WO2020041495A1 - Prosthetic cardiac valve devices, systems, and methods - Google Patents

Prosthetic cardiac valve devices, systems, and methods Download PDF

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Publication number
WO2020041495A1
WO2020041495A1 PCT/US2019/047542 US2019047542W WO2020041495A1 WO 2020041495 A1 WO2020041495 A1 WO 2020041495A1 US 2019047542 W US2019047542 W US 2019047542W WO 2020041495 A1 WO2020041495 A1 WO 2020041495A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
frame structure
valve prosthesis
wire
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.)
Ceased
Application number
PCT/US2019/047542
Other languages
English (en)
French (fr)
Inventor
Claudio Argento
Andrew Backus
Alice Yang
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.)
SHIFAMED LLC
Original Assignee
SHIFAMED LLC
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
Priority to AU2019325548A priority Critical patent/AU2019325548B2/en
Priority to CN202510028014.2A priority patent/CN119564382A/zh
Priority to CA3109642A priority patent/CA3109642C/en
Priority to EP24196111.9A priority patent/EP4442226A3/en
Priority to JP2021509754A priority patent/JP7421546B2/ja
Priority to CN201980065767.3A priority patent/CN112804966B/zh
Application filed by SHIFAMED LLC filed Critical SHIFAMED LLC
Priority to EP19852661.8A priority patent/EP3840696B1/en
Publication of WO2020041495A1 publication Critical patent/WO2020041495A1/en
Anticipated expiration legal-status Critical
Priority to JP2024002985A priority patent/JP7821205B2/ja
Priority to AU2025238053A priority patent/AU2025238053A1/en
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/825—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having longitudinal struts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
    • 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
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a 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
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
    • A61F2250/0063—Nested prosthetic parts

Definitions

  • the present invention relates generally to treatment of heart disease, and more particularly, implantable valve prostheses and treatments for heart valve diseases.
  • the heart 2 includes four chambers connected by four valves.
  • the upper part of the heart 2 includes the left atrium 25 and right atrium 5.
  • the lower part includes the left ventricle 26 and right ventricle 6.
  • the heart 2 and cardiovascular system operates like a closed circuit.
  • the right side of the heart 2 receives de-oxygenated blood from the body and delivers the blood through the pulmonary artery 7 to the lungs where it becomes re- oxygenated.
  • the oxygenated blood is returned to the left side of the heart 2, referred to as the systemic side, which delivers the oxygenated blood throughout the body.
  • Heart chambers Blood flow between the heart chambers is regulated by the valves.
  • the mitral valve 4 is located between the left atrium 25 and the left ventricle 26 and the aortic valve 9 is located between the left ventricle 26 and the aorta 1.
  • the pulmonary valve 3 is located between the right ventricle 6 and the pulmonary artery 7 and the tricuspid valve 8 is located between the right ventricle 6 and the right atrium 5.
  • All four of heart valves are passive one-way valves with“leaflets” which open and close in response to differential pressures.
  • the left ventricle 26 contracts and pushes blood out the aortic valve 9.
  • the pressure in the left ventricle 26 causes the mitral valve 4 to close thereby preventing blood from going back into the left atrium 25 during systole.
  • a significant population will acquire valve disease in their lifetime.
  • Congenital heart disease is also a significant problem. Patients with valvular disease have abnormal anatomy and/or function of at least one valve. Congenital valve abnormalities may be tolerated and/or treated palliatively for some years before developing into a life-threatening problem in later years. However, congenital heart disease may present life-threatening risk without notice.
  • Patients may acquire valvular disease from rheumatic fever, heart failure, degenerative leaflet tissue, bacterial infection, and more.
  • FIG. 3 shows a healthy mitral valve 4.
  • FIGs. 4 to 5 show a diseased mitral valve 4.
  • the valve 4 in FIG. 4 suffers from insufficiency, also referred to as regurgitation.
  • Such a valve 4 does not fully close and allows blood to flow retrograde. In this case, blood will flow back into the left atrium 25 during systole.
  • FIG. 5 shows a mitral valve 4 with stenosis.
  • Such a valve 4 does not open properly.
  • Some valves 4 can have concomitant insufficiency and stenosis.
  • Other diseases may also be present, such as Barlow’s disease, which prevent the valve 4 from functioning properly. These diseases reduce cardiac output and force the heart 2 to work harder, thus increasing the risk of heart failure and chordae failures.
  • While medications may be used to treat the disease, in many cases the defective valve may need to be repaired or replaced at some point during the patient’s lifetime.
  • the native valve can be replaced with a mechanical valve or tissue valve.
  • Mechanical valves have a disc or other member which opens and closes. Although mechanical valves are formed of biocompatible materials, they carry an increased risk of clotting. Thus, patients usually need to take
  • Tissue valves can be formed of human or animal tissue, as well as polymeric materials. Tissue valves, unlike mechanical valves, do not typically require long-term use of anti-coagulants, but because they are formed of a living tissue they are not as widely available nor do they last as long as mechanical valves. Common tissue valves include porcine aortic valves mounted within a stent like structure.
  • the aortic valve can be accessed via the femoral artery whereas the mitral valve, for example, typically requires a transseptal approach.
  • the mitral valve anatomy presents more complexities to transcatheter procedures than the aortic valve.
  • the mitral valve 4 includes two asymmetrical leaflets 4a, 4b and an irregularly-shaped annulus 4c.
  • the mitral valve 4 also varies far more considerably patient-to-patient than the aortic valve. For these and other reasons, surgical replacement and percutaneous repair thus far are the only widely-available commercial treatments for mitral valve disease.
  • the present disclosure relates to prosthetic cardiac devices, and in some embodiments, prosthetic heart valves such as catheter-based mitral valves.
  • a heart valve prosthesis for replacing a diseased native valve in a patient.
  • the heart valve prosthesis includes a compressible and expandable frame structure and an anchor connected to an outer periphery of the frame structure.
  • the anchor comprises a helical wire having a free end.
  • the valve may further include a valve segment within the frame structure.
  • the valve segment may include a biocompatible one-way valve.
  • a heart valve prosthesis for replacing a diseased native valve in a heart of a patient.
  • the valve prosthesis comprises a compressible and expandable frame structure, a valve segment disposed within the frame structure, the valve segment comprising a biocompatible one-way valve, and an anchor connected to an outer periphery of the frame structure, wherein the anchor comprises a helical wire having a free end.
  • the free end of the helical wire may be configured to guide the helical wire through a commissure of a native valve of a patient.
  • the free end may comprise an atraumatic tip.
  • the free end may comprise a ball tip.
  • the free end may be configured for piercing tissue.
  • the anchor may comprise a first portion comprising the helical wire and another portion.
  • the anchor may comprise a plurality of anchors.
  • the plurality of anchors may comprise at least two helical wires having different diameters.
  • the plurality of anchors may comprise at least two helical wires having different winding pitches.
  • the helical wire may have a generally tubular shape.
  • the free end of the helical wire may extend radially outward from the tubular shape.
  • the helical wire may have a generally frustoconical shape.
  • the free end of the helical wire may extend radially outward from the frustoconical shape.
  • the frame structure may be configured for expanding within a native valve of a patient.
  • the frame structure may have a compressed state sized and dimensioned for percutaneous insertion and an expanded state sized and dimensioned for implantation in a native valve of a patient.
  • the frame structure may comprise first and second opposite ends, the first end extending above a native valve and the second end extending below the native valve when the valve prosthesis is positioned across the native valve.
  • the frame structure may comprise an expandable stent.
  • the frame structure may comprise a generally tubular expanded shape.
  • the frame structure may comprise an expanded outer periphery and a compressed outer periphery when subject to an external radial force.
  • the compressed outer periphery may be slightly smaller in diameter than the expanded outer periphery.
  • the frame structure may be balloon-expandable.
  • the frame structure may be self-expanding.
  • At least a portion of the valve segment may be positioned within at least a portion of the frame structure.
  • the valve segment may comprise at least one leaflet having an inner layer and an outer layer.
  • the frame structure may be attached to the outer layer at one or more ends of the frame structure.
  • the valve segment may comprise a plurality of leaflets.
  • the valve segment may comprise two leaflets.
  • the helical wire may comprise a second end, and wherein the second end is attached to the frame structure.
  • the helical wire may be attached to the frame structure only at the location of the second end.
  • the anchor and the frame structure may be adapted to be independently and separately expanded.
  • a method of replacing a diseased native valve of a patient comprises loading a valve prosthesis into a delivery catheter, the valve prosthesis comprising an expandable frame structure carrying a biocompatible valve segment and an anchor attached to an outer periphery of the frame structure, the anchor comprising a wire having a free end; delivering the valve prosthesis to a target location above a native valve; inserting the valve prosthesis through the native valve to a position posterior the native valve; rotating the wire such that the free end wraps around at least a portion of chordae tendineae below the valve; and expanding the frame structure including the valve segment within the native valve.
  • the method may further comprise anchoring the valve prosthesis by rotating the wire until the frame structure is positioned within leaflets of the native valve.
  • the method may further comprise anchoring the valve prosthesis by rotating the wire until the wire tightens around the chordae tendineae.
  • the frame structure may be balloon-expandable. Expanding the frame structure may comprise expanding a balloon within the frame structure.
  • the frame structure may be self-expanding. Expanding the frame structure may comprise removing a sheath of the delivery device from the frame structure.
  • the wire may be a helical wire.
  • inserting the valve prosthesis may comprise guiding the free end of the wire through a commissure of the native valve.
  • rotating the wire may comprise rotating the wire through the commissure.
  • a heart valve prosthesis for replacing a diseased native valve in a patient.
  • the valve prosthesis comprises a compressible and expandable frame structure, a valve segment disposed within the frame structure comprising a biocompatible one- way valve, and an anchor connected to the frame structure and disposed radially outward from the frame structure, wherein the anchor comprises a helical member having a free end.
  • the second end of the anchor may be connected to the frame structure.
  • the helical member may comprise a wire or a flat ribbon.
  • FIG. 1 is a schematic of a human heart illustrating the path of blood flow through the heart.
  • FIG. 2 is a cross-sectional view of a heart looking down through the mitral valve, aortic valve, and aorta.
  • FIG. 3 is a schematic of a healthy mitral valve.
  • FIGs. 4 and 5 are schematics of diseased mitral valves.
  • FIGs. 6 to 10 are several views of a percutaneous valve for replacement of a diseased native valve, in accordance with embodiments.
  • FIG. 11 is a perspective view of the prosthetic valve leaflet of the valve of FIG. 6, in accordance with embodiments.
  • FIGs. 12 to 18 are several views of the frame structure of the valve of FIG. 6, in accordance with embodiments.
  • FIGs. 19 to 26 are several views of the method of implanting the valve of FIG. 6, in accordance with embodiments.
  • FIGs. 27 to 28 illustrate expanding of the frame structure using a balloon, in accordance with embodiments.
  • FIG. 29 is a front view of another percutaneous valve similar to the one of FIG. 6, in accordance with embodiments.
  • FIGs. 30A to 30F are front views of other percutaneous valves similar to the one of FIG. 6, in accordance with embodiments.
  • the present disclosure is described in relation to deployment of systems, devices, or methods for treatment of a diseased native valve of the heart, for example a mitral valve.
  • FIG. 1 shows a human heart 2 and the blood flow pathways through the four chambers of the heart.
  • FIG. 2 is a human heart 2 showing the mitral valve 4, aortic valve 9, and aorta 1.
  • the mitral valve 4 includes two leaflets 4a, 4b.
  • the anterior (aortic) leaflet 4a is adjacent the aorta 1.
  • the posterior (mural) leaflet 4b is remote from the aorta 1.
  • the aortic valve 9 includes three leaflets.
  • the heart 2 is in systole with the aortic valve 9 open and the mitral valve 4 closed.
  • FIG. 1 illustrates a healthy heart 2
  • FIGs. 2-5 illustrate exemplary mitral valve 4 disease states which may be addressed by the prosthetic valve in accordance with the present disclosure.
  • the prosthetic valve may also be used to treat functional regurgitation such as functional mitral regurgitation (FMR).
  • FMR functional mitral regurgitation
  • FIGs. 6-18 show an exemplary valve prosthesis 10 (also referred to herein as“valve device”) for replacement of a diseased mitral valve in accordance with the present disclosure.
  • valve device also referred to herein as“valve device”
  • the illustrated valve prosthesis 10 comprises a frame structure 12, a valve segment 14, and an anchor 15.
  • FIGs. 6-10 show the valve prosthesis 10 in an expanded, deployed state.
  • FIGs. 12-18 show the frame structure 12 without the valve segment 14.
  • the frame structure 12 is in a collapsed state in FIGs. 12-15 and an expanded state in FIGs. 16-18.
  • the anchor 15 is shown in a deployed state.
  • valve prosthesis 10 is configured for replacement of a native mitral valve.
  • Valve 10 includes a frame structure 12, valve segment 14, and anchor 15.
  • the anchor includes a wire 20 formed in a helical or spiral shape around the frame structure.
  • Exemplary frame structure 12 is configured like a stent.
  • the frame has an expanded state and a collapsed or compressed state.
  • the compressed state is sized and dimensioned for percutaneous insertion and the expanded state sized and dimensioned for implantation in a native valve of a patient.
  • the frame structure 12 comprises an expanded outer periphery and a compressed outer periphery when subject to an external radial force, the compressed outer periphery being slightly smaller in diameter than the expanded outer periphery.
  • the frame structure 12 is shown in the expanded, deployed state in FIG. 6.
  • the frame structure 12 is shown in the collapsed, delivery state in FIG. 12.
  • the exemplary frame structure 12 is a scaffold in a diamond pattern formed from a shape memory material (e.g. NiTi).
  • a shape memory material e.g. NiTi
  • the frame structure 12 may be formed of a polymer of sufficient elasticity.
  • the frame structure 12 may be formed of a combination of a metal and polymer, such as a metal (e.g. shape memory material) covered in polymer.
  • the frame structure 12 may include a variety of patterns besides diamond shapes.
  • Valve prosthesis 10 includes a valve segment 14 within the frame structure 12.
  • the exemplary valve segment 14 is expandable and collapsible.
  • the valve segment 14 is affixed within the frame structure 12 and expands and collapses with the frame structure 12.
  • Valve segment is used somewhat interchangeably with prosthetic valve leaflet and generally refers to the prosthetic leaflets and frame.
  • “prosthetic valve” may refer to all manner of prosthetic and artificial replacement valves including tissue (biological) valves, tissue-engineered valves, polymer valves (e.g. biodegradable polymer valves), and even certain mechanical valves.
  • frame structure 12 is a closed frame such that blood flow is forced through valve segment 14 therein.
  • One or more skirts and/or seals may help force blood through valve segment 14.
  • Valve segment 14 can be configured as would be understood by one of skill from the description herein.
  • the valve segment 14 can be similar to existing transcatheter valves.
  • the valve segment 14 can be similar to existing surgical tissue valves, and mechanical valves.
  • the valve segment 14 includes leaflets 16 formed of multi-layered materials for preferential function. At least one leaflet 16 may have an inner layer and an outer layer.
  • the leaflet 16 is connected to a valve structure which in turn is connected to the frame structure 12.
  • the valve structure may be connected to the frame structure 12 before or after the frame structure 12 has been deployed adjacent a native valve.
  • the leaflet 16 is attached to the frame structure 12 directly.
  • the leaflet 16 may have an inner layer and an outer layer, with the outer layer attached to the frame structure 12.
  • the leaflet 16 may be attached to an end of the frame structure 12. Alternatively, or in combination, the leaflet 16 may be attached to an intermediate portion of the frame structure 12.
  • the valve segment 14 includes a plurality of leaflets 16, such as two, three, or more leaflets. In the illustrated embodiment, the valve segment 14 includes three leaflets 16 which are attached to frame structure 12. An exemplary leaflet 16 is shown in FIG. 11. The leaflet 16 is concave to permit flow in one direction. In particular, flow in one direction causes the leaflet(s) 16 to deflect open and flow in the opposite direction causes the leaflet(s) 16 to close.
  • an exemplary anchor 15 comprises a helical member, such as wire 20, having a free end 22.
  • the other end of the wire 20 is attached to a top end of frame structure 12.
  • one end of the wire 20 is fixed to a strut of the frame structure 12.
  • This end can be attached by suitable means as would be understood by one of skill in the art from the description herein including, but not limited to, a weld, an adhesive, and a mechanical fastener.
  • the helical wire 20 is attached to the frame structure only at the location of the second end.
  • anchor 15 does not require performing an anchor function in the traditional sense. As will be described in more detail below, the anchor guides valve prosthesis 10 into a desired position within a native valve. The anchor 15 may also mitigate against undesired entanglement and disturbances to the chordae tendineae and valve leaflets of the mitral valve.
  • Wire 20 is formed of a material having sufficient rigidity to hold a predetermined shape.
  • the wire 20 is formed of a shape memory material (e.g. NiTi). It may be desirable for at least an end portion to be relatively rigid such that it can exert a force to move chordae tendineae, while still retaining flexibility to be collapsed within a catheter.
  • the end portion (including free end 22) only needs sufficient rigidity to hold its shape and will deform under a load.
  • the end portion may be configured with similar rigidity to a guidewire, or slightly stiffer.
  • the anchor 15 comprises a helical member.
  • the helical member may comprise a helical wire or flat ribbon.
  • the helical member may comprise a three- dimensional surface as described herein.
  • the anchor 15 may comprise a first portion comprising the helical wire 20 and another portion. Alternatively or in combination, the anchor 15 may comprise a plurality of helical wires 20. For example, the anchor 15 may comprise at least two helical wires 20 having the same or different diameters. Alternatively or in combination, the anchor 15 may comprise at least two helical wires 20 having the same or different winding pitches. [0079] In various embodiments, the anchor 15 may comprise a plurality of anchors, for example a plurality of helical wires 20 as described herein.
  • valve prosthesis 10 is configured for replacing a mitral valve and free end 22 is configured for insertion through a commissure.
  • FIG. l is a schematic of a human heart 2 having a mitral valve 4.
  • FIGs. 2 and 4 show an exemplary mitral valve 4.
  • several commissure points (anterolateral commissure 4d and posteromedial commissure 4e) are presented at the ends of the valve leaflets 4a, 4b.
  • the exemplary free end 22 is sized and dimensioned for insertion through one of the commissures.
  • the free end 22 is configured to be atraumatic to avoid risk of injury to the valve tissue and leaflets.
  • the free end 22 may be in the form of a blunt end, a ball tip, a curved tip (e.g., J-tip or pigtail), and other atraumatic shapes.
  • the free end 22 is configured with a sharp end to pierce tissue.
  • wire 20 has varying stiffness along its length.
  • the wire 20 may have two or more segments of differing stiffness and/or the stiffness may transition over its length.
  • wire 20 is attached to frame 12 at multiple points such that free end 22 is relatively flexible and the wire 20 is more rigid along portions where it is attached to the frame structure 12.
  • free end 22 extends radially outward from frame structure 12, and in particular the remainder of wire 20.
  • the free end 22 is configured to encircle a larger radius than the main coils of the wire 20.
  • the free end 22 may extend radially outward from the tubular shape.
  • the free end 22 may extend radially outward from the helical shape.
  • the main coils of wire 20 have a generally frustoconical shape
  • the free end 22 may extend radially outward from the frustoconical shape.
  • the larger diameter facilitates capturing of the valve leaflets and/or chordae tendineae within the sweep of the free end 22 during rotation as will be described in more detail below.
  • FIGs. 19-28 The method of implanting valve prosthesis 10 in accordance with the present disclosure will now be described with reference to FIGs. 19-28. Although shown and described with respect to a mitral valve, one will understand that the principles described herein may be applied equally to other atrioventricular valves. Aspects of the procedure, delivery tool, and implanted valve prosthesis are similar to those described in U.S. Pat. Nos. 9,034,032; 9,005,273; 8,323,336; 8,075,615; 7,621,948; and 7,175,656 and U.S. Pub. No. 2011/0288637, which are incorporated herein for all purposes in their entirety.
  • valve prosthesis 10 Prior to implantation, valve prosthesis 10 is collapsed and loaded into a delivery device 30, for example, a delivery catheter.
  • the valve system is optionally primed before or after loading into the delivery catheter 30.
  • FIG. 19 shows a cross-sectional side view of a heart 2 with a transseptal puncture 27 in the atrial septum thereof. The leaflets 42 of valve 4 do not fully prolapse and the patient is experiencing regurgitation.
  • the delivery catheter 30 is inserted through an introducer into a vessel.
  • the delivery catheter 30 can be guided over a guidewire to a target location using the Seldinger technique.
  • the delivery catheter 30 is guided to the left atrium 25 through a transseptal puncture 27 in conventional fasion as shown in FIG. 20.
  • valve prosthesis 10 is then pushed out of the distal end of delivery catheter 30.
  • the delivery device 30 may comprise an outer catheter 50 and an inner catheter or shaft 52.
  • the delivery tube 52 extends out of the outer catheter 50 to move valve device 10 distally towards the native valve 4.
  • an anchor 15, such as wire 20 is deployed (e.g., from a straightened shape within the delivery device 30) to its pre-formed deployed shape and wraps around frame 12, which remains in its collapsed state as shown in FIG. 22.
  • the valve prosthesis 10 is then aligned with the target native valve 4 so the axis of the prosthetic valve 10 is aligned with a central axis of the native valve 4.
  • valve 10 is anchored to the native valve 4 using exemplary helical wire 20.
  • the valve prosthesis 10 frame 12, wire 20, and valve segment 14— are slowly rotated into the native mitral valve 4.
  • a torquer is provided in the delivery catheter 30 for rotating valve 10. Free end 22 of wire 20 is rotated through a
  • chordae tendineae also referred to as“papillary muscles”
  • Free end 22 has a larger radius than the main body of the helical coil in order to facilitate capture of the chordae tendineae 40 during rotation of the valve prosthesis 10.
  • Frame structure 12 also moves into the native valve 4 as the wire 20 is rotated.
  • Valve prosthesis 10 is in the correct position when the chordae tendineae 40 have been captured to a sufficient degree and/or frame structure 12 is in the desired location in the native valve 40. Insertion of the device through the native valve may be facilitated by the natural opening and closing of the native valve during the cardiac cycle. In the illustrated embodiment, the chordae tendineae 40 are pulled inwardly into a bunches (best seen in FIG. 25). The native valve leaflets 42 are also in communication with the helical coil 20. At this stage valve device 10 is rigidly anchored adjacent the native valve 40 annulus.
  • the helical wire 20 can be counter-rotated to back out the device 10 from the native valve 4. The implant rotation procedure can then be repeated.
  • Frame structure 12 is expanded once valve 10 is in the desired location as shown in FIG. 25.
  • the frame structure 12 may comprise a first and second opposite ends, the first end extending above a native valve and the second end extending below the native valve when the frame structure 12 is anchored to the native valve 4.
  • the frame structure 12 is expanded with a balloon 48 as shown in FIGs. 27-28.
  • the frame structure 12 is self-expanding.
  • the self-expanding exemplary frame structure 12 is formed of a shape memory material or any material having superelastic properties.
  • the self expanding frame structure 12 is configured and expands in a similar manner to a self-expanding stent or scaffold. Expanding the frame structure 12 comprises removing a sheath (for example, outer sheath 50) of the delivery device 30 from the frame structure 12.
  • the entire valve assembly 10 is released from the delivery catheter 30 and the delivery catheter 30 is removed as shown in FIG. 26.
  • expansion of the frame structure 12 may occur simultaneously with release of the frame structure 12 from the delivery catheter 30.
  • valve structure 14 and frame structure 12 are deployed together.
  • the frame structure 12 can be deployed first and then receive the prosthetic valve segment 14.
  • valve prosthesis 10 does not include a valve segment 14.
  • the frame structure 12 and anchor 15 are positioned within the native valve 4.
  • the frame structure 12 is configured to receive a valve segment 14 delivered separately.
  • the frame structure 12 can be configured to receive one of several valve sizes and types. In this manner, a clinician can choose the proper valve for the individual patient.
  • the helical wire 20 of anchor 15 guides the valve system 10 along a desired axis into position adjacent the native valve 4.
  • the wire 20 also provides an initial anchoring.
  • the valve prosthesis 10 is finally anchored when the frame structure 12 is expanded within the native valve 4.
  • the frame structure 12 dilates the valve leaflets 14 and the compressive force fixes the valve prosthesis 10 into position. Thereafter tissue ingrowth ensures the valve prosthesis 10 remains seated and does not migrate.
  • the valve device in accordance with the present disclosure provides several advantages over conventional valve systems.
  • Embodiments described herein provide an easy-to-use, repositionable device.
  • the valve prosthesis described herein reduces the risk of injuring or tearing chordae.
  • Typical mitral valve replacement systems involve implanting a prosthetic annulus or ring around the valve. The ring increases the circumference of the valve and risks occluding the entry to the aortic valve.
  • the valve device described herein overcomes these and other problems.
  • FIG. 29 illustrates another embodiment in accordance with the present disclosure.
  • a valve prosthesis 10’ includes a helical wire 20’ and frame structure 12’.
  • Valve structure 10’ is similar to valve 10 except that valve segment 14’ is fixed within a separate end of frame structure 12’.
  • Wire 20’ is wrapped around a lower portion of the frame structure 12 having a smaller diameter than the upper portion of the frame structure 12 to which the valve segment 14’ is fixed.
  • FIGs. 30A to 30F illustrate several other embodiments in accordance with the present disclosure.
  • Each of valves 10a to lOf includes a helical wire and frame.
  • Each can optionally include a valve segment within the frame.
  • FIG. 30A shows a valve prosthesis 10a which is similar to valve prosthesis 10 except that free end 22a includes an atraumatic ball tip. Also, wire 20a has a tubular shape at one end and a frustoconical shape at another end. Frame structure 12a is substantially similar to frame structure
  • FIG. 30B shows a valve prosthesis 10b which is similar to valve prosthesis 10 except that free end 22 has a pigtail tip. Also, wire 20b is attached to an intermediate portion of frame structure 12b instead of an end of the frame structure 12b. Frame structure 12b is substantially similar to frame structure 12.
  • FIG. 30C shows a valve prosthesis 10c which is similar to valve prosthesis 10 except that frame structure 12c is a tubular structure instead of a scaffold or stent-like structure.
  • the frame structure 12c can be formed of expandable materials such as polyurethane or polycarbonate urethane.
  • the wire 20c is substantially similar to wire 20.
  • the free end 22c is substantially similar to free end 22.
  • FIG. 30D shows a valve prosthesis lOd which is similar to valve prosthesis 10 except that the anchor 15 is formed of a three-dimensional surface 20d instead of a wire 20.
  • Three- dimensional surface 20d comprises a free end 22d, which may be substantially similar to any of the free ends described herein.
  • Frame structure 12d is substantially similar to frame structure 12.
  • FIG. 30E shows a valve prosthesis lOe which is similar to valve prosthesis 10 except that frame structure 12e has a conical shape instead of a tubular shape.
  • frame structure 12 may take a variety of shapes in accordance with the present disclosure.
  • the wire 20e is substantially similar to wire 20.
  • the free end 22e is substantially similar to free end 22.
  • FIG. 30F shows a valve prosthesis lOf which is similar to valve prosthesis 10 except that the valve device lOf includes a plurality of wires 20f and 20P.
  • the use of a plurality of wires 20f and 20P provides increased anchoring security. Because it may be difficult to insert both free ends 22f and 22G, one or both free ends 22f and 22G may include a sharp point for piercing tissue. In this manner, the sharp end can pierce the valve annulus or leaflets. Barbs or other mechanisms may be employed to increase anchoring of the wire.
  • one or both of the wires 20f and 20G may include a braided surface or barbs to prevent axial dislocation once it is screwed into place.
  • references to a structure or feature that is disposed“adjacent” another feature may have portions that overlap or underlie the adjacent feature.
  • Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.
  • the singular forms“a”,“an” and“the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.
  • the terms“comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.
  • the term“and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as“/”.
  • spatially relative terms such as“under”,“below”,“lower”,“over”,“upper” and the like, may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as“under” or“beneath” other elements or features would then be oriented“over” the other elements or features. Thus, the exemplary term“under” can encompass both an orientation of over and under.
  • the device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
  • the terms“upwardly”,“downwardly”,“vertical”,“horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
  • first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
  • the word“comprise”, and variations such as“comprises” and“comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods).
  • the term“comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.
  • references to a structure or feature that is disposed“adjacent” another feature may have portions that overlap or underlie the adjacent feature.
  • Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.
  • the singular forms“a”,“an” and“the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.
  • the terms“comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.
  • the term“and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as“/”.
  • spatially relative terms such as“under”,“below”,“lower”,“over”,“upper” and the like, may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as“under” or“beneath” other elements or features would then be oriented“over” the other elements or features. Thus, the exemplary term“under” can encompass both an orientation of over and under.
  • the device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
  • the terms“upwardly”,“downwardly”,“vertical”,“horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
  • the word“comprise”, and variations such as“comprises” and“comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods).
  • the term“comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.
  • a numeric value may have a value that is +/- 0.1% of the stated value (or range of values), +/- 1% of the stated value (or range of values), +/- 2% of the stated value (or range of values), +/- 5% of the stated value (or range of values), +/- 10% of the stated value (or range of values), etc.
  • Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value“10” is disclosed, then“about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Prostheses (AREA)
PCT/US2019/047542 2018-08-21 2019-08-21 Prosthetic cardiac valve devices, systems, and methods Ceased WO2020041495A1 (en)

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CN202510028014.2A CN119564382A (zh) 2018-08-21 2019-08-21 人工心脏瓣膜装置、系统和方法
CA3109642A CA3109642C (en) 2018-08-21 2019-08-21 DEVICES, SYSTEMS AND METHODS FOR PROSTHETIC HEART VALVES
EP24196111.9A EP4442226A3 (en) 2018-08-21 2019-08-21 Prosthetic cardiac valve devices, systems, and methods
JP2021509754A JP7421546B2 (ja) 2018-08-21 2019-08-21 人工心弁デバイス、システム、および方法
CN201980065767.3A CN112804966B (zh) 2018-08-21 2019-08-21 人工心脏瓣膜装置、系统和方法
AU2019325548A AU2019325548B2 (en) 2018-08-21 2019-08-21 Prosthetic cardiac valve devices, systems, and methods
EP19852661.8A EP3840696B1 (en) 2018-08-21 2019-08-21 Prosthetic cardiac valve devices and systems
JP2024002985A JP7821205B2 (ja) 2018-08-21 2024-01-12 人工心弁デバイス、システム、および方法
AU2025238053A AU2025238053A1 (en) 2018-08-21 2025-09-26 Prosthetic cardiac valve devices, systems, and methods

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WO2022047395A1 (en) 2020-08-31 2022-03-03 Shifamed Holding, Llc Flared prosthetic cardiac valve delivery devices and systems
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US20200060852A1 (en) 2020-02-27

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