, 39A, and 39B.
  • the leaflet hooks 302 are configured to capture, engage, or grab a native valve leaflet of the native heart valve and to move the captured valve leaflet out of, or away from, the left ventricular outflow tract LVOT, thereby reducing left ventricular outflow tract obstruction LVOTO, as explained in more detail below.
  • Each of the first and second arms 320, 340 of the leaflet hooks 302 includes a first portion 326, 346, a second portion 328, 348, and a third portion 330, 350.
  • the first and second arms 320, 340 and the head 304 of the leaflet hooks 302 extend distally and generally parallel to the central longitudinal axis of the fixation frame 300.
  • each of the first portions 326, 346, second portions 328, 348, and third portions 330, 350 extend distally and generally parallel to the central longitudinal axis in the radially compressed configuration.
  • the leaflet hooks 302 curve radially outwardly and proximally.
  • each of the first portions 326, 346 extends generally distally from the first ends 322, 342 coupled to the respective fourth outer nodes MOD
  • each of the second portions 328, 348 extends from the first portions 322, 342 outwardly and begins to curve proximally
  • each of the third portions 330, 350 extends outward and distally from the second portions 328, 348.
  • each head 304 is coupled to the second ends 324, 344 of the first and second arms 320, 340.
  • the head 304 includes a first portion 310 extending from the first end 306 of the head 304 and a second portion 312 extending from the first portion 310 to the second end 308 of the head 304.
  • the head 304 of the leaflet hook 302 extends distally from the first arm 320 and the second arm 340 of the leaflet hook 302, as shown in FIGS. 38 and 40.
  • the head 304 of the leaflet hook 302 extends generally proximally and inwardly from the first arm 320 to the second arm 340 of the leaflet hook 302, as shown in FIG. 37 and FIGS. 39A-39B. More precisely, when the leaflet hook 302 is in the radially expanded configuration, the first portion 310 of the head 304 extends generally proximally, and the second portion 312 of the head 304 extends from the first portion 310 generally proximally and inwardly, as best shown in FIGS. 39A- 39B. However, this is not meant to be limiting, and the head 304 need not extend inwardly.
  • the fixation frame 300 includes six leaflet hooks 302, as best seen in FIG. 40.
  • Each leaflet hook 302 is separated circumferentially from immediately adjacent leaflet hooks 302 by a connector 173, as best shown in FIG. 40. More specifically, and with respect to the heart valve prosthesis 100 described previously, each leaflet hook 302 replaces one connector 173 extending from a fourth outer node 140D to a seventh outer node MOG, as shown in FIG. 40.
  • leaflet hooks 302 and connectors 173 alternate around the circumference of the fixation frame 300.
  • circumferential gaps 318 between circumferentially adjacent connectors 173 are created where the leaflet hooks 302 were located in the radially compressed configuration, as shown in FIG. 39C.
  • the gaps 318 provide additional free space for blood flow through the tapered portion 170 of the fixation frame 300, thereby reducing left ventricular outflow obstruction LVOTO.
  • one or more of the prongs 118 coupled to the fourth outer nodes 140D of the fixation frame 300 may be omitted.
  • the leaflet hooks 302 are configured to capture native leaflets of the native heart valve and to move the captured native valve leaflet in an upstream, proximal, or atrial direction to reduce interference of the native leaflets into the left ventricular outflow tract LVOT, thereby reducing left ventricular outflow tract obstruction LVOTO.
  • the gaps 318 formed by replacing a plurality of the connectors 173 with the leaflet hooks 302 that radially expand away from the tapered portion 170 further minimize heart valve prosthesis obstruction within the left ventricular outflow tract LVOT to improve blood flow to the aortic valve, as shown by the flow arrow FL1 in FIG. 41. Reducing or eliminating left ventricular outflow tract obstruction LVOTO increases the number of patients eligible for transcatheter mitral valve replacement.
  • each leaflet hooks 302 may be formed as a part of the fixation frame 300 of the heart valve prosthesis 100. Accordingly, each leaflet hook 302 may be formed of from any number of suitable biocompatible, shape-memory materials, e.g., stainless steel, nickel titanium alloys such as NitinolTM, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials. The plurality of leaflet hooks 302 may be formed as part of the fixation frame 300 by methods such as, but not limited to laser cutting.
  • suitable biocompatible, shape-memory materials e.g., stainless steel, nickel titanium alloys such as NitinolTM, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers,
  • FIGS. 42-45 show another embodiment of a fixation frame 400 including a plurality of leaflet hooks 402.
  • the fixation frame 400 may be the same as the fixation frames 104 described above with respect to FIGS. 1-36 and/or the fixation frame 300 described above with respect to FIGS. 37-41.
  • the fixation frame 300 may be part of a heart valve prosthesis according to any of the embodiments described above. Accordingly, components of the heart valve prosthesis will not be described again here. Therefore, the components described above with respect to the heart valve prostheses 100 are incorporated into this embodiment by reference, such as, but not limited to, the inner frame, the brim, the prosthetic valve component, the inner skirt, the fixation skirt, and bridge skirts.
  • the fixation frame 400 of FIGS. 42-45 is the same as the fixation frame 300 shown in FIGS. 37-41 except as described herein, and all of the details described above are incorporated into the description of FIGS. 42-45. Accordingly, the same reference numerals are used where appropriate.
  • the fixation frame 400 differs from the fixation frame 300 in that the leaflet hooks 402 of the fixation frame 400 are coupled to the fixation frame by rivets, rather than being integrally formed.
  • the leaflet hooks 402 include a differently shaped head as described below, although it is noted that either of the leaflet hooks 302 or 402 may be used in either embodiment, in addition to other, differently shaped leaflet hooks.
  • the fixation frame 400 does not remove the connectors 173 that were removed in the fixation frame 300 to accommodate integrally forming the leaflet hooks 302 of the fixation frame 300.
  • the gaps 318 described above with respect to the fixation frame 300 and shown in FIG. 39C are not present in the fixation frame 400.
  • the fixation hooks 402 coupled to the fixation frame may be used with the fixation frame 300 such that the gaps 318 are present.
  • every other connector 173 of the fixation frame 400 may be removed such that the gaps 318 are present in the fixation frame 400.
  • each leaflet hook 402 includes the head 404, a first arm 420, and a second arm 440.
  • a longitudinal centerline CL divides the leaflet hook 402 into two equal sides.
  • Each side of the leaflet hook 402 is a mirror-image of the other side of the leaflet hook 402.
  • the first arm 420 is disposed on a first side 416 of the leaflet hook 402 and the second arm 440 is disposed on a second side 418 of the leaflet hook 402.
  • the head 404 is C-shaped and extends between the first arm 420 and the second arm 440.
  • each leaflet hook 402 includes an expanded state and a compressed state, shown in FIGS. 42 and 43, respectively.
  • each leaflet hook 402 When each leaflet hook 402 is in the compressed state, each leaflet hook 402 extends proximally from the fixation frame 400 substantially parallel to a central longitudinal axis of the fixation frame 400, as shown in FIG. 43.
  • each leaflet hook 402 When each leaflet hook 402 is in the expanded state, each leaflet hook 402 extends outwardly proximally, as shown in FIG. 42.
  • the leaflet hooks 402 are configured to capture, engage, or grab native valve leaflets of a native heart valve and to move the captured native valve leaflets out of, or away from, the left ventricular outflow tract LVOT to reduce left ventricular outflow tract obstruction LVOTO when the leaflet hook 402 is in the expanded configuration and the heart valve prosthesis is deployed at the site of the native heart valve.
  • first and second arms 420, 440 of each leaflet hook 402 is coupled to adjacent fourth outer nodes 140D of the fixation frame 400, corresponding to the elbow 171 of the fixation frame 400. It is understood that this is not meant to be limiting, and the first and second arms 420, 440 may be coupled to other locations of the fixation frame 400, and that the elbow 171 may not necessarily correspond to the row of fourth outer nodes 140D of the fixation frame 400 (e.g., if there are more or fewer rows of angled struts and nodes proximal of the elbow 171).
  • first ends 422, 442 of the first and second arms 420, 440 are coupled to corresponding fourth outer nodes 140D of the fixation frame 400.
  • First portions 426, 446 of the first and second arms 420, 440 extend generally proximally from the first ends 422, 442.
  • Second portions 428, 448 of the first and second arms 420, 440 extend from the first portions 426, 446.
  • the second portions 428, 448 extend proximally and in a direction converging towards the centerline CL of the leaflet hook 402, as shown in FIG. 43.
  • the second portion 428 extends outwardly, proximally, and in the direction converging towards the centerline CL of the leaflet hook 402, as shown in FIGS. 42, 44A, and 44B.
  • the third portions 430, 450 of the first and second arms 420, 440 extend from the second portions 428, 448.
  • the third portions 430, 450 extend proximally and in a direction diverging from the centerline CL of the leaflet hook 402 from the second portions 428, 448, as shown in FIG. 43.
  • the third portions 430, 450 of the first and second arms 420, 450 extend radially inwardly, proximally, and in the direction diverging from the centerline CL of the leaflet hook 402, as shown in FIGS. 42, 44A, and 44B.
  • the first arm 420 is S-shaped, as shown in FIGS. 44A-44B.
  • the leaflet hooks 402 may be set-shape so as to return to the expanded state.
  • an outside restraining force such as by a sheath or capsule or other retainer, maintains the leaflet hooks 402 in the compressed state during delivery, as described below.
  • the head 404 of each leaflet hook 402 includes a first portion 410, a second portion 412, and a central portion 414.
  • the first portion 410 of the head 404 is disposed on the first side 416 of the leaflet hook 402 and extends from the first arm 420.
  • the first portion 410 of the head 404 extends from the second end 424 of the first arm 420 radially inwardly, proximally, and in a direction diverging from the centerline CL of the leaflet hook 402.
  • the second portion 412 is a mirror-image of the first portion 410.
  • the second portion 412 of the head 404 is disposed on the second side 418 of the leaflet hook 402 and extends from the second arm 440.
  • the second portion 412 of the head 404 extends from the second end 444 of the second arm 440 radially inwardly, proximally, and in a direction diverging from the centerline CL of the leaflet hook 402.
  • the central portion 414 of the head 404 extends between and connects the first portion 410 to the second portion 412.
  • the central portion 414 extends in a generally circumferential direction of the fixation frame 400.
  • the central portion 414 may be a curved segment, as shown in FIG. 44A.
  • first portions 426, 446 of the first and second arms 420, 440 of each leaflet hook 402 are each coupled to corresponding fourth outer nodes MOD of the fixation frame 400 by corresponding rivets 460.
  • Each rivet 460 is disposed through the corresponding openings 432, 452 of the first portions 426, 446 of the first and second arms 420, 450, and through corresponding openings 462 in the fourth outer nodes 140 of the fixation frame 400, as best shown in FIGS. 44A, 44B, and 45.
  • leaflet hooks 402 may be coupled to the fixation frame 400 in other ways, such as, but not limited to, sutures, soldering, welding, staples, or other fasteners, mechanical interlocking, snap fit, friction or interference fit, or any combination thereof.
  • Each leaflet hook 402 of the heart valve prosthesis 400 may be formed from any number of suitable biocompatible, shape-memory materials, non-limiting examples of which include stainless steel, nickel titanium alloys such as NitinolTM, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials.
  • suitable biocompatible, shape-memory materials non-limiting examples of which include stainless steel, nickel titanium alloys such as NitinolTM, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials.
  • FIGS. 46 and 47 show a leaflet hook 402A including another embodiment of a head 404A for use with embodiments of the fixation frame 400.
  • the head 404A is configured to engage a lacerated valve leaflet at the laceration area to stabilize the captured native valve leaflet.
  • the head 404A of each leaflet hook 402A includes a first portion 410A, a second portion 412A, and a central portion 414A.
  • the first portion 410A is disposed on the first side 416 of the leaflet hook 402A and is generally U-shaped, extending radially outwardly and in a direction diverging from a centerline CL, from the first arm 420, and then back radially inwardly and towards the centerline CL.
  • the second portion 412A is a mirror image of the first portion 410A and is disposed on the second side 418 of the leaflet hook 402.
  • the second portion 412A of the head 404A is generally U-shaped, extending radially outwardly and in a direction diverging from a centerline CL from the second arm 440, and then radially inwardly and in a direct toward the centerline CL.
  • the central portion 414A of the head 404A is generally U-shaped, extending between the first portion 410 and the second portion 412A.
  • the central portion 414A extends from the first portion 410A, curving distally and then radially outwardly, then curving back radially inwardly, and then curving proximally to meet the second portion 412A.
  • the head 404A is configured to be disposed within a laceration in a native valve leaflet LF to capture the valve leaflet LF, as shown in FIG. 47.
  • the native valve leaflet LF is captured by the leaflet hook 402A with the first portion 410A and the second portion 412A of the head 404A on a first side of the valve leaflet LF (e.g., an upstream side) and the central portion 414A of the head 404A on a second, or opposite side of the valve leaflet LF (e.g., a downstream side).
  • the splayed first and second portions 410A, 412A of the head 404A engage with portions of the native valve leaflet LF on opposite lateral sides of the laceration, as shown in FIG. 47.
  • leaflet hooks described herein may be used in interchangeably in any of the embodiments described herein.
  • FIGS. 48-51 a method of deploying a heart valve prosthesis including a fixation frame including leaflet hooks will be described.
  • FIGS. 48-51 are described with reference to the fixation frame 300 and the leaflet hooks 302, but that is just for convenience, and the method can be used equally with the fixation frame 400 and the leaflet hooks 402 or 402A, or any combination thereof.
  • a delivery device DD such as a catheter with the heart valve prosthesis 100 disposed therein is tracked to a native mitral valve MV by established methods and procedures.
  • the hearth valve prosthesis 100 is disposed in the delivery device DD in the radially compressed configuration with the plurality of leaflet hooks 302 in the compressed state.
  • the heart valve prosthesis in the radially compressed configuration is positioned within the native mitral valve MV slightly distal of the desired final position relative to the annulus AN of the native mitral valve.
  • the heart valve prosthesis 100 is partially released from the delivery device DD such that the heart valve prosthesis 100 transitions to a partially radially expanded configuration and the plurality of leaflet hooks 302 transition to the expanded state.
  • the heart valve prosthesis 100 may be retracted proximally, if necessary, to capture the native leaflets LF between the leaflet hooks 302 and the fixation frame 300.
  • the delivery device DD and the heart valve prosthesis 100 may be proximally retracted in a direction PR1 to move the native valve leaflets LF proximally or towards the left atrium, as shown in FIG. 49. This moves the native leaflets LF away from the left ventricular outflow tract LVOT.
  • the heart valve prosthesis 100 is further released from the delivery device DD but has not been fully released and therefore has not fully transitioned to the radially expanded configuration.
  • the native valve leaflets LF of the mitral valve MV are disposed between the leaflet hooks 302 and the fixation frame 300 of the heart valve prosthesis 300.
  • FIG. 51 shows the heart valve prosthesis 100 released from the delivery device DD and the delivery device DD removed using established procedures.
  • the heart valve prosthesis 100 has transitioned to the radially expanded configuration and is anchored at the desired position within the native mitral valve MV.
  • the valve leaflets LF of the native mitral valve are captured by the leaflet hooks 302 of the heart valve prosthesis 100 and are disposed and held between the leaflet hooks 302 and an outer surface of the fixation frame 300, up and out of the left ventricular outflow tract LVOT, thereby reducing the likelihood of left ventricular outflow tract obstruction LVOTO.
  • the heart valve prosthesis poses less risk of left ventricular outflow tract obstruction, thereby improving performance and enabling a larger percentage of patients to receive a transcatheter mitral heart valve replacement procedure.
  • Example 1 A heart valve prosthesis having a radially expanded configuration and a radially compressed configuration, the heart valve prosthesis comprising: an inner frame including a plurality side openings; a fixation frame coupled to and radially surrounding the inner frame, the fixation frame including a plurality of side openings; an inner skirt coupled to a surface of the inner frame, the inner skirt including an inflow end and an outflow end; a fixation skirt coupled to a surface of the fixation frame, the fixation skirt including an inflow end and an outflow end; a bridge skirt, having an inner edge coupled to the inner skirt and an outer edge coupled to the fixation skirt; and a prosthetic valve component including a plurality of leaflets, wherein the prosthetic valve component is disposed within and coupled to the inner frame, the prosthetic valve component being configured to block blood flow in one direction to regulate blood flow through a central lumen of the inner frame.
  • Example 2 The heart valve prosthesis of Example 1, wherein the bridge skirt is torus shaped.
  • Example 3 The heart valve prosthesis of Example 1, wherein the bridge skirt is frustoconically shaped.
  • Example 4 The heart valve prosthesis of any one of Examples 1 to 3, wherein the outer edge of the bridge skirt is coupled to the inflow end of the fixation skirt.
  • Example 5 The heart valve prosthesis of any one of Examples 1 to 3, wherein the outer edge of the bridge skirt is coupled to a brim at the inflow end of the fixation skirt.
  • Example 6 The heart valve prosthesis of Example 4 or Example 5, wherein the inner edge of the bridge skirt is coupled to the inflow end of the inner skirt.
  • Example 7 The heart valve prosthesis of Example 4 or Example 5, wherein the inner edge of the bridge skirt is coupled to the outflow end of the inner skirt.
  • Example 8 The heart valve prosthesis of any one of Examples 1 to 3, wherein the outer edge of the bridge skirt is coupled to the outflow end of the fixation skirt.
  • Example 9 The heart valve prosthesis of Example 8, wherein the inner edge of the bridge skirt is coupled to the inflow end of the inner skirt.
  • Example 10 The heart valve prosthesis of Example 8, wherein the inner edge of the bridge skirt is coupled to the outflow end of the inner skirt.
  • Example 11 The heart valve prosthesis of any one of Examples 1 to 10, wherein the fixation frame includes a fixation ring extending from an inflow end of the fixation frame in a downstream direction to an elbow, and a tapered portion extending in a downstream direction and radially inwardly from the elbow to an outflow end of the fixation frame
  • Example 12 The heart valve prosthesis of Example 11, wherein a downstream end of the fixation skirt is upstream of the elbow of the fixation frame.
  • Example 13 The heart valve prosthesis of Example 12, wherein the downstream end of the fixation skirt is scalloped.
  • Example 14 The heart valve prosthesis of any one of Examples 1 to 13, wherein the downstream end of the inner skirt is scalloped, wherein the downstream end of the inner skirt is coupled to an upstream end of the plurality of leaflets along a margin of attachment.
  • Example 15 The heart valve prosthesis of Example 14, wherein the inner skirt does not extend downstream of the margin of attachment.
  • Example 16 The heart valve prosthesis of any one of Examples 1 to 15, wherein the bridge skirt is a fabric material and includes a support configured to provide support and structure to the bridge skirt.
  • Example 17 The heart valve prosthesis of Example 16, wherein the support is a fabric quilting structure formed by stitching the bridge skirt in a pattern.
  • Example 18 The heart valve prosthesis of Example 17, wherein the pattern comprises a plurality of circumferential sinusoid patterns, plurality of radial stitching lines, a zig-zag pattern, or a plurality of radial zig-zags.
  • Example 19 The heart valve prosthesis of Example 16, wherein the support comprises a suture support coupling the bridge skirt to at least one of inner frame, the fixation frame, or the brim around at least a portion of a circumference of the bridge skirt.
  • Example 20 The heart valve prosthesis of Example 19, wherein the suture support couples the bridge skirt to at least one of the inner frame or the fixation frame downstream of the bridge skirt.
  • Example 21 The heart valve prosthesis of Example 19, wherein the suture support couples the bridge skirt to at least one of the inner frame, the fixation frame, or the brim upstream of the bridge skirt.
  • Example 22 The heart valve prosthesis of Example 16, wherein the support comprises a plurality of wires extend radially along and coupled to the bridge skirt, wherein each wire is configured to preferentially bend the bridge skirt in an upstream direction when the heart valve prosthesis is in the radially compressed configuration.
  • Example 23 The heart valve prosthesis of Example 16, wherein the support comprises a fabric layer attached to the bridge skirt.
  • Example 24 The heart valve prosthesis of Example 23, wherein the fabric layer includes an inner ring, an outer ring, and a circumferential gap between the inner ring and the outer ring, the circumferential gap configured to enable the bridge skirt to preferentially bend in an upstream direction when the heart valve prosthesis is in the radially compressed configuration.
  • Example 25 A heart valve prosthesis having a radially expanded configuration and a radially compressed configuration, the heart valve prosthesis comprising: an inner frame including a plurality side openings; an inner skirt coupled to a surface of the inner frame, the inner skirt including an inflow end and an outflow end; a prosthetic valve component including a plurality of leaflets, wherein the prosthetic valve component is disposed within and coupled to the inner frame, the prosthetic valve component being configured to block blood flow in one direction to regulate blood flow through a central lumen of the inner frame; a fixation frame coupled to and radially surrounding the inner frame, the fixation frame including a plurality of side openings; a bridge skirt having an outer edge coupled to the fixation frame adjacent an inflow end of the fixation frame and an inner edge coupled to the inner skirt distal of plurality of leaflets.
  • Example 26 The heart valve prosthesis of Example 25, wherein the bridge skirt is frustoconically shaped.
  • Example 27 The heart valve prosthesis of Example 25 or Example 26, wherein the fixation frame does not include a skirt.
  • Example 29 The heart valve prosthesis of any one of Examples 25 to 27, wherein the fixation frame includes a fixation ring extending from an inflow end of the fixation frame in a downstream direction to an elbow, and a tapered portion extending in a downstream direction and radially inwardly from the elbow to an outflow end of the fixation frame
  • Example 30 The heart valve prosthesis of Example 29, further comprising a fixation skirt coupled to a surface of the fixation ring, wherein a distal end of the fixation skirt is proximal of the elbow.
  • Example 31 The heart valve prosthesis of Example 30, wherein the fixation skirt is scalloped.
  • Example 32 The heart valve prosthesis of any one of Examples 25 to 31, wherein the outer edge of the bridge skirt is coupled to a brim at an inflow end of the fixation frame.
  • Example 33 The heart valve prosthesis of any one of Examples 25 to 32, wherein the bridge skirt comprises a graft material and a support coupled to the graft material.
  • Example 34 The heart valve prosthesis of Example 33, wherein the support is a wire mesh.
  • Example 35 A heart valve prosthesis having a radially expanded configuration and a radially compressed configuration, the heart valve prosthesis comprising: an inner frame including a plurality side openings; a fixation frame coupled to and radially surrounding the inner frame, the fixation frame including a plurality of side openings; a prosthetic valve component including a plurality of leaflets, wherein the prosthetic valve component is disposed within and coupled to the inner frame, the prosthetic valve component being configured to block blood flow in one direction to regulate blood flow through a central lumen of the inner frame; and a plurality of leaflet hooks extending from the fixation frame, the plurality of leaflet hooks having a compressed state and an expanded state, wherein in the expanded state the plurality of leaflet hooks extend radially outwardly and proximally and are configured to capture native valve leaflets of a heart valve.
  • Example 36 The heart valve prosthesis of Example 35, wherein with the heart valve prosthesis in the radially expanded configuration, the fixation frame includes a fixation ring extending from an inflow end of the fixation frame in a downstream direction to an elbow, and a tapered portion extending in a downstream direction and radially inwardly from the elbow to an outflow end of the fixation frame, and wherein the leaflet hooks extends from the elbow of the fixation frame.
  • Example 37 The heart valve prosthesis of Example 35 or 36, wherein each leaflet hook of the plurality of leaflet hooks includes a first arm, a second arm, and a head.
  • Example 38 The heart valve prosthesis of Example 37, wherein the first arm is coupled to a first node at the elbow, the second arm is coupled to a second node at the elbow adjacent the first node, and the head is coupled to the first arm and the second arm.
  • Example 39 The heart valve prosthesis of any one of Examples 35 to 38, wherein the plurality of leaflet hooks are integrally formed with the fixation frame.
  • Example 40 The heart valve prosthesis of Example 39, wherein the tapered portion of the fixation frame comprises a plurality of connectors extending from the elbow to the outflow end of the fixation frame, wherein with the leaflet hooks in the compressed stated, the plurality of connectors and the leaflet hooks alternate around a circumference of the fixation frame in the tapered portion.
  • Example 41 The heart valve prosthesis of Example 40, wherein with the leaflet hooks in the expanded state, the leaflet hooks extend radially outwardly and proximally from the elbow such that gaps are formed between circumferentially adjacent connectors of the tapered portion where the leaflet hooks were located in the compressed state.
  • Example 42 The heart valve prosthesis of any one of Examples 35 to 37, wherein the plurality of leaflet hooks are formed separate from the fixation frame and are coupled to the fixation frame.
  • Example 43 The heart valve prosthesis of Example 42, further comprising rivets coupling the plurality of leaflet hooks to the fixation frame.
  • Example 44 The heart valve prosthesis of any one of Examples 35 to 38, wherein the plurality of leaflet hooks extend in a distal direction from the fixation frame with the leaflet hooks in the compressed state.
  • Example 45 The heart valve prosthesis of any one of Examples 35 to 38, wherein the plurality of leaflet hooks extend in a proximal direction from the fixation frame with the leaflet hooks in the compressed state.

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

Abstract

Une prothèse de valvule cardiaque comprend un cadre interne, un cadre de fixation couplé à et entourant radialement le cadre interne, une jupe interne couplée à une surface du cadre interne, une jupe de fixation couplée à une surface du cadre de fixation, une jupe de pont ayant un bord interne couplé à la jupe interne et un bord externe couplé à la jupe de fixation, et un composant de valvule prothétique disposé à l'intérieur et couplé au cadre interne.
PCT/IB2024/060429 2023-10-27 2024-10-23 Prothèse de valvule cardiaque transcathéter comprenant une jupe de pont Pending WO2025088515A1 (fr)

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US202363593567P 2023-10-27 2023-10-27
US63/593,567 2023-10-27
US202463625301P 2024-01-26 2024-01-26
US63/625,301 2024-01-26
US202463675529P 2024-07-25 2024-07-25
US63/675,529 2024-07-25

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