US20200093589A1 - Side-delivered transcatheter heart valve replacement - Google Patents
Side-delivered transcatheter heart valve replacement Download PDFInfo
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- US20200093589A1 US20200093589A1 US16/435,687 US201916435687A US2020093589A1 US 20200093589 A1 US20200093589 A1 US 20200093589A1 US 201916435687 A US201916435687 A US 201916435687A US 2020093589 A1 US2020093589 A1 US 2020093589A1
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- 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
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- 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
- A61F2/2436—Deployment by retracting a sheath
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—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 sheet material or tubes, e.g. perforated by laser cuts or etched holes
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
- A61L27/3625—Vascular tissue, e.g. heart valves
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/005—Ingredients of undetermined constitution or reaction products thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/02—Inorganic materials
- A61L31/022—Metals or alloys
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- A—HUMAN NECESSITIES
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L31/125—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L31/129—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing macromolecular fillers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/068—Modifying the blood flow model, e.g. by diffuser or deflector
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
-
- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- 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
- A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
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- 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
Definitions
- the invention relates to a transcatheter heart valve replacement (A61F2/2412).
- tilting disc technology which was introduced in the late 1960s. These valves were a great improvement over the ball designs.
- the tilting disc technology allowed blood to flow in a more natural way while reducing damage to blood cells from mechanical forces.
- the struts of these valves tended to fracture from fatigue over time.
- more than 100,000 Omniscience and 300,000 Hall-Kaster/Medtronic-Hall tilting disc valves were implanted with essentially no mechanical failure.
- bi-leaflet heart valves were introduced by St. Jude. Similar to a native heart valve, blood flows directly through the center of the annulus of pyrolytic carbon valves mounted within nickel-titanium housing which makes these valves superior to other designs. However, a downside of this design is that it allows some regurgitation. A vast majority of mechanical heart valves used today have this design. As of 2003, more than 1.3 million St. Jude valves were deployed and over 500,000 Carbomedics valves with no failures to leaflets or housing. It should be noted that the human heart beats about 31 million times per year.
- the present invention is directed to a side delivered transcatheter prosthetic valve comprising:
- a compressible tubular frame having a side wall and a central axial lumen, said tubular frame having a height of 8-20 mm and a diameter of 40-80 mm,
- an atrial sealing cuff attached to a top edge of the side wall
- a subannular anchoring component attached to the tubular frame, said subannular anchoring component selected from one or more of the group consisting of a lower tension arm extending from a distal side of the tubular frame, a proximal anchoring tab extending from a proximal side of the tubular frame, a ventricular sealing collar attached to a bottom edge of the side wall, and at least one tissue anchor to connect the tubular frame to native tissue, and
- a flow control component comprising a leaflet structure having three leaflets of pericardial material sewn to a leaflet frame to form a rounded cylinder mounted within the lumen of the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve,
- valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a mitral valve annulus or tricuspid valve annulus of a patient, said delivery catheter having an internal diameter from 22 Fr (7.33 mm) to 34 Fr (11.33 mm),
- said compressed configuration having a long-axis that is substantially parallel to a length-wise cylindrical axis of the delivery catheter, and substantially orthogonal to the blood flow through the flow control component mounted in the central axial lumen,
- said compressed configuration having a height and a width to fit within the delivery catheter, the height and width of the compressed configuration compressed by longitudinal/length-wise rolling or folding,
- valve is expandable to an expanded configuration having a long-axis substantially orthogonal to the blood flow through the flow control component mounted in the central axial lumen
- tubular frame and said atrial sealing cuff having a polyester cover
- said tubular frame and said atrial sealing cuff made from superelastic shape-memory material selected from Ni-Ti alloy, Cu-Zn-Al-Ni alloys, Cu-Al-Ni alloys, a polymer composite, a composite containing one or more of carbon nanotubes, carbon fibers, metal fibers, glass fibers, and polymer fibers, a stainless steel, a cobalt chromium material, and a titanium material.
- a side delivered transcatheter prosthetic valve wherein the at least one tissue anchor to connect the tubular frame to native tissue is an anterior leaflet clip or anchor, a posterior leaflet clip or anchor, or a septal leaflet clip or anchor.
- a side delivered transcatheter prosthetic valve wherein said tubular frame is comprised of a braided, wire, or laser-cut wire frame, and said tubular frame is covered with a biocompatible material.
- a side delivered transcatheter prosthetic valve wherein the tubular frame has a side profile of a flat cone shape having a diameter R of 40-80 mm, a diameter r of 20-60 mm, and a height of 8-20 mm.
- a side delivered transcatheter prosthetic valve wherein the tubular frame has an inner surface and an outer surface, said inner surface and said outer surface covered with pericardial tissue.
- a side delivered transcatheter prosthetic valve wherein the tubular frame has a side profile of an hourglass shape having a top diameter R1 of 40-80 mm, a bottom diameter R2 of 50-70 mm, an internal diameter r of 20-60 mm, and a height of 8-20 mm.
- a side delivered transcatheter prosthetic valve wherein the flow control component has an internal diameter of 20-60 mm and a height of 8-20 mm.
- a side delivered transcatheter prosthetic valve wherein the flow control component is supported with one or more longitudinal supports integrated into or mounted upon the flow control component, the one or more longitudinal supports selected from rigid or semi-rigid posts, rigid or semi-rigid ribs, rigid or semi-rigid battons, rigid or semi-rigid panels, and combinations thereof.
- a side delivered transcatheter prosthetic valve wherein the tension arm extending from the distal side of the tubular frame is comprised of wire loop or wire frame, integrated frame section, or stent, and extend from about 10-40 mm away from the tubular frame.
- a side delivered transcatheter prosthetic valve wherein the valve also comprises (i) an upper tension arm attached to a distal upper edge of the tubular frame, the upper tension arm comprised of wire loop or wire frame extending from about 2-20 mm away from the tubular frame, and (ii) the lower tension arm extending from the distal side of the tubular frame is comprised of wire loop or wire frame, integrated frame section, or stent, and extends from about 10-40 mm away from the tubular frame.
- the present invention is also directed to a method for side delivery of implantable prosthetic valve between a ventricle and an atrium of a heart, the method comprising the steps:
- a method for side delivery of implantable prosthetic valve between a ventricle and an atrium of a heart wherein releasing the valve from the delivery catheter is selected from the steps consisting of: (i) pulling the valve out of the delivery catheter using a rigid elongated pushing rod that is releasably connected to the distal side of the valve, wherein advancing the pushing rod away from the delivery catheter pulls the compressed valve out of the delivery catheter, or (ii) pushing the valve out of the delivery catheter using a rigid elongated pushing rod that is releasably connected to the proximal side of the valve, wherein advancing the pushing rod out of from the delivery catheter pushes the compressed valve out of the delivery catheter.
- a method for side delivery of implantable prosthetic valve between a ventricle and an atrium of a heart comprising the additional step of anchoring one or more tissue anchors attached to the valve into native tissue.
- a method for side delivery of implantable prosthetic valve between a ventricle and an atrium of a heart wherein the subannular anchoring component is a lower tension arm extending from a distal side of the tubular frame.
- a method for side delivery of implantable prosthetic valve between a ventricle and an atrium of a heart comprising the additional step of rotating the heart valve prosthesis using a steerable catheter along an axis parallel to the plane of the valve annulus, wherein an upper tension arm mounted on the valve is conformationally pressure locked against supra-annular tissue, and wherein a lower tension arm mounted on the valve is conformationally pressure locked against sub-annular tissue.
- a side delivered transcatheter prosthetic valve comprising: (i) a tubular frame having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter, and expandable to an expanded configuration for implanting at a desired location in the body, wherein the valve is compressible and expandable along a long-axis substantially parallel to a cylindrical axis of the delivery catheter, and wherein the valve has a height of about 5-60 mm and a diameter of about 25-80 mm.
- a side delivered transcatheter prosthetic valve wherein the tubular frame forms a two part framework, a first part comprises a flared atrial cuff joined to a second part that comprises cylindrical member, wherein the cuff is joined to the cylindrical member around the circumference of a top edge of the cylindrical member.
- a side delivered transcatheter prosthetic valve wherein said tubular frame is comprised of a braid, wire, or laser-cut wire frame, and said tubular frame is covered with a biocompatible material.
- a side delivered transcatheter prosthetic valve wherein the tubular frame has a side profile of a flat cone shape having a diameter R of 40-80 mm, a diameter r of 20-40 mm, and a height of 10-20 mm.
- a side delivered transcatheter prosthetic valve wherein the tubular frame has an inner surface and an outer surface, said inner surface covered with a biocompatible material comprising pericardial tissue, and said outer surface covered with a biocompatible material comprising a woven synthetic polyester material.
- a side delivered transcatheter prosthetic valve wherein the tubular frame has a side profile of an hourglass flat conical shape having a top diameter R1 of 40-80 mm, a bottom diameter R2 of 50-70 mm, an internal diameter r of 20-30 mm, and a height of 5-60 mm.
- a side delivered transcatheter prosthetic valve wherein the valve in an expanded configuration has a central tube axis that is substantially parallel to the first direction.
- a side delivered transcatheter prosthetic valve wherein the flow control component has an internal diameter of 20-30 mm and a height of 20-40 mm, and a plurality of leaflets of pericardial material joined to form a rounded cylinder at an inflow end and having a flat closable aperture at an outflow end.
- a side delivered transcatheter prosthetic valve wherein the flow control component is supported with one or more longitudinal supports integrated into or mounted upon the flow control component, the one or more longitudinal supports selected from rigid or semi-rigid ribs, rigid or semi-rigid battons, rigid or semi-rigid panels, and combination thereof.
- a side delivered transcatheter prosthetic valve comprising a tension arm extending from a distal side of the tubular frame, the tension arm comprised of wire loop or wire frame extending from about 10-40 mm away from the tubular frame.
- a side delivered transcatheter prosthetic valve comprising (i) an upper tension arm attached to a distal upper edge of the tubular frame, the upper tension arm comprised of wire loop or wire frame extending from about 2-20 mm away from the tubular frame, and (ii) a lower tension arm extending from a distal side of the tubular frame, the lower tension arm comprised of wire loop or wire frame extending from about 10-40 mm away from the tubular frame.
- a side delivered transcatheter prosthetic valve comprising at least one tissue anchor connected to the tubular frame for engaging annular tissue.
- a method for side delivery of implantable prosthetic valve to a desired location in the body comprising the steps: (i) advancing a delivery catheter to the desired location in the body and delivering an expandable prosthetic valve to the desired location in the body by releasing the valve from the delivery catheter, wherein the valve comprises a tubular frame having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter, and expandable to an expanded configuration for implanting at a desired location in the body, wherein the valve is compressible and expandable along a long-axis substantially parallel to a cylindrical axis of the delivery catheter, wherein the valve has a height of about 5-60 mm and a diameter of about 25-80 mm.
- a method for side delivery of implantable prosthetic valve wherein releasing the valve from the delivery catheter comprises pulling the valve out of the delivery catheter using a rigid elongated pushing rod that is releasably connected to the distal side of the valve, wherein advancing the pushing rod away from the delivery catheter pulls the compressed valve out of the delivery catheter.
- a method for side delivery of implantable prosthetic valve comprising the additional step of anchoring one or more tissue anchors attached to the valve into annular tissue.
- a method for side delivery of implantable prosthetic valve comprising the additional step of positioning a tension arm of the heart valve prosthesis into the right ventricular outflow tract of the right ventricle.
- a method for side delivery of implantable prosthetic valve comprising the additional steps of positioning a lower tension arm of the heart valve prosthesis into the right ventricular outflow tract of the right ventricle, and positioning an upper tension arm into a supra-annular position, the upper tension arm connected to the lower tension arm, and the upper tension arm providing a supra-annular downward force in the direction of the ventricle and lower tension arm providing a sub-annular upward force in the direction of the atrium.
- a method for side delivery of implantable prosthetic valve comprising the additional step of rotating the heart valve prosthesis using a steerable catheter along an axis parallel to the plane of the valve annulus, wherein an upper tension arm mounted on the valve is conformationally pressure locked against supra-annular tissue, and wherein a lower tension arm mounted on the valve is conformationally pressure locked against sub-annular tissue.
- a method for loading an implantable prosthetic valve into a delivery catheter comprising the steps: (i) attaching a pulling wire to a sidewall of an implantable prosthetic valve and pulling the valve into a tapering fixture or funnel, wherein the valve comprises a tubular frame having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein pulling the valve into a tapering fixture or funnel compresses the valve to a compressed configuration for loading into a delivery catheter, wherein the valve is compressible and expandable along a long-axis substantially parallel to a cylindrical axis of the delivery catheter, wherein the valve has a height of about 5-60 mm and a diameter of about 25-80 mm.
- FIG. 1 is an illustration of a plan view of a heart valve prosthesis according to the present invention with a valve frame having a distal upper and lower tension arm mounted on, and anchored to, the anterior leaflet side of the native annulus, and having a mechanical anchor element, e.g. surgical tissue screw, anchored on a posterior or septal side of the native annulus.
- a mechanical anchor element e.g. surgical tissue screw
- FIG. 2 is an illustration of a plan view of a heart valve prosthesis according to the present invention with a valve frame having a distal upper and lower tension arm mounted on, and anchored to, the anterior leaflet side of the native annulus, and having a mechanical anchor element, e.g. proximal sealing cuff, for anchoring on the posterior and septal side of the native annulus.
- a mechanical anchor element e.g. proximal sealing cuff
- FIG. 3 is an illustration of a plan view of a heart valve prosthesis according to the present invention with a valve frame having a distal upper and lower tension arm mounted on, and anchored to, the anterior leaflet side of the native annulus, and having a mechanical anchor element, e.g. hourglass annular seal, for anchoring on the posterior and/or septal side of the native annulus.
- a mechanical anchor element e.g. hourglass annular seal
- FIG. 4 is an illustration of a PLAN view of a low-profile, e.g. 10 mm in height, wire loop embodiment of the heart valve prosthesis having an annulus support loop and an upper and lower tension arm formed as a unitary or integral part, and covered with a biocompatible material.
- a low-profile e.g. 10 mm in height
- wire loop embodiment of the heart valve prosthesis having an annulus support loop and an upper and lower tension arm formed as a unitary or integral part, and covered with a biocompatible material.
- FIG. 5 is an illustration of a TOP view of a low-profile, e.g. 10 mm in height, wire loop embodiment of the heart valve prosthesis having an annulus support loop, an upper and lower tension arm formed as a unitary or integral part, an inner two-panel conical valve sleeve, and covered with a biocompatible material.
- FIG. 6 is an illustration of a BOTTOM view of a low-profile, e.g. 10 mm in height, wire loop embodiment of the heart valve prosthesis having an annulus support loop, an upper and lower tension arm formed as a unitary or integral part, an inner two-panel conical valve sleeve, and covered with a biocompatible material.
- a low-profile e.g. 10 mm in height
- wire loop embodiment of the heart valve prosthesis having an annulus support loop, an upper and lower tension arm formed as a unitary or integral part, an inner two-panel conical valve sleeve, and covered with a biocompatible material.
- FIG. 7 is an illustration of a compressed and elongated wire loop embodiment of the heart valve prosthesis disposed within a delivery catheter and having an annulus support loop and an upper and lower tension arm formed as a unitary or integral part.
- FIG. 8 is an illustration of a compressed and elongated wire loop embodiment of the heart valve prosthesis partially ejected, and partially disposed within, a delivery catheter and having an annulus support loop and an upper and lower tension arm formed as a unitary or integral part.
- FIG. 9 is an illustration of a plan view of a heart valve prosthesis partially mounted within the valve annulus.
- FIG. 10 is an illustration of a plan view of a heart valve prosthesis completely seated within the valve annulus.
- FIG. 11 is an illustration of a plan view of a native right atrium of a human heart, and shows the superior vena cava (SVC), the inferior vena cava (IVC), the right atrium (RA), the tricuspid valve and annulus (TCV), the anterior leaflet (A), the posterior leaflet (P), the septal leaflet (S), the right ventricle (RV), and the right ventricular outflow tract (RVOT).
- SVC superior vena cava
- IVC inferior vena cava
- RA right atrium
- TCV tricuspid valve and annulus
- A anterior leaflet
- P posterior leaflet
- S septal leaflet
- RV right ventricle
- RVOT right ventricular outflow tract
- FIG. 12 is an illustration of a heart valve prosthesis having a wire-frame according to the present invention being delivered to tricuspid valve annulus.
- FIG. 13 is an illustration of a heart valve prosthesis having a wire-frame according to the present invention being delivered to tricuspid valve annulus.
- FIG. 14 is an illustration of a heart valve prosthesis having a wire-frame according to the present invention that has been delivered to tricuspid valve annulus.
- FIG. 15 is an illustration of a heart valve prosthesis having a braided/laser cut-frame according to the present invention being delivered to tricuspid valve annulus.
- FIG. 16 is an illustration of a heart valve prosthesis having a braided/laser cut-frame according to the present invention being delivered to tricuspid valve annulus.
- FIG. 17 is an illustration of a heart valve prosthesis having a braided/laser cut-frame according to the present invention that has been delivered to tricuspid valve annulus.
- FIG. 18 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus and shows step 1 in a valve assessment process.
- FIG. 19 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus, and shows Step 2 in a valve assessment process.
- FIG. 20 is an illustration of a heart valve prosthesis according to the present invention that has been delivered to tricuspid valve annulus, and shows Step 3 in a valve assessment process.
- FIG. 21 is an illustration of a wire-frame embodiment of a heart valve prosthesis according to the present invention in a compressed, intra-catheter phase.
- FIG. 22 is an illustration of a profile, or plan, view of a wire-frame embodiment of the heart valve prosthesis according to the present invention in a un-compressed, post-catheter-ejection phase.
- FIG. 23 is an illustration of a profile, or plan, view of a braided or laser-cut frame embodiment of the heart valve prosthesis according to the present invention in a un-compressed, post-catheter-ejection phase.
- FIG. 24 is an illustration of a TOP view of a heart valve prosthesis according to the present invention having covered wire loops for the upper tension arm(s).
- FIG. 25 is an illustration of a PLAN view of a heart valve prosthesis according to the present invention having a wire loop construction for the upper and lower tension arms.
- FIG. 26 is an illustration of a CUT-AWAY PLAN view of a heart valve prosthesis according to the present invention, and shows the inner panel valve sleeve mounted within the inner space defined by the tubular frame.
- FIG. 27 is an illustration of a BOTTOM view of a heart valve prosthesis according to the present invention having covered wire loops for the lower tension arm.
- FIG. 28 is an illustration of a TOP view of a heart valve prosthesis according to the present invention having braid or laser-cut wire frame for the upper tension arm(s).
- FIG. 29 is an illustration of a PLAN view of a heart valve prosthesis according to the present invention having braid or laser-cut wire frame construction for the upper and lower tension arms.
- FIG. 30 is an illustration of a CUT-AWAY PLAN view of a braid or laser-cut embodiment of the heart valve prosthesis according to the present invention, and shows the inner panel valve sleeve mounted within the inner space defined by the tubular frame.
- FIG. 31 is an illustration of a BOTTOM view of a heart valve prosthesis according to the present invention having braid or laser-cut wire frame for the lower tension arm.
- FIG. 32 is an illustration of a heart valve prosthesis according to the present invention having a wire loop construction for the tubular frame, with two vertical support posts extending down the edge on opposing sides of the valve sleeve.
- the posts are engineered to fold horizontally during compression, and to elastically unfold during ejection to deploy the valve sleeve.
- FIG. 33 is an illustration of a CUT-AWAY PLAN view of a heart valve prosthesis according to the present invention, and shows a two-post embodiment of the inner panel valve sleeve mounted within the inner space defined by the tubular frame.
- FIG. 34 is an illustration of a CUT-AWAY PLAN view of a heart valve prosthesis according to the present invention, and shows a three-panel, three-post embodiment of the inner panel valve sleeve mounted within the inner space defined by the tubular frame.
- FIG. 35 is an illustration of a heart valve prosthesis according to the present invention having a braid or laser-cut construction for the tubular frame, with a valve sleeve that extends beyond the bottom of the tubular frame.
- FIG. 36 is an illustration of a heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve compressed within a delivery catheter.
- FIG. 37 is an illustration of a heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve shown partially compressed within a delivery catheter, and partially ejected from the delivery catheter.
- FIG. 38 is an illustration of a heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve engaging the tissue on the anterior side of the native annulus with the curved distal side-wall of the tubular frame sealing around the native annulus.
- FIG. 39 is an illustration of a heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve engaging the tissue on the anterior side of the native annulus with the curved distal side-wall of the tubular frame sealing around the native annulus, and with the proximal side-wall tension-mounted into the posterior side of the native annulus.
- FIG. 40 is an illustration of a TOP view of a heart valve prosthesis according to the present invention having braid or laser-cut wire frame and shown mounted within a cross-sectional view of the atrial floor at the annulus.
- FIG. 41 is an illustration of a BOTTOM view of a heart valve prosthesis according to the present invention having braid or laser-cut wire frame for a lower tension arm and shown mounted within a cross-sectional view of the ventricular ceiling at the annulus.
- FIG. 42 is an illustration of a PLAN view of an embodiment of the prosthetic valve shown in a compressed configuration within a delivery catheter.
- FIG. 43 is an illustration of a cross-sectional view of one embodiment of a compressed valve within a delivery catheter.
- FIG. 44 is an illustration of a cross-sectional view of another embodiment of a compressed valve within a delivery catheter.
- FIG. 45 is an illustration of a cross-sectional view of one embodiment of the prosthetic valve.
- FIG. 46 ( a )-( b )-( c ) is an illustration of a sequence of a low-profile valve being rolled into a configuration for placement within a delivery catheter.
- FIG. 47 is an illustration of an END-VIEW of a low-profile valve that has been longitudinally rolled and loaded within a delivery catheter.
- FIG. 48 is an illustration of a rotational lock embodiment of the present invention where the prosthetic valve is delivered to the native annulus with an off-set sub-annular tension arm/tab positioned below the native annulus, and an off-set supra-annular tension arm/tab positioned above the native annulus, while the tubular frame is partially rolled off-set from the annular plane along a longitudinal axis.
- FIG. 49 is an illustration of a rotational lock embodiment of the present invention where the prosthetic valve is delivered to the native annulus with an off-set sub-annular tension arm/tab positioned below the native annulus, and an off-set supra-annular tension arm/tab positioned above the native annulus, while the tubular frame is rolled into functional position parallel to the annular plane.
- FIG. 50 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve shown deployed into the native annulus.
- FIG. 51 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve shown compressed or housed within the delivery catheter.
- FIG. 52 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve shown ejected from the delivery catheter and positioned against the anterior side of the native annulus.
- FIG. 53 is an illustration of a open cross-section view of a low-profile, side-delivered prosthetic valve and shows the inner valve sleeve.
- FIG. 54 is an illustration of a two-panel embodiment of an inner valve sleeve.
- FIG. 55 is an illustration of one embodiment of an inner valve sleeve having two rigid support posts.
- FIG. 56 is an illustration of a three-panel embodiment of an inner valve sleeve.
- FIG. 57 is an illustration of a three-panel embodiment of an inner valve sleeve having three rigid support posts.
- FIG. 58 is a flowchart describing one set of method steps for delivery of a low-profile, side-delivered prosthetic valve.
- FIG. 59 a - b - c is a series of illustrations of a plan view of a tissue anchor having a floating radio-opaque marker.
- 59 a shows the tissue anchor accessing the annular tissue with the radio-opaque marker at the distal end of the anchor and in contact with the atrial surface of the annular tissue.
- 59 b shows the tissue anchor advancing into the annular tissue with the radio-opaque marker threaded onto the tissue anchor and maintaining position on the atrial surface of the annular tissue.
- 59 c shows the tissue anchor completely advanced into the annular tissue such that the tissue anchor and the threaded floating marker are now adjacent, indicating the desired depth, tension, and/or plication of the tissue anchor with respect to the annular tissue.
- FIG. 60 is an illustration of a plan view of of a tissue anchor having a straight thread and a constant pitch.
- FIG. 61 is an illustration of a plan view of of a tissue anchor having a straight thread and a variable pitch.
- FIG. 62 is an illustration of a plan view of of a tissue anchor having a tapered thread and a constant pitch.
- FIG. 63 is an illustration of a plan view of of a tissue anchor having a sunken taper thread and a variable pitch.
- FIG. 64 is an illustration of Step 1 of a 4 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 64 shows a low profile valve being inserted into the valve annulus and low profile valve having an integral anchor delivery conduit or channel with an anchor disposed in the lumen of the channel and an anchor delivery catheter attached to the anchor.
- FIG. 65 is an illustration of Step 2 of a 4 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 65 shows a low profile valve completely deployed within the valve annulus and an integral anchor delivery conduit or channel with an anchor disposed in the lumen of the channel and an anchor delivery catheter attached to the anchor.
- FIG. 66 is an illustration of Step 3 of a 4 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 66 shows the anchor being pushed out of the lumen of the delivery conduit or channel and into the annular tissue.
- FIG. 67 is an illustration of Step 4 of a 4 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 67 shows the anchor in a locked position after being pushed out of the lumen of the delivery conduit or channel and into the annular tissue, thus anchoring the proximal side of the low profile valve.
- FIG. 68 is an illustration of Step 1 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 68 shows catheter delivery of an attachment wire with the clip housed within the lumen of the clip delivery catheter.
- FIG. 69 is an illustration of Step 2 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 69 shows the clip delivery catheter inserted into an intra-annular space and shows an attachment wire and shows the clip housed within the lumen of the clip delivery catheter.
- FIG. 70 is an illustration of Step 3 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 70 shows a receiver element ejected from the delivery catheter and positioned behind tissue to be captured.
- FIG. 71 is an illustration of Step 4 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 71 shows an anchor element piercing the annular tissue and inserting into a receiver element.
- FIG. 72 is an illustration of Step 5 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 72 shows that the clip delivery catheter is withdrawn and the anchor element and receiver element are connected to the annular tissue and a also connected by connector wire to the low profile valve.
- FIG. 73 is an illustration of one embodiment of a partial cut-away interior view of a tri-leaflet embodiment of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve.
- FIG. 74 is an illustration of another embodiment of a partial cut-away interior view of a tri-leaflet embodiment of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve.
- FIG. 75 is an illustration of a top view of a tri-leaflet embodiment of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve.
- FIG. 76 is an illustration of the trans-septal (femoral-IVC) delivery of a low-profile, e.g. 8-20 mm, side-delivered prosthetic MITRAL valve shown partially housed within the delivery catheter, and partially ejected for deployment into the native mitral annulus.
- a low-profile e.g. 8-20 mm
- side-delivered prosthetic MITRAL valve shown partially housed within the delivery catheter, and partially ejected for deployment into the native mitral annulus.
- FIG. 77 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic MITRAL valve shown housed within the delivery catheter.
- FIG. 78 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic MITRAL valve shown partially housed within a delivery catheter and partially latterally ejected from the delivery catheter and positioned for deployment against the anterior side of the native mitral annulus.
- a low-profile e.g. 8-20 mm
- side-delivered prosthetic MITRAL valve shown partially housed within a delivery catheter and partially latterally ejected from the delivery catheter and positioned for deployment against the anterior side of the native mitral annulus.
- FIG. 79 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic MITRAL valve shown ejected from the delivery catheter and positioned against the anterior side of the native mitral annulus.
- a low-profile e.g. 8-20 mm
- side-delivered prosthetic MITRAL valve shown ejected from the delivery catheter and positioned against the anterior side of the native mitral annulus.
- FIG. 80 is an illustration of a side or plan view of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve shown deployed into the native MITRAL annulus.
- the invention is directed to a transcatheter heart valve replacement that is a low profile, orthogonally delivered (side delivered) implantable prosthetic valve having an ring-shaped tubular frame, an inner 2- or 3-panel sleeve, an elongated sub-annular tension arm extending into the right ventricular outflow tract, and one or more anchor elements.
- valves of the present invention are compressed and delivered at a roughly 90 degree angle compared to traditional transcatheter heart valves.
- Traditional valves have a central cylinder axis that is parallel to the length-wise axis of the delivery catheter and are deployed from the end of the delivery catheter in a manner akin to pushing a closed umbrella out of a sleeve.
- the valves of the present invention are compressed and delivered in a sideways manner.
- Traditional valves can only be expanded as large as what the internal diameter of the delivery catheter will allow.
- orthogonal refers to an intersecting angle of 90 degrees between two lines or planes.
- substantially orthogonal refers to an intersecting angle ranging from 75 to 105 degrees.
- the intersecting angle or orthogonal angle refers to both (i) the relationship between the length-wise cylindrical axis of the delivery catheter and the long-axis of the compressed valve of the invention, where the long-axis is perpendicular to the central cylinder axis of traditional valves, and (ii) the relationship between the long-axis of the compressed or expanded valve of the invention and the axis defined by the blood flow through the prosthetic valve where the blood is flowing, eg. from one part of the body or chamber of the heart to another downstream part of the body or chamber of the heart, such as from an atrium to a ventricle through a native annulus.
- Transcatheter is used to define the process of accessing, controlling, and delivering a medical device or instrument within the lumen of a catheter that is deployed into a heart chamber, as well as an item that has been delivered or controlled by such as process.
- Transcatheter access is known to include via femoral artery and femoral vein, via brachial artery and vein, via carotid and jugular, via intercostal (rib) space, and via sub-xyphoid.
- Transcatheter can be synonymous with transluminal and is functionally related to the term “percutaneous” as it relates to delivery of heart valves.
- tubular frame and also “wire frame” or “flange or “collar” refers to a three-dimensional structural component that is seated within a native valve annulus and is used as a mounting element for a leaflet structure, a flow control component, or a flexible reciprocating sleeve or sleeve-valve.
- the tubular frame can be a ring, or cylindrical or conical tube, made from a durable, biocompatible structural material such as Nitinol or similar alloy, wherein the tubular frame is formed by manufacturing the structural material as a braided wire frame, a laser-cut wire frame, or a wire loop.
- the tubular frame is about 5-60 mm in height, has an outer diameter dimension, R, of 30-80 mm, and an inner diameter dimension of 31-79 mm, accounting for the thickness of the wire material itself.
- the tubular frame can have a side-profile of a ring shape, cylinder shape, conical tube shape, but may also have a side profile of a flat-cone shape, an inverted flat-cone shape (narrower at top, wider at bottom), a concave cylinder (walls bent in), a convex cylinder (walls bulging out), an angular hourglass, a curved, graduated hourglass, a ring or cylinder having a flared top, flared bottom, or both.
- the tubular frame used in the prosthetic valve deployed in the tricuspid annulus may have a complex shape determined by the anatomical structures where the valve is being mounted.
- the circumference of the tricuspid valve may be a rounded ellipse
- the septal wall is known to be substantially vertical
- the tricuspid is known to enlarge in disease states along the anterior-posterior line.
- a prosthetic valve may start in a roughly tubular configuration, and be heat-shaped to provide an upper atrial cuff or flange for atrial sealing and a lower trans-annular tubular section having an hourglass cross-section for about 60-80% of the circumference to conform to the native annulus along the posterior and anterior annular segments while remaining substantially vertically flat along 20-40% of the annular circumference to conform to the septal annular segment.
- the tubular frame is optionally internally or externally covered, partially or completely, with a biocompatible material such as pericardium.
- the tubular frame may also be optionally externally covered, partially or completely, with a second biocompatible material such as polyester or Dacron (R).
- the tubular frame has a central axial lumen where a prosthetic valve or flow-control structure, such as a reciprocating compressible sleeve, is mounted across the diameter of the lumen.
- a prosthetic valve or flow-control structure such as a reciprocating compressible sleeve.
- the tubular frame is also tensioned against the inner aspect of the native annulus and provides structural patency to a weakened annular ring.
- the tubular frame may optionally have a separate atrial collar attached to the upper (atrial) edge of the frame, for deploying on the atrial floor, that is used to direct blood from the atrium into the sleeve and to seal against blood leakage around the tubular frame.
- the tubular frame may also optionally have a separate ventricular collar attached to the lower (ventricular) edge of the frame, for deploying in the ventricle immediately below the native annulus that is used to prevent regurgitant leakage during systole, to prevent dislodging of the device during systole, to sandwich or compress the native annulus or adjacent tissue against the atrial collar, and optionally to attach to and support the sleeve/conduit.
- the tubular frame may be compressed for transcatheter delivery and may be expandable as a self-expandable shape-memory element or using a transcatheter expansion balloon.
- Some embodiments may have both an atrial collar and a ventricular collar, whereas other embodiments within the scope of the invention include prosthetic valves having either a single atrial collar, a single ventricular collar, or having no additional collar structure.
- flow control component refers in a non-limiting sense to a leaflet structure having 2-, 3-, 4-leaflets of flexible biocompatible material such a treated or untreated pericardium that is sewn or joined to a tubular frame, to function as a prosthetic valve.
- a valve can be a heart valve, such as a tricuspid, mitral, aortic, or pulmonary, that is open to blood flowing during diastole from atrium to ventricle, and that closes from systolic ventricular pressure applied to the outer surface. Repeated opening and closing in sequence can be described as “reciprocating”.
- tissue anchor or “plication tissue anchor” or “secondary tissue anchor”, or “dart” or “pin” refers to a fastening device that connects the upper atrial frame to the the native annular tissue, usually at or near the periphery of the collar.
- the anchor may be positioned to avoid piercing tissue and just rely on the compressive force of the two plate-like collars on the captured tissue, or the anchor, itself or with an integrated securement wire, may pierce through native tissue to provide anchoring, or a combination of both.
- the anchor may have a specialized securement mechanism, such as a pointed tip with a groove and flanged shoulder that is inserted or popped into a mated aperture or an array of mated apertures that allow the anchor to attach, but prevent detachment when the aperture periphery locks into the groove near the flanged shoulder.
- the securement wire may be attached or anchored to the collar opposite the pin by any attachment or anchoring mechanisms, including a knot, a suture, a wire crimp, a wire lock having a cam mechanism, or combinations.
- support post refers to a rigid or semi-rigid length of material such as Nitinol or PEEK, that may be mounted on a spoked frame and that runs axially, or down the center of, or within a sewn seam of-, the flexible sleeve.
- the sleeve may be unattached to the support post, or the sleeve may be directly or indirectly attached to the support post.
- body channel is used to define a blood conduit or vessel within the body.
- An aortic valve replacement for example, would be implanted in, or adjacent to, the aortic annulus.
- a tricuspid or mitral valve replacement will be implanted at the tricuspid or mitral annulus.
- Lumen refers to the inside of a cylinder tube.
- bore refers to the inner diameter.
- Displacement The volume of fluid displaced by one complete stroke or revolution
- Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. During each heartbeat pumping cycle, the heart contracts and relaxes. When your heart contracts, it ejects blood from the two pumping chambers (ventricles)
- the term “expandable” is used herein to refer to a component of the heart valve capable of expanding from a first, delivery diameter to a second, implantation diameter.
- An expandable structure therefore, does not mean one that might undergo slight expansion from a rise in temperature, or other such incidental cause.
- “non-expandable” should not be interpreted to mean completely rigid or a dimensionally stable, as some slight expansion of conventional “non-expandable” heart valves, for example, may be observed.
- prosthesis or prosthetic encompasses both complete replacement of an anatomical part, e.g. a new mechanical valve replaces a native valve, as well as medical devices that take the place of and/or assist, repair, or improve existing anatomical parts, e.g. native valve is left in place.
- anatomical part e.g. a new mechanical valve replaces a native valve
- medical devices that take the place of and/or assist, repair, or improve existing anatomical parts, e.g. native valve is left in place.
- the invention contemplates a wide variety of (bio)prosthetic artificial heart valves. Contemplated as within the scope of the invention are ball valves (e.g. Starr-Edwards), bileaflet valves (St. Jude), tilting disc valves (e.g.
- pericardium heart-valve prosthesis' bovine, porcine, ovine
- homograft and autograft valves aortic valves, bioprosthetic mitral valves, bioprosthetic tricuspid valves, and bioprosthetic pulmonary valves.
- the frame is made from superelastic metal wire, such as Nitinol (TM) wire or other similarly functioning material.
- the material may be used for the frame/stent, for the collar, and/or for anchors. It is contemplated as within the scope of the invention to use other shape memory alloys such as Cu—Zn—Al—Ni alloys, Cu—Al—Ni alloys, as well as polymer composites including composites containing carbon nanotubes, carbon fibers, metal fibers, glass fibers, and polymer fibers.
- the frame may be constructed as a braid, wire, or laser cut wire frame. Such materials are available from any number of commercial manufacturers, such as Pulse Systems.
- Laser cut wire frames are preferably made from Nickel-Titanium (Nitinol (TM)), but also without limitation made from stainless steel, cobalt chromium, titanium, and other functionally equivalent metals and alloys, or Pulse Systems braided frame that is shape-set by heat treating on a fixture or mandrel.
- TM Nickel-Titanium
- TM cobalt chromium
- titanium titanium
- other functionally equivalent metals and alloys or Pulse Systems braided frame that is shape-set by heat treating on a fixture or mandrel.
- One key aspect of the frame design is that it be compressible and when released have the stated property that it return to its original (uncompressed) shape. This requirement limits the potential material selections to metals and plastics that have shape memory properties. With regards to metals, Nitinol has been found to be especially useful since it can be processed to be austenitic, martensitic or super elastic. Martensitic and super elastic alloys can be processed to demonstrate the required compression features.
- the wire frame envisions the laser cutting of a thin, isodiametric Nitinol tube.
- the laser cuts form regular cutouts in the thin Nitinol tube.
- the Nitinol tube expands to form a three-dimensional structure formed from diamond-shaped cells.
- the structure may also have additional functional elements, e.g. loops, anchors, etc. for attaching accessory components such as biocompatible covers, tissue anchors, releasable deployment and retrieval control guides, knobs, attachments, rigging, and so forth.
- the tube is placed on a mold of the desired shape, heated to the Martensitic temperature and quenched.
- the treatment of the wire frame in this manner will form a device that has shape memory properties and will readily revert to the memory shape at the calibrated temperature.
- a frame can be constructed utilizing simple braiding techniques.
- a Nitinol wire for example a 0.012′′ wire—and a simple braiding fixture
- the wire is wound on the braiding fixture in a simple over/under braiding pattern until an isodiametric tube is formed from a single wire.
- the two loose ends of the wire are coupled using a stainless steel or Nitinol coupling tube into which the loose ends are placed and crimped.
- Angular braids of approximately 60 degrees have been found to be particularly useful.
- the braided wire frame is placed on a shaping fixture and placed in a muffle furnace at a specified temperature to set the wire frame to the desired shape and to develop the martensitic or super elastic properties desired.
- Tethers are made from surgical-grade materials such as biocompatible polymer suture material.
- Non-limiting examples of such material include ultra high-molecular weight polyethylene (UHMWPE), 2-0 exPFTE(polytetrafluoroethylene) or 2-0 polypropylene.
- UHMWPE ultra high-molecular weight polyethylene
- 2-0 exPFTE(polytetrafluoroethylene) polytetrafluoroethylene
- 2-0 polypropylene polypropylene.
- the tethers are inelastic. It is also contemplated that one or more of the tethers may optionally be elastic to provide an even further degree of compliance of the valve during the cardiac cycle.
- the device can be seated within the valvular annulus through the use of tines or barbs. These may be used in conjunction with, or in place of one or more tethers.
- the tines or barbs are located to provide attachment to adjacent tissue.
- Tines are forced into the annular tissue by mechanical means such as using a balloon catheter.
- the tines may optionally be semi-circular hooks that upon expansion of the wire frame body, pierce, rotate into, and hold annular tissue securely.
- Anchors are deployed by over-wire delivery of an anchor or anchors through a delivery catheter.
- the catheter may have multiple axial lumens for delivery of a variety of anchoring tools, including anchor setting tools, force application tools, hooks, snaring tools, cutting tools, radio-frequency and radiological visualization tools and markers, and suture/thread manipulation tools.
- anchoring tools may be used to adjust the length of tethers that connect to an implanted valve to adjust and secure the implant as necessary for proper functioning.
- anchors may be spring-loaded and may have tether-attachment or tether-capture mechanisms built into the tethering face of the anchor(s).
- Anchors may also have in-growth material, such as polyester fibers, to promote in-growth of the anchors into the myocardium.
- a prosthetic valve may or may not include a ventricular collar
- the anchor or dart is not attached to a lower ventricular collar, but is attached directly into annular tissue or other tissue useful for anchoring.
- the tissue used herein is a biological tissue that is a chemically stabilized pericardial tissue of an animal, such as a cow (bovine pericardium) or sheep (ovine pericardium) or pig (porcine pericardium) or horse (equine pericardium).
- the tissue is bovine pericardial tissue.
- suitable tissue include that used in the products Duraguard®, Peri-Guard®, and Vascu-Guard®, all products currently used in surgical procedures, and which are marketed as being harvested generally from cattle less than 30 months old.
- Other patents and publications disclose the surgical use of harvested, biocompatible animal thin tissues suitable herein as biocompatible “jackets” or sleeves for implantable stents, including for example, U.S.
- the conduit may optionally be made from a synthetic material such a polyurethane or polytetrafluoroethylene.
- synthetic polymer materials such expanded polytetrafluoroethylene or polyester may optionally be used.
- suitable materials may optionally include thermoplastic polycarbonate urethane, polyether urethane, segmented polyether urethane, silicone polyether urethane, silicone-polycarbonate urethane, and ultra-high molecular weight polyethylene.
- Additional biocompatible polymers may optionally include polyamides, polyolefins, polyesters, elastomers, polyethylene-glycols, polyethersulphones, polysulphones, polyvinylpyrrolidones, polyvinylchlorides, other fluoropolymers, silicone polyesters, siloxane polymers and/or oligomers, and/or polylactones, and block co-polymers using the same.
- PA is an early engineering thermoplastic invented that consists of a “super polyester” fiber with molecular weight greater than 10,000. It is commonly called Nylon.
- Application of polyamides includes transparent tubing's for cardiovascular applications, hemodialysis membranes, and also production of percutaneous transluminal coronary angioplasty (PTCA) catheters.
- PTCA percutaneous transluminal coronary angioplasty
- Polyolefins include polyethylene and polypropylene are the two important polymers of polyolefins and have better biocompatibility and chemical resistance. In cardiovascular uses, both low-density polyethylene and high-density polyethylene are utilized in making tubing and housings. Polypropylene is used for making heart valve structures.
- Polyesters includes polyethylene-terephthalate (PET), using the name Dacron. It is typically used as knitted or woven fabric for vascular grafts. Woven PET has smaller pores which reduces blood leakage and better efficiency as vascular grafts compared with the knitted one. PET grafts are also available with a protein coating (collagen or albumin) for reducing blood loss and better biocompatibility [39]. PET vascular grafts with endothelial cells have been searched as a means for improving patency rates. Moreover, polyesters are widely preferred material for the manufacturing of bioabsorbable stents. Poly-L-lactic acids (PLLA), polyglycolic acid (PGA), and poly(D, L-lactide/glycolide) copolymer (PDLA) are some of the commonly used bioabsorbable polymers.
- PLLA poly-L-lactic acids
- PGA polyglycolic acid
- PDLA poly(D, L-lactide/glycolide) copoly
- PTFE Polytetrafluoroethylene
- vascular grafts and heart valves.
- PTFE sutures are used in the repair of mitral valve for myxomatous disease and also in surgery for prolapse of the anterior or posterior leaflets of mitral valves.
- PTFE is particularly used in implantable prosthetic heart valve rings. It has been successfully used as vascular grafts when the devices are implanted in high-flow, large-diameter arteries such as the aorta.
- elongated-PTFE Expanded PTFE is formed by compression of PTFE in the presence of career medium and finally extruding the mixture. Extrudate formed by this process is then heated to near its glass transition temperature and stretched to obtain microscopically porous PTFE known as e-PTFE. This form of PTFE was indicated for use in smaller arteries with lower flow rates promoting low thrombogenicity, lower rates of restenosis and hemostasis, less calcification, and biochemically inert properties.
- Polyurethane has good physiochemical and mechanical properties and is highly biocompatible which allows unrestricted usage in blood contacting devices. It has high shear strength, elasticity, and transparency. Moreover, the surface of polyurethane has good resistance for microbes and the thrombosis formation by PU is almost similar to the versatile cardiovascular biomaterial like PTFE. Conventionally, segmented polyurethanes (SPUs) have been used for various cardiovascular applications such as valve structures, pacemaker leads and ventricular assisting device.
- SPUs segmented polyurethanes
- DES Drug-eluting wire frames are contemplated for use herein.
- DES basically consist of three parts: wire frame platform, coating, and drug.
- Some of the examples for polymer free DES are Amazon Pax (MINVASYS) using Amazonia CroCo (L605) cobalt chromium (Co-Cr) wire frame with Paclitaxel as an antiproliferative agent and abluminal coating have been utilized as the carrier of the drug.
- BioFreedom Biosensors Inc.
- stainless steel using stainless steel as base with modified abluminal coating as carrier surface for the antiproliferative drug Biolimus A9.
- Optima CID S.r.I.
- 316 L stainless steel wire frame as base for the drug Tacrolimus and utilizing integrated turbostratic carbofilm as the drug carrier.
- VESTA sync MIV Therapeutics
- GenX stainless steel 316 L
- YUKON choice Translumina
- 316 L stainless steel used 316 L stainless steel as base for the drugs Sirolimus in combination with Probucol.
- Biosorbable polymers may also be used herein as a carrier matrix for drugs.
- Cypher, Taxus, and Endeavour are the three basic type of bioabsorbable DES.
- Cypher J&J, Cordis
- PBMA polybutyl methacrylate
- Taxus (Boston Scientific) utilizes 316 L stainless steel wire frames coated with translute Styrene Isoprene Butadiene (SIBS) copolymer for carrying Paclitaxel which elutes over a period of about 90 days.
- SIBS translute Styrene Isoprene Butadiene
- Endeavour uses a cobalt chrome driver wire frame for carrying zotarolimus with phosphorylcholine as drug carrier.
- BioMatrix employing S-Wire frame (316 L) stainless steel as base with polylactic acid surface for carrying the antiproliferative drug Biolimus.
- ELIXIR-DES program (Elixir Medical Corp) consisting both polyester and polylactide coated wire frames for carrying the drug novolimus with cobalt-chromium (Co-Cr) as base.
- JACTAX (Boston Scientific Corp.) utilized D-lactic polylactic acid (DLPLA) coated (316 L) stainless steel wire frames for carrying Paclitaxel.
- NEVO Cordis Corporation, Johnson & Johnson
- Examples of preferred embodiments of the reciprocating pressure conduit valve include the following details and features.
- a side delivered transcatheter prosthetic valve has a tubular frame with a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, wherein the long-axis of the compressed configuration of the valve is substantially parallel to a length-wise cylindrical axis of the delivery catheter,
- valve has a height of about 5-60 mm and a diameter of about 25-80 mm.
- this heart valve substitute does not have a traditional valve configuration, can be delivered to the heart using the inferior vena cava (IVC/femoral transcatheter delivery pathway compressed within a catheter, and expelled from the catheter to be deployed without open heart surgery.
- IVC/femoral transcatheter delivery pathway compressed within a catheter, and expelled from the catheter to be deployed without open heart surgery.
- a transcatheter valve comprises: a cylindrical tubular frame having a height of about 5-60 mm and an outer diameter of about 25-80 mm, said tubular frame comprised of a braid, wire, or laser-cut wire frame having a substantially circular central aperture, said tubular frame partially covered with a biocompatible material; a collapsible flow control component disposed within the central aperture, said sleeve having a height of about 5-60 mm and comprised of at least two opposing leaflets that provide a reciprocating closable channel from a heart atrium to a heart ventricle; an upper tension arm attached to a distal upper edge of the tubular frame, the upper tension arm comprised of stent, segment of tubular frame, wire loop or wire frame extending from about 10-30 mm away from the tubular frame; a lower tension arm extending from a distal side of the tubular frame, the lower tension arm comprised of stent, segment of tubular frame, wire loop or wire frame extending from about 10-40
- a transcatheter valve In another preferred embodiment of a transcatheter valve, there is provided a feature wherein the sleeve is shaped as a conic cylinder, said top end having a diameter of 30-35 mm and said bottom end having a diameter of 8-20 mm.
- a transcatheter valve there is provided a feature wherein the cover is comprised of polyester, polyethylene terephthalate, decellularized pericardium, or a layered combination thereof.
- a method for side delivery of implantable prosthetic valve to a desired location in the body comprising the steps: (i) advancing a delivery catheter to the desired location in the body and delivering an expandable prosthetic valve to the desired location in the body by releasing the valve from the delivery catheter, wherein the valve comprises a tubular frame having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, wherein the long-axis of the compressed configuration of the
- a method for loading an implantable prosthetic valve into a delivery catheter comprising the steps: loading an implantable prosthetic valve sideways into a tapering fixture or funnel attached to a delivery catheter, wherein the valve comprises a tubular frame having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, wherein the long-axis of the compressed configuration of the valve is substantially parallel to a length-wise cylindrical axis of the delivery catheter, wherein the
- a method for loading an implantable prosthetic valve into a delivery catheter comprising the steps: (i) loading an implantable prosthetic valve into a tapering fixture or funnel attached to a delivery catheter, wherein the valve comprises a tubular frame having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein said loading is perpendicular or substantially orthogonal to the first direction, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, wherein the long-axis of the compressed configuration of the valve is
- the transcatheter prosthetic heart valve may be percutaneously delivered using a transcatheter process via the femoral through the IVC, carotid, sub-xyphoid, intercostal access across the chest wall, and trans-septal to the mitral annulus through the fossa ovalis.
- the device is delivered via catheter to the right or left atrium and is expanded from a compressed shape that fits with the internal diameter of the catheter lumen.
- the compressed valve is loaded external to the patient into the delivery catheter, and is then pushed out of the catheter when the capsule arrives to the atrium.
- the cardiac treatment technician visualizes this delivery using available imaging techniques such as fluoroscopy or ultrasound, and in a preferred embodiment the valve self-expands upon release from the catheter since it is constructed in part from shape-memory material, such as Nitinol®, a nickel-titanium alloy used in biomedical implants.
- shape-memory material such as Nitinol®, a nickel-titanium alloy used in biomedical implants.
- the valve may be constructed of materials that requires balloon-expansion after the capsule has been ejected from the catheter into the atrium.
- the atrial collar/frame and the flow control component are expanded to their functional diameter, as they are deployed into the native annulus, providing a radial tensioning force to secure the valve.
- fasteners secure the device about the native annulus. Additional fastening of the device to native structures may be performed, and the deployment is complete. Further adjustments using hemodynamic imaging techniques are contemplated as within the scope of the invention in order to ensure the device is secure, is located and oriented as planned, and is functioning as a substitute or successor to the native tricuspid valve.
- FIG. 1 is an illustration of a plan view of a heart valve prosthesis 100 according to the present invention with a valve frame 102 having upper tension arm 128 and lower tension arm 126 mounted on and anchoring to the annulus.
- FIG. 1 shows lower tension arm/tab 126 extending into the Right Ventricular Outflow Tract (RVOT).
- RVOT Right Ventricular Outflow Tract
- the lateral, or side-delivered, delivery of the valve 100 through the inferior vena cava provides for direct access to the valve annulus without the need to delivery a compressed valve around a right angle turn, as is required for IVC delivery of axially, or vertically loaded, traditional transcatheter valves.
- FIG. 1 is an illustration of a plan view of a heart valve prosthesis 100 according to the present invention with a valve frame 102 having upper tension arm 128 and lower tension arm 126 mounted on and anchoring to the annulus.
- FIG. 1 shows lower tension arm/tab 126 extending into the Right Ventricular Outflow Tract (R
- FIG. 1 shows one embodiment where a screw or other anchor device 138 is used in conjunction with the tension-mounting method described herein where upper and lower tension arms on the anterior leaflet side anchor the valve in place, and a secondary anchor element completes the securement of the valve in the annular site.
- FIG. 1 shows polyester mesh covering 108 a valve tubular frame 102 encircling a collapsible flow control sleeve 110 .
- FIG. 1 also shows the frame 102 having Nitinol wire frame in diamond shapes with a biocompatible covering.
- the frame may have a pericardial material on top and a polyester material, e.g. surgical Dacron(R), underneath to be in contact with the native annulus and promote ingrowth.
- FIG. 2 is an illustration of a plan view of another embodiment of a heart valve prosthesis according to the present invention with a valve frame 102 having a distal upper tension arm 128 and lower tension arm 126 mounted on, and anchored to, the anterior leaflet side of the native annulus, and having a mechanical anchor element, e.g. proximal sealing cuff, 130 for anchoring on the posterior and septal side of the native annulus.
- the sealing cuff 130 may be a short tab on the posterior side of the valve or may be a semi-circular or circular collar or cuff that engages the atrial floor to seal the annulus from perivalvular leaks.
- FIG. 3 is an illustration of a plan view of another embodiment of a heart valve prosthesis according to the present invention with a valve frame having a distal upper and lower tension arm mounted on, and anchored to, the anterior leaflet side of the native annulus, and having a mechanical anchor element, e.g. hourglass annular seal, 132 for anchoring on the posterior and/or septal side of the native annulus.
- the hourglass, or concave, sealing cuff 132 may be only a short segment on the posterior side of the valve or may be a semi-circular or circular combined upper and lower collar or cuff that engages the atrial floor and the ventricular ceiling to seal the annulus from perivalvular leaks.
- This embodiment may also include embodiments having a partial collar. This embodiment may be used in conjunction with other anchoring elements described herein.
- FIG. 4 is an illustration of a PLAN view of a low-profile, e.g. 10 mm in height, wire loop embodiment of the heart valve prosthesis having an annulus support loop 140 and an upper and lower tension arm 142 , 144 formed as a unitary or integral part, and covered with a biocompatible material.
- This embodiment shows how a low profile, side-delivered valve can having a very large diameter, 40-80 mm, with requiring an excessively large delivery catheter, as would be required by a large diameter valve that is delivered using the traditional, vertical or axial, orientation.
- FIG. 5 is an illustration of a TOP view of a low-profile, e.g. 10 mm in height, wire loop embodiment of the heart valve prosthesis having an annulus support loop 140 , an upper and lower tension arm 142 , 144 formed as a unitary or integral part, an inner two-panel conical valve sleeve 110 , and covered with a biocompatible material.
- FIG. 5 shows the inner two-panel sleeve and the reciprocating collapsible aperture at the lower end for delivering blood to the ventricle.
- FIG. 6 is an illustration of a BOTTOM view of a low-profile, e.g. 10 mm in height, wire loop embodiment of the heart valve prosthesis having an annulus support loop, an upper and lower tension arm formed as a unitary or integral part, an inner two-panel conical valve sleeve, and covered with a biocompatible material.
- FIG. 6 shows a PLAN view of the inner two-panel sleeve 110 and the collapsible terminal aperture 156 at the ventricular side.
- FIG. 7 is an illustration of a compressed and elongated wire loop embodiment of the heart valve prosthesis disposed within a delivery catheter 118 and having an ring shaped tubular frame 102 with braid/laser-cut 104 and an upper and lower tension arm 142 , 144 formed as a unitary or integral part.
- FIG. 7 illustrates how a large diameter valve, using side-loading, can be delivered.
- FIG. 8 is an illustration of a compressed and elongated wire loop embodiment of the heart valve prosthesis partially ejected, and partially disposed within, a delivery catheter and having an annulus support loop and an upper and lower tension arm formed as a unitary or integral part.
- FIG. 8 shows how a valve can be partially delivered for positioning in the annulus.
- the lower tension arm 144 can be used to navigate through the tricupid leaflets and chordae tendinae while the valve body, the tubular frame, 102 is still within the steerable IVC delivery catheter 118 .
- FIG. 9 is an illustration of a plan view of a heart valve prosthesis partially mounted within the valve annulus.
- the distal side of the prosthesis 142 , 144 can be mounted against the anterior aspect of the native annulus, and valve function can be assessed.
- a practitioner can determine if the heart is decompensating or if valve function is less than optimal.
- FIG. 10 is an illustration of a plan view of a heart valve prosthesis completely seated within the valve annulus.
- FIG. 19 shows that the valve can be secured in place once the valve function assessment shows that the deployment is successful.
- the side-loading valve can be easily retrieved using the same delivery catheter that is used to deploy the valve.
- FIG. 11 is an illustration of a plan view of a native right atrium of a human heart, and shows the superior vena cava (SVC), the inferior vena cava (IVC), the right atrium (RA), the tricuspid valve and annulus (TCV), the anterior leaflet (A), the posterior leaflet (P), the septal leaflet (S), the right ventricle (RV), and the right ventricular outflow tract (RVOT).
- SVC superior vena cava
- IVC inferior vena cava
- RA right atrium
- TCV tricuspid valve and annulus
- A anterior leaflet
- P posterior leaflet
- S septal leaflet
- RV right ventricle
- RVOT right ventricular outflow tract
- FIG. 12 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus.
- FIG. 12 shows wire-frame lower tension arm 144 ejected from the delivery catheter 118 and being directed through the annulus and towards the right ventricular outflow tract.
- FIG. 12 shows an embodiment of an accordion-compressed low-profile valve 122 and shows the lower tension arm directed towards the anterior leaflet for placement into the RVOT.
- FIG. 13 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus.
- FIG. 13 shows wire-frame lower tension arm 144 and upper tension arm 142 ejected from the delivery catheter 118 , the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus.
- FIG. 13 also shows steerable anchoring catheter 150 attached to a proximal anchoring tab 152 .
- the valve While the valve is held in a pre-seating position, the valve can be assessed, and once valve function and patient conditions are correct, the steerable anchoring catheter can push the proximal side of the valve from its oblique angle, down into the annulus. The steerable anchoring catheter can then install one or more anchoring elements 152 .
- FIG. 14 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus.
- FIG. 14 shows the entire valve ejected from the delivery catheter, the wire-frame lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper wire-frame tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus, and at least one tissue anchor anchoring the proximal side of the prosthesis into the annulus tissue.
- FIG. 15 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus.
- FIG. 15 shows braided/laser cut-frame lower tension arm 126 ejected from the delivery catheter 118 and being directed through the annulus and towards the right ventricular outflow tract.
- FIG. 16 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus.
- FIG. 16 shows braided/laser cut-frame lower tension arm 126 and upper tension arm 128 ejected from the delivery catheter 118 , the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus.
- FIG. 17 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus.
- FIG. 17 shows the entire braided/laser cut-frame valve 102 ejected from the delivery catheter 118 , the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus, and at least one tissue anchor anchoring the proximal side of the prosthesis into the annulus tissue.
- FIG. 18 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus and shows step 1 in a valve assessment process.
- FIG. 18 shows braided/laser cut-frame lower tension arm ejected from the delivery catheter and being directed through the annulus and towards the right ventricular outflow tract.
- FIG. 19 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus, and shows Step 2 in a valve assessment process.
- FIG. 19 shows braided/laser cut-frame lower tension arm and upper tension arm ejected from the delivery catheter, the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus.
- FIG. 19 shows braided/laser cut-frame lower tension arm and upper tension arm ejected from the delivery catheter, the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus.
- a steerable anchoring catheter can hold the valve at an oblique angle in a pre-attachment position, so that the valve can be assessed, and once valve function and patient conditions are correct, the steerable anchoring catheter can push the proximal side of the valve from its oblique angle, down into the annulus. The steerable anchoring catheter can then install one or more anchoring elements.
- FIG. 20 is an illustration of a heart valve prosthesis according to the present invention that has been delivered to tricuspid valve annulus, and shows Step 3 in a valve assessment process.
- FIG. 20 shows the entire braided/laser cut-frame valve ejected from the delivery catheter, the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus, and at least one tissue anchor anchoring the proximal side of the prosthesis into the annulus tissue.
- FIG. 21 is an illustration of a heart valve prosthesis according to the present invention in a compressed, intra-catheter phase.
- the lower and upper tension arms 144 , 142 are elongated to the right, and the prosthetic valve 102 is shown laterally compressed in the delivery catheter 118 .
- the lateral compression is a function of the use of minimal structural materials, e.g. a minimal inner valve sleeve 110 , and the relatively short height of the outer cylindrical frame 102 .
- This lateral delivery provides for very large, e.g. up to 80 mm or more, valve prosthesis' to be delivered.
- the lateral delivery also avoids the need to perform a 90 degree right turn when delivering a valve using the IVC femoral route. This sharp delivery angle has also limited the size and make up of prior valve prosthesis', but is not a problem for the inventive valve herein.
- FIG. 22 is an illustration of a profile, or plan, view of a wire-frame embodiment of the heart valve prosthesis according to the present invention in a un-compressed, post-catheter-ejection phase.
- FIG. 22 shows an embodiment where the upper wire-frame tension arm 142 is attached to the tubular frame 102 , but the lower tension arm 144 is shaped in an S-shape and connects only to the upper tension arm 142 .
- FIG. 23 is an illustration of a profile, or plan, view of a braid or laser-cut frame embodiment of the heart valve prosthesis according to the present invention in a un-compressed, post-catheter-ejection phase.
- FIG. 23 shows an embodiment where the upper braid or laser-cut tension arm 128 is attached to the upper edge of the tubular frame 102 , and the lower tension arm 126 is attached to the lower edge of the tubular frame 102 .
- FIG. 24 is an illustration of a TOP view of a heart valve prosthesis according to the present invention having covered wire loop for the upper tension arm(s).
- FIG. 24 shows the tubular frame 102 having an inner sleeve 110 sewn into the central aperture 106 , with the two (2) panels extending downward (into the page) in a ventricular direction.
- FIG. 24 shows the upper tension arms 142 oriented towards the anterior leaflet side of the atrial floor, shown in dashed outline.
- FIG. 25 is an illustration of a PLAN view of a heart valve prosthesis according to the present invention having a wire loop construction for the upper 142 and lower 144 tension arms.
- FIG. 26 is an illustration of a CUT-AWAY PLAN view of a heart valve prosthesis according to the present invention, and shows the inner panel valve sleeve 110 mounted within the inner space defined by the tubular frame.
- FIG. 27 is an illustration of a BOTTOM view of a heart valve prosthesis according to the present invention having a covered wire loop for the lower tension arm 144 .
- FIG. 27 shows the tubular frame 102 having an inner sleeve 110 sewn into the central aperture, with the two (2) panels extending upward (out of the page) in a ventricular direction.
- FIG. 27 shows the lower tension arm 144 oriented towards the anterior leaflet side of the ventricular ceiling, shown in dashed outline.
- FIG. 28 is an illustration of a TOP view of a heart valve prosthesis according to the present invention having covered braid or laser-cut frame 102 for the upper tension arm 128 .
- FIG. 28 shows the tubular frame 102 having an inner sleeve 110 sewn into the central aperture, with the two (2) panels extending downward (into the page) in a ventricular direction.
- FIG. 28 shows the upper tension arm 128 oriented towards the anterior leaflet side of the atrial floor, shown in dashed outline.
- FIG. 29 is an illustration of a PLAN view of a heart valve prosthesis according to the present invention having a braid or laser-cut frame construction 102 for the upper and lower tension arms 128 , 126 .
- FIG. 30 is an illustration of a CUT-AWAY PLAN view of a heart valve prosthesis according to the present invention, and shows the inner panel valve sleeve 110 mounted within the inner space defined by the tubular frame 102 .
- FIG. 31 is an illustration of a BOTTOM view of a heart valve prosthesis according to the present invention having a covered braid or laser-cut frame for the lower tension arm.
- FIG. 31 shows the tubular frame 102 having an inner sleeve 110 sewn into the central aperture, with the two (2) panels extending upward (out of the page) in a ventricular direction.
- FIG. 31 shows the lower tension arm 126 oriented towards the anterior leaflet side of the ventricular ceiling, shown in dashed outline.
- FIG. 32 is an illustration of a heart valve prosthesis according to the present invention having a wire loop construction for the tubular frame 102 , with two vertical support posts 154 extending down the edge on opposing sides of the sleeve 110 .
- the posts 154 are engineered to fold horizontally during compression, and to elastically unfold during ejection to deploy the valve sleeve 110 .
- FIG. 33 is an illustration of a CUT-AWAY PLAN view of a heart valve prosthesis according to the present invention, and shows a two-post embodiment 154 of the inner panel valve sleeve 110 mounted within the inner space defined by the tubular frame 102 .
- FIG. 34 is an illustration of a CUT-AWAY PLAN view of a heart valve prosthesis according to the present invention, and shows a three-panel, three-post embodiment of the inner panel valve sleeve mounted within the inner space defined by the tubular frame.
- FIG. 35 is an illustration of a low-profile, side-delivered heart valve prosthesis according to the present invention having a braid or laser-cut construction for the tubular frame 102 , with a valve sleeve 110 that extends beyond the bottom of the tubular frame.
- FIG. 35 shows a longer lower tension arm 126 for extending sub-annularly towards the RVOT, and a shorter upper tension arm 128 for extending over the atrial floor.
- FIG. 35 shows an elongated two (2) panel valve sleeve 110 that extends into the sub-annular leaflet space.
- the tubular frame 102 shown in FIG. 35 is about 10 mm in height and the valve sleeve 110 extends about 10 mm below the bottom of the tubular frame, resulting in a valve 20 mm in total height.
- FIG. 36 is an illustration of a low-profile, side-delivered heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve compressed within a delivery catheter 118 .
- FIG. 36 shows the valve attached to a secondary steerable catheter 150 for ejecting, positioning, and anchoring the valve.
- the secondary catheter 150 can also be used to retrieve a failed deployment of a valve.
- FIG. 37 is an illustration of a heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve shown partially compressed within a delivery catheter, and partially ejected from the delivery catheter.
- FIG. 37 shows that while the valve is still compressed the lower tension arm can be manipulated through the leaflets and chordae tendinae to find a stable anterior-side lodgment for the distal side of the valve.
- FIG. 38 is an illustration of a heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve engaging the tissue on the anterior side of the native annulus with the curved distal side-wall of the tubular frame sealing around the native annulus.
- FIG. 38 shows the valve held by the steerable secondary catheter at an oblique angle while valve function is assessed.
- FIG. 39 is an illustration of a heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve fully deployed into the tricuspid annulus.
- the distal side of the valve is shown engaging the tissue on the anterior side of the native annulus with the curved distal side-wall of the tubular frame sealing around the native annulus, and with the proximal side-wall tension-mounted into the posterior side of the native annulus.
- FIG. 40 is an illustration of a TOP view of a heart valve prosthesis according to the present invention having braid or laser-cut wire frame 102 and shown mounted within a cross-sectional view of the atrial floor at the annulus.
- FIG. 41 is an illustration of a BOTTOM view of a heart valve prosthesis according to the present invention having braid or laser-cut wire frame 102 for a lower tension arm 126 and shown mounted within a cross-sectional view of the ventricular ceiling at the annulus.
- FIG. 41 shows the two panel valve sleeve 110 in an open position 106 , e.g. atrial systole and ventricular diastole.
- FIG. 41 shows RVOT as a darkened circle.
- FIG. 42 is an illustration of a PLAN view of an embodiment of the prosthetic valve shown in a compressed configuration within a delivery catheter.
- FIG. 42 shows the tubular frame wall rolled-over, outwardly, resulting in a 50% reduction in height of the catheter-housed valve.
- the low profile, side-delivered valves of the present invention do not require the aggressive, strut-breaking, tissue-tearing, stitch-pulling forces that traditional transcatheter valves are engineered to mitigate.
- FIG. 43 is an illustration of a cross-sectional view of one embodiment of a compressed valve within a delivery catheter 118 .
- This cross-sectional end view shows one embodiment of a single-fold compression configuration where the tubular frame wall 102 and attached two-panel sleeve 110 are rolled-over, outwardly, resulting in a 50% reduction in height, and providing the ability to fit within the inner diameter of a 1 cm (10 mm) delivery catheter.
- FIG. 44 is an illustration of a cross-sectional view of another embodiment of a compressed valve within a delivery catheter.
- This cross-sectional end view shows another embodiment of a single-fold compression configuration where the tubular frame wall and attached two-panel sleeve are folded-over, outwardly, resulting in a 50% reduction in height, and providing the ability to fit within the inner diameter of a 1 cm (10 mm) delivery catheter.
- FIG. 45 is an illustration of a cross-sectional view of an embodiment of the prosthetic valve to further illustrate how the folding and rolling configurations can be effectuated due to the minimal material requirement of the low-profile, side-delivered valve 102 , 110 .
- FIG. 46 ( a )-( b )-( c ) is an illustration of a sequence of a low-profile valve being rolled into a configuration for placement within a delivery catheter.
- Tubular frame 102 having aperture 106 supports sleeve 110 .
- FIG. 47 is an illustration of an END-VIEW of a low-profile valve that has been longitudinally rolled and loaded within a delivery catheter 118 , and show frame 102 and sleeve 110 .
- FIG. 48 is an illustration of a rotational lock embodiment of the present invention where the prosthetic valve is delivered to the native annulus with an off-set sub-annular tension arm/tab 126 positioned below the native annulus, and an off-set supra-annular tension arm/tab 128 positioned above the native annulus, while the tubular frame 102 is partially rolled off-set from the annular plane along a longitudinal axis.
- FIG. 49 is an illustration of a rotational lock embodiment of the present invention where the prosthetic valve is delivered to the native annulus with an off-set sub-annular tension arm/tab 126 positioned below the native annulus, and an off-set supra-annular tension arm/tab 128 positioned above the native annulus, while the tubular frame 102 is rolled into functional position parallel to the annular plane.
- the valve can also be further anchored using traditional anchoring elements as disclosed herein.
- FIG. 50 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve 100 shown deployed into the native annulus.
- FIG. 50 shows that low-profile, side-delivered valves can be delivered and traditionally anchored with or without the need for shaped, tension arms.
- FIG. 51 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve having frame 102 and sleeve 110 shown compressed or housed within the delivery catheter 118 .
- FIG. 52 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve shown ejected from the delivery catheter 118 and positioned against the anterior side of the native annulus. While the valve is held at this oblique angle by secondary catheter 150 , valve function and patient condition are assessed, and if appropriate the valve is completely deployed within the native annulus, and anchored using traditional anchoring elements.
- a low-profile e.g. 8-20 mm
- side-delivered prosthetic valve shown ejected from the delivery catheter 118 and positioned against the anterior side of the native annulus. While the valve is held at this oblique angle by secondary catheter 150 , valve function and patient condition are assessed, and if appropriate the valve is completely deployed within the native annulus, and anchored using traditional anchoring elements.
- FIG. 53 is an illustration of an open cross-section view of a low-profile, side-delivered prosthetic valve and shows the inner valve sleeve 110 and frame 102 .
- FIG. 54 is an illustration of a two-panel embodiment of an inner valve sleeve 110 .
- FIG. 55 is an illustration of one embodiment of an inner valve sleeve 110 having two rigid support posts 154 .
- FIG. 56 is an illustration of a three-panel embodiment of an inner valve sleeve 110 .
- FIG. 57 is an illustration of a three-panel embodiment of an inner valve sleeve 110 having three rigid support posts 154 .
- FIG. 58 is a flowchart describing one set of method steps for delivery of a low-profile, side-delivered prosthetic valve.
- STEP 1 Provide low profile, side-loading prosthetic valve
- STEP 2 compress valve into a delivery catheter, where the valve is compressed along a horizontal axis that is parallel to the length-wise axis of the delivery catheter;
- STEP 3 advance the delivery catheter containing the side-loaded valve to the right atrium via the inferior vena cava;
- STEP 4 expel the side-loaded valve from the delivery catheter, and using a steerable secondary catheter, seat the valve into the native annulus;
- STEP 5 optionally, before fully seating the valve into the native annulus, hold the valve at an oblique angle to assess valve function, and then after assessing valve function, fully seat the valve into the native annulus.
- FIG. 59 is an illustration of a plan view of a tissue anchor having a floating radio-opaque marker.
- This figure shows the tissue anchor accessing the annular tissue withe the radio-opaque marker at the distal end of the anchor and in contact with the atrial surface of the annular tissue.
- This figure shows the tissue anchor advancing into the annular tissue with the radio-opaque marker threaded onto the tissue anchor and maintaining position on the atrial surface of the annular tissue.
- This figure shows the tissue anchor completely advanced into the annular tissue such that the tissue anchor and the threaded floating marker are now adjacent, indicating the desired depth, tension, and/or plication of the tissue anchor with respect to the annular tissue.
- FIG. 60 is an illustration of a plan view of of a tissue anchor having a straight thread and a constant pitch.
- FIG. 61 is an illustration of a plan view of of a tissue anchor having a straight thread and a variable pitch.
- FIG. 62 is an illustration of a plan view of of a tissue anchor having a tapered thread and a constant pitch.
- FIG. 63 is an illustration of a plan view of of a tissue anchor having a sunken taper thread and a variable pitch.
- FIG. 64 is an illustration of Step 1 of a 4 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 64 shows a low profile valve being inserted into the valve annulus and low profile valve having an integral anchor delivery conduit or channel with an anchor disposed in the lumen of the channel and an anchor delivery catheter attached to the anchor.
- FIG. 65 is an illustration of Step 2 of a 4 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 65 shows a low profile valve completely deployed within the valve annulus and an integral anchor delivery conduit or channel with an anchor disposed in the lumen of the channel and an anchor delivery catheter attached to the anchor.
- FIG. 66 is an illustration of Step 3 of a 4 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 66 shows the anchor being pushed out of the lumen of the delivery conduit or channel and into the annular tissue.
- FIG. 67 is an illustration of Step 4 of a 4 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 67 shows the anchor in a locked position after being pushed out of the lumen of the delivery conduit or channel and into the annular tissue, thus anchoring the proximal side of the low profile valve.
- FIG. 68 is an illustration of Step 1 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 68 shows catheter delivery of an attachment wire with the clip housed within the lumen of the clip delivery catheter.
- FIG. 69 is an illustration of Step 2 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 69 shows the clip delivery catheter inserted into an intra-annular space and shows an attachment wire and shows the clip housed within the lumen of the clip delivery catheter.
- FIG. 70 is an illustration of Step 3 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 70 shows a receiver element ejected from the delivery catheter and positioned behind tissue to be captured.
- FIG. 71 is an illustration of Step 4 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 71 shows an anchor element piercing the annular tissue and inserting into a receiver element.
- FIG. 72 is an illustration of Step 5 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.
- FIG. 72 shows that the clip delivery catheter is withdrawn and the anchor element and receiver element are connected to the annular tissue and a also connected by connector wire to the low profile valve.
- FIG. 73 is an illustration of one embodiment of a partial cut-away interior view of a tri-leaflet embodiment of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve.
- FIG. 74 is an illustration of another embodiment of a partial cut-away interior view of a tri-leaflet embodiment of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve.
- FIG. 75 is an illustration of a top view of a tri-leaflet embodiment of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve.
- FIG. 76 is an illustration of the trans-septal (femoral-IVC) delivery of a low-profile, e.g. 8-20 mm, side-delivered prosthetic MITRAL valve shown partially housed within the delivery catheter, and partially ejected for deployment into the native mitral annulus.
- a low-profile e.g. 8-20 mm
- side-delivered prosthetic MITRAL valve shown partially housed within the delivery catheter, and partially ejected for deployment into the native mitral annulus.
- FIG. 77 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic MITRAL valve shown housed within the delivery catheter.
- FIG. 78 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic MITRAL valve shown partially housed within a delivery catheter and partially laterally ejected from the delivery catheter and positioned for deployment against the anterior side of the native mitral annulus.
- a low-profile e.g. 8-20 mm
- side-delivered prosthetic MITRAL valve shown partially housed within a delivery catheter and partially laterally ejected from the delivery catheter and positioned for deployment against the anterior side of the native mitral annulus.
- FIG. 79 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic MITRAL valve shown ejected from the delivery catheter and positioned against the anterior side of the native mitral annulus.
- a low-profile e.g. 8-20 mm
- side-delivered prosthetic MITRAL valve shown ejected from the delivery catheter and positioned against the anterior side of the native mitral annulus.
- FIG. 80 is an illustration of a side or plan view of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve shown deployed into the native MITRAL annulus.
- valve sleeve aka a collapsible flow control sleeve
- 116 a reciprocating closable channel from a heart atrium to a heart ventricle
Abstract
Description
- Provided by Application Data Sheet per USPTO rules.
- Provided by Application Data Sheet per with USPTO rules.
- Provided by Application Data Sheet per with USPTO rules.
- Provided by Application Data Sheet per USPTO rules.
- Provided by Application Data Sheet per USPTO rules.
- The invention relates to a transcatheter heart valve replacement (A61F2/2412).
- In 1952 surgeons implanted the first mechanical heart valve. This first valve was a ball valve and it was designed by Dr. Charles Hufnagel. The recipient of this valve was a 30-year-old woman who could lead a normal life after the surgery. However, one downside of this design was that it could only be placed in the descending aorta instead of the heart itself. For this reason it did not fully correct the valve problem, only alleviate the symptoms. However it was a significant achievement because it proved that synthetic materials could be used to create heart valves.
- In 1960, a new type of valve was invented and was successfully implanted. This valve is the Starr-Edwards ball valve, named after its originators. This valve was a modification of Hufnagel's original valve. The ball of the valve was slightly smaller and caged from both sides so it could be inserted into the heart itself.
- The next development was tilting disc technology which was introduced in the late 1960s. These valves were a great improvement over the ball designs. The tilting disc technology allowed blood to flow in a more natural way while reducing damage to blood cells from mechanical forces. However, the struts of these valves tended to fracture from fatigue over time. As of 2003, more than 100,000 Omniscience and 300,000 Hall-Kaster/Medtronic-Hall tilting disc valves were implanted with essentially no mechanical failure.
- In 1977, bi-leaflet heart valves were introduced by St. Jude. Similar to a native heart valve, blood flows directly through the center of the annulus of pyrolytic carbon valves mounted within nickel-titanium housing which makes these valves superior to other designs. However, a downside of this design is that it allows some regurgitation. A vast majority of mechanical heart valves used today have this design. As of 2003, more than 1.3 million St. Jude valves were deployed and over 500,000 Carbomedics valves with no failures to leaflets or housing. It should be noted that the human heart beats about 31 million times per year.
- Development continues with compressible valves that are delivered via a catheter instead of requiring the trauma and complications of open heart surgery. This means that a cardiologist trained in endoscopy can, in theory, deploy a heart valve replacement during an outpatient procedure. However, transcatheter valves are often delivered by perforating the apex of the heart to access the ventricle, and the perforation is often used to anchor an annular valve replacement.
- Additionally, a problem with stent-style replacement valves is that they often continue to have the regurgitation or leakage problems of prior generations of valves, as well as require expensive materials engineering in order to cope with the 100's of millions of cycles encountered during just a few years of normal heart function. Accordingly, there is still a need for alternative and simpler solutions to addressing valve-related heart pathologies.
- Accordingly, the present invention is directed to a side delivered transcatheter prosthetic valve comprising:
- a compressible tubular frame having a side wall and a central axial lumen, said tubular frame having a height of 8-20 mm and a diameter of 40-80 mm,
- an atrial sealing cuff attached to a top edge of the side wall,
- a subannular anchoring component attached to the tubular frame, said subannular anchoring component selected from one or more of the group consisting of a lower tension arm extending from a distal side of the tubular frame, a proximal anchoring tab extending from a proximal side of the tubular frame, a ventricular sealing collar attached to a bottom edge of the side wall, and at least one tissue anchor to connect the tubular frame to native tissue, and
- a flow control component comprising a leaflet structure having three leaflets of pericardial material sewn to a leaflet frame to form a rounded cylinder mounted within the lumen of the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve,
- wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a mitral valve annulus or tricuspid valve annulus of a patient, said delivery catheter having an internal diameter from 22 Fr (7.33 mm) to 34 Fr (11.33 mm),
- said compressed configuration having a long-axis that is substantially parallel to a length-wise cylindrical axis of the delivery catheter, and substantially orthogonal to the blood flow through the flow control component mounted in the central axial lumen,
- said compressed configuration having a height and a width to fit within the delivery catheter, the height and width of the compressed configuration compressed by longitudinal/length-wise rolling or folding,
- wherein the valve is expandable to an expanded configuration having a long-axis substantially orthogonal to the blood flow through the flow control component mounted in the central axial lumen,
- said tubular frame and said atrial sealing cuff having a polyester cover, and said tubular frame and said atrial sealing cuff made from superelastic shape-memory material selected from Ni-Ti alloy, Cu-Zn-Al-Ni alloys, Cu-Al-Ni alloys, a polymer composite, a composite containing one or more of carbon nanotubes, carbon fibers, metal fibers, glass fibers, and polymer fibers, a stainless steel, a cobalt chromium material, and a titanium material.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve wherein the at least one tissue anchor to connect the tubular frame to native tissue is an anterior leaflet clip or anchor, a posterior leaflet clip or anchor, or a septal leaflet clip or anchor.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve wherein said tubular frame is comprised of a braided, wire, or laser-cut wire frame, and said tubular frame is covered with a biocompatible material.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve wherein the tubular frame has a side profile of a flat cone shape having a diameter R of 40-80 mm, a diameter r of 20-60 mm, and a height of 8-20 mm.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve wherein the tubular frame has an inner surface and an outer surface, said inner surface and said outer surface covered with pericardial tissue.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve wherein the tubular frame has a side profile of an hourglass shape having a top diameter R1 of 40-80 mm, a bottom diameter R2 of 50-70 mm, an internal diameter r of 20-60 mm, and a height of 8-20 mm.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve wherein the flow control component has an internal diameter of 20-60 mm and a height of 8-20 mm.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve wherein the flow control component is supported with one or more longitudinal supports integrated into or mounted upon the flow control component, the one or more longitudinal supports selected from rigid or semi-rigid posts, rigid or semi-rigid ribs, rigid or semi-rigid battons, rigid or semi-rigid panels, and combinations thereof.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve wherein the tension arm extending from the distal side of the tubular frame is comprised of wire loop or wire frame, integrated frame section, or stent, and extend from about 10-40 mm away from the tubular frame.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve wherein the valve also comprises (i) an upper tension arm attached to a distal upper edge of the tubular frame, the upper tension arm comprised of wire loop or wire frame extending from about 2-20 mm away from the tubular frame, and (ii) the lower tension arm extending from the distal side of the tubular frame is comprised of wire loop or wire frame, integrated frame section, or stent, and extends from about 10-40 mm away from the tubular frame.
- The present invention is also directed to a method for side delivery of implantable prosthetic valve between a ventricle and an atrium of a heart, the method comprising the steps:
-
- advancing a delivery catheter containing the valve described and claimed herein in a compressed configuration to the atrium of the heart,
- and
- partially releasing the valve from the delivery catheter to position the distal side wall of the tubular frame at an oblique angle against a distal portion of the native annulus and allowing blood to flow from the atrium to the ventricle both through the native valve and through the prosthetic valve,
- releasing the remainder of the prosthetic valve from the delivery catheter to an expanded configuration to assess valve function at the oblique angle before seating the valve completely into the native annulus,
- pushing a proximal side wall of the tubular frame into the native annulus to complete seating of the valve in the native annulus, wherein said atrial sealing cuff is disposed on the atrial floor and the tubular frame is seated within the native annulus, and
- anchoring the subannular anchoring component of the valve to native annular or subannular tissue,
-
- wherein the native valve is a tricuspid valve or a mitral valve.
- In another preferred embodiment, there is provided a method for side delivery of implantable prosthetic valve between a ventricle and an atrium of a heart wherein releasing the valve from the delivery catheter is selected from the steps consisting of: (i) pulling the valve out of the delivery catheter using a rigid elongated pushing rod that is releasably connected to the distal side of the valve, wherein advancing the pushing rod away from the delivery catheter pulls the compressed valve out of the delivery catheter, or (ii) pushing the valve out of the delivery catheter using a rigid elongated pushing rod that is releasably connected to the proximal side of the valve, wherein advancing the pushing rod out of from the delivery catheter pushes the compressed valve out of the delivery catheter.
- In another preferred embodiment, there is provided a method for side delivery of implantable prosthetic valve between a ventricle and an atrium of a heart comprising the additional step of anchoring one or more tissue anchors attached to the valve into native tissue.
- In another preferred embodiment, there is provided a method for side delivery of implantable prosthetic valve between a ventricle and an atrium of a heart wherein the subannular anchoring component is a lower tension arm extending from a distal side of the tubular frame.
- In another preferred embodiment, there is provided a method for side delivery of implantable prosthetic valve between a ventricle and an atrium of a heart comprising the additional step of rotating the heart valve prosthesis using a steerable catheter along an axis parallel to the plane of the valve annulus, wherein an upper tension arm mounted on the valve is conformationally pressure locked against supra-annular tissue, and wherein a lower tension arm mounted on the valve is conformationally pressure locked against sub-annular tissue.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve comprising: (i) a tubular frame having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter, and expandable to an expanded configuration for implanting at a desired location in the body, wherein the valve is compressible and expandable along a long-axis substantially parallel to a cylindrical axis of the delivery catheter, and wherein the valve has a height of about 5-60 mm and a diameter of about 25-80 mm.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve wherein the tubular frame forms a two part framework, a first part comprises a flared atrial cuff joined to a second part that comprises cylindrical member, wherein the cuff is joined to the cylindrical member around the circumference of a top edge of the cylindrical member.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve wherein said tubular frame is comprised of a braid, wire, or laser-cut wire frame, and said tubular frame is covered with a biocompatible material.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve wherein the tubular frame has a side profile of a flat cone shape having a diameter R of 40-80 mm, a diameter r of 20-40 mm, and a height of 10-20 mm.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve wherein the tubular frame has an inner surface and an outer surface, said inner surface covered with a biocompatible material comprising pericardial tissue, and said outer surface covered with a biocompatible material comprising a woven synthetic polyester material.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve wherein the tubular frame has a side profile of an hourglass flat conical shape having a top diameter R1 of 40-80 mm, a bottom diameter R2 of 50-70 mm, an internal diameter r of 20-30 mm, and a height of 5-60 mm.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve wherein the valve in an expanded configuration has a central tube axis that is substantially parallel to the first direction.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve wherein the flow control component has an internal diameter of 20-30 mm and a height of 20-40 mm, and a plurality of leaflets of pericardial material joined to form a rounded cylinder at an inflow end and having a flat closable aperture at an outflow end.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve wherein the flow control component is supported with one or more longitudinal supports integrated into or mounted upon the flow control component, the one or more longitudinal supports selected from rigid or semi-rigid ribs, rigid or semi-rigid battons, rigid or semi-rigid panels, and combination thereof.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve comprising a tension arm extending from a distal side of the tubular frame, the tension arm comprised of wire loop or wire frame extending from about 10-40 mm away from the tubular frame.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve comprising (i) an upper tension arm attached to a distal upper edge of the tubular frame, the upper tension arm comprised of wire loop or wire frame extending from about 2-20 mm away from the tubular frame, and (ii) a lower tension arm extending from a distal side of the tubular frame, the lower tension arm comprised of wire loop or wire frame extending from about 10-40 mm away from the tubular frame.
- In another preferred embodiment, there is provided a side delivered transcatheter prosthetic valve comprising at least one tissue anchor connected to the tubular frame for engaging annular tissue.
- In another preferred embodiment, there is provided a method for side delivery of implantable prosthetic valve to a desired location in the body, the method comprising the steps: (i) advancing a delivery catheter to the desired location in the body and delivering an expandable prosthetic valve to the desired location in the body by releasing the valve from the delivery catheter, wherein the valve comprises a tubular frame having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter, and expandable to an expanded configuration for implanting at a desired location in the body, wherein the valve is compressible and expandable along a long-axis substantially parallel to a cylindrical axis of the delivery catheter, wherein the valve has a height of about 5-60 mm and a diameter of about 25-80 mm.
- In another preferred embodiment, there is provided a method for side delivery of implantable prosthetic valve wherein releasing the valve from the delivery catheter comprises pulling the valve out of the delivery catheter using a rigid elongated pushing rod that is releasably connected to the distal side of the valve, wherein advancing the pushing rod away from the delivery catheter pulls the compressed valve out of the delivery catheter.
- In another preferred embodiment, there is provided a method for side delivery of implantable prosthetic valve comprising the additional step of anchoring one or more tissue anchors attached to the valve into annular tissue.
- In another preferred embodiment, there is provided a method for side delivery of implantable prosthetic valve comprising the additional step of positioning a tension arm of the heart valve prosthesis into the right ventricular outflow tract of the right ventricle.
- In another preferred embodiment, there is provided a method for side delivery of implantable prosthetic valve comprising the additional steps of positioning a lower tension arm of the heart valve prosthesis into the right ventricular outflow tract of the right ventricle, and positioning an upper tension arm into a supra-annular position, the upper tension arm connected to the lower tension arm, and the upper tension arm providing a supra-annular downward force in the direction of the ventricle and lower tension arm providing a sub-annular upward force in the direction of the atrium.
- In another preferred embodiment, there is provided a method for side delivery of implantable prosthetic valve comprising the the additional step of rotating the heart valve prosthesis using a steerable catheter along an axis parallel to the plane of the valve annulus, wherein an upper tension arm mounted on the valve is conformationally pressure locked against supra-annular tissue, and wherein a lower tension arm mounted on the valve is conformationally pressure locked against sub-annular tissue.
- In another preferred embodiment, there is provided a method for loading an implantable prosthetic valve into a delivery catheter, the method comprising the steps: (i) attaching a pulling wire to a sidewall of an implantable prosthetic valve and pulling the valve into a tapering fixture or funnel, wherein the valve comprises a tubular frame having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein pulling the valve into a tapering fixture or funnel compresses the valve to a compressed configuration for loading into a delivery catheter, wherein the valve is compressible and expandable along a long-axis substantially parallel to a cylindrical axis of the delivery catheter, wherein the valve has a height of about 5-60 mm and a diameter of about 25-80 mm.
-
FIG. 1 is an illustration of a plan view of a heart valve prosthesis according to the present invention with a valve frame having a distal upper and lower tension arm mounted on, and anchored to, the anterior leaflet side of the native annulus, and having a mechanical anchor element, e.g. surgical tissue screw, anchored on a posterior or septal side of the native annulus. -
FIG. 2 is an illustration of a plan view of a heart valve prosthesis according to the present invention with a valve frame having a distal upper and lower tension arm mounted on, and anchored to, the anterior leaflet side of the native annulus, and having a mechanical anchor element, e.g. proximal sealing cuff, for anchoring on the posterior and septal side of the native annulus. -
FIG. 3 is an illustration of a plan view of a heart valve prosthesis according to the present invention with a valve frame having a distal upper and lower tension arm mounted on, and anchored to, the anterior leaflet side of the native annulus, and having a mechanical anchor element, e.g. hourglass annular seal, for anchoring on the posterior and/or septal side of the native annulus. -
FIG. 4 is an illustration of a PLAN view of a low-profile, e.g. 10 mm in height, wire loop embodiment of the heart valve prosthesis having an annulus support loop and an upper and lower tension arm formed as a unitary or integral part, and covered with a biocompatible material. -
FIG. 5 is an illustration of a TOP view of a low-profile, e.g. 10 mm in height, wire loop embodiment of the heart valve prosthesis having an annulus support loop, an upper and lower tension arm formed as a unitary or integral part, an inner two-panel conical valve sleeve, and covered with a biocompatible material. -
FIG. 6 is an illustration of a BOTTOM view of a low-profile, e.g. 10 mm in height, wire loop embodiment of the heart valve prosthesis having an annulus support loop, an upper and lower tension arm formed as a unitary or integral part, an inner two-panel conical valve sleeve, and covered with a biocompatible material. -
FIG. 7 is an illustration of a compressed and elongated wire loop embodiment of the heart valve prosthesis disposed within a delivery catheter and having an annulus support loop and an upper and lower tension arm formed as a unitary or integral part. -
FIG. 8 is an illustration of a compressed and elongated wire loop embodiment of the heart valve prosthesis partially ejected, and partially disposed within, a delivery catheter and having an annulus support loop and an upper and lower tension arm formed as a unitary or integral part. -
FIG. 9 is an illustration of a plan view of a heart valve prosthesis partially mounted within the valve annulus. -
FIG. 10 is an illustration of a plan view of a heart valve prosthesis completely seated within the valve annulus. -
FIG. 11 is an illustration of a plan view of a native right atrium of a human heart, and shows the superior vena cava (SVC), the inferior vena cava (IVC), the right atrium (RA), the tricuspid valve and annulus (TCV), the anterior leaflet (A), the posterior leaflet (P), the septal leaflet (S), the right ventricle (RV), and the right ventricular outflow tract (RVOT). -
FIG. 12 is an illustration of a heart valve prosthesis having a wire-frame according to the present invention being delivered to tricuspid valve annulus. -
FIG. 13 is an illustration of a heart valve prosthesis having a wire-frame according to the present invention being delivered to tricuspid valve annulus. -
FIG. 14 is an illustration of a heart valve prosthesis having a wire-frame according to the present invention that has been delivered to tricuspid valve annulus. -
FIG. 15 is an illustration of a heart valve prosthesis having a braided/laser cut-frame according to the present invention being delivered to tricuspid valve annulus. -
FIG. 16 is an illustration of a heart valve prosthesis having a braided/laser cut-frame according to the present invention being delivered to tricuspid valve annulus. -
FIG. 17 is an illustration of a heart valve prosthesis having a braided/laser cut-frame according to the present invention that has been delivered to tricuspid valve annulus. -
FIG. 18 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus and showsstep 1 in a valve assessment process. -
FIG. 19 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus, and shows Step 2 in a valve assessment process. -
FIG. 20 is an illustration of a heart valve prosthesis according to the present invention that has been delivered to tricuspid valve annulus, and shows Step 3 in a valve assessment process. -
FIG. 21 is an illustration of a wire-frame embodiment of a heart valve prosthesis according to the present invention in a compressed, intra-catheter phase. -
FIG. 22 is an illustration of a profile, or plan, view of a wire-frame embodiment of the heart valve prosthesis according to the present invention in a un-compressed, post-catheter-ejection phase. -
FIG. 23 is an illustration of a profile, or plan, view of a braided or laser-cut frame embodiment of the heart valve prosthesis according to the present invention in a un-compressed, post-catheter-ejection phase. -
FIG. 24 is an illustration of a TOP view of a heart valve prosthesis according to the present invention having covered wire loops for the upper tension arm(s). -
FIG. 25 is an illustration of a PLAN view of a heart valve prosthesis according to the present invention having a wire loop construction for the upper and lower tension arms. -
FIG. 26 is an illustration of a CUT-AWAY PLAN view of a heart valve prosthesis according to the present invention, and shows the inner panel valve sleeve mounted within the inner space defined by the tubular frame. -
FIG. 27 is an illustration of a BOTTOM view of a heart valve prosthesis according to the present invention having covered wire loops for the lower tension arm. -
FIG. 28 is an illustration of a TOP view of a heart valve prosthesis according to the present invention having braid or laser-cut wire frame for the upper tension arm(s). -
FIG. 29 is an illustration of a PLAN view of a heart valve prosthesis according to the present invention having braid or laser-cut wire frame construction for the upper and lower tension arms. -
FIG. 30 is an illustration of a CUT-AWAY PLAN view of a braid or laser-cut embodiment of the heart valve prosthesis according to the present invention, and shows the inner panel valve sleeve mounted within the inner space defined by the tubular frame. -
FIG. 31 is an illustration of a BOTTOM view of a heart valve prosthesis according to the present invention having braid or laser-cut wire frame for the lower tension arm. -
FIG. 32 is an illustration of a heart valve prosthesis according to the present invention having a wire loop construction for the tubular frame, with two vertical support posts extending down the edge on opposing sides of the valve sleeve. During compression into the delivery catheter, the posts are engineered to fold horizontally during compression, and to elastically unfold during ejection to deploy the valve sleeve. -
FIG. 33 is an illustration of a CUT-AWAY PLAN view of a heart valve prosthesis according to the present invention, and shows a two-post embodiment of the inner panel valve sleeve mounted within the inner space defined by the tubular frame. -
FIG. 34 is an illustration of a CUT-AWAY PLAN view of a heart valve prosthesis according to the present invention, and shows a three-panel, three-post embodiment of the inner panel valve sleeve mounted within the inner space defined by the tubular frame. -
FIG. 35 is an illustration of a heart valve prosthesis according to the present invention having a braid or laser-cut construction for the tubular frame, with a valve sleeve that extends beyond the bottom of the tubular frame. -
FIG. 36 is an illustration of a heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve compressed within a delivery catheter. -
FIG. 37 is an illustration of a heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve shown partially compressed within a delivery catheter, and partially ejected from the delivery catheter. -
FIG. 38 is an illustration of a heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve engaging the tissue on the anterior side of the native annulus with the curved distal side-wall of the tubular frame sealing around the native annulus. -
FIG. 39 is an illustration of a heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve engaging the tissue on the anterior side of the native annulus with the curved distal side-wall of the tubular frame sealing around the native annulus, and with the proximal side-wall tension-mounted into the posterior side of the native annulus. -
FIG. 40 is an illustration of a TOP view of a heart valve prosthesis according to the present invention having braid or laser-cut wire frame and shown mounted within a cross-sectional view of the atrial floor at the annulus. -
FIG. 41 is an illustration of a BOTTOM view of a heart valve prosthesis according to the present invention having braid or laser-cut wire frame for a lower tension arm and shown mounted within a cross-sectional view of the ventricular ceiling at the annulus. -
FIG. 42 is an illustration of a PLAN view of an embodiment of the prosthetic valve shown in a compressed configuration within a delivery catheter. -
FIG. 43 is an illustration of a cross-sectional view of one embodiment of a compressed valve within a delivery catheter. -
FIG. 44 is an illustration of a cross-sectional view of another embodiment of a compressed valve within a delivery catheter. -
FIG. 45 is an illustration of a cross-sectional view of one embodiment of the prosthetic valve. -
FIG. 46 (a)-(b)-(c) is an illustration of a sequence of a low-profile valve being rolled into a configuration for placement within a delivery catheter. -
FIG. 47 is an illustration of an END-VIEW of a low-profile valve that has been longitudinally rolled and loaded within a delivery catheter. -
FIG. 48 is an illustration of a rotational lock embodiment of the present invention where the prosthetic valve is delivered to the native annulus with an off-set sub-annular tension arm/tab positioned below the native annulus, and an off-set supra-annular tension arm/tab positioned above the native annulus, while the tubular frame is partially rolled off-set from the annular plane along a longitudinal axis. -
FIG. 49 is an illustration of a rotational lock embodiment of the present invention where the prosthetic valve is delivered to the native annulus with an off-set sub-annular tension arm/tab positioned below the native annulus, and an off-set supra-annular tension arm/tab positioned above the native annulus, while the tubular frame is rolled into functional position parallel to the annular plane. -
FIG. 50 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve shown deployed into the native annulus. -
FIG. 51 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve shown compressed or housed within the delivery catheter. -
FIG. 52 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve shown ejected from the delivery catheter and positioned against the anterior side of the native annulus. -
FIG. 53 is an illustration of a open cross-section view of a low-profile, side-delivered prosthetic valve and shows the inner valve sleeve. -
FIG. 54 is an illustration of a two-panel embodiment of an inner valve sleeve. -
FIG. 55 is an illustration of one embodiment of an inner valve sleeve having two rigid support posts. -
FIG. 56 is an illustration of a three-panel embodiment of an inner valve sleeve. -
FIG. 57 is an illustration of a three-panel embodiment of an inner valve sleeve having three rigid support posts. -
FIG. 58 is a flowchart describing one set of method steps for delivery of a low-profile, side-delivered prosthetic valve. -
FIG. 59 a-b-c is a series of illustrations of a plan view of a tissue anchor having a floating radio-opaque marker. 59 a shows the tissue anchor accessing the annular tissue with the radio-opaque marker at the distal end of the anchor and in contact with the atrial surface of the annular tissue. 59 b shows the tissue anchor advancing into the annular tissue with the radio-opaque marker threaded onto the tissue anchor and maintaining position on the atrial surface of the annular tissue. 59 c shows the tissue anchor completely advanced into the annular tissue such that the tissue anchor and the threaded floating marker are now adjacent, indicating the desired depth, tension, and/or plication of the tissue anchor with respect to the annular tissue. -
FIG. 60 is an illustration of a plan view of of a tissue anchor having a straight thread and a constant pitch. -
FIG. 61 is an illustration of a plan view of of a tissue anchor having a straight thread and a variable pitch. -
FIG. 62 is an illustration of a plan view of of a tissue anchor having a tapered thread and a constant pitch. -
FIG. 63 is an illustration of a plan view of of a tissue anchor having a sunken taper thread and a variable pitch. -
FIG. 64 is an illustration ofStep 1 of a 4 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 64 shows a low profile valve being inserted into the valve annulus and low profile valve having an integral anchor delivery conduit or channel with an anchor disposed in the lumen of the channel and an anchor delivery catheter attached to the anchor. -
FIG. 65 is an illustration of Step 2 of a 4 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 65 shows a low profile valve completely deployed within the valve annulus and an integral anchor delivery conduit or channel with an anchor disposed in the lumen of the channel and an anchor delivery catheter attached to the anchor. -
FIG. 66 is an illustration of Step 3 of a 4 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 66 shows the anchor being pushed out of the lumen of the delivery conduit or channel and into the annular tissue. -
FIG. 67 is an illustration of Step 4 of a 4 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 67 shows the anchor in a locked position after being pushed out of the lumen of the delivery conduit or channel and into the annular tissue, thus anchoring the proximal side of the low profile valve. -
FIG. 68 is an illustration ofStep 1 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 68 shows catheter delivery of an attachment wire with the clip housed within the lumen of the clip delivery catheter. -
FIG. 69 is an illustration of Step 2 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 69 shows the clip delivery catheter inserted into an intra-annular space and shows an attachment wire and shows the clip housed within the lumen of the clip delivery catheter. -
FIG. 70 is an illustration of Step 3 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 70 shows a receiver element ejected from the delivery catheter and positioned behind tissue to be captured. -
FIG. 71 is an illustration of Step 4 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 71 shows an anchor element piercing the annular tissue and inserting into a receiver element. -
FIG. 72 is an illustration of Step 5 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 72 shows that the clip delivery catheter is withdrawn and the anchor element and receiver element are connected to the annular tissue and a also connected by connector wire to the low profile valve. -
FIG. 73 is an illustration of one embodiment of a partial cut-away interior view of a tri-leaflet embodiment of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve. -
FIG. 74 is an illustration of another embodiment of a partial cut-away interior view of a tri-leaflet embodiment of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve. -
FIG. 75 is an illustration of a top view of a tri-leaflet embodiment of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve. -
FIG. 76 is an illustration of the trans-septal (femoral-IVC) delivery of a low-profile, e.g. 8-20 mm, side-delivered prosthetic MITRAL valve shown partially housed within the delivery catheter, and partially ejected for deployment into the native mitral annulus. -
FIG. 77 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic MITRAL valve shown housed within the delivery catheter. -
FIG. 78 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic MITRAL valve shown partially housed within a delivery catheter and partially latterally ejected from the delivery catheter and positioned for deployment against the anterior side of the native mitral annulus. -
FIG. 79 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic MITRAL valve shown ejected from the delivery catheter and positioned against the anterior side of the native mitral annulus. -
FIG. 80 is an illustration of a side or plan view of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve shown deployed into the native MITRAL annulus. - The invention is directed to a transcatheter heart valve replacement that is a low profile, orthogonally delivered (side delivered) implantable prosthetic valve having an ring-shaped tubular frame, an inner 2- or 3-panel sleeve, an elongated sub-annular tension arm extending into the right ventricular outflow tract, and one or more anchor elements.
- The embodiments herein and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.
- Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Like numbers refer to like elements throughout. As used herein the term “and/or” includes any and all combinations of one or more of the associated listed items.
- The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the full scope of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.
- Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. Nothing in this disclosure is to be construed as an admission that the embodiments described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention. As used in this document, the term “comprising” means “including, but not limited to.”
- Many modifications and variations can be made without departing from its spirit and scope, as will be apparent to those skilled in the art. Functionally equivalent methods and apparatuses within the scope of the disclosure, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing descriptions. Such modifications and variations are intended to fall within the scope of the appended claims. The present disclosure is to be limited only by the terms of the appended claims, along with the full scope of equivalents to which such claims are entitled. It is to be understood that this disclosure is not limited to particular methods, reagents, compounds, compositions or biological systems, which can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.
- With respect to the use of substantially any plural and/or singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. The various singular/plural permutations may be expressly set forth herein for sake of clarity.
- It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as “open” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include the possibilities of “A” or “B” or “A and B.”
- In addition, where features or aspects of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group.
- As will be understood by one skilled in the art, for any and all purposes, such as in terms of providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal subparts. As will be understood by one skilled in the art, a range includes each individual member.
- In the description and claims herein, the term “orthogonal” or “side-delivered” or “side-delivery” is used to describe that the valves of the present invention are compressed and delivered at a roughly 90 degree angle compared to traditional transcatheter heart valves. Traditional valves have a central cylinder axis that is parallel to the length-wise axis of the delivery catheter and are deployed from the end of the delivery catheter in a manner akin to pushing a closed umbrella out of a sleeve. The valves of the present invention are compressed and delivered in a sideways manner. Traditional valves can only be expanded as large as what the internal diameter of the delivery catheter will allow. Efforts to increase the expanded diameter of traditional valves have run into the problems of trying to compress too much material and structure into too little space. Mathematically, the term orthogonal refers to an intersecting angle of 90 degrees between two lines or planes. As used, herein the term “substantially orthogonal” refers to an intersecting angle ranging from 75 to 105 degrees. The intersecting angle or orthogonal angle refers to both (i) the relationship between the length-wise cylindrical axis of the delivery catheter and the long-axis of the compressed valve of the invention, where the long-axis is perpendicular to the central cylinder axis of traditional valves, and (ii) the relationship between the long-axis of the compressed or expanded valve of the invention and the axis defined by the blood flow through the prosthetic valve where the blood is flowing, eg. from one part of the body or chamber of the heart to another downstream part of the body or chamber of the heart, such as from an atrium to a ventricle through a native annulus.
- In the description and claims herein, the term “transcatheter” is used to define the process of accessing, controlling, and delivering a medical device or instrument within the lumen of a catheter that is deployed into a heart chamber, as well as an item that has been delivered or controlled by such as process. Transcatheter access is known to include via femoral artery and femoral vein, via brachial artery and vein, via carotid and jugular, via intercostal (rib) space, and via sub-xyphoid. Transcatheter can be synonymous with transluminal and is functionally related to the term “percutaneous” as it relates to delivery of heart valves.
- In the description and claims herein, the term “tubular frame”, and also “wire frame” or “flange or “collar” refers to a three-dimensional structural component that is seated within a native valve annulus and is used as a mounting element for a leaflet structure, a flow control component, or a flexible reciprocating sleeve or sleeve-valve.
- The tubular frame can be a ring, or cylindrical or conical tube, made from a durable, biocompatible structural material such as Nitinol or similar alloy, wherein the tubular frame is formed by manufacturing the structural material as a braided wire frame, a laser-cut wire frame, or a wire loop. The tubular frame is about 5-60 mm in height, has an outer diameter dimension, R, of 30-80 mm, and an inner diameter dimension of 31-79 mm, accounting for the thickness of the wire material itself. As stated, the tubular frame can have a side-profile of a ring shape, cylinder shape, conical tube shape, but may also have a side profile of a flat-cone shape, an inverted flat-cone shape (narrower at top, wider at bottom), a concave cylinder (walls bent in), a convex cylinder (walls bulging out), an angular hourglass, a curved, graduated hourglass, a ring or cylinder having a flared top, flared bottom, or both. In one preferred embodiment, the tubular frame used in the prosthetic valve deployed in the tricuspid annulus may have a complex shape determined by the anatomical structures where the valve is being mounted. For example, in the tricuspid annulus, the circumference of the tricuspid valve may be a rounded ellipse, the septal wall is known to be substantially vertical, and the tricuspid is known to enlarge in disease states along the anterior-posterior line. Accordingly, a prosthetic valve may start in a roughly tubular configuration, and be heat-shaped to provide an upper atrial cuff or flange for atrial sealing and a lower trans-annular tubular section having an hourglass cross-section for about 60-80% of the circumference to conform to the native annulus along the posterior and anterior annular segments while remaining substantially vertically flat along 20-40% of the annular circumference to conform to the septal annular segment.
- The tubular frame is optionally internally or externally covered, partially or completely, with a biocompatible material such as pericardium. The tubular frame may also be optionally externally covered, partially or completely, with a second biocompatible material such as polyester or Dacron (R).
- The tubular frame has a central axial lumen where a prosthetic valve or flow-control structure, such as a reciprocating compressible sleeve, is mounted across the diameter of the lumen. The tubular frame is also tensioned against the inner aspect of the native annulus and provides structural patency to a weakened annular ring.
- The tubular frame may optionally have a separate atrial collar attached to the upper (atrial) edge of the frame, for deploying on the atrial floor, that is used to direct blood from the atrium into the sleeve and to seal against blood leakage around the tubular frame. The tubular frame may also optionally have a separate ventricular collar attached to the lower (ventricular) edge of the frame, for deploying in the ventricle immediately below the native annulus that is used to prevent regurgitant leakage during systole, to prevent dislodging of the device during systole, to sandwich or compress the native annulus or adjacent tissue against the atrial collar, and optionally to attach to and support the sleeve/conduit.
- The tubular frame may be compressed for transcatheter delivery and may be expandable as a self-expandable shape-memory element or using a transcatheter expansion balloon. Some embodiments may have both an atrial collar and a ventricular collar, whereas other embodiments within the scope of the invention include prosthetic valves having either a single atrial collar, a single ventricular collar, or having no additional collar structure.
- In the description and claims herein, the term “flow control component” refers in a non-limiting sense to a leaflet structure having 2-, 3-, 4-leaflets of flexible biocompatible material such a treated or untreated pericardium that is sewn or joined to a tubular frame, to function as a prosthetic valve. Such a valve can be a heart valve, such as a tricuspid, mitral, aortic, or pulmonary, that is open to blood flowing during diastole from atrium to ventricle, and that closes from systolic ventricular pressure applied to the outer surface. Repeated opening and closing in sequence can be described as “reciprocating”.
- In the description and claims herein, the term “tissue anchor” or “plication tissue anchor” or “secondary tissue anchor”, or “dart” or “pin” refers to a fastening device that connects the upper atrial frame to the the native annular tissue, usually at or near the periphery of the collar. The anchor may be positioned to avoid piercing tissue and just rely on the compressive force of the two plate-like collars on the captured tissue, or the anchor, itself or with an integrated securement wire, may pierce through native tissue to provide anchoring, or a combination of both. The anchor may have a specialized securement mechanism, such as a pointed tip with a groove and flanged shoulder that is inserted or popped into a mated aperture or an array of mated apertures that allow the anchor to attach, but prevent detachment when the aperture periphery locks into the groove near the flanged shoulder. The securement wire may be attached or anchored to the collar opposite the pin by any attachment or anchoring mechanisms, including a knot, a suture, a wire crimp, a wire lock having a cam mechanism, or combinations.
- The term “support post” refers to a rigid or semi-rigid length of material such as Nitinol or PEEK, that may be mounted on a spoked frame and that runs axially, or down the center of, or within a sewn seam of-, the flexible sleeve. The sleeve may be unattached to the support post, or the sleeve may be directly or indirectly attached to the support post.
- In the description that follows, the term “body channel” is used to define a blood conduit or vessel within the body. Of course, the particular application of the prosthetic heart valve determines the body channel at issue. An aortic valve replacement, for example, would be implanted in, or adjacent to, the aortic annulus. Likewise, a tricuspid or mitral valve replacement will be implanted at the tricuspid or mitral annulus. Certain features of the present invention are particularly advantageous for one implantation site or the other. However, unless the combination is structurally impossible, or excluded by claim language, any of the heart valve embodiments described herein could be implanted in any body channel.
- The term “lumen” refers to the inside of a cylinder tube. The term “bore” refers to the inner diameter.
- Displacement—The volume of fluid displaced by one complete stroke or revolution
- Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. During each heartbeat pumping cycle, the heart contracts and relaxes. When your heart contracts, it ejects blood from the two pumping chambers (ventricles)
- As a point of further definition, the term “expandable” is used herein to refer to a component of the heart valve capable of expanding from a first, delivery diameter to a second, implantation diameter. An expandable structure, therefore, does not mean one that might undergo slight expansion from a rise in temperature, or other such incidental cause. Conversely, “non-expandable” should not be interpreted to mean completely rigid or a dimensionally stable, as some slight expansion of conventional “non-expandable” heart valves, for example, may be observed.
- Force—A push or pull acting upon a body. In a hydraulic cylinder, it is the product of the pressure on the fluid, multiplied by the effective area of the cylinder piston.
- The term prosthesis or prosthetic encompasses both complete replacement of an anatomical part, e.g. a new mechanical valve replaces a native valve, as well as medical devices that take the place of and/or assist, repair, or improve existing anatomical parts, e.g. native valve is left in place. For mounting within a passive assist cage, the invention contemplates a wide variety of (bio)prosthetic artificial heart valves. Contemplated as within the scope of the invention are ball valves (e.g. Starr-Edwards), bileaflet valves (St. Jude), tilting disc valves (e.g. Bjork-Shiley), stented pericardium heart-valve prosthesis' (bovine, porcine, ovine) (Edwards line of bioprostheses, St. Jude prosthetic valves), as well as homograft and autograft valves. For bioprosthetic pericardial valves, it is contemplated to use bioprosthetic aortic valves, bioprosthetic mitral valves, bioprosthetic tricuspid valves, and bioprosthetic pulmonary valves.
- Preferably, the frame is made from superelastic metal wire, such as Nitinol (TM) wire or other similarly functioning material. The material may be used for the frame/stent, for the collar, and/or for anchors. It is contemplated as within the scope of the invention to use other shape memory alloys such as Cu—Zn—Al—Ni alloys, Cu—Al—Ni alloys, as well as polymer composites including composites containing carbon nanotubes, carbon fibers, metal fibers, glass fibers, and polymer fibers. It is contemplated that the frame may be constructed as a braid, wire, or laser cut wire frame. Such materials are available from any number of commercial manufacturers, such as Pulse Systems. Laser cut wire frames are preferably made from Nickel-Titanium (Nitinol (TM)), but also without limitation made from stainless steel, cobalt chromium, titanium, and other functionally equivalent metals and alloys, or Pulse Systems braided frame that is shape-set by heat treating on a fixture or mandrel.
- One key aspect of the frame design is that it be compressible and when released have the stated property that it return to its original (uncompressed) shape. This requirement limits the potential material selections to metals and plastics that have shape memory properties. With regards to metals, Nitinol has been found to be especially useful since it can be processed to be austenitic, martensitic or super elastic. Martensitic and super elastic alloys can be processed to demonstrate the required compression features.
- One possible construction of the wire frame envisions the laser cutting of a thin, isodiametric Nitinol tube. The laser cuts form regular cutouts in the thin Nitinol tube. In one preferred embodiment, the Nitinol tube expands to form a three-dimensional structure formed from diamond-shaped cells. The structure may also have additional functional elements, e.g. loops, anchors, etc. for attaching accessory components such as biocompatible covers, tissue anchors, releasable deployment and retrieval control guides, knobs, attachments, rigging, and so forth.
- Secondarily the tube is placed on a mold of the desired shape, heated to the Martensitic temperature and quenched. The treatment of the wire frame in this manner will form a device that has shape memory properties and will readily revert to the memory shape at the calibrated temperature.
- A frame can be constructed utilizing simple braiding techniques. Using a Nitinol wire—for example a 0.012″ wire—and a simple braiding fixture, the wire is wound on the braiding fixture in a simple over/under braiding pattern until an isodiametric tube is formed from a single wire. The two loose ends of the wire are coupled using a stainless steel or Nitinol coupling tube into which the loose ends are placed and crimped. Angular braids of approximately 60 degrees have been found to be particularly useful. Secondarily, the braided wire frame is placed on a shaping fixture and placed in a muffle furnace at a specified temperature to set the wire frame to the desired shape and to develop the martensitic or super elastic properties desired.
- Tethers—The tethers are made from surgical-grade materials such as biocompatible polymer suture material. Non-limiting examples of such material include ultra high-molecular weight polyethylene (UHMWPE), 2-0 exPFTE(polytetrafluoroethylene) or 2-0 polypropylene. In one embodiment the tethers are inelastic. It is also contemplated that one or more of the tethers may optionally be elastic to provide an even further degree of compliance of the valve during the cardiac cycle.
- The device can be seated within the valvular annulus through the use of tines or barbs. These may be used in conjunction with, or in place of one or more tethers. The tines or barbs are located to provide attachment to adjacent tissue. Tines are forced into the annular tissue by mechanical means such as using a balloon catheter. In one non-limiting embodiment, the tines may optionally be semi-circular hooks that upon expansion of the wire frame body, pierce, rotate into, and hold annular tissue securely. Anchors are deployed by over-wire delivery of an anchor or anchors through a delivery catheter. The catheter may have multiple axial lumens for delivery of a variety of anchoring tools, including anchor setting tools, force application tools, hooks, snaring tools, cutting tools, radio-frequency and radiological visualization tools and markers, and suture/thread manipulation tools. Once the anchor(s) are attached, tensioning tools may be used to adjust the length of tethers that connect to an implanted valve to adjust and secure the implant as necessary for proper functioning. It is also contemplated that anchors may be spring-loaded and may have tether-attachment or tether-capture mechanisms built into the tethering face of the anchor(s). Anchors may also have in-growth material, such as polyester fibers, to promote in-growth of the anchors into the myocardium.
- In one embodiment, where a prosthetic valve may or may not include a ventricular collar, the anchor or dart is not attached to a lower ventricular collar, but is attached directly into annular tissue or other tissue useful for anchoring.
- The tissue used herein is a biological tissue that is a chemically stabilized pericardial tissue of an animal, such as a cow (bovine pericardium) or sheep (ovine pericardium) or pig (porcine pericardium) or horse (equine pericardium). Preferably, the tissue is bovine pericardial tissue. Examples of suitable tissue include that used in the products Duraguard®, Peri-Guard®, and Vascu-Guard®, all products currently used in surgical procedures, and which are marketed as being harvested generally from cattle less than 30 months old. Other patents and publications disclose the surgical use of harvested, biocompatible animal thin tissues suitable herein as biocompatible “jackets” or sleeves for implantable stents, including for example, U.S. Pat. No. 5,554,185 to Block, U.S. Pat. No. 7,108,717 to Design & Performance-Cyprus Limited disclosing a covered stent assembly, U.S. Pat. No. 6,440,164 to Scimed Life Systems, Inc. disclosing a bioprosthetic valve for implantation, and U.S. Pat. No. 5,336,616 to LifeCell Corporation discloses acellular collagen-based tissue matrix for transplantation.
- In one preferred embodiment, the conduit may optionally be made from a synthetic material such a polyurethane or polytetrafluoroethylene.
- Where a thin, durable synthetic material is contemplated, e.g. for a covering, synthetic polymer materials such expanded polytetrafluoroethylene or polyester may optionally be used. Other suitable materials may optionally include thermoplastic polycarbonate urethane, polyether urethane, segmented polyether urethane, silicone polyether urethane, silicone-polycarbonate urethane, and ultra-high molecular weight polyethylene. Additional biocompatible polymers may optionally include polyamides, polyolefins, polyesters, elastomers, polyethylene-glycols, polyethersulphones, polysulphones, polyvinylpyrrolidones, polyvinylchlorides, other fluoropolymers, silicone polyesters, siloxane polymers and/or oligomers, and/or polylactones, and block co-polymers using the same.
- PA is an early engineering thermoplastic invented that consists of a “super polyester” fiber with molecular weight greater than 10,000. It is commonly called Nylon. Application of polyamides includes transparent tubing's for cardiovascular applications, hemodialysis membranes, and also production of percutaneous transluminal coronary angioplasty (PTCA) catheters.
- Polyolefins include polyethylene and polypropylene are the two important polymers of polyolefins and have better biocompatibility and chemical resistance. In cardiovascular uses, both low-density polyethylene and high-density polyethylene are utilized in making tubing and housings. Polypropylene is used for making heart valve structures.
- Polyesters includes polyethylene-terephthalate (PET), using the name Dacron. It is typically used as knitted or woven fabric for vascular grafts. Woven PET has smaller pores which reduces blood leakage and better efficiency as vascular grafts compared with the knitted one. PET grafts are also available with a protein coating (collagen or albumin) for reducing blood loss and better biocompatibility [39]. PET vascular grafts with endothelial cells have been searched as a means for improving patency rates. Moreover, polyesters are widely preferred material for the manufacturing of bioabsorbable stents. Poly-L-lactic acids (PLLA), polyglycolic acid (PGA), and poly(D, L-lactide/glycolide) copolymer (PDLA) are some of the commonly used bioabsorbable polymers.
- Polytetrafluoroethylene (PTFE) is synthetic fluorocarbon polymer with the common commercial name of Teflon by Dupont Co. Common applications of PTFE in cardiovascular engineering include vascular grafts and heart valves. PTFE sutures are used in the repair of mitral valve for myxomatous disease and also in surgery for prolapse of the anterior or posterior leaflets of mitral valves. PTFE is particularly used in implantable prosthetic heart valve rings. It has been successfully used as vascular grafts when the devices are implanted in high-flow, large-diameter arteries such as the aorta. Problem occurs when it is implanted below aortic bifurcations and another form of PTFE called elongated-PTFE (e-PTFE) was explored. Expanded PTFE is formed by compression of PTFE in the presence of career medium and finally extruding the mixture. Extrudate formed by this process is then heated to near its glass transition temperature and stretched to obtain microscopically porous PTFE known as e-PTFE. This form of PTFE was indicated for use in smaller arteries with lower flow rates promoting low thrombogenicity, lower rates of restenosis and hemostasis, less calcification, and biochemically inert properties.
- Polyurethane has good physiochemical and mechanical properties and is highly biocompatible which allows unrestricted usage in blood contacting devices. It has high shear strength, elasticity, and transparency. Moreover, the surface of polyurethane has good resistance for microbes and the thrombosis formation by PU is almost similar to the versatile cardiovascular biomaterial like PTFE. Conventionally, segmented polyurethanes (SPUs) have been used for various cardiovascular applications such as valve structures, pacemaker leads and ventricular assisting device.
- Drug-eluting wire frames are contemplated for use herein. DES basically consist of three parts: wire frame platform, coating, and drug. Some of the examples for polymer free DES are Amazon Pax (MINVASYS) using Amazonia CroCo (L605) cobalt chromium (Co-Cr) wire frame with Paclitaxel as an antiproliferative agent and abluminal coating have been utilized as the carrier of the drug. BioFreedom (Biosensors Inc.) using stainless steel as base with modified abluminal coating as carrier surface for the antiproliferative drug Biolimus A9. Optima (CID S.r.I.) using 316 L stainless steel wire frame as base for the drug Tacrolimus and utilizing integrated turbostratic carbofilm as the drug carrier. VESTA sync (MIV Therapeutics) using GenX stainless steel (316 L) as base utilizing microporous hydroxyapatite coating as carrier for the drug Sirolimus. YUKON choice (Translumina) used 316 L stainless steel as base for the drugs Sirolimus in combination with Probucol.
- Biosorbable polymers may also be used herein as a carrier matrix for drugs. Cypher, Taxus, and Endeavour are the three basic type of bioabsorbable DES. Cypher (J&J, Cordis) uses a 316 L stainless steel coated with polyethylene vinyl acetate (PEVA) and polybutyl methacrylate (PBMA) for carrying the drug Sirolimus. Taxus (Boston Scientific) utilizes 316 L stainless steel wire frames coated with translute Styrene Isoprene Butadiene (SIBS) copolymer for carrying Paclitaxel which elutes over a period of about 90 days. Endeavour (Medtronic) uses a cobalt chrome driver wire frame for carrying zotarolimus with phosphorylcholine as drug carrier. BioMatrix employing S-Wire frame (316 L) stainless steel as base with polylactic acid surface for carrying the antiproliferative drug Biolimus. ELIXIR-DES program (Elixir Medical Corp) consisting both polyester and polylactide coated wire frames for carrying the drug novolimus with cobalt-chromium (Co-Cr) as base. JACTAX (Boston Scientific Corp.) utilized D-lactic polylactic acid (DLPLA) coated (316 L) stainless steel wire frames for carrying Paclitaxel. NEVO (Cordis Corporation, Johnson & Johnson) used cobalt chromium (Co-Cr) wire frame coated with polylactic-co-glycolic acid (PLGA) for carrying the drug Sirolimus.
- Examples of preferred embodiments of the reciprocating pressure conduit valve include the following details and features.
- One preferred embodiment of a side delivered transcatheter prosthetic valve has a tubular frame with a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, wherein the long-axis of the compressed configuration of the valve is substantially parallel to a length-wise cylindrical axis of the delivery catheter,
- wherein the valve has a height of about 5-60 mm and a diameter of about 25-80 mm. Importantly, this heart valve substitute does not have a traditional valve configuration, can be delivered to the heart using the inferior vena cava (IVC/femoral transcatheter delivery pathway compressed within a catheter, and expelled from the catheter to be deployed without open heart surgery.
- In another preferred embodiment of a transcatheter valve, comprises: a cylindrical tubular frame having a height of about 5-60 mm and an outer diameter of about 25-80 mm, said tubular frame comprised of a braid, wire, or laser-cut wire frame having a substantially circular central aperture, said tubular frame partially covered with a biocompatible material; a collapsible flow control component disposed within the central aperture, said sleeve having a height of about 5-60 mm and comprised of at least two opposing leaflets that provide a reciprocating closable channel from a heart atrium to a heart ventricle; an upper tension arm attached to a distal upper edge of the tubular frame, the upper tension arm comprised of stent, segment of tubular frame, wire loop or wire frame extending from about 10-30 mm away from the tubular frame; a lower tension arm extending from a distal side of the tubular frame, the lower tension arm comprised of stent, segment of tubular frame, wire loop or wire frame extending from about 10-40 mm away from the tubular frame; and at least one tissue anchor to connect the tubular frame to native tissue.
- In another preferred embodiment of a transcatheter valve, there is provided a feature wherein the sleeve is shaped as a conic cylinder, said top end having a diameter of 30-35 mm and said bottom end having a diameter of 8-20 mm.
- In another preferred embodiment of a transcatheter valve, there is provided a feature wherein the cover is comprised of polyester, polyethylene terephthalate, decellularized pericardium, or a layered combination thereof.
- In a preferred embodiment of the invention, there is also provided a method for side delivery of implantable prosthetic valve to a desired location in the body, the method comprising the steps: (i) advancing a delivery catheter to the desired location in the body and delivering an expandable prosthetic valve to the desired location in the body by releasing the valve from the delivery catheter, wherein the valve comprises a tubular frame having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, wherein the long-axis of the compressed configuration of the valve is substantially parallel to a length-wise cylindrical axis of the delivery catheter, wherein the valve has a height of about 5-60 mm and a diameter of about 25-80 mm.
- In a preferred embodiment of the invention, there is also provided a method for loading an implantable prosthetic valve into a delivery catheter, the method comprising the steps: loading an implantable prosthetic valve sideways into a tapering fixture or funnel attached to a delivery catheter, wherein the valve comprises a tubular frame having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, wherein the long-axis of the compressed configuration of the valve is substantially parallel to a length-wise cylindrical axis of the delivery catheter, wherein the valve has a height of about 5-60 mm and a diameter of about 25-80 mm.
- In a preferred embodiment of the invention, there is also provided a method for loading an implantable prosthetic valve into a delivery catheter, the method comprising the steps: (i) loading an implantable prosthetic valve into a tapering fixture or funnel attached to a delivery catheter, wherein the valve comprises a tubular frame having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein said loading is perpendicular or substantially orthogonal to the first direction, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, wherein the long-axis of the compressed configuration of the valve is substantially parallel to a length-wise cylindrical axis of the delivery catheter, wherein the valve has a height of about 5-60 mm and a diameter of about 25-80 mm.
- The transcatheter prosthetic heart valve may be percutaneously delivered using a transcatheter process via the femoral through the IVC, carotid, sub-xyphoid, intercostal access across the chest wall, and trans-septal to the mitral annulus through the fossa ovalis. The device is delivered via catheter to the right or left atrium and is expanded from a compressed shape that fits with the internal diameter of the catheter lumen. The compressed valve is loaded external to the patient into the delivery catheter, and is then pushed out of the catheter when the capsule arrives to the atrium. The cardiac treatment technician visualizes this delivery using available imaging techniques such as fluoroscopy or ultrasound, and in a preferred embodiment the valve self-expands upon release from the catheter since it is constructed in part from shape-memory material, such as Nitinol®, a nickel-titanium alloy used in biomedical implants.
- In another embodiment, the valve may be constructed of materials that requires balloon-expansion after the capsule has been ejected from the catheter into the atrium.
- The atrial collar/frame and the flow control component are expanded to their functional diameter, as they are deployed into the native annulus, providing a radial tensioning force to secure the valve. Once the frame is deployed about the tricuspid annulus, fasteners secure the device about the native annulus. Additional fastening of the device to native structures may be performed, and the deployment is complete. Further adjustments using hemodynamic imaging techniques are contemplated as within the scope of the invention in order to ensure the device is secure, is located and oriented as planned, and is functioning as a substitute or successor to the native tricuspid valve.
- Referring now to the drawings,
FIG. 1 is an illustration of a plan view of aheart valve prosthesis 100 according to the present invention with avalve frame 102 havingupper tension arm 128 andlower tension arm 126 mounted on and anchoring to the annulus.FIG. 1 shows lower tension arm/tab 126 extending into the Right Ventricular Outflow Tract (RVOT). The lateral, or side-delivered, delivery of thevalve 100 through the inferior vena cava, provides for direct access to the valve annulus without the need to delivery a compressed valve around a right angle turn, as is required for IVC delivery of axially, or vertically loaded, traditional transcatheter valves.FIG. 1 shows one embodiment where a screw orother anchor device 138 is used in conjunction with the tension-mounting method described herein where upper and lower tension arms on the anterior leaflet side anchor the valve in place, and a secondary anchor element completes the securement of the valve in the annular site. -
FIG. 1 shows polyester mesh covering 108 avalve tubular frame 102 encircling a collapsibleflow control sleeve 110.FIG. 1 also shows theframe 102 having Nitinol wire frame in diamond shapes with a biocompatible covering. In one embodiment, the frame may have a pericardial material on top and a polyester material, e.g. surgical Dacron(R), underneath to be in contact with the native annulus and promote ingrowth. -
FIG. 2 is an illustration of a plan view of another embodiment of a heart valve prosthesis according to the present invention with avalve frame 102 having a distalupper tension arm 128 andlower tension arm 126 mounted on, and anchored to, the anterior leaflet side of the native annulus, and having a mechanical anchor element, e.g. proximal sealing cuff, 130 for anchoring on the posterior and septal side of the native annulus. Thesealing cuff 130 may be a short tab on the posterior side of the valve or may be a semi-circular or circular collar or cuff that engages the atrial floor to seal the annulus from perivalvular leaks. -
FIG. 3 is an illustration of a plan view of another embodiment of a heart valve prosthesis according to the present invention with a valve frame having a distal upper and lower tension arm mounted on, and anchored to, the anterior leaflet side of the native annulus, and having a mechanical anchor element, e.g. hourglass annular seal, 132 for anchoring on the posterior and/or septal side of the native annulus. The hourglass, or concave, sealingcuff 132 may be only a short segment on the posterior side of the valve or may be a semi-circular or circular combined upper and lower collar or cuff that engages the atrial floor and the ventricular ceiling to seal the annulus from perivalvular leaks. This embodiment may also include embodiments having a partial collar. This embodiment may be used in conjunction with other anchoring elements described herein. -
FIG. 4 is an illustration of a PLAN view of a low-profile, e.g. 10 mm in height, wire loop embodiment of the heart valve prosthesis having anannulus support loop 140 and an upper andlower tension arm -
FIG. 5 is an illustration of a TOP view of a low-profile, e.g. 10 mm in height, wire loop embodiment of the heart valve prosthesis having anannulus support loop 140, an upper andlower tension arm conical valve sleeve 110, and covered with a biocompatible material.FIG. 5 shows the inner two-panel sleeve and the reciprocating collapsible aperture at the lower end for delivering blood to the ventricle. -
FIG. 6 is an illustration of a BOTTOM view of a low-profile, e.g. 10 mm in height, wire loop embodiment of the heart valve prosthesis having an annulus support loop, an upper and lower tension arm formed as a unitary or integral part, an inner two-panel conical valve sleeve, and covered with a biocompatible material.FIG. 6 shows a PLAN view of the inner two-panel sleeve 110 and the collapsibleterminal aperture 156 at the ventricular side. -
FIG. 7 is an illustration of a compressed and elongated wire loop embodiment of the heart valve prosthesis disposed within adelivery catheter 118 and having an ring shapedtubular frame 102 with braid/laser-cut 104 and an upper andlower tension arm FIG. 7 illustrates how a large diameter valve, using side-loading, can be delivered. -
FIG. 8 is an illustration of a compressed and elongated wire loop embodiment of the heart valve prosthesis partially ejected, and partially disposed within, a delivery catheter and having an annulus support loop and an upper and lower tension arm formed as a unitary or integral part.FIG. 8 shows how a valve can be partially delivered for positioning in the annulus. Thelower tension arm 144 can be used to navigate through the tricupid leaflets and chordae tendinae while the valve body, the tubular frame, 102 is still within the steerableIVC delivery catheter 118. -
FIG. 9 is an illustration of a plan view of a heart valve prosthesis partially mounted within the valve annulus. By using the side-delivered valve of the present invention, the distal side of theprosthesis -
FIG. 10 is an illustration of a plan view of a heart valve prosthesis completely seated within the valve annulus.FIG. 19 shows that the valve can be secured in place once the valve function assessment shows that the deployment is successful. Importantly, since the valve is a low-profile valve, and fits easily within a standard, e.g. 8-12 mm, delivery catheter without requiring the forceful loading of typical transcatheter valves, the side-loading valve can be easily retrieved using the same delivery catheter that is used to deploy the valve. -
FIG. 11 is an illustration of a plan view of a native right atrium of a human heart, and shows the superior vena cava (SVC), the inferior vena cava (IVC), the right atrium (RA), the tricuspid valve and annulus (TCV), the anterior leaflet (A), the posterior leaflet (P), the septal leaflet (S), the right ventricle (RV), and the right ventricular outflow tract (RVOT). -
FIG. 12 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus.FIG. 12 shows wire-framelower tension arm 144 ejected from thedelivery catheter 118 and being directed through the annulus and towards the right ventricular outflow tract.FIG. 12 shows an embodiment of an accordion-compressed low-profile valve 122 and shows the lower tension arm directed towards the anterior leaflet for placement into the RVOT. -
FIG. 13 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus.FIG. 13 shows wire-framelower tension arm 144 andupper tension arm 142 ejected from thedelivery catheter 118, the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus.FIG. 13 also showssteerable anchoring catheter 150 attached to aproximal anchoring tab 152. While the valve is held in a pre-seating position, the valve can be assessed, and once valve function and patient conditions are correct, the steerable anchoring catheter can push the proximal side of the valve from its oblique angle, down into the annulus. The steerable anchoring catheter can then install one ormore anchoring elements 152. -
FIG. 14 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus.FIG. 14 shows the entire valve ejected from the delivery catheter, the wire-frame lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper wire-frame tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus, and at least one tissue anchor anchoring the proximal side of the prosthesis into the annulus tissue. -
FIG. 15 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus.FIG. 15 shows braided/laser cut-framelower tension arm 126 ejected from thedelivery catheter 118 and being directed through the annulus and towards the right ventricular outflow tract. -
FIG. 16 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus.FIG. 16 shows braided/laser cut-framelower tension arm 126 andupper tension arm 128 ejected from thedelivery catheter 118, the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus. -
FIG. 17 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus.FIG. 17 shows the entire braided/laser cut-frame valve 102 ejected from thedelivery catheter 118, the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus, and at least one tissue anchor anchoring the proximal side of the prosthesis into the annulus tissue. -
FIG. 18 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus and showsstep 1 in a valve assessment process.FIG. 18 shows braided/laser cut-frame lower tension arm ejected from the delivery catheter and being directed through the annulus and towards the right ventricular outflow tract. -
FIG. 19 is an illustration of a heart valve prosthesis according to the present invention being delivered to tricuspid valve annulus, and shows Step 2 in a valve assessment process.FIG. 19 shows braided/laser cut-frame lower tension arm and upper tension arm ejected from the delivery catheter, the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus.FIG. 28 shows that a steerable anchoring catheter can hold the valve at an oblique angle in a pre-attachment position, so that the valve can be assessed, and once valve function and patient conditions are correct, the steerable anchoring catheter can push the proximal side of the valve from its oblique angle, down into the annulus. The steerable anchoring catheter can then install one or more anchoring elements. -
FIG. 20 is an illustration of a heart valve prosthesis according to the present invention that has been delivered to tricuspid valve annulus, and shows Step 3 in a valve assessment process.FIG. 20 shows the entire braided/laser cut-frame valve ejected from the delivery catheter, the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus, and at least one tissue anchor anchoring the proximal side of the prosthesis into the annulus tissue. -
FIG. 21 is an illustration of a heart valve prosthesis according to the present invention in a compressed, intra-catheter phase. The lower andupper tension arms prosthetic valve 102 is shown laterally compressed in thedelivery catheter 118. The lateral compression is a function of the use of minimal structural materials, e.g. a minimalinner valve sleeve 110, and the relatively short height of the outercylindrical frame 102. This lateral delivery provides for very large, e.g. up to 80 mm or more, valve prosthesis' to be delivered. The lateral delivery also avoids the need to perform a 90 degree right turn when delivering a valve using the IVC femoral route. This sharp delivery angle has also limited the size and make up of prior valve prosthesis', but is not a problem for the inventive valve herein. -
FIG. 22 is an illustration of a profile, or plan, view of a wire-frame embodiment of the heart valve prosthesis according to the present invention in a un-compressed, post-catheter-ejection phase.FIG. 22 shows an embodiment where the upper wire-frame tension arm 142 is attached to thetubular frame 102, but thelower tension arm 144 is shaped in an S-shape and connects only to theupper tension arm 142. -
FIG. 23 is an illustration of a profile, or plan, view of a braid or laser-cut frame embodiment of the heart valve prosthesis according to the present invention in a un-compressed, post-catheter-ejection phase.FIG. 23 shows an embodiment where the upper braid or laser-cut tension arm 128 is attached to the upper edge of thetubular frame 102, and thelower tension arm 126 is attached to the lower edge of thetubular frame 102. -
FIG. 24 is an illustration of a TOP view of a heart valve prosthesis according to the present invention having covered wire loop for the upper tension arm(s).FIG. 24 shows thetubular frame 102 having aninner sleeve 110 sewn into thecentral aperture 106, with the two (2) panels extending downward (into the page) in a ventricular direction.FIG. 24 shows theupper tension arms 142 oriented towards the anterior leaflet side of the atrial floor, shown in dashed outline. -
FIG. 25 is an illustration of a PLAN view of a heart valve prosthesis according to the present invention having a wire loop construction for the upper 142 and lower 144 tension arms. -
FIG. 26 is an illustration of a CUT-AWAY PLAN view of a heart valve prosthesis according to the present invention, and shows the innerpanel valve sleeve 110 mounted within the inner space defined by the tubular frame. -
FIG. 27 is an illustration of a BOTTOM view of a heart valve prosthesis according to the present invention having a covered wire loop for thelower tension arm 144.FIG. 27 shows thetubular frame 102 having aninner sleeve 110 sewn into the central aperture, with the two (2) panels extending upward (out of the page) in a ventricular direction.FIG. 27 shows thelower tension arm 144 oriented towards the anterior leaflet side of the ventricular ceiling, shown in dashed outline. -
FIG. 28 is an illustration of a TOP view of a heart valve prosthesis according to the present invention having covered braid or laser-cut frame 102 for theupper tension arm 128.FIG. 28 shows thetubular frame 102 having aninner sleeve 110 sewn into the central aperture, with the two (2) panels extending downward (into the page) in a ventricular direction.FIG. 28 shows theupper tension arm 128 oriented towards the anterior leaflet side of the atrial floor, shown in dashed outline. -
FIG. 29 is an illustration of a PLAN view of a heart valve prosthesis according to the present invention having a braid or laser-cut frame construction 102 for the upper andlower tension arms -
FIG. 30 is an illustration of a CUT-AWAY PLAN view of a heart valve prosthesis according to the present invention, and shows the innerpanel valve sleeve 110 mounted within the inner space defined by thetubular frame 102. -
FIG. 31 is an illustration of a BOTTOM view of a heart valve prosthesis according to the present invention having a covered braid or laser-cut frame for the lower tension arm.FIG. 31 shows thetubular frame 102 having aninner sleeve 110 sewn into the central aperture, with the two (2) panels extending upward (out of the page) in a ventricular direction.FIG. 31 shows thelower tension arm 126 oriented towards the anterior leaflet side of the ventricular ceiling, shown in dashed outline. -
FIG. 32 is an illustration of a heart valve prosthesis according to the present invention having a wire loop construction for thetubular frame 102, with two vertical support posts 154 extending down the edge on opposing sides of thesleeve 110. During compression into the delivery catheter 118 (not shown), theposts 154 are engineered to fold horizontally during compression, and to elastically unfold during ejection to deploy thevalve sleeve 110. -
FIG. 33 is an illustration of a CUT-AWAY PLAN view of a heart valve prosthesis according to the present invention, and shows a two-post embodiment 154 of the innerpanel valve sleeve 110 mounted within the inner space defined by thetubular frame 102. -
FIG. 34 is an illustration of a CUT-AWAY PLAN view of a heart valve prosthesis according to the present invention, and shows a three-panel, three-post embodiment of the inner panel valve sleeve mounted within the inner space defined by the tubular frame. -
FIG. 35 is an illustration of a low-profile, side-delivered heart valve prosthesis according to the present invention having a braid or laser-cut construction for thetubular frame 102, with avalve sleeve 110 that extends beyond the bottom of the tubular frame.FIG. 35 shows a longerlower tension arm 126 for extending sub-annularly towards the RVOT, and a shorterupper tension arm 128 for extending over the atrial floor.FIG. 35 shows an elongated two (2)panel valve sleeve 110 that extends into the sub-annular leaflet space. Thetubular frame 102 shown inFIG. 35 is about 10 mm in height and thevalve sleeve 110 extends about 10 mm below the bottom of the tubular frame, resulting in a valve 20 mm in total height. -
FIG. 36 is an illustration of a low-profile, side-delivered heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve compressed within adelivery catheter 118.FIG. 36 shows the valve attached to a secondarysteerable catheter 150 for ejecting, positioning, and anchoring the valve. Thesecondary catheter 150 can also be used to retrieve a failed deployment of a valve. -
FIG. 37 is an illustration of a heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve shown partially compressed within a delivery catheter, and partially ejected from the delivery catheter.FIG. 37 shows that while the valve is still compressed the lower tension arm can be manipulated through the leaflets and chordae tendinae to find a stable anterior-side lodgment for the distal side of the valve. -
FIG. 38 is an illustration of a heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve engaging the tissue on the anterior side of the native annulus with the curved distal side-wall of the tubular frame sealing around the native annulus.FIG. 38 shows the valve held by the steerable secondary catheter at an oblique angle while valve function is assessed. -
FIG. 39 is an illustration of a heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve fully deployed into the tricuspid annulus. The distal side of the valve is shown engaging the tissue on the anterior side of the native annulus with the curved distal side-wall of the tubular frame sealing around the native annulus, and with the proximal side-wall tension-mounted into the posterior side of the native annulus. -
FIG. 40 is an illustration of a TOP view of a heart valve prosthesis according to the present invention having braid or laser-cut wire frame 102 and shown mounted within a cross-sectional view of the atrial floor at the annulus. -
FIG. 41 is an illustration of a BOTTOM view of a heart valve prosthesis according to the present invention having braid or laser-cut wire frame 102 for alower tension arm 126 and shown mounted within a cross-sectional view of the ventricular ceiling at the annulus.FIG. 41 shows the twopanel valve sleeve 110 in anopen position 106, e.g. atrial systole and ventricular diastole.FIG. 41 shows RVOT as a darkened circle. -
FIG. 42 is an illustration of a PLAN view of an embodiment of the prosthetic valve shown in a compressed configuration within a delivery catheter.FIG. 42 shows the tubular frame wall rolled-over, outwardly, resulting in a 50% reduction in height of the catheter-housed valve. The low profile, side-delivered valves of the present invention do not require the aggressive, strut-breaking, tissue-tearing, stitch-pulling forces that traditional transcatheter valves are engineered to mitigate. -
FIG. 43 is an illustration of a cross-sectional view of one embodiment of a compressed valve within adelivery catheter 118. This cross-sectional end view shows one embodiment of a single-fold compression configuration where thetubular frame wall 102 and attached two-panel sleeve 110 are rolled-over, outwardly, resulting in a 50% reduction in height, and providing the ability to fit within the inner diameter of a 1 cm (10 mm) delivery catheter. -
FIG. 44 is an illustration of a cross-sectional view of another embodiment of a compressed valve within a delivery catheter. This cross-sectional end view shows another embodiment of a single-fold compression configuration where the tubular frame wall and attached two-panel sleeve are folded-over, outwardly, resulting in a 50% reduction in height, and providing the ability to fit within the inner diameter of a 1 cm (10 mm) delivery catheter. -
FIG. 45 is an illustration of a cross-sectional view of an embodiment of the prosthetic valve to further illustrate how the folding and rolling configurations can be effectuated due to the minimal material requirement of the low-profile, side-deliveredvalve -
FIG. 46 (a)-(b)-(c) is an illustration of a sequence of a low-profile valve being rolled into a configuration for placement within a delivery catheter.Tubular frame 102 havingaperture 106 supportssleeve 110. -
FIG. 47 is an illustration of an END-VIEW of a low-profile valve that has been longitudinally rolled and loaded within adelivery catheter 118, andshow frame 102 andsleeve 110. -
FIG. 48 is an illustration of a rotational lock embodiment of the present invention where the prosthetic valve is delivered to the native annulus with an off-set sub-annular tension arm/tab 126 positioned below the native annulus, and an off-set supra-annular tension arm/tab 128 positioned above the native annulus, while thetubular frame 102 is partially rolled off-set from the annular plane along a longitudinal axis. -
FIG. 49 is an illustration of a rotational lock embodiment of the present invention where the prosthetic valve is delivered to the native annulus with an off-set sub-annular tension arm/tab 126 positioned below the native annulus, and an off-set supra-annular tension arm/tab 128 positioned above the native annulus, while thetubular frame 102 is rolled into functional position parallel to the annular plane. Once the valve is rolled into position, and the tension arms are locked against the sub-annular and supra-annular tissues, the valve can also be further anchored using traditional anchoring elements as disclosed herein. -
FIG. 50 is an illustration of a low-profile, e.g. 8-20 mm, side-deliveredprosthetic valve 100 shown deployed into the native annulus.FIG. 50 shows that low-profile, side-delivered valves can be delivered and traditionally anchored with or without the need for shaped, tension arms. -
FIG. 51 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prostheticvalve having frame 102 andsleeve 110 shown compressed or housed within thedelivery catheter 118. -
FIG. 52 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve shown ejected from thedelivery catheter 118 and positioned against the anterior side of the native annulus. While the valve is held at this oblique angle bysecondary catheter 150, valve function and patient condition are assessed, and if appropriate the valve is completely deployed within the native annulus, and anchored using traditional anchoring elements. -
FIG. 53 is an illustration of an open cross-section view of a low-profile, side-delivered prosthetic valve and shows theinner valve sleeve 110 andframe 102. -
FIG. 54 is an illustration of a two-panel embodiment of aninner valve sleeve 110. -
FIG. 55 is an illustration of one embodiment of aninner valve sleeve 110 having two rigid support posts 154. -
FIG. 56 is an illustration of a three-panel embodiment of aninner valve sleeve 110. -
FIG. 57 is an illustration of a three-panel embodiment of aninner valve sleeve 110 having three rigid support posts 154. -
FIG. 58 is a flowchart describing one set of method steps for delivery of a low-profile, side-delivered prosthetic valve. - STEP 1: Provide low profile, side-loading prosthetic valve;
- STEP 2: compress valve into a delivery catheter, where the valve is compressed along a horizontal axis that is parallel to the length-wise axis of the delivery catheter;
- STEP 3: advance the delivery catheter containing the side-loaded valve to the right atrium via the inferior vena cava;
- STEP 4: expel the side-loaded valve from the delivery catheter, and using a steerable secondary catheter, seat the valve into the native annulus;
- STEP 5: optionally, before fully seating the valve into the native annulus, hold the valve at an oblique angle to assess valve function, and then after assessing valve function, fully seat the valve into the native annulus.
-
FIG. 59 is an illustration of a plan view of a tissue anchor having a floating radio-opaque marker. This figure shows the tissue anchor accessing the annular tissue withe the radio-opaque marker at the distal end of the anchor and in contact with the atrial surface of the annular tissue. This figure shows the tissue anchor advancing into the annular tissue with the radio-opaque marker threaded onto the tissue anchor and maintaining position on the atrial surface of the annular tissue. This figure shows the tissue anchor completely advanced into the annular tissue such that the tissue anchor and the threaded floating marker are now adjacent, indicating the desired depth, tension, and/or plication of the tissue anchor with respect to the annular tissue. -
FIG. 60 is an illustration of a plan view of of a tissue anchor having a straight thread and a constant pitch. -
FIG. 61 is an illustration of a plan view of of a tissue anchor having a straight thread and a variable pitch. -
FIG. 62 is an illustration of a plan view of of a tissue anchor having a tapered thread and a constant pitch. -
FIG. 63 is an illustration of a plan view of of a tissue anchor having a sunken taper thread and a variable pitch. -
FIG. 64 is an illustration ofStep 1 of a 4 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 64 shows a low profile valve being inserted into the valve annulus and low profile valve having an integral anchor delivery conduit or channel with an anchor disposed in the lumen of the channel and an anchor delivery catheter attached to the anchor. -
FIG. 65 is an illustration of Step 2 of a 4 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 65 shows a low profile valve completely deployed within the valve annulus and an integral anchor delivery conduit or channel with an anchor disposed in the lumen of the channel and an anchor delivery catheter attached to the anchor. -
FIG. 66 is an illustration of Step 3 of a 4 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 66 shows the anchor being pushed out of the lumen of the delivery conduit or channel and into the annular tissue. -
FIG. 67 is an illustration of Step 4 of a 4 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 67 shows the anchor in a locked position after being pushed out of the lumen of the delivery conduit or channel and into the annular tissue, thus anchoring the proximal side of the low profile valve. -
FIG. 68 is an illustration ofStep 1 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 68 shows catheter delivery of an attachment wire with the clip housed within the lumen of the clip delivery catheter. -
FIG. 69 is an illustration of Step 2 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 69 shows the clip delivery catheter inserted into an intra-annular space and shows an attachment wire and shows the clip housed within the lumen of the clip delivery catheter. -
FIG. 70 is an illustration of Step 3 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 70 shows a receiver element ejected from the delivery catheter and positioned behind tissue to be captured. -
FIG. 71 is an illustration of Step 4 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 71 shows an anchor element piercing the annular tissue and inserting into a receiver element. -
FIG. 72 is an illustration of Step 5 of a 5 step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG. 72 shows that the clip delivery catheter is withdrawn and the anchor element and receiver element are connected to the annular tissue and a also connected by connector wire to the low profile valve. -
FIG. 73 is an illustration of one embodiment of a partial cut-away interior view of a tri-leaflet embodiment of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve. -
FIG. 74 is an illustration of another embodiment of a partial cut-away interior view of a tri-leaflet embodiment of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve. -
FIG. 75 is an illustration of a top view of a tri-leaflet embodiment of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve. -
FIG. 76 is an illustration of the trans-septal (femoral-IVC) delivery of a low-profile, e.g. 8-20 mm, side-delivered prosthetic MITRAL valve shown partially housed within the delivery catheter, and partially ejected for deployment into the native mitral annulus. -
FIG. 77 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic MITRAL valve shown housed within the delivery catheter. -
FIG. 78 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic MITRAL valve shown partially housed within a delivery catheter and partially laterally ejected from the delivery catheter and positioned for deployment against the anterior side of the native mitral annulus. -
FIG. 79 is an illustration of a low-profile, e.g. 8-20 mm, side-delivered prosthetic MITRAL valve shown ejected from the delivery catheter and positioned against the anterior side of the native mitral annulus. -
FIG. 80 is an illustration of a side or plan view of a low-profile, e.g. 8-20 mm, side-delivered prosthetic valve shown deployed into the native MITRAL annulus. - 100 side-loading transcatheter heart valve replacement
- 102 a ring-shaped tubular frame
- 104 a braid, wire, or laser-cut wire frame
- 106 substantially circular central aperture,
- 108 biocompatible material cover for frame;
- 110 valve sleeve, aka a collapsible flow control sleeve
- 112,114 valve sleeve panels
- 116 a reciprocating closable channel from a heart atrium to a heart ventricle;
- 118 a transcatheter implantation (delivery) catheter
- 120 an internal diameter from 22 Fr (7.33 mm) to 34 Fr (11.33 mm),
- 122 compressed tubular frame oriented parallel to length-wise axis delivery catheter
- 124 length-wise axis of a delivery catheter.
- 126 lower tension arm/tab, braid/laser
- 128 upper tension arm/tab, braid/laser
- 130 proximal sealing cuff
- 132 hourglass annular seal
- 134 upper proximal tab
- 136 lower proximal tab
- 138 screw anchor
- 140 wire tubular frame
- 142 upper tension arm/tab, wire
- 144 lower tension arm/tab, wire
- 146 substantially circular central aperture
- 148 upper proximal tab, wire
- 150 steerable anchoring/deployment catheter
- 152 screw/anchor tab
- 154 valve sleeve support posts
- 156 sleeve terminus aperture
- Various of the above-disclosed and other features and functions, or alternatives thereof, may be combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art, each of which is also intended to be encompassed by the disclosed embodiments.
- Having described embodiments for the invention herein, it is noted that modifications and variations can be made by persons skilled in the art in light of the above teachings. It is therefore to be understood that changes may be made in the particular embodiments of the invention disclosed which are within the scope and spirit of the invention as defined by the appended claims. Having thus described the invention with the details and particularity required by the patent laws, what is claimed and desired protected by Letters Patent is set forth in the appended claims.
Claims (16)
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US16/435,687 US10595994B1 (en) | 2018-09-20 | 2019-06-10 | Side-delivered transcatheter heart valve replacement |
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US201862737343P | 2018-09-27 | 2018-09-27 | |
US16/435,687 US10595994B1 (en) | 2018-09-20 | 2019-06-10 | Side-delivered transcatheter heart valve replacement |
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Families Citing this family (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11083580B2 (en) | 2016-12-30 | 2021-08-10 | Pipeline Medical Technologies, Inc. | Method of securing a leaflet anchor to a mitral valve leaflet |
US10925731B2 (en) | 2016-12-30 | 2021-02-23 | Pipeline Medical Technologies, Inc. | Method and apparatus for transvascular implantation of neo chordae tendinae |
US9877833B1 (en) | 2016-12-30 | 2018-01-30 | Pipeline Medical Technologies, Inc. | Method and apparatus for transvascular implantation of neo chordae tendinae |
WO2019195860A2 (en) | 2018-04-04 | 2019-10-10 | Vdyne, Llc | Devices and methods for anchoring transcatheter heart valve |
US10321995B1 (en) | 2018-09-20 | 2019-06-18 | Vdyne, Llc | Orthogonally delivered transcatheter heart valve replacement |
US11278437B2 (en) | 2018-12-08 | 2022-03-22 | Vdyne, Inc. | Compression capable annular frames for side delivery of transcatheter heart valve replacement |
US11344413B2 (en) | 2018-09-20 | 2022-05-31 | Vdyne, Inc. | Transcatheter deliverable prosthetic heart valves and methods of delivery |
US11071627B2 (en) | 2018-10-18 | 2021-07-27 | Vdyne, Inc. | Orthogonally delivered transcatheter heart valve frame for valve in valve prosthesis |
US11109969B2 (en) | 2018-10-22 | 2021-09-07 | Vdyne, Inc. | Guidewire delivery of transcatheter heart valve |
AU2019397490A1 (en) | 2018-12-12 | 2021-07-29 | Pipeline Medical Technologies, Inc. | Method and apparatus for mitral valve chord repair |
US11253359B2 (en) | 2018-12-20 | 2022-02-22 | Vdyne, Inc. | Proximal tab for side-delivered transcatheter heart valves and methods of delivery |
US11273032B2 (en) | 2019-01-26 | 2022-03-15 | Vdyne, Inc. | Collapsible inner flow control component for side-deliverable transcatheter heart valve prosthesis |
US11185409B2 (en) | 2019-01-26 | 2021-11-30 | Vdyne, Inc. | Collapsible inner flow control component for side-delivered transcatheter heart valve prosthesis |
CA3132162A1 (en) * | 2019-03-05 | 2020-09-10 | Vdyne, Inc. | Tricuspid regurgitation control devices for orthogonal transcatheter heart valve prosthesis |
US11076956B2 (en) | 2019-03-14 | 2021-08-03 | Vdyne, Inc. | Proximal, distal, and anterior anchoring tabs for side-delivered transcatheter mitral valve prosthesis |
US11173027B2 (en) * | 2019-03-14 | 2021-11-16 | Vdyne, Inc. | Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same |
JP2022530764A (en) | 2019-05-04 | 2022-07-01 | ブイダイン,インコーポレイテッド | Tightening device and method for deploying a laterally delivered artificial heart valve with a native annulus. |
JP2022544707A (en) | 2019-08-20 | 2022-10-20 | ブイダイン,インコーポレイテッド | Devices and methods for delivery and retrieval of laterally deliverable transcatheter valve prostheses |
CN114630665A (en) | 2019-08-26 | 2022-06-14 | 维迪内股份有限公司 | Laterally deliverable transcatheter prosthetic valve and methods of delivery and anchoring thereof |
US11234813B2 (en) | 2020-01-17 | 2022-02-01 | Vdyne, Inc. | Ventricular stability elements for side-deliverable prosthetic heart valves and methods of delivery |
US11266502B1 (en) | 2020-12-14 | 2022-03-08 | Versa Vascular Inc. | System and method for cardiac valve repair |
Family Cites Families (909)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5397351A (en) | 1991-05-13 | 1995-03-14 | Pavcnik; Dusan | Prosthetic valve for percutaneous insertion |
US6123715A (en) | 1994-07-08 | 2000-09-26 | Amplatz; Curtis | Method of forming medical devices; intravascular occlusion devices |
WO1996001591A1 (en) | 1994-07-08 | 1996-01-25 | Microvena Corporation | Method of forming medical devices; intravascular occlusion devices |
US5846261A (en) | 1994-07-08 | 1998-12-08 | Aga Medical Corp. | Percutaneous catheter directed occlusion devices |
US6197013B1 (en) | 1996-11-06 | 2001-03-06 | Setagon, Inc. | Method and apparatus for drug and gene delivery |
US6491619B1 (en) | 1997-01-31 | 2002-12-10 | Endologix, Inc | Radiation delivery catheters and dosimetry methods |
AU768071B2 (en) | 1999-01-22 | 2003-12-04 | W.L. Gore & Associates, Inc. | Low profile stent and graft combination |
IL144646A0 (en) | 1999-02-01 | 2002-05-23 | Univ Texas | Woven intravascular and methods for making the same and apparatus for delivery of the same |
EP1576937B1 (en) | 1999-02-01 | 2012-10-31 | Board Of Regents, The University Of Texas System | Woven intravascular devices and methods for making the same and apparatus for delvery of the same |
US7018401B1 (en) | 1999-02-01 | 2006-03-28 | Board Of Regents, The University Of Texas System | Woven intravascular devices and methods for making the same and apparatus for delivery of the same |
IL144695A0 (en) | 1999-02-01 | 2002-06-30 | Univ Texas | Woven bifurcated and trifurcated stents and methods for making the same |
US20020058911A1 (en) | 1999-05-07 | 2002-05-16 | Paul Gilson | Support frame for an embolic protection device |
US7736687B2 (en) | 2006-01-31 | 2010-06-15 | Advance Bio Prosthetic Surfaces, Ltd. | Methods of making medical devices |
AU2001233227A1 (en) | 2000-02-02 | 2001-08-14 | Robert V. Snyders | Artificial heart valve |
GB2369575A (en) | 2000-04-20 | 2002-06-05 | Salviac Ltd | An embolic protection system |
US6482222B1 (en) | 2000-07-11 | 2002-11-19 | Rafael Medical Technologies Inc. | Intravascular filter |
US6582467B1 (en) | 2000-10-31 | 2003-06-24 | Vertelink Corporation | Expandable fusion cage |
US9107605B2 (en) | 2000-11-17 | 2015-08-18 | Advanced Bio Prosthetic Surfaces, Ltd., A Wholly Owned Subsidiary Of Palmaz Scientific, Inc. | Device for in vivo delivery of bioactive agents and method of manufacture thereof |
US6899727B2 (en) | 2001-01-22 | 2005-05-31 | Gore Enterprise Holdings, Inc. | Deployment system for intraluminal devices |
US20070027535A1 (en) | 2005-07-28 | 2007-02-01 | Cook Incorporated | Implantable thromboresistant valve |
US7374571B2 (en) | 2001-03-23 | 2008-05-20 | Edwards Lifesciences Corporation | Rolled minimally-invasive heart valves and methods of manufacture |
JP2005501602A (en) | 2001-08-29 | 2005-01-20 | カルバーリョ、リカルド エイ.ピー. デ | Sealable implantable device for unidirectional delivery of therapeutic agents to tissue |
US7074189B1 (en) | 2002-01-23 | 2006-07-11 | Valentino Montegrande | Endoscopically deliverable ultrasound imaging system and method of use |
US20030153901A1 (en) | 2002-02-08 | 2003-08-14 | Atrium Medical Corporation | Drug delivery panel |
AU2003217835A1 (en) | 2002-02-27 | 2003-09-09 | University Of Virginia Patent Foundation | Methods for making implantable medical devices having microstructures |
US20030171801A1 (en) | 2002-03-06 | 2003-09-11 | Brian Bates | Partially covered intraluminal support device |
US20030187495A1 (en) | 2002-04-01 | 2003-10-02 | Cully Edward H. | Endoluminal devices, embolic filters, methods of manufacture and use |
AU2006203686B2 (en) | 2002-04-01 | 2008-11-20 | W. L. Gore & Associates, Inc. | Endoluminal devices, embolic filters, methods of manufacture and use |
US7125418B2 (en) | 2002-04-16 | 2006-10-24 | The International Heart Institute Of Montana Foundation | Sigmoid valve and method for its percutaneous implantation |
US20040093012A1 (en) | 2002-10-17 | 2004-05-13 | Cully Edward H. | Embolic filter frame having looped support strut elements |
US11213253B2 (en) | 2003-02-21 | 2022-01-04 | 3Dt Holdings, Llc | Luminal organ sizing devices and methods |
US7175656B2 (en) | 2003-04-18 | 2007-02-13 | Alexander Khairkhahan | Percutaneous transcatheter heart valve replacement |
US7717952B2 (en) | 2003-04-24 | 2010-05-18 | Cook Incorporated | Artificial prostheses with preferred geometries |
WO2004103209A2 (en) | 2003-05-19 | 2004-12-02 | Secant Medical Llc | Tissue distention device and related methods for therapeutic intervention |
KR20060112705A (en) | 2003-07-08 | 2006-11-01 | 벤터 테크놀로지 리미티드 | Implantable prosthetic devices particularly for transarterial delivery in the treatment of aortic stenosis, and methods of implanting such devices |
AU2011236036B2 (en) | 2003-07-08 | 2014-06-12 | Medtronic Ventor Technologies Ltd. | Implantable prosthetic devices particularly for transarterial delivery in the treatment of aortic stenosis, and methods of implanting such devices |
EP1684666A4 (en) | 2003-10-14 | 2010-04-07 | James C Peacock Iii | Aneurysm treatment system and method |
EP1689482A1 (en) | 2003-10-28 | 2006-08-16 | Peacock, James C., III | Embolic filter device and related systems and methods |
EP2529697B1 (en) | 2003-12-23 | 2014-01-29 | Sadra Medical, Inc. | Repositionable heart valve |
EP3308744B2 (en) | 2004-03-11 | 2023-08-02 | Percutaneous Cardiovascular Solutions Pty Limited | Percutaneous heart valve prosthesis |
US8777974B2 (en) | 2004-03-19 | 2014-07-15 | Aga Medical Corporation | Multi-layer braided structures for occluding vascular defects |
US7449027B2 (en) | 2004-03-29 | 2008-11-11 | Cook Incorporated | Modifying fluid flow in a body vessel lumen to promote intraluminal flow-sensitive processes |
US8007737B2 (en) | 2004-04-14 | 2011-08-30 | Wyeth | Use of antioxidants to prevent oxidation and reduce drug degradation in drug eluting medical devices |
CA2563426C (en) | 2004-05-05 | 2013-12-24 | Direct Flow Medical, Inc. | Unstented heart valve with formed in place support structure |
WO2006010130A1 (en) | 2004-07-09 | 2006-01-26 | University Of Florida Research Foundation, Inc. | Tubular polymer stent coverings |
US8308789B2 (en) | 2004-07-16 | 2012-11-13 | W. L. Gore & Associates, Inc. | Deployment system for intraluminal devices |
US20060052867A1 (en) | 2004-09-07 | 2006-03-09 | Medtronic, Inc | Replacement prosthetic heart valve, system and method of implant |
EP1846078A4 (en) | 2004-12-16 | 2009-12-23 | Carlos Ruiz | Separable sheath and method of using |
US20070032850A1 (en) | 2004-12-16 | 2007-02-08 | Carlos Ruiz | Separable sheath and method for insertion of a medical device into a bodily vessel using a separable sheath |
ES2573672T3 (en) | 2005-02-04 | 2016-06-09 | Boston Scientific Scimed Inc. | Needle design for male sling transobturator |
US7331991B2 (en) | 2005-02-25 | 2008-02-19 | California Institute Of Technology | Implantable small percutaneous valve and methods of delivery |
SE531468C2 (en) | 2005-04-21 | 2009-04-14 | Edwards Lifesciences Ag | An apparatus for controlling blood flow |
AU2005334555A1 (en) | 2005-07-19 | 2007-01-25 | Stout Medical Group L.P. | Embolic filtering method and apparatus |
US9125732B2 (en) | 2005-07-25 | 2015-09-08 | Vascular Dynamics, Inc. | Devices and methods for control of blood pressure |
US20070038295A1 (en) | 2005-08-12 | 2007-02-15 | Cook Incorporated | Artificial valve prosthesis having a ring frame |
US7503928B2 (en) | 2005-10-21 | 2009-03-17 | Cook Biotech Incorporated | Artificial valve with center leaflet attachment |
US7563277B2 (en) | 2005-10-24 | 2009-07-21 | Cook Incorporated | Removable covering for implantable frame projections |
WO2007054015A1 (en) | 2005-11-09 | 2007-05-18 | Ning Wen | An artificial heart valve stent and weaving method thereof |
CN100584292C (en) | 2005-11-09 | 2010-01-27 | 温宁 | Artificial heart valve with scaffold |
CN2855366Y (en) | 2005-11-09 | 2007-01-10 | 王蓉珍 | Artificial cardiac valves stand and its delivery placer |
US7919108B2 (en) | 2006-03-10 | 2011-04-05 | Cook Incorporated | Taxane coatings for implantable medical devices |
US9078781B2 (en) | 2006-01-11 | 2015-07-14 | Medtronic, Inc. | Sterile cover for compressible stents used in percutaneous device delivery systems |
WO2007095233A2 (en) | 2006-02-10 | 2007-08-23 | The Regents Of The University Of California | Thin film metal alloy covered stent |
EP2583640B1 (en) | 2006-02-16 | 2022-06-22 | Venus MedTech (HangZhou), Inc. | Minimally invasive replacement heart valve |
US20080077165A1 (en) | 2006-02-24 | 2008-03-27 | National University Of Ireland, Galway | Minimally Invasive Intravascular Treatment Device |
US20080275550A1 (en) | 2006-02-24 | 2008-11-06 | Arash Kheradvar | Implantable small percutaneous valve and methods of delivery |
DE602006010171D1 (en) | 2006-02-24 | 2009-12-17 | Nat Univ Ireland | Minimally invasive intravascular treatment device |
US7648527B2 (en) | 2006-03-01 | 2010-01-19 | Cook Incorporated | Methods of reducing retrograde flow |
US9155641B2 (en) | 2006-03-09 | 2015-10-13 | Cook Medical Technologies Llc | Expandable stent grafts |
US7875284B2 (en) | 2006-03-10 | 2011-01-25 | Cook Incorporated | Methods of manufacturing and modifying taxane coatings for implantable medical devices |
US8157837B2 (en) | 2006-03-13 | 2012-04-17 | Pneumrx, Inc. | Minimally invasive lung volume reduction device and method |
WO2007109171A2 (en) | 2006-03-17 | 2007-09-27 | Microcube, Llc | Devices and methods for creating continuous lesions |
US8075615B2 (en) | 2006-03-28 | 2011-12-13 | Medtronic, Inc. | Prosthetic cardiac valve formed from pericardium material and methods of making same |
US8303648B2 (en) | 2006-04-25 | 2012-11-06 | Cook Medical Technologies Llc | Artificial venous valve containing therapeutic agent |
EP1849440A1 (en) | 2006-04-28 | 2007-10-31 | Younes Boudjemline | Vascular stents with varying diameter |
WO2007127433A2 (en) | 2006-04-28 | 2007-11-08 | Medtronic, Inc. | Method and apparatus for cardiac valve replacement |
EP2478872B1 (en) | 2006-05-30 | 2018-07-04 | Cook Medical Technologies LLC | Artificial valve prosthesis |
US20080004686A1 (en) | 2006-06-30 | 2008-01-03 | Cook Incorporated | Implantable device with light-transmitting material |
US20090306768A1 (en) | 2006-07-28 | 2009-12-10 | Cardiaq Valve Technologies, Inc. | Percutaneous valve prosthesis and system and method for implanting same |
US9339367B2 (en) | 2006-09-11 | 2016-05-17 | Edwards Lifesciences Ag | Embolic deflection device |
US20100179584A1 (en) | 2006-09-11 | 2010-07-15 | Carpenter Judith T | Methods of diverting embolic debris away from the cerebral circulation |
US20100324589A1 (en) | 2006-09-11 | 2010-12-23 | Carpenter Judith T | Embolic deflection device |
US20100179583A1 (en) | 2006-09-11 | 2010-07-15 | Carpenter Judith T | Methods of deploying and retrieving an embolic diversion device |
US20100179647A1 (en) | 2006-09-11 | 2010-07-15 | Carpenter Judith T | Methods of reducing embolism to cerebral circulation as a consequence of an index cardiac procedure |
US8834564B2 (en) | 2006-09-19 | 2014-09-16 | Medtronic, Inc. | Sinus-engaging valve fixation member |
US9943409B2 (en) | 2006-11-14 | 2018-04-17 | The United States Of America, As Represented By The Secretary, Department Of Health And Human Services | Transcatheter coronary sinus mitral valve annuloplasty procedure and coronary artery and myocardial protection device |
EP2091465B1 (en) | 2006-11-14 | 2018-01-31 | The Government of the United States of America as represented by the Secretary of the Department of Health and Human Services | Coronary artery and myocardial protection device |
EP2263605A1 (en) | 2006-11-20 | 2010-12-22 | SeptRx, Inc. | Device and method for preventing the undesired passage of emboli from a venous blood pool to an arterial blood pool |
US11389171B2 (en) | 2006-11-21 | 2022-07-19 | David S. Goldsmith | Integrated system for the infixion and retrieval of implants |
WO2010004546A1 (en) | 2008-06-16 | 2010-01-14 | Valtech Cardio, Ltd. | Annuloplasty devices and methods of delivery therefor |
EP2088965B1 (en) | 2006-12-05 | 2012-11-28 | Valtech Cardio, Ltd. | Segmented ring placement |
US9883943B2 (en) | 2006-12-05 | 2018-02-06 | Valtech Cardio, Ltd. | Implantation of repair devices in the heart |
US9510943B2 (en) | 2007-01-19 | 2016-12-06 | Medtronic, Inc. | Stented heart valve devices and methods for atrioventricular valve replacement |
WO2008091925A2 (en) | 2007-01-23 | 2008-07-31 | Cook Incorporated | Treatment of aortic dissection or aneurysm |
WO2008092101A2 (en) | 2007-01-26 | 2008-07-31 | 3F Therapeutics, Inc. | Methods and systems for reducing paravalvular leakage in heart valves |
ATE515244T1 (en) | 2007-02-15 | 2011-07-15 | Cook Inc | ARTIFICIAL VALVE PROSTHESIS WITH FREE LEAF SECTION |
WO2008103280A2 (en) | 2007-02-16 | 2008-08-28 | Medtronic, Inc. | Delivery systems and methods of implantation for replacement prosthetic heart valves |
US8070802B2 (en) | 2007-02-23 | 2011-12-06 | The Trustees Of The University Of Pennsylvania | Mitral valve system |
US20080208328A1 (en) | 2007-02-23 | 2008-08-28 | Endovalve, Inc. | Systems and Methods For Placement of Valve Prosthesis System |
WO2010058398A2 (en) | 2007-03-08 | 2010-05-27 | Sync-Rx, Ltd. | Image processing and tool actuation for medical procedures |
EP2129284A4 (en) | 2007-03-08 | 2012-11-28 | Sync Rx Ltd | Imaging and tools for use with moving organs |
US9968256B2 (en) | 2007-03-08 | 2018-05-15 | Sync-Rx Ltd. | Automatic identification of a tool |
US8042720B2 (en) | 2007-03-29 | 2011-10-25 | Es Vascular Ltd. | Device for affixing of tubular medical accessory to a body passage |
CA2822636A1 (en) | 2007-04-13 | 2008-10-23 | Jenavalve Technology Inc. | Medical device for treating a heart valve insufficiency or stenosis |
WO2008125145A1 (en) | 2007-04-13 | 2008-10-23 | Synergio Ag | A tissue penetration device and method |
US8915958B2 (en) | 2007-06-08 | 2014-12-23 | St. Jude Medical, Inc. | Devices for transcatheter prosthetic heart valve implantation and access closure |
US8007429B2 (en) | 2007-07-05 | 2011-08-30 | Gt Urological, Llc | Vessel occlusive device and method of occluding a vessel |
US8858490B2 (en) | 2007-07-18 | 2014-10-14 | Silk Road Medical, Inc. | Systems and methods for treating a carotid artery |
US9566178B2 (en) | 2010-06-24 | 2017-02-14 | Edwards Lifesciences Cardiaq Llc | Actively controllable stent, stent graft, heart valve and method of controlling same |
US9814611B2 (en) | 2007-07-31 | 2017-11-14 | Edwards Lifesciences Cardiaq Llc | Actively controllable stent, stent graft, heart valve and method of controlling same |
US20090094189A1 (en) | 2007-10-08 | 2009-04-09 | At&T Bls Intellectual Property, Inc. | Methods, systems, and computer program products for managing tags added by users engaged in social tagging of content |
WO2009052188A1 (en) | 2007-10-15 | 2009-04-23 | Edwards Lifesciences Corporation | Transcatheter heart valve with micro-anchors |
US7819844B2 (en) | 2007-10-17 | 2010-10-26 | Gardia Medical Ltd. | Guidewire stop |
EP2217153B1 (en) | 2007-10-19 | 2021-03-03 | Ancora Heart, Inc. | Systems for cardiac remodeling |
US7828840B2 (en) | 2007-11-15 | 2010-11-09 | Med Institute, Inc. | Medical devices and methods for local delivery of angiotensin II type 2 receptor antagonists |
US7846199B2 (en) | 2007-11-19 | 2010-12-07 | Cook Incorporated | Remodelable prosthetic valve |
WO2010070649A1 (en) | 2008-12-21 | 2010-06-24 | Mor Research Applications Ltd. | Elongated body for deployment in a coronary sinus |
EP2231028A2 (en) | 2007-12-20 | 2010-09-29 | Mor Research Applications Ltd. | Methods and devices for treatment of a heart |
US9393115B2 (en) | 2008-01-24 | 2016-07-19 | Medtronic, Inc. | Delivery systems and methods of implantation for prosthetic heart valves |
EP2254512B1 (en) | 2008-01-24 | 2016-01-06 | Medtronic, Inc. | Markers for prosthetic heart valves |
US8157852B2 (en) | 2008-01-24 | 2012-04-17 | Medtronic, Inc. | Delivery systems and methods of implantation for prosthetic heart valves |
EP3572044B1 (en) | 2008-01-24 | 2021-07-28 | Medtronic, Inc. | Stents for prosthetic heart valves |
US9149358B2 (en) | 2008-01-24 | 2015-10-06 | Medtronic, Inc. | Delivery systems for prosthetic heart valves |
US20090287290A1 (en) | 2008-01-24 | 2009-11-19 | Medtronic, Inc. | Delivery Systems and Methods of Implantation for Prosthetic Heart Valves |
WO2009094197A1 (en) | 2008-01-24 | 2009-07-30 | Medtronic, Inc. | Stents for prosthetic heart valves |
US8790367B2 (en) | 2008-02-06 | 2014-07-29 | Guided Delivery Systems Inc. | Multi-window guide tunnel |
AU2009219415B2 (en) | 2008-02-25 | 2013-01-17 | Medtronic Vascular Inc. | Infundibular reducer devices |
US8968393B2 (en) | 2008-02-28 | 2015-03-03 | Medtronic, Inc. | System and method for percutaneous mitral valve repair |
US9241792B2 (en) | 2008-02-29 | 2016-01-26 | Edwards Lifesciences Corporation | Two-step heart valve implantation |
DE102008015781B4 (en) | 2008-03-26 | 2011-09-29 | Malte Neuss | Device for sealing defects in the vascular system |
AU2009232400B2 (en) | 2008-04-03 | 2013-09-12 | Cook Medical Technologies Llc | Self cleaning devices, systems and methods of use |
US8430927B2 (en) | 2008-04-08 | 2013-04-30 | Medtronic, Inc. | Multiple orifice implantable heart valve and methods of implantation |
US20100131057A1 (en) | 2008-04-16 | 2010-05-27 | Cardiovascular Technologies, Llc | Transvalvular intraannular band for aortic valve repair |
US20100121437A1 (en) | 2008-04-16 | 2010-05-13 | Cardiovascular Technologies, Llc | Transvalvular intraannular band and chordae cutting for ischemic and dilated cardiomyopathy |
WO2009129481A1 (en) | 2008-04-18 | 2009-10-22 | Cook Incorporated | Branched vessel prosthesis |
US8696743B2 (en) | 2008-04-23 | 2014-04-15 | Medtronic, Inc. | Tissue attachment devices and methods for prosthetic heart valves |
EP3141219A1 (en) | 2008-04-23 | 2017-03-15 | Medtronic, Inc. | Stented heart valve devices |
US8312825B2 (en) | 2008-04-23 | 2012-11-20 | Medtronic, Inc. | Methods and apparatuses for assembly of a pericardial prosthetic heart valve |
EP3967274B1 (en) | 2008-04-23 | 2022-08-24 | Medtronic, Inc. | Stented heart valve devices |
US8136218B2 (en) | 2008-04-29 | 2012-03-20 | Medtronic, Inc. | Prosthetic heart valve, prosthetic heart valve assembly and method for making same |
US9440054B2 (en) | 2008-05-14 | 2016-09-13 | Onset Medical Corporation | Expandable transapical sheath and method of use |
US8728153B2 (en) | 2008-05-14 | 2014-05-20 | Onset Medical Corporation | Expandable transapical sheath and method of use |
SI3476367T1 (en) | 2008-06-06 | 2020-02-28 | Edwards Lifesciences Corporation | Low profile transcatheter heart valve |
ES2586111T3 (en) | 2008-07-15 | 2016-10-11 | St. Jude Medical, Inc. | Collapsible and re-expandable prosthetic heart valve sleeve designs and complementary technological applications |
SG195610A1 (en) | 2008-09-15 | 2013-12-30 | Aeeg Ab | Medical device, method and system for temporary occlusion of an opening in a lumen of a body |
US8790387B2 (en) | 2008-10-10 | 2014-07-29 | Edwards Lifesciences Corporation | Expandable sheath for introducing an endovascular delivery device into a body |
US9119714B2 (en) | 2008-10-29 | 2015-09-01 | The Regents Of The University Of Colorado, A Body Corporate | Shape memory polymer prosthetic medical device |
RU2526567C2 (en) | 2008-12-12 | 2014-08-27 | Конинклейке Филипс Электроникс Н.В. | Automatic creation of reference points for replacement of heart valve |
US8308798B2 (en) | 2008-12-19 | 2012-11-13 | Edwards Lifesciences Corporation | Quick-connect prosthetic heart valve and methods |
US8926696B2 (en) | 2008-12-22 | 2015-01-06 | Valtech Cardio, Ltd. | Adjustable annuloplasty devices and adjustment mechanisms therefor |
US8545553B2 (en) | 2009-05-04 | 2013-10-01 | Valtech Cardio, Ltd. | Over-wire rotation tool |
US9011530B2 (en) | 2008-12-22 | 2015-04-21 | Valtech Cardio, Ltd. | Partially-adjustable annuloplasty structure |
US10517719B2 (en) | 2008-12-22 | 2019-12-31 | Valtech Cardio, Ltd. | Implantation of repair devices in the heart |
US8241351B2 (en) | 2008-12-22 | 2012-08-14 | Valtech Cardio, Ltd. | Adjustable partial annuloplasty ring and mechanism therefor |
US8940044B2 (en) | 2011-06-23 | 2015-01-27 | Valtech Cardio, Ltd. | Closure element for use with an annuloplasty structure |
US8808368B2 (en) | 2008-12-22 | 2014-08-19 | Valtech Cardio, Ltd. | Implantation of repair chords in the heart |
WO2012176195A2 (en) | 2011-06-23 | 2012-12-27 | Valtech Cardio, Ltd. | Closure element for use with annuloplasty structure |
US20100174363A1 (en) | 2009-01-07 | 2010-07-08 | Endovalve, Inc. | One Piece Prosthetic Valve Support Structure and Related Assemblies |
US9402720B2 (en) | 2009-01-12 | 2016-08-02 | Valve Medical Ltd. | Modular percutaneous valve structure and delivery method |
US8353956B2 (en) | 2009-02-17 | 2013-01-15 | Valtech Cardio, Ltd. | Actively-engageable movement-restriction mechanism for use with an annuloplasty structure |
WO2010096570A2 (en) | 2009-02-23 | 2010-08-26 | John To | Stent strut appositioner |
US20100217382A1 (en) | 2009-02-25 | 2010-08-26 | Edwards Lifesciences | Mitral valve replacement with atrial anchoring |
EP2403439B1 (en) | 2009-03-06 | 2016-07-20 | The Regents of The University of California | Thin film vascular stent and biocompatible surface treatment |
US8021420B2 (en) | 2009-03-12 | 2011-09-20 | Medtronic Vascular, Inc. | Prosthetic valve delivery system |
EP3708123A1 (en) | 2009-03-30 | 2020-09-16 | JC Medical, Inc. | Sutureless valve prostheses and devices and methods for delivery |
US9980818B2 (en) | 2009-03-31 | 2018-05-29 | Edwards Lifesciences Corporation | Prosthetic heart valve system with positioning markers |
US9011522B2 (en) | 2009-04-10 | 2015-04-21 | Lon Sutherland ANNEST | Device and method for temporary or permanent suspension of an implantable scaffolding containing an orifice for placement of a prosthetic or bio-prosthetic valve |
EP2241284B1 (en) | 2009-04-15 | 2012-09-19 | National University of Ireland, Galway | Intravasculature devices and balloons for use therewith |
WO2010121076A2 (en) | 2009-04-15 | 2010-10-21 | Cardiaq Valve Technologies, Inc. | Vascular implant and delivery system |
US9011524B2 (en) | 2009-04-24 | 2015-04-21 | Medtronic, Inc. | Prosthetic heart valves and methods of attaching same |
US9034034B2 (en) | 2010-12-22 | 2015-05-19 | V-Wave Ltd. | Devices for reducing left atrial pressure, and methods of making and using same |
US10076403B1 (en) | 2009-05-04 | 2018-09-18 | V-Wave Ltd. | Shunt for redistributing atrial blood volume |
US8075611B2 (en) | 2009-06-02 | 2011-12-13 | Medtronic, Inc. | Stented prosthetic heart valves |
US9636094B2 (en) | 2009-06-22 | 2017-05-02 | W. L. Gore & Associates, Inc. | Sealing device and delivery system |
US8348998B2 (en) | 2009-06-26 | 2013-01-08 | Edwards Lifesciences Corporation | Unitary quick connect prosthetic heart valve and deployment system and methods |
US9005649B2 (en) | 2009-07-14 | 2015-04-14 | Board Of Regents, The University Of Texas System | Methods for making controlled delivery devices having zero order kinetics |
AU2010286587B2 (en) | 2009-08-27 | 2013-10-17 | Medtronic Inc. | Transcatheter valve delivery systems and methods |
US8801706B2 (en) | 2009-08-27 | 2014-08-12 | Medtronic, Inc. | Paravalvular leak closure devices and methods |
US10034748B2 (en) | 2009-09-18 | 2018-07-31 | The Regents Of The University Of California | Endovascular prosthetic heart valve replacement |
AU2010295291B2 (en) | 2009-09-21 | 2013-10-24 | Medtronic Inc. | Stented transcatheter prosthetic heart valve delivery system and method |
US10022222B2 (en) | 2009-10-06 | 2018-07-17 | Adam Groothuis | Systems and methods for treating lumenal valves |
WO2011047168A1 (en) | 2009-10-14 | 2011-04-21 | Cardiovascular Technologies, Llc | Percutaneous transvalvular intraannular band for mitral valve repair |
BR112012010321B8 (en) | 2009-11-02 | 2021-06-22 | Symetis Sa | replacement valve for use on a human body |
WO2011067770A1 (en) | 2009-12-02 | 2011-06-09 | Valtech Cardio, Ltd. | Delivery tool for implantation of spool assembly coupled to a helical anchor |
US8449599B2 (en) | 2009-12-04 | 2013-05-28 | Edwards Lifesciences Corporation | Prosthetic valve for replacing mitral valve |
US20130190861A1 (en) | 2012-01-23 | 2013-07-25 | Tendyne Holdings, Inc. | Prosthetic Valve for Replacing Mitral Valve |
US20110319988A1 (en) | 2009-12-08 | 2011-12-29 | Avalon Medical, Ltd. | Device and System for Transcatheter Mitral Valve Replacement |
CN102858272B (en) | 2009-12-15 | 2015-07-15 | 爱德华兹生命科学公司 | Expansion device for treatment of vascular passageways |
US20110160838A1 (en) | 2009-12-31 | 2011-06-30 | Blanzy Jeffrey S | Endoprosthesis containing multi-phase ferrous steel |
US8888838B2 (en) | 2009-12-31 | 2014-11-18 | W. L. Gore & Associates, Inc. | Endoprosthesis containing multi-phase ferrous steel |
EA201892282A1 (en) | 2010-01-12 | 2019-07-31 | Вэлв Медикал Лтд | INSERTED THROUGH THE SKIN MODULAR VALVE STRUCTURE AND METHOD OF DELIVERY |
US9358109B2 (en) | 2010-01-13 | 2016-06-07 | Vinay Badhwar | Transcorporeal delivery system and method |
US10959840B2 (en) | 2010-01-20 | 2021-03-30 | Micro Interventional Devices, Inc. | Systems and methods for affixing a prosthesis to tissue |
DE102010008362A1 (en) | 2010-02-17 | 2011-08-18 | Transcatheter Technologies GmbH, 93053 | Medical implant which is expandable from a non-expanded state |
US20110208293A1 (en) | 2010-02-23 | 2011-08-25 | Medtronic, Inc. | Catheter-Based Heart Valve Therapy System with Sizing Balloon |
US9226826B2 (en) | 2010-02-24 | 2016-01-05 | Medtronic, Inc. | Transcatheter valve structure and methods for valve delivery |
JP5575931B2 (en) | 2010-03-01 | 2014-08-20 | コリブリ ハート バルブ エルエルシー | Percutaneously deliverable heart valve and related methods |
US8398708B2 (en) | 2010-03-05 | 2013-03-19 | Edwards Lifesciences Corporation | Retaining mechanisms for prosthetic valves |
EP2674174B1 (en) | 2010-03-23 | 2019-10-16 | Edwards Lifesciences Corporation | Methods of conditioning sheet bioprosthetic tissue |
US9480557B2 (en) | 2010-03-25 | 2016-11-01 | Medtronic, Inc. | Stents for prosthetic heart valves |
US9320597B2 (en) | 2010-03-30 | 2016-04-26 | Medtronic, Inc. | Transcatheter prosthetic heart valve delivery system with recapturing feature and method |
US8491650B2 (en) | 2010-04-08 | 2013-07-23 | Medtronic, Inc. | Transcatheter prosthetic heart valve delivery system and method with stretchable stability tube |
US8512400B2 (en) | 2010-04-09 | 2013-08-20 | Medtronic, Inc. | Transcatheter heart valve delivery system with reduced area moment of inertia |
US8926692B2 (en) | 2010-04-09 | 2015-01-06 | Medtronic, Inc. | Transcatheter prosthetic heart valve delivery device with partial deployment and release features and methods |
US8998980B2 (en) | 2010-04-09 | 2015-04-07 | Medtronic, Inc. | Transcatheter prosthetic heart valve delivery system with recapturing feature and method |
US8512401B2 (en) | 2010-04-12 | 2013-08-20 | Medtronic, Inc. | Transcatheter prosthetic heart valve delivery system with funnel recapturing feature and method |
US8579963B2 (en) | 2010-04-13 | 2013-11-12 | Medtronic, Inc. | Transcatheter prosthetic heart valve delivery device with stability tube and method |
US20110257721A1 (en) | 2010-04-15 | 2011-10-20 | Medtronic, Inc. | Prosthetic Heart Valves and Delivery Methods |
US8465541B2 (en) | 2010-04-19 | 2013-06-18 | Medtronic, Inc. | Transcatheter prosthetic heart valve delivery system and method with expandable stability tube |
US8623075B2 (en) | 2010-04-21 | 2014-01-07 | Medtronic, Inc. | Transcatheter prosthetic heart valve delivery system and method with controlled expansion of prosthetic heart valve |
US8740976B2 (en) | 2010-04-21 | 2014-06-03 | Medtronic, Inc. | Transcatheter prosthetic heart valve delivery system with flush report |
US8876892B2 (en) | 2010-04-21 | 2014-11-04 | Medtronic, Inc. | Prosthetic heart valve delivery system with spacing |
US9545306B2 (en) | 2010-04-21 | 2017-01-17 | Medtronic, Inc. | Prosthetic valve with sealing members and methods of use thereof |
WO2011133792A1 (en) | 2010-04-23 | 2011-10-27 | Medtronic Inc. | Delivery systems and methods of implantation for prosthetic heart valves |
US8623079B2 (en) | 2010-04-23 | 2014-01-07 | Medtronic, Inc. | Stents for prosthetic heart valves |
US8568474B2 (en) | 2010-04-26 | 2013-10-29 | Medtronic, Inc. | Transcatheter prosthetic heart valve post-dilatation remodeling devices and methods |
WO2011139746A1 (en) | 2010-04-27 | 2011-11-10 | Medtronic Inc. | Transcatheter prosthetic heart valve delivery device with passive trigger release |
US8852271B2 (en) | 2010-04-27 | 2014-10-07 | Medtronic Vascular, Inc. | Transcatheter prosthetic heart valve delivery device with biased release features |
US8974475B2 (en) | 2010-04-30 | 2015-03-10 | Medtronic, Inc. | Methods and devices for cardiac valve repair or replacement |
US8579964B2 (en) | 2010-05-05 | 2013-11-12 | Neovasc Inc. | Transcatheter mitral valve prosthesis |
CN103002833B (en) | 2010-05-25 | 2016-05-11 | 耶拿阀门科技公司 | Artificial heart valve and comprise artificial heart valve and support through conduit carry interior prosthese |
US9561102B2 (en) | 2010-06-02 | 2017-02-07 | Medtronic, Inc. | Transcatheter delivery system and method with controlled expansion and contraction of prosthetic heart valve |
CN103189015B (en) | 2010-07-09 | 2016-07-06 | 海莱夫简易股份公司 | Transcatheter atrioventricular valves (A V valves) prosthese |
EP3552655B1 (en) | 2010-07-13 | 2020-12-23 | Loma Vista Medical, Inc. | Inflatable medical devices |
US8657872B2 (en) | 2010-07-19 | 2014-02-25 | Jacques Seguin | Cardiac valve repair system and methods of use |
US9763657B2 (en) | 2010-07-21 | 2017-09-19 | Mitraltech Ltd. | Techniques for percutaneous mitral valve replacement and sealing |
US9132009B2 (en) | 2010-07-21 | 2015-09-15 | Mitraltech Ltd. | Guide wires with commissural anchors to advance a prosthetic valve |
US8992604B2 (en) | 2010-07-21 | 2015-03-31 | Mitraltech Ltd. | Techniques for percutaneous mitral valve replacement and sealing |
US9326853B2 (en) | 2010-07-23 | 2016-05-03 | Edwards Lifesciences Corporation | Retaining mechanisms for prosthetic valves |
WO2012019052A2 (en) | 2010-08-04 | 2012-02-09 | Micardia Corporation | Percutaneous transcatheter repair of heart valves |
US20120035721A1 (en) | 2010-08-09 | 2012-02-09 | Valvexchange, Inc. | Temporary sub-valvular check valve |
WO2012021406A2 (en) | 2010-08-12 | 2012-02-16 | Silk Road Medical, Inc. | Systems and methods for treating a carotid artery |
WO2012023980A1 (en) | 2010-08-17 | 2012-02-23 | St. Jude Medical, Inc. | Sleeve for facilitating movement of a transfemoral catheter |
WO2012027515A2 (en) | 2010-08-24 | 2012-03-01 | Southern Lights Ventures 2002 Limited | Biomaterials with enhanced properties and devices made therefrom |
AU2011296361B2 (en) | 2010-09-01 | 2015-05-28 | Medtronic Vascular Galway | Prosthetic valve support structure |
US10105224B2 (en) | 2010-09-01 | 2018-10-23 | Mvalve Technologies Ltd. | Cardiac valve support structure |
EP2428189A1 (en) | 2010-09-10 | 2012-03-14 | Symetis Sa | Catheter delivery system for stent valve |
US8641757B2 (en) | 2010-09-10 | 2014-02-04 | Edwards Lifesciences Corporation | Systems for rapidly deploying surgical heart valves |
US9370418B2 (en) | 2010-09-10 | 2016-06-21 | Edwards Lifesciences Corporation | Rapidly deployable surgical heart valves |
EP2613737B2 (en) | 2010-09-10 | 2023-03-15 | Symetis SA | Valve replacement devices, delivery device for a valve replacement device and method of production of a valve replacement device |
US9579200B2 (en) | 2010-09-15 | 2017-02-28 | The United States Of America, As Represented By The Secretary, Department Of Health & Human Services | Methods and devices for transcatheter cerclage annuloplasty |
CA2811589A1 (en) | 2010-09-23 | 2012-03-29 | Colibri Heart Valve Llc | Percutaneously deliverable heart or blood vessel valve with frame having abluminally situated tissue membrane |
EP2618784B1 (en) | 2010-09-23 | 2016-05-25 | Edwards Lifesciences CardiAQ LLC | Replacement heart valves and delivery devices |
JP5926265B2 (en) | 2010-09-24 | 2016-05-25 | シメティス・ソシエテ・アノニムSymetis Sa | Stent valve, delivery device, and delivery method |
US8845720B2 (en) | 2010-09-27 | 2014-09-30 | Edwards Lifesciences Corporation | Prosthetic heart valve frame with flexible commissures |
CN114209472A (en) | 2010-10-05 | 2022-03-22 | 爱德华兹生命科学公司 | Artificial heart valve |
US8568475B2 (en) | 2010-10-05 | 2013-10-29 | Edwards Lifesciences Corporation | Spiraled commissure attachment for prosthetic valve |
JP5995110B2 (en) | 2010-10-21 | 2016-09-21 | メドトロニック,インコーポレイテッド | Intraventricular low profile prosthetic mitral valve |
US9468547B2 (en) | 2010-11-11 | 2016-10-18 | W. L. Gore & Associates, Inc. | Deployment of endoluminal devices |
IT1402571B1 (en) | 2010-11-12 | 2013-09-13 | Ht Consultant Di Giovanni Righini | PROSTHETIC SYSTEM FOR CARDIO-VASCULAR VALVE WITH SEPARATE ANCHORAGE STRUCTURE |
US20130226285A1 (en) | 2010-11-12 | 2013-08-29 | Gera Strommer | Percutaneous heart bypass graft surgery apparatus and method |
US9095466B2 (en) | 2010-11-16 | 2015-08-04 | W. L. Gore & Associates, Inc. | Apposition fiber for use in endoluminal deployment of expandable devices in tortuous anatomies |
US20120130475A1 (en) | 2010-11-16 | 2012-05-24 | Shaw Edward E | Sleeves for expandable medical devices |
SG191008A1 (en) | 2010-12-14 | 2013-07-31 | Colibri Heart Valve Llc | Percutaneously deliverable heart valve including folded membrane cusps with integral leaflets |
EP2651337B8 (en) | 2010-12-14 | 2023-10-04 | Colibri Heart Valve LLC | Percutaneously deliverable heart valve including folded membrane cusps with integral leaflets |
US9498317B2 (en) | 2010-12-16 | 2016-11-22 | Edwards Lifesciences Corporation | Prosthetic heart valve delivery systems and packaging |
EP2658476B1 (en) | 2010-12-30 | 2022-04-06 | Boston Scientific Scimed, Inc. | Intravascular blood filter |
US9055997B2 (en) | 2010-12-30 | 2015-06-16 | Claret Medical, Inc. | Method of isolating the cerebral circulation during a cardiac procedure |
US20120172981A1 (en) | 2011-01-05 | 2012-07-05 | Curia, Inc. | Prosthetic valves formed with supporting structure and isotropic filter screen leaflets |
US8948848B2 (en) | 2011-01-07 | 2015-02-03 | Innovative Cardiovascular Solutions, Llc | Angiography catheter |
US20140005540A1 (en) | 2011-01-07 | 2014-01-02 | Innovative Cardiovascular Solutions, Inc. | Angiography Catheter |
EP2474287A1 (en) | 2011-01-11 | 2012-07-11 | Symetis Sa | Delivery catheter for stent-valve, and sub-assembly therefor |
WO2012099956A1 (en) | 2011-01-18 | 2012-07-26 | Gt Urological, Llc | Vessel occlusive device and method of occluding a vessel |
US8641752B1 (en) | 2011-01-20 | 2014-02-04 | W. L. Gore & Associates, Inc. | Integrated sheath and deployment |
US8888843B2 (en) | 2011-01-28 | 2014-11-18 | Middle Peak Medical, Inc. | Device, system, and method for transcatheter treatment of valve regurgitation |
US20120209375A1 (en) | 2011-02-11 | 2012-08-16 | Gilbert Madrid | Stability device for use with percutaneous delivery systems |
CN103429193B (en) | 2011-02-15 | 2015-09-16 | 梅迪瓦尔夫有限公司 | Percutaneous positioner |
US9232996B2 (en) | 2011-02-25 | 2016-01-12 | University Of Connecticut | Prosthetic heart valve |
US9155619B2 (en) | 2011-02-25 | 2015-10-13 | Edwards Lifesciences Corporation | Prosthetic heart valve delivery apparatus |
US9381082B2 (en) | 2011-04-22 | 2016-07-05 | Edwards Lifesciences Corporation | Devices, systems and methods for accurate positioning of a prosthetic valve |
US9554897B2 (en) | 2011-04-28 | 2017-01-31 | Neovasc Tiara Inc. | Methods and apparatus for engaging a valve prosthesis with tissue |
US9308087B2 (en) | 2011-04-28 | 2016-04-12 | Neovasc Tiara Inc. | Sequentially deployed transcatheter mitral valve prosthesis |
EP2520251A1 (en) | 2011-05-05 | 2012-11-07 | Symetis SA | Method and Apparatus for Compressing Stent-Valves |
US9144494B2 (en) | 2011-05-12 | 2015-09-29 | Medtronic, Inc. | Delivery catheter system with micro and macro movement control |
US9486604B2 (en) | 2011-05-12 | 2016-11-08 | Medtronic, Inc. | Packaging and preparation tray for a delivery system |
US9289282B2 (en) | 2011-05-31 | 2016-03-22 | Edwards Lifesciences Corporation | System and method for treating valve insufficiency or vessel dilatation |
US9402721B2 (en) | 2011-06-01 | 2016-08-02 | Valcare, Inc. | Percutaneous transcatheter repair of heart valves via trans-apical access |
US10022054B2 (en) | 2011-06-08 | 2018-07-17 | Integrated Sensing Systems, Inc. | Implantable wireless sensor systems |
US8840664B2 (en) | 2011-06-15 | 2014-09-23 | Edwards Lifesciences Corporation | Heart valve prosthesis anchoring device and methods |
WO2012175483A1 (en) | 2011-06-20 | 2012-12-27 | Jacques Seguin | Prosthetic leaflet assembly for repairing a defective cardiac valve and methods of using the same |
WO2012177441A1 (en) | 2011-06-21 | 2012-12-27 | St. Jude Medical, Inc. | Apparatus and method for heart valve repair |
AU2012272855C1 (en) | 2011-06-21 | 2018-04-05 | Twelve, Inc. | Prosthetic heart valve devices and associated systems and methods |
WO2012178115A2 (en) | 2011-06-24 | 2012-12-27 | Rosenbluth, Robert | Percutaneously implantable artificial heart valve system and associated methods and devices |
US9339384B2 (en) | 2011-07-27 | 2016-05-17 | Edwards Lifesciences Corporation | Delivery systems for prosthetic heart valve |
US10010412B2 (en) | 2011-07-27 | 2018-07-03 | Edwards Lifesciences Corporation | Conical crimper |
WO2013017359A1 (en) | 2011-08-03 | 2013-02-07 | Aeeg Ab | Delivery device for medical implant and medical procedure |
WO2013021375A2 (en) | 2011-08-05 | 2013-02-14 | Mitraltech Ltd. | Percutaneous mitral valve replacement and sealing |
US8852272B2 (en) | 2011-08-05 | 2014-10-07 | Mitraltech Ltd. | Techniques for percutaneous mitral valve replacement and sealing |
AU2012299311B2 (en) | 2011-08-11 | 2016-03-03 | Tendyne Holdings, Inc. | Improvements for prosthetic valves and related inventions |
US9060860B2 (en) | 2011-08-18 | 2015-06-23 | St. Jude Medical, Cardiology Division, Inc. | Devices and methods for transcatheter heart valve delivery |
US9216076B2 (en) | 2011-09-09 | 2015-12-22 | Endoluminal Sciences Pty. Ltd. | Means for controlled sealing of endovascular devices |
US20130331929A1 (en) | 2011-09-09 | 2013-12-12 | Endoluminal Sciences Pty Ltd. | Means for Controlled Sealing of Endovascular Devices |
US20130190857A1 (en) | 2011-09-09 | 2013-07-25 | Endoluminal Sciences Pty Ltd. | Means for controlled sealing of endovascular devices |
BR112014005395A2 (en) | 2011-09-09 | 2017-03-28 | Endoluminal Sciences Pty Ltd | biocompatible hydrogel or foam, endoluminal sealing and method for sealing a lumen |
DE102014102725A1 (en) | 2014-02-28 | 2015-09-17 | Highlife Sas | Transcatheter valve prosthesis |
AU2012307772B2 (en) | 2011-09-12 | 2016-08-04 | Highlife Sas | Transcatheter valve prosthesis |
DE102014102721A1 (en) | 2014-02-28 | 2015-09-03 | Highlife Sas | Transcatheter valve prosthesis |
DE102014102653A1 (en) | 2014-02-28 | 2015-09-03 | Highlife Sas | Transcatheter valve prosthesis |
US9387075B2 (en) | 2011-09-12 | 2016-07-12 | Highlife Sas | Transcatheter valve prosthesis |
US8956404B2 (en) | 2011-09-12 | 2015-02-17 | Highlife Sas | Transcatheter valve prosthesis |
EP2572644A1 (en) | 2011-09-22 | 2013-03-27 | Occlutech Holding AG | Medical implantable occlusion device |
US9554904B2 (en) | 2011-09-28 | 2017-01-31 | Medtronic CV Luxembourg S.a.r.l. | Distal tip assembly for a heart valve delivery catheter |
EP2765954B1 (en) | 2011-10-13 | 2021-12-22 | The Research Foundation Of State University Of New York | Polymeric heart valve |
US9827093B2 (en) | 2011-10-21 | 2017-11-28 | Edwards Lifesciences Cardiaq Llc | Actively controllable stent, stent graft, heart valve and method of controlling same |
US20130131714A1 (en) | 2011-11-14 | 2013-05-23 | Boston Scientific Scimed, Inc. | Embolic protection device and methods of making the same |
US9445893B2 (en) | 2011-11-21 | 2016-09-20 | Mor Research Applications Ltd. | Device for placement in the tricuspid annulus |
US9480558B2 (en) | 2011-12-05 | 2016-11-01 | Medtronic, Inc. | Transcatheter valve having reduced seam exposure |
EP4049625A1 (en) | 2011-12-09 | 2022-08-31 | Edwards Lifesciences Corporation | Prosthetic heart valve having improved commissure supports |
EP2793969B1 (en) | 2011-12-13 | 2016-09-14 | Boston Scientific Scimed, Inc. | Decalcifying heart valve |
US9827092B2 (en) | 2011-12-16 | 2017-11-28 | Tendyne Holdings, Inc. | Tethers for prosthetic mitral valve |
US9078645B2 (en) | 2011-12-19 | 2015-07-14 | Edwards Lifesciences Corporation | Knotless suture anchoring devices and tools for implants |
US9078652B2 (en) | 2011-12-19 | 2015-07-14 | Edwards Lifesciences Corporation | Side-entry knotless suture anchoring clamps and deployment tools |
WO2013103612A1 (en) | 2012-01-04 | 2013-07-11 | Tendyne Holdings, Inc. | Improved multi-component cuff designs for transcatheter mitral valve replacement, subvalvular sealing apparatus for transcatheter mitral valves and wire framed leaflet assembly |
WO2013109623A1 (en) | 2012-01-17 | 2013-07-25 | Lumen Biomedical, Inc. | Aortic arch filtration system for carotid artery protection |
WO2013114214A2 (en) | 2012-01-31 | 2013-08-08 | Orford Holdings Sa | Mitral valve docking devices, systems and methods |
JP6211539B2 (en) | 2012-02-01 | 2017-10-11 | エイチエルティー, インコーポレイテッド | Invertible tissue valve and method |
EP3281608B1 (en) | 2012-02-10 | 2020-09-16 | CVDevices, LLC | Medical product comprising a frame and visceral pleura |
US20150051687A1 (en) | 2012-02-10 | 2015-02-19 | The University Of Iowa Research Foundation | Vascular prosthetic assemblies |
EP3424469A1 (en) | 2012-02-22 | 2019-01-09 | Syntheon TAVR, LLC | Actively controllable stent, stent graft and heart valve |
US20150094802A1 (en) | 2012-02-28 | 2015-04-02 | Mvalve Technologies Ltd. | Single-ring cardiac valve support |
JP2015508004A (en) | 2012-02-28 | 2015-03-16 | ムバルブ・テクノロジーズ・リミテッド | Single ring heart valve support structure |
US9180008B2 (en) | 2012-02-29 | 2015-11-10 | Valcare, Inc. | Methods, devices, and systems for percutaneously anchoring annuloplasty rings |
WO2013128461A1 (en) | 2012-02-29 | 2013-09-06 | Cardiapex Ltd. | Minimally invasive surgical techniques |
WO2013130641A1 (en) | 2012-02-29 | 2013-09-06 | Valcare, Inc. | Percutaneous annuloplasty system with anterior-posterior adjustment |
US10213288B2 (en) | 2012-03-06 | 2019-02-26 | Crux Biomedical, Inc. | Distal protection filter |
EP2822473B1 (en) | 2012-03-06 | 2018-08-22 | Highlife SAS | Treatment catheter member with encircling function |
EP2822503A2 (en) | 2012-03-09 | 2015-01-14 | Keystone Heart Ltd. | Device and method for deflecting emboli in an aorta |
CA2866315C (en) | 2012-03-12 | 2021-03-02 | Colorado State University Research Foundation | Glycosaminoglycan and synthetic polymer materials for blood-contacting applications |
US10363153B2 (en) | 2012-03-13 | 2019-07-30 | Asahi Kasei Fibers Corporation | Superfine polyester fiber and tubular seamless fabric |
WO2013142201A1 (en) | 2012-03-21 | 2013-09-26 | Nexeon Medsystems, Inc. | Apparatus and methods for filtering emboli during percutaneous aortic valve replacement and repair procedures with filtration system coupled in-situ to distal end of sheath |
US8735702B1 (en) | 2012-03-21 | 2014-05-27 | Deborah R. Miles | Portable dissipating medium used for removal of vibrational interference in a bowed string of a violin family instrument |
US20130274873A1 (en) | 2012-03-22 | 2013-10-17 | Symetis Sa | Transcatheter Stent-Valves and Methods, Systems and Devices for Addressing Para-Valve Leakage |
JP2015512288A (en) | 2012-03-23 | 2015-04-27 | サイトグラフト ティッシュ エンジニアリング インコーポレイテッドCytograft Tissue Engineering, Inc. | Regenerative medical heart valve for transcatheter repair |
US9066800B2 (en) | 2012-03-28 | 2015-06-30 | Medtronic, Inc. | Dual valve prosthesis for transcatheter valve implantation |
US9295547B2 (en) | 2012-03-28 | 2016-03-29 | Medtronic Vascular Galway | Prosthesis for transcatheter valve implantation |
US9023098B2 (en) | 2012-03-28 | 2015-05-05 | Medtronic, Inc. | Dual valve prosthesis for transcatheter valve implantation |
US8926694B2 (en) | 2012-03-28 | 2015-01-06 | Medtronic Vascular Galway Limited | Dual valve prosthesis for transcatheter valve implantation |
EP2833836B1 (en) | 2012-04-05 | 2018-05-30 | Mvalve Technologies Ltd. | Cardiac valve support structure |
WO2013154765A2 (en) | 2012-04-13 | 2013-10-17 | Regents Of The University Of Minnesota | Cardio-embolic stroke prevention |
US9301839B2 (en) | 2012-04-17 | 2016-04-05 | Medtronic CV Luxembourg S.a.r.l. | Transcatheter prosthetic heart valve delivery device with release features |
US20130274618A1 (en) | 2012-04-17 | 2013-10-17 | Boston Scientific Scimed, Inc. | Guidewire system for use in transcatheter aortic valve implantation procedures |
US9427315B2 (en) | 2012-04-19 | 2016-08-30 | Caisson Interventional, LLC | Valve replacement systems and methods |
ITTO20120372A1 (en) | 2012-04-27 | 2013-10-28 | Marcio Scorsin | MONOCUSPIDE CARDIAC VALVE PROSTHESIS |
US9445897B2 (en) | 2012-05-01 | 2016-09-20 | Direct Flow Medical, Inc. | Prosthetic implant delivery device with introducer catheter |
US9277990B2 (en) | 2012-05-04 | 2016-03-08 | St. Jude Medical, Cardiology Division, Inc. | Hypotube shaft with articulation mechanism |
US9345573B2 (en) | 2012-05-30 | 2016-05-24 | Neovasc Tiara Inc. | Methods and apparatus for loading a prosthesis onto a delivery system |
US20150297241A1 (en) | 2012-05-31 | 2015-10-22 | Javelin Medical Ltd. | Apparatus and Method of Monofilament Implant Delivery in a Body Vessel of a Patient |
ES2811798T3 (en) | 2012-06-06 | 2021-03-15 | Loma Vista Medical Inc | Inflatable medical devices |
US9554902B2 (en) | 2012-06-28 | 2017-01-31 | St. Jude Medical, Cardiology Division, Inc. | Leaflet in configuration for function in various shapes and sizes |
US9241791B2 (en) | 2012-06-29 | 2016-01-26 | St. Jude Medical, Cardiology Division, Inc. | Valve assembly for crimp profile |
CN104427956B (en) | 2012-07-13 | 2016-09-28 | 波士顿科学国际有限公司 | For the collapsible cage ball artificial valve through catheter delivery |
JP2014022678A (en) | 2012-07-23 | 2014-02-03 | Disco Abrasive Syst Ltd | Wafer etching method |
US9283072B2 (en) | 2012-07-25 | 2016-03-15 | W. L. Gore & Associates, Inc. | Everting transcatheter valve and methods |
US10376360B2 (en) | 2012-07-27 | 2019-08-13 | W. L. Gore & Associates, Inc. | Multi-frame prosthetic valve apparatus and methods |
WO2014022124A1 (en) | 2012-07-28 | 2014-02-06 | Tendyne Holdings, Inc. | Improved multi-component designs for heart valve retrieval device, sealing structures and stent assembly |
WO2014021905A1 (en) | 2012-07-30 | 2014-02-06 | Tendyne Holdings, Inc. | Improved delivery systems and methods for transcatheter prosthetic valves |
US9254141B2 (en) | 2012-08-02 | 2016-02-09 | St. Jude Medical, Inc. | Apparatus and method for heart valve repair |
US8926690B2 (en) | 2012-08-13 | 2015-01-06 | Medtronic, Inc. | Heart valve prosthesis |
US10206775B2 (en) * | 2012-08-13 | 2019-02-19 | Medtronic, Inc. | Heart valve prosthesis |
EP2887890A4 (en) | 2012-08-23 | 2016-05-18 | Minimally Invasive Surgical Access Ltd | Direct aortic access system for transcatheter aortic valve procedures |
US10543088B2 (en) | 2012-09-14 | 2020-01-28 | Boston Scientific Scimed, Inc. | Mitral valve inversion prostheses |
US10849755B2 (en) | 2012-09-14 | 2020-12-01 | Boston Scientific Scimed, Inc. | Mitral valve inversion prostheses |
WO2014049106A1 (en) | 2012-09-27 | 2014-04-03 | Symetis Sa | Stent-valve, delivery apparatus, and stent-holder therefor |
CN104918587B (en) | 2012-10-09 | 2018-05-04 | 通合公司 | The method and apparatus of flowing occlusion during being exchanged for device |
US10524909B2 (en) | 2012-10-12 | 2020-01-07 | St. Jude Medical, Cardiology Division, Inc. | Retaining cage to permit resheathing of a tavi aortic-first transapical system |
EP2908779B1 (en) | 2012-10-18 | 2018-04-18 | Loma Vista Medical, Inc. | Reinforced inflatable medical devices |
US9066710B2 (en) | 2012-10-19 | 2015-06-30 | St. Jude Medical, Cardiology Division, Inc. | Apparatus and method for heart valve repair |
US9211162B2 (en) | 2012-10-23 | 2015-12-15 | Medtronic CV Luxembourg S.a.r.l. | Visualization device for use with a tray for loading a medical device |
EP3730066A1 (en) | 2012-10-23 | 2020-10-28 | Valtech Cardio, Ltd. | Percutaneous tissue anchor techniques |
US10219895B2 (en) | 2012-10-26 | 2019-03-05 | Wake Forest University Health Sciences | Nanofiber-based graft for heart valve replacement and methods of using the same |
US9675456B2 (en) | 2012-11-02 | 2017-06-13 | Medtronic, Inc. | Transcatheter valve prosthesis delivery system with recapturing feature and method |
US9387105B2 (en) | 2012-11-12 | 2016-07-12 | W.L. Gore & Associates, Inc | Sleeves for expandable medical devices and methods of making the same |
EP2732794A1 (en) | 2012-11-14 | 2014-05-21 | Contego AB | Improved embolic protection device and method |
US11744594B2 (en) | 2012-11-16 | 2023-09-05 | W.L. Gore & Associates, Inc. | Space filling devices |
EP2928538B1 (en) | 2012-12-07 | 2018-11-21 | Valcare, Inc. | Devices for percutaneously anchoring annuloplasty rings |
US9101469B2 (en) | 2012-12-19 | 2015-08-11 | W. L. Gore & Associates, Inc. | Prosthetic heart valve with leaflet shelving |
US10321986B2 (en) | 2012-12-19 | 2019-06-18 | W. L. Gore & Associates, Inc. | Multi-frame prosthetic heart valve |
US9398952B2 (en) | 2012-12-19 | 2016-07-26 | W. L. Gore & Associates, Inc. | Planar zone in prosthetic heart valve leaflet |
US9144492B2 (en) | 2012-12-19 | 2015-09-29 | W. L. Gore & Associates, Inc. | Truncated leaflet for prosthetic heart valves, preformed valve |
US9737398B2 (en) | 2012-12-19 | 2017-08-22 | W. L. Gore & Associates, Inc. | Prosthetic valves, frames and leaflets and methods thereof |
US10039638B2 (en) | 2012-12-19 | 2018-08-07 | W. L. Gore & Associates, Inc. | Geometric prosthetic heart valves |
US10966820B2 (en) | 2012-12-19 | 2021-04-06 | W. L. Gore & Associates, Inc. | Geometric control of bending character in prosthetic heart valve leaflets |
US9968443B2 (en) | 2012-12-19 | 2018-05-15 | W. L. Gore & Associates, Inc. | Vertical coaptation zone in a planar portion of prosthetic heart valve leaflet |
US20140180069A1 (en) | 2012-12-21 | 2014-06-26 | Volcano Corporation | Intraluminal imaging system |
US20140180070A1 (en) | 2012-12-21 | 2014-06-26 | Volcano Corporation | Intraluminal imaging system |
US20140194704A1 (en) | 2012-12-21 | 2014-07-10 | Volcano Corporation | Intraluminal imaging system |
US10543085B2 (en) | 2012-12-31 | 2020-01-28 | Edwards Lifesciences Corporation | One-piece heart valve stents adapted for post-implant expansion |
EP3375411A1 (en) | 2012-12-31 | 2018-09-19 | Edwards Lifesciences Corporation | Surgical heart valves adapted for post-implant expansion |
US9132007B2 (en) | 2013-01-10 | 2015-09-15 | Medtronic CV Luxembourg S.a.r.l. | Anti-paravalvular leakage components for a transcatheter valve prosthesis |
US20140200662A1 (en) | 2013-01-16 | 2014-07-17 | Mvalve Technologies Ltd. | Anchoring elements for intracardiac devices |
US20140214069A1 (en) | 2013-01-30 | 2014-07-31 | Edwards Lifesciences Corporation | Inflatable Embolic Deflector |
US10413401B2 (en) | 2013-02-01 | 2019-09-17 | Medtronic CV Luxembourg S.a.r.l. | Anti-paravalvular leakage component for a transcatheter valve prosthesis |
US9675451B2 (en) | 2013-02-01 | 2017-06-13 | Medtronic CV Luxembourg S.a.r.l. | Anti-paravalvular leakage component for a transcatheter valve prosthesis |
US9439763B2 (en) | 2013-02-04 | 2016-09-13 | Edwards Lifesciences Corporation | Prosthetic valve for replacing mitral valve |
US11793636B2 (en) | 2013-02-06 | 2023-10-24 | Symetis Sa | Prosthetic valve. delivery apparatus and delivery method |
US9168129B2 (en) | 2013-02-12 | 2015-10-27 | Edwards Lifesciences Corporation | Artificial heart valve with scalloped frame design |
US9456897B2 (en) | 2013-02-21 | 2016-10-04 | Medtronic, Inc. | Transcatheter valve prosthesis and a concurrently delivered sealing component |
WO2014132260A1 (en) | 2013-02-28 | 2014-09-04 | Mor Research Applications Ltd. | Adjustable annuloplasty apparatus |
US9155616B2 (en) | 2013-02-28 | 2015-10-13 | St. Jude Medical, Cardiology Division, Inc. | Prosthetic heart valve with expandable microspheres |
US10034667B2 (en) | 2013-02-28 | 2018-07-31 | St. Jude Medical, Cardiology Division, Inc. | Apparatus and method for heart valve repair |
US20140249566A1 (en) | 2013-03-01 | 2014-09-04 | Aga Medical Corporation | Embolic protection shield |
US10973618B2 (en) | 2013-03-01 | 2021-04-13 | St. Jude Medical, Cardiology Division, Inc. | Embolic protection device |
EP2964152B1 (en) | 2013-03-07 | 2021-04-28 | Medtronic Vascular Galway | Prosthesis for transcatheter valve implantation |
EP2964277B1 (en) | 2013-03-08 | 2018-10-24 | St. Jude Medical, Cardiology Division, Inc. | Method of preparing a tissue swatch for a bioprosthetic device |
US10583002B2 (en) | 2013-03-11 | 2020-03-10 | Neovasc Tiara Inc. | Prosthetic valve with anti-pivoting mechanism |
US8986375B2 (en) | 2013-03-12 | 2015-03-24 | Medtronic, Inc. | Anti-paravalvular leakage component for a transcatheter valve prosthesis |
US9333077B2 (en) | 2013-03-12 | 2016-05-10 | Medtronic Vascular Galway Limited | Devices and methods for preparing a transcatheter heart valve system |
US9636222B2 (en) | 2013-03-12 | 2017-05-02 | St. Jude Medical, Cardiology Division, Inc. | Paravalvular leak protection |
US20140277388A1 (en) | 2013-03-12 | 2014-09-18 | Aga Medical Corporation | Biocompatible foam occlusion device for self-expanding heart valves |
WO2014164151A1 (en) | 2013-03-12 | 2014-10-09 | Medtronic Inc. | Heart valve prosthesis |
US20140277408A1 (en) | 2013-03-12 | 2014-09-18 | Boston Scientific Scimed, Inc. | Prosthetic Heart Valve System |
WO2014164832A1 (en) | 2013-03-12 | 2014-10-09 | Edwards Lifesciences Corporation | Rapidly deployable surgical heart valves |
US20140350668A1 (en) | 2013-03-13 | 2014-11-27 | Symetis Sa | Prosthesis Seals and Methods for Sealing an Expandable Prosthesis |
US9999425B2 (en) | 2013-03-13 | 2018-06-19 | St. Jude Medical, Cardiology Division, Inc. | Mitral valve leaflet clip |
US9539094B2 (en) | 2013-03-13 | 2017-01-10 | St. Jude Medical, Cardiology Division, Inc. | Simulated environment for transcatheter heart valve repair |
US11259923B2 (en) | 2013-03-14 | 2022-03-01 | Jc Medical, Inc. | Methods and devices for delivery of a prosthetic valve |
US9907681B2 (en) | 2013-03-14 | 2018-03-06 | 4Tech Inc. | Stent with tether interface |
US11406497B2 (en) | 2013-03-14 | 2022-08-09 | Jc Medical, Inc. | Heart valve prosthesis |
US20160030165A1 (en) | 2013-03-15 | 2016-02-04 | Endoluminal Sciences Pty Ltd | Means for Controlled Sealing of Endovascular Devices |
US20140276616A1 (en) | 2013-03-15 | 2014-09-18 | Syntheon Cardiology, Llc | Catheter-based devices and methods for identifying specific anatomical landmarks of the human aortic valve |
CN105392432B (en) | 2013-03-15 | 2019-04-30 | 火山公司 | Distal embolic protection system and method with pressure and ultrasonic wave characteristic |
EP3804646A1 (en) | 2013-03-15 | 2021-04-14 | Valcare, Inc. | Systems for delivery of annuloplasty rings |
EP2967864A2 (en) | 2013-03-15 | 2016-01-20 | Valve Medical Ltd. | System and method for sealing percutaneous valve |
JP6272915B2 (en) | 2013-03-15 | 2018-01-31 | シメティス・ソシエテ・アノニムSymetis Sa | Improvement of transcatheter stent valve |
US9986967B2 (en) | 2013-03-15 | 2018-06-05 | Volcano Corporation | Distal protection systems and methods with pressure and ultrasound features |
US9232994B2 (en) | 2013-03-15 | 2016-01-12 | Medtronic Vascular Galway Limited | Stented prosthetic heart valve and methods for making |
US9089414B2 (en) | 2013-03-22 | 2015-07-28 | Edwards Lifesciences Corporation | Device and method for increasing flow through the left atrial appendage |
WO2014162306A2 (en) | 2013-04-02 | 2014-10-09 | Tendyne Holdings, Inc. | Improved devices and methods for transcatheter prosthetic heart valves |
US10463489B2 (en) | 2013-04-02 | 2019-11-05 | Tendyne Holdings, Inc. | Prosthetic heart valve and systems and methods for delivering the same |
US20140296969A1 (en) | 2013-04-02 | 2014-10-02 | Tendyne Holdlings, Inc. | Anterior Leaflet Clip Device for Prosthetic Mitral Valve |
US9486306B2 (en) | 2013-04-02 | 2016-11-08 | Tendyne Holdings, Inc. | Inflatable annular sealing device for prosthetic mitral valve |
US20140303718A1 (en) | 2013-04-04 | 2014-10-09 | Tendyne Holdings, Inc. | Retrieval and repositioning system for prosthetic heart valve |
US10478293B2 (en) | 2013-04-04 | 2019-11-19 | Tendyne Holdings, Inc. | Retrieval and repositioning system for prosthetic heart valve |
US9572665B2 (en) | 2013-04-04 | 2017-02-21 | Neovasc Tiara Inc. | Methods and apparatus for delivering a prosthetic valve to a beating heart |
FR3004336A1 (en) | 2013-04-12 | 2014-10-17 | St George Medical Inc | MITRAL HEART VALVE PROSTHESIS AND RELIEF CATHETER |
US9629718B2 (en) | 2013-05-03 | 2017-04-25 | Medtronic, Inc. | Valve delivery tool |
JP2016517748A (en) | 2013-05-03 | 2016-06-20 | メドトロニック,インコーポレイテッド | Medical device and related methods for implantation in a valve |
WO2014185969A2 (en) | 2013-05-14 | 2014-11-20 | Transverse Medical, Inc. | Catheter-based apparatuses and methods |
WO2014190329A1 (en) | 2013-05-24 | 2014-11-27 | Valcare, Inc. | Heart and peripheral vascular valve replacement in conjunction with a support ring |
US20140358224A1 (en) | 2013-05-30 | 2014-12-04 | Tendyne Holdlings, Inc. | Six cell inner stent device for prosthetic mitral valves |
US9610159B2 (en) | 2013-05-30 | 2017-04-04 | Tendyne Holdings, Inc. | Structural members for prosthetic mitral valves |
US10182911B2 (en) | 2013-06-05 | 2019-01-22 | St. Jude Medical, Cardiology Division, Inc. | Devices and methods for transcatheter heart valve delivery |
US10463495B2 (en) | 2013-06-12 | 2019-11-05 | The United States Of America, As Represented By The Secretary, Department Of Health And Human Services | Encircling implant delivery systems and methods |
US9326854B2 (en) | 2013-06-13 | 2016-05-03 | Medtronic Vascular Galway | Delivery system with pacing element |
US9968445B2 (en) | 2013-06-14 | 2018-05-15 | The Regents Of The University Of California | Transcatheter mitral valve |
US11076952B2 (en) | 2013-06-14 | 2021-08-03 | The Regents Of The University Of California | Collapsible atrioventricular valve prosthesis |
JP6403763B2 (en) | 2013-06-16 | 2018-10-10 | ピ−カーディア・リミテッド | Percutaneous embolic protection sleeve |
US20140371844A1 (en) | 2013-06-18 | 2014-12-18 | St. Jude Medical, Cardiology Division, Inc. | Transcatheter mitral valve and delivery system |
US20140379076A1 (en) | 2013-06-25 | 2014-12-25 | Tendyne Holdings, Inc. | Halo Wire Fluid Seal Device for Prosthetic Mitral Valves |
US9962259B2 (en) | 2013-06-25 | 2018-05-08 | National University Of Singapore | Stent member, artificial valve, and method of implanting the same |
WO2014210124A1 (en) | 2013-06-25 | 2014-12-31 | Mark Christianson | Thrombus management and structural compliance features for prosthetic heart valves |
US11911258B2 (en) | 2013-06-26 | 2024-02-27 | W. L. Gore & Associates, Inc. | Space filling devices |
US10123805B2 (en) | 2013-06-26 | 2018-11-13 | W. L. Gore & Associates, Inc. | Space filling devices |
US11291452B2 (en) | 2013-06-26 | 2022-04-05 | W. L. Gore & Associates, Inc. | Medical device deployment system |
US20150005874A1 (en) | 2013-06-27 | 2015-01-01 | Tendyne Holdings, Inc. | Atrial Thrombogenic Sealing Pockets for Prosthetic Mitral Valves |
WO2015002832A1 (en) | 2013-07-01 | 2015-01-08 | St. Jude Medical, Cardiology Division, Inc. | Hybrid orientation pravalvular sealing stent |
WO2015006575A1 (en) | 2013-07-10 | 2015-01-15 | Medtronic Inc. | Helical coil mitral valve annuloplasty systems and methods |
US9237948B2 (en) | 2013-07-11 | 2016-01-19 | Medtronic, Inc. | Delivery system with projections |
WO2015004173A1 (en) | 2013-07-11 | 2015-01-15 | Jenavalve Technology Gmbh | Delivery system for transcatheter aortic valve implantation |
US20150018860A1 (en) | 2013-07-12 | 2015-01-15 | Inceptus Medical, Llc | Methods and apparatus for treating small vessel thromboembolisms |
EP2832318B1 (en) | 2013-07-31 | 2017-04-05 | Venus MedTech (HangZhou), Inc. | Handle assembly for implant delivery apparatus comprising a force limiter, a displacement limiter and/or a brake frame assembly |
CN105899150B (en) | 2013-07-31 | 2018-07-27 | Neuvt 有限公司 | Method and apparatus for Endovascular Embolization |
EP2832316B1 (en) | 2013-07-31 | 2017-03-29 | Venus MedTech (HangZhou), Inc. | Handle assembly for implant delivery apparatus comprising a displacement limiter, a force limiter and/or a brake frame assembly |
US9895219B2 (en) | 2013-07-31 | 2018-02-20 | Medtronic Vascular Galway | Mitral valve prosthesis for transcatheter valve implantation |
US20160250051A1 (en) | 2013-07-31 | 2016-09-01 | Transcatheter Technologies Gmbh | Set comprising a catheter and a valve supporting implant |
EP2832315B1 (en) | 2013-07-31 | 2017-11-22 | Venus MedTech (HangZhou), Inc. | Handle assembly for implant delivery apparatus comprising a brake frame assembly, a force limiter and/or a displacement limiter |
US20150051696A1 (en) | 2013-08-14 | 2015-02-19 | Boston Scientific Scimed, Inc. | Medical guidewire |
US10195028B2 (en) | 2013-09-10 | 2019-02-05 | Edwards Lifesciences Corporation | Magnetic retaining mechanisms for prosthetic valves |
WO2015038615A1 (en) | 2013-09-12 | 2015-03-19 | St. Jude Medical, Cardiology Division, Inc. | Atraumatic interface in an implant delivery device |
WO2015037671A1 (en) | 2013-09-12 | 2015-03-19 | 旭化成せんい株式会社 | Ultrafine polyester fiber |
JP6659934B2 (en) | 2013-09-16 | 2020-03-04 | ボストン サイエンティフィック リミテッド | Method and apparatus for compressing / loading a stent valve |
US20150080945A1 (en) | 2013-09-18 | 2015-03-19 | W. L. Gore Associates, Inc. | Partial Circumferential Stent with Non-Radial Apposition |
US20150112188A1 (en) | 2013-09-20 | 2015-04-23 | Volcano Corporation | Systems and methods for monitoring endoluminal valve formation |
EP3052155A4 (en) | 2013-10-02 | 2017-10-04 | The Regents of the University of Colorado, a body corporate | Photo-active and radio-opaque shape memory polymer - gold nanocomposite materials for trans-catheter medical devices |
US9393111B2 (en) | 2014-01-15 | 2016-07-19 | Sino Medical Sciences Technology Inc. | Device and method for mitral valve regurgitation treatment |
US9839511B2 (en) | 2013-10-05 | 2017-12-12 | Sino Medical Sciences Technology Inc. | Device and method for mitral valve regurgitation treatment |
AU2014334772B2 (en) | 2013-10-05 | 2018-12-13 | Sinomed Cardiovita Technology Inc. | Device and method for mitral valve regurgitation method |
EP3052053B1 (en) | 2013-10-05 | 2020-08-12 | Sino Medical Sciences Technology, Inc. | Device for mitral valve regurgitation method |
EP2859864A1 (en) | 2013-10-14 | 2015-04-15 | Protembis GmbH | Medical device for embolic protection |
WO2015057735A1 (en) | 2013-10-15 | 2015-04-23 | Cedars-Sinai Medical Center | Anatomically-orientated and self-positioning transcatheter mitral valve |
WO2015058039A1 (en) | 2013-10-17 | 2015-04-23 | Robert Vidlund | Apparatus and methods for alignment and deployment of intracardiac devices |
US9421094B2 (en) | 2013-10-23 | 2016-08-23 | Caisson Interventional, LLC | Methods and systems for heart valve therapy |
US10646333B2 (en) | 2013-10-24 | 2020-05-12 | Medtronic, Inc. | Two-piece valve prosthesis with anchor stent and valve component |
US9662202B2 (en) | 2013-10-24 | 2017-05-30 | Medtronic, Inc. | Heart valve prosthesis |
US10166098B2 (en) | 2013-10-25 | 2019-01-01 | Middle Peak Medical, Inc. | Systems and methods for transcatheter treatment of valve regurgitation |
US10575851B2 (en) | 2013-10-26 | 2020-03-03 | The United States of America, as Represented by the the Secretary, Department of Health and Human Services | Atrial appendage ligation |
WO2015063118A1 (en) | 2013-10-28 | 2015-05-07 | Symetis Sa | Stent-valve, delivery apparatus and method of use |
EP3656353A1 (en) | 2013-10-28 | 2020-05-27 | Tendyne Holdings, Inc. | Prosthetic heart valve and systems for delivering the same |
US9549818B2 (en) | 2013-11-12 | 2017-01-24 | St. Jude Medical, Cardiology Division, Inc. | Pneumatically power-assisted tavi delivery system |
ES2833120T3 (en) | 2013-11-15 | 2021-06-14 | Guys And St Thomas Nhs Found Trust | Information markers for cardiac prostheses |
US9889004B2 (en) | 2013-11-19 | 2018-02-13 | St. Jude Medical, Cardiology Division, Inc. | Sealing structures for paravalvular leak protection |
US9622863B2 (en) | 2013-11-22 | 2017-04-18 | Edwards Lifesciences Corporation | Aortic insufficiency repair device and method |
JP2016538076A (en) | 2013-11-28 | 2016-12-08 | ムバルブ・テクノロジーズ・リミテッド | Intracardiac device comprising a stabilizing element with improved fatigue resistance |
US9504565B2 (en) | 2013-12-06 | 2016-11-29 | W. L. Gore & Associates, Inc. | Asymmetric opening and closing prosthetic valve leaflet |
US20150196391A1 (en) | 2014-01-15 | 2015-07-16 | Medtronic, Inc. | Tray for Loading a Medical Device Including a Temperature Measuring and Indicating Device |
US9750603B2 (en) | 2014-01-27 | 2017-09-05 | Medtronic Vascular Galway | Stented prosthetic heart valve with variable stiffness and methods of use |
EP3099345B1 (en) | 2014-01-31 | 2018-10-10 | Cedars-Sinai Medical Center | Pigtail for optimal aortic valvular complex imaging and alignment |
EP3590473A1 (en) | 2014-02-04 | 2020-01-08 | Innovheart S.r.l. | Prosthetic device for a heart valve |
WO2016126942A2 (en) | 2015-02-05 | 2016-08-11 | Vidlund Robert M | Expandable epicardial pads and devices and methods for delivery of same |
WO2015120122A2 (en) | 2014-02-05 | 2015-08-13 | Robert Vidlund | Apparatus and methods for transfemoral delivery of prosthetic mitral valve |
US9072604B1 (en) | 2014-02-11 | 2015-07-07 | Gilberto Melnick | Modular transcatheter heart valve and implantation method |
WO2015123607A2 (en) | 2014-02-13 | 2015-08-20 | Valvexchange, Inc. | Temporary sub-valvular check valve |
CN111772881A (en) | 2014-02-14 | 2020-10-16 | 爱德华兹生命科学公司 | Percutaneous leaflet augmentation |
GB201402643D0 (en) | 2014-02-14 | 2014-04-02 | Univ Southampton | A method of mapping images of human disease |
EP3107495B1 (en) | 2014-02-18 | 2022-03-30 | St. Jude Medical, Cardiology Division, Inc. | Bowed runners and corresponding valve assemblies for paravalvular leak protection |
HUE057160T2 (en) | 2014-02-18 | 2022-04-28 | Edwards Lifesciences Corp | Flexible commissure frame |
CN106572905B (en) | 2014-02-20 | 2019-11-05 | 米特拉尔维尔福科技有限责任公司 | It is used to support the anchoring piece curled up, heart valve prosthesis and deployment device of heart valve prosthesis |
EP3110367B1 (en) | 2014-02-28 | 2020-04-29 | Highlife SAS | Transcatheter valve prosthesis |
EP3110371B1 (en) | 2014-02-28 | 2020-01-15 | Highlife SAS | Transcatheter valve prosthesis |
DE102014102648B4 (en) | 2014-02-28 | 2021-09-30 | Highlife Sas | Transcatheter valve prosthesis |
WO2015128748A2 (en) | 2014-02-28 | 2015-09-03 | Highlife Sas | Transcatheter valve prosthesis |
DE102014102650A1 (en) | 2014-02-28 | 2015-09-03 | Highlife Sas | Transcatheter valve prosthesis |
US9763779B2 (en) | 2014-03-11 | 2017-09-19 | Highlife Sas | Transcatheter valve prosthesis |
US10064719B2 (en) | 2014-03-11 | 2018-09-04 | Highlife Sas | Transcatheter valve prosthesis |
DE102014102718A1 (en) | 2014-02-28 | 2015-09-03 | Highlife Sas | Transcatheter valve prosthesis |
DE102014102722A1 (en) | 2014-02-28 | 2015-09-03 | Highlife Sas | Transcatheter valve prosthesis |
US9889003B2 (en) | 2014-03-11 | 2018-02-13 | Highlife Sas | Transcatheter valve prosthesis |
JP6865037B2 (en) | 2014-03-10 | 2021-04-28 | テンダイン ホールディングス,インコーポレイテッド | Devices and methods for positioning the artificial mitral valve and monitoring the tether load of the artificial mitral valve |
US9687343B2 (en) | 2014-03-11 | 2017-06-27 | Highlife Sas | Transcatheter valve prosthesis |
GB2527075A (en) | 2014-03-17 | 2015-12-16 | Daassist As | Percutaneous system, devices and methods |
US10390943B2 (en) | 2014-03-17 | 2019-08-27 | Evalve, Inc. | Double orifice device for transcatheter mitral valve replacement |
EP2921139B1 (en) | 2014-03-18 | 2018-11-21 | Nvt Ag | Heartvalve implant |
US9763778B2 (en) | 2014-03-18 | 2017-09-19 | St. Jude Medical, Cardiology Division, Inc. | Aortic insufficiency valve percutaneous valve anchoring |
AU2015236516A1 (en) | 2014-03-26 | 2016-09-22 | St. Jude Medical, Cardiology Division, Inc. | Transcatheter mitral valve stent frames |
US20170014115A1 (en) | 2014-03-27 | 2017-01-19 | Transmural Systems Llc | Devices and methods for closure of transvascular or transcameral access ports |
EP3125827B1 (en) | 2014-04-01 | 2021-09-15 | Medtronic CV Luxembourg S.à.r.l. | Anti-paravalvular leakage component for a transcatheter valve prosthesis |
US10149758B2 (en) | 2014-04-01 | 2018-12-11 | Medtronic, Inc. | System and method of stepped deployment of prosthetic heart valve |
ES2635438T3 (en) | 2014-04-07 | 2017-10-03 | Nvt Ag | Device for implantation in the heart of a mammal |
US10413410B2 (en) | 2014-04-11 | 2019-09-17 | Medtronic Vascular, Inc. | Profile altering tip for a delivery system |
US9381083B2 (en) | 2014-04-11 | 2016-07-05 | Medtronic Vascular Galway | Profile altering tip for a delivery system |
WO2015160598A1 (en) | 2014-04-17 | 2015-10-22 | Medtronic Vascular Galway | Hinged transcatheter prosthetic heart valve delivery system |
US10321987B2 (en) | 2014-04-23 | 2019-06-18 | Medtronic, Inc. | Paravalvular leak resistant prosthetic heart valve system |
US10220192B2 (en) | 2014-04-23 | 2019-03-05 | Intervalve Medical, Inc. | Post dilation balloon with marker bands for use with stented valves |
US9993251B2 (en) | 2014-05-02 | 2018-06-12 | W. L. Gore & Associates, Inc. | Anastomosis devices |
US10195025B2 (en) | 2014-05-12 | 2019-02-05 | Edwards Lifesciences Corporation | Prosthetic heart valve |
ES2841448T3 (en) | 2014-05-14 | 2021-07-08 | Harvard College | Catheter device to transmit and reflect light |
US9668858B2 (en) | 2014-05-16 | 2017-06-06 | St. Jude Medical, Cardiology Division, Inc. | Transcatheter valve with paravalvular leak sealing ring |
ES2795358T3 (en) | 2014-05-16 | 2020-11-23 | St Jude Medical Cardiology Div Inc | Subannular sealing for paravalvular leak protection |
EP3146507B1 (en) | 2014-05-20 | 2023-10-04 | Materialise NV | System and method for valve quantification |
JP6806670B2 (en) | 2014-05-21 | 2021-01-06 | スウァット メディカル エービー | Improved embolization protection devices and methods |
WO2015179468A1 (en) | 2014-05-21 | 2015-11-26 | St. Jude Medical, Cardiology Division, Inc. | Self-expanding heart valves for coronary perfusion and sealing |
EP3145434A4 (en) | 2014-05-21 | 2018-03-07 | The Royal Institution for the Advancement of Learning / McGill University | Methods and systems for anatomical structure and transcatheter device visualization |
WO2015184450A1 (en) | 2014-05-30 | 2015-12-03 | Cardiac Valve Solutions Llc | Temporary valve and filter on guide catheter |
US9532870B2 (en) | 2014-06-06 | 2017-01-03 | Edwards Lifesciences Corporation | Prosthetic valve for replacing a mitral valve |
EP2954875B1 (en) | 2014-06-10 | 2017-11-15 | St. Jude Medical, Cardiology Division, Inc. | Stent cell bridge for cuff attachment |
US9662203B2 (en) | 2014-06-11 | 2017-05-30 | Medtronic Vascular, Inc. | Prosthetic valve with vortice-inducing baffle |
US10111749B2 (en) | 2014-06-11 | 2018-10-30 | Medtronic Vascular, Inc. | Prosthetic valve with flow director |
US9974647B2 (en) | 2014-06-12 | 2018-05-22 | Caisson Interventional, LLC | Two stage anchor and mitral valve assembly |
US9913718B2 (en) | 2014-06-17 | 2018-03-13 | Ta Instruments-Waters L.L.C. | System for testing valves |
ES2908178T3 (en) | 2014-06-18 | 2022-04-28 | Polares Medical Inc | Mitral valve implants for the treatment of valvular regurgitation |
JP6559161B2 (en) | 2014-06-19 | 2019-08-14 | 4テック インコーポレイテッド | Tightening heart tissue |
CN106659394A (en) | 2014-07-13 | 2017-05-10 | 三河城心血管系统有限公司 | System and apparatus comprising multisensor guidewire for use in interventional cardiology |
US9180005B1 (en) | 2014-07-17 | 2015-11-10 | Millipede, Inc. | Adjustable endolumenal mitral valve ring |
WO2016011267A1 (en) | 2014-07-18 | 2016-01-21 | Pigott John P | Embolic protection device |
US10195026B2 (en) | 2014-07-22 | 2019-02-05 | Edwards Lifesciences Corporation | Mitral valve anchoring |
EP3174503A1 (en) | 2014-08-03 | 2017-06-07 | Mvalve Technologies Ltd. | Sealing elements for intracardiac devices |
US20160038283A1 (en) | 2014-08-06 | 2016-02-11 | The University Of Iowa Research Foundation | Systems and methods utilizing expandable transcatheter valve |
US9801719B2 (en) | 2014-08-15 | 2017-10-31 | Edwards Lifesciences Corporation | Annulus rings with suture clips |
WO2016025733A1 (en) | 2014-08-15 | 2016-02-18 | Direct Flow Medical, Inc. | Prosthetic implant delivery device |
US20160045306A1 (en) | 2014-08-18 | 2016-02-18 | Boston Scientific Scimed, Inc. | Cut pattern transcatheter valve frame |
WO2016028583A1 (en) | 2014-08-18 | 2016-02-25 | St. Jude Medical, Cardiology Division, Inc. | Sensors for prosthetic heart devices |
US10058424B2 (en) | 2014-08-21 | 2018-08-28 | Edwards Lifesciences Corporation | Dual-flange prosthetic valve frame |
US9877832B2 (en) | 2014-08-22 | 2018-01-30 | Medtronic Vascular, Inc. | Rapid exchange transcatheter valve delivery system |
US20160067031A1 (en) | 2014-09-08 | 2016-03-10 | Ghassan S. Kassab | Methods and uses of mediastinal pleura tissue for various stent and other medical applications |
TR201815290T4 (en) | 2014-09-09 | 2018-11-21 | Occlutech Holding Ag | Flow regulator in the heart. |
US10390950B2 (en) | 2014-10-03 | 2019-08-27 | St. Jude Medical, Cardiology Division, Inc. | Flexible catheters and methods of forming same |
JP2017530814A (en) | 2014-10-13 | 2017-10-19 | シメティス・ソシエテ・アノニムSymetis Sa | Catheter delivery system for stent valves |
US9750607B2 (en) | 2014-10-23 | 2017-09-05 | Caisson Interventional, LLC | Systems and methods for heart valve therapy |
US9750605B2 (en) | 2014-10-23 | 2017-09-05 | Caisson Interventional, LLC | Systems and methods for heart valve therapy |
US10111741B2 (en) | 2014-10-29 | 2018-10-30 | W. L. Gore & Associates, Inc. | Intralumenal stent graft fixation |
US10709820B2 (en) | 2014-11-24 | 2020-07-14 | Biotronik Ag | Method for producing a storable molded body made of bacterial cellulose |
US20160143739A1 (en) | 2014-11-25 | 2016-05-26 | Boston Scientific Scimed Inc. | Prosthetic ventricular heart system |
WO2016083551A1 (en) | 2014-11-26 | 2016-06-02 | Konstantinos Spargias | Transcatheter prosthetic heart valve and delivery system |
US9693860B2 (en) | 2014-12-01 | 2017-07-04 | Medtronic, Inc. | Segmented transcatheter valve prosthesis having an unsupported valve segment |
EP3068311B1 (en) | 2014-12-02 | 2017-11-15 | 4Tech Inc. | Off-center tissue anchors |
EP3028668A1 (en) | 2014-12-05 | 2016-06-08 | Nvt Ag | Prosthetic heart valve system and delivery system therefor |
JP6835719B2 (en) | 2014-12-08 | 2021-02-24 | コーニンクレッカ フィリップス エヌ ヴェKoninklijke Philips N.V. | Bedside interface for percutaneous coronary intervention treatment planning |
US9517131B2 (en) | 2014-12-12 | 2016-12-13 | Than Nguyen | Cardiac valve repair device |
WO2016100799A1 (en) | 2014-12-18 | 2016-06-23 | Medtronic Inc. | Transcatheter prosthetic heart valve delivery system with clinician feedback |
US10512460B2 (en) | 2014-12-19 | 2019-12-24 | Renzo Cecere | Surgical method and system for performing the same |
EP3037064B1 (en) | 2014-12-23 | 2018-03-14 | Venus MedTech (HangZhou), Inc. | Minimally invasive mitral valve replacement with brim |
WO2016097337A1 (en) | 2014-12-19 | 2016-06-23 | Transcatheter Technologies Gmbh | Minimally invasive mitral valve replacement with brim |
US20160194425A1 (en) | 2015-01-05 | 2016-07-07 | Endoluminal Sciences Pty. Ltd. | Highly expandable hydrogels in medical device sealing technology |
CA2972966C (en) | 2015-01-07 | 2023-01-10 | Tendyne Holdings, Inc. | Prosthetic mitral valves and apparatus and methods for delivery of same |
WO2016115361A1 (en) | 2015-01-14 | 2016-07-21 | Surmodics, Inc. | Insertion tools for medical device |
CA3082533A1 (en) | 2015-01-20 | 2016-07-28 | Keystone Heart Ltd. | Intravascular devices and delivery systems and uses thereof |
WO2016118851A1 (en) | 2015-01-22 | 2016-07-28 | SZABOLCS, Annamaria | Methods and devices for minimally invasive transcatheter coronary artery bypass grafting |
US10478297B2 (en) | 2015-01-27 | 2019-11-19 | Medtronic Vascular, Inc. | Delivery system having an integral centering mechanism for positioning a valve prosthesis in situ |
WO2016126699A1 (en) | 2015-02-02 | 2016-08-11 | On-X Life Technologies, Inc. | Rapid deployment artificial chordae tendinae system |
US20160220367A1 (en) | 2015-02-04 | 2016-08-04 | Medtronic Vascular, Inc. | Balloon valvuloplasty delivery system |
US10039637B2 (en) | 2015-02-11 | 2018-08-07 | Edwards Lifesciences Corporation | Heart valve docking devices and implanting methods |
US20160235525A1 (en) | 2015-02-12 | 2016-08-18 | Medtronic, Inc. | Integrated valve assembly and method of delivering and deploying an integrated valve assembly |
EP3258886B1 (en) | 2015-02-17 | 2023-03-29 | Medtronic Vascular Inc. | Catheter for anchoring a heart valve prosthesis |
US20160235530A1 (en) | 2015-02-18 | 2016-08-18 | St. Jude Medical, Cardiology Division, Inc. | Introducer sheath for transcatheter heart valve delivery |
WO2016134239A1 (en) | 2015-02-20 | 2016-08-25 | 4C Medical Technologies, Inc. | Devices, systems and methods for cardiac treatment |
US10583004B2 (en) | 2015-02-27 | 2020-03-10 | University of Pittsburgh — Of the Commonwealth System of Higher Education | Retrievable self-expanding non-thrombogenic low-profile percutaneous atrioventricular valve prosthesis |
WO2016139590A1 (en) | 2015-03-02 | 2016-09-09 | Accurate Medical Therapeutics Ltd. | Embolization particulates for occluding a blood vessel |
US20160256269A1 (en) | 2015-03-05 | 2016-09-08 | Mitralign, Inc. | Devices for treating paravalvular leakage and methods use thereof |
US10285809B2 (en) | 2015-03-06 | 2019-05-14 | Boston Scientific Scimed Inc. | TAVI anchoring assist device |
US10758349B2 (en) | 2015-03-13 | 2020-09-01 | Medtronic Vascular, Inc. | Delivery device for prosthetic heart valve with capsule adjustment device |
US10327899B2 (en) | 2015-03-13 | 2019-06-25 | Medtronic Vascular, Inc. | Delivery device for prosthetic heart valve with capsule adjustment device |
US11504236B2 (en) | 2015-03-13 | 2022-11-22 | Medtronic Vascular, Inc. | Delivery device for prosthetic heart valve with capsule adjustment device |
US10231827B2 (en) | 2015-03-18 | 2019-03-19 | Medtronic Vascular, Inc. | Valve prostheses having an integral centering mechanism and methods of use thereof |
EP3270827B1 (en) | 2015-03-19 | 2023-12-20 | Caisson Interventional, LLC | Systems for heart valve therapy |
JP6829692B2 (en) | 2015-03-20 | 2021-02-10 | イェーナヴァルヴ テクノロジー インコーポレイテッド | Heart valve prosthesis delivery system and method for delivering the heart valve prosthesis through the introducer sheath |
EP3078350B1 (en) | 2015-04-09 | 2018-01-31 | Frid Mind Technologies | 3d filter for prevention of stroke |
US10368986B2 (en) | 2015-04-15 | 2019-08-06 | Medtronic, Inc. | Transcatheter prosthetic heart valve delivery system and method |
US9931790B2 (en) | 2015-04-16 | 2018-04-03 | Siemens Healthcare Gmbh | Method and system for advanced transcatheter aortic valve implantation planning |
CN107750150B (en) | 2015-04-16 | 2021-03-05 | 坦迪尼控股股份有限公司 | Devices and methods for delivering, repositioning and retrieving transcatheter prosthetic valves |
US10232564B2 (en) | 2015-04-29 | 2019-03-19 | Edwards Lifesciences Corporation | Laminated sealing member for prosthetic heart valve |
US10376363B2 (en) | 2015-04-30 | 2019-08-13 | Edwards Lifesciences Cardiaq Llc | Replacement mitral valve, delivery system for replacement mitral valve and methods of use |
CR20170480A (en) | 2015-04-30 | 2018-02-21 | Valtech Cardio Ltd | Annuloplasty technologies |
WO2016177562A1 (en) | 2015-05-01 | 2016-11-10 | Jenavalve Technology, Inc. | Device and method with reduced pacemaker rate in heart valve replacement |
US9629720B2 (en) | 2015-05-04 | 2017-04-25 | Jacques Seguin | Apparatus and methods for treating cardiac valve regurgitation |
US10433960B1 (en) | 2015-05-07 | 2019-10-08 | Cardioprecision Limited | Method and system for transcatheter intervention |
GB201508150D0 (en) | 2015-05-13 | 2015-06-24 | Cambridge Entpr Ltd | Device for insertion into human or animal body and associated methods |
JP6816889B2 (en) | 2015-05-28 | 2021-01-20 | 4テック インコーポレイテッド | Eccentric tissue anchor with tension member |
ES2742204T5 (en) | 2015-06-04 | 2023-10-05 | Epygon | Atrioventricular valve stent with native leaflet clamping and clamping mechanism |
EP3100701A1 (en) | 2015-06-04 | 2016-12-07 | Epygon Sasu | Mitral valve stent with anterior native leaflet grasping and holding mechanism |
US10016273B2 (en) | 2015-06-05 | 2018-07-10 | Medtronic, Inc. | Filtered sealing components for a transcatheter valve prosthesis |
EP3302363A1 (en) | 2015-06-05 | 2018-04-11 | Tendyne Holdings, Inc. | Apical control of transvascular delivery of prosthetic mitral valve |
GB2539444A (en) | 2015-06-16 | 2016-12-21 | Ucl Business Plc | Prosthetic heart valve |
ES2921535T3 (en) | 2015-06-18 | 2022-08-29 | Ascyrus Medical Llc | Branch aortic graft |
CA2990872C (en) | 2015-06-22 | 2022-03-22 | Edwards Lifescience Cardiaq Llc | Actively controllable heart valve implant and methods of controlling same |
EP3310302A4 (en) | 2015-06-22 | 2018-07-11 | Edwards Lifescience Cardiaq LLC | Actively controllable heart valve implant and methods of controlling same |
CN107735051B (en) | 2015-07-02 | 2020-07-31 | 爱德华兹生命科学公司 | Hybrid heart valve adapted for post-implant expansion |
CA2990733C (en) | 2015-07-02 | 2023-07-18 | Edwards Lifesciences Corporation | Integrated hybrid heart valves |
US9974650B2 (en) | 2015-07-14 | 2018-05-22 | Edwards Lifesciences Corporation | Prosthetic heart valve |
JP6600068B2 (en) | 2015-07-16 | 2019-10-30 | セント・ジュード・メディカル,カーディオロジー・ディヴィジョン,インコーポレイテッド | Non-sutured prosthetic heart valve |
US10154905B2 (en) | 2015-08-07 | 2018-12-18 | Medtronic Vascular, Inc. | System and method for deflecting a delivery catheter |
US10213301B2 (en) | 2015-08-14 | 2019-02-26 | Caisson Interventional, LLC | Systems and methods for heart valve therapy |
US11026788B2 (en) | 2015-08-20 | 2021-06-08 | Edwards Lifesciences Corporation | Loader and retriever for transcatheter heart valve, and methods of crimping transcatheter heart valve |
US10034747B2 (en) | 2015-08-27 | 2018-07-31 | Medtronic Vascular, Inc. | Prosthetic valve system having a docking component and a prosthetic valve component |
US10350066B2 (en) | 2015-08-28 | 2019-07-16 | Edwards Lifesciences Cardiaq Llc | Steerable delivery system for replacement mitral valve and methods of use |
US20170056215A1 (en) | 2015-09-01 | 2017-03-02 | Medtronic, Inc. | Stent assemblies including passages to provide blood flow to coronary arteries and methods of delivering and deploying such stent assemblies |
CN108135592B (en) | 2015-09-02 | 2021-05-14 | 爱德华兹生命科学公司 | Spacer for securing a transcatheter valve to a bioprosthetic cardiac structure |
US10350047B2 (en) | 2015-09-02 | 2019-07-16 | Edwards Lifesciences Corporation | Method and system for packaging and preparing a prosthetic heart valve and associated delivery system |
US20170056164A1 (en) | 2015-09-02 | 2017-03-02 | Medtronic Vascular, Inc. | Transcatheter valve prostheses having a sealing component formed from tissue having an altered extracellular matrix |
EP3344189B1 (en) | 2015-09-03 | 2019-07-31 | St. Jude Medical, Cardiology Division, Inc. | Introducer sheath having expandable portions |
US10080653B2 (en) | 2015-09-10 | 2018-09-25 | Edwards Lifesciences Corporation | Limited expansion heart valve |
US10561496B2 (en) | 2015-09-16 | 2020-02-18 | Edwards Lifesciences Corporation | Perfusion balloon designs |
US10327894B2 (en) | 2015-09-18 | 2019-06-25 | Tendyne Holdings, Inc. | Methods for delivery of prosthetic mitral valves |
US10314703B2 (en) | 2015-09-21 | 2019-06-11 | Edwards Lifesciences Corporation | Cylindrical implant and balloon |
US10022223B2 (en) | 2015-10-06 | 2018-07-17 | W. L. Gore & Associates, Inc. | Leaflet support devices and methods of making and using the same |
BR112018007157B1 (en) | 2015-10-09 | 2022-06-14 | Transverse Medical, INC | CATHETER-BASED APPARATUS |
US10456243B2 (en) | 2015-10-09 | 2019-10-29 | Medtronic Vascular, Inc. | Heart valves prostheses and methods for percutaneous heart valve replacement |
US20170112620A1 (en) | 2015-10-22 | 2017-04-27 | Medtronic Vascular, Inc. | Systems and methods of sealing a deployed valve component |
EP3370649B1 (en) | 2015-11-02 | 2023-03-15 | Edwards Lifesciences Corporation | Devices for reducing cardiac valve regurgitation |
US9592121B1 (en) | 2015-11-06 | 2017-03-14 | Middle Peak Medical, Inc. | Device, system, and method for transcatheter treatment of valvular regurgitation |
CN108992207B (en) | 2015-11-06 | 2021-10-26 | 麦克尔有限公司 | Mitral valve prosthesis |
US10555814B2 (en) | 2015-11-17 | 2020-02-11 | Edwards Lifesciences Corporation | Ultrasound probe for cardiac treatment |
FR3043907A1 (en) | 2015-11-23 | 2017-05-26 | Alain Dibie | ASSEMBLY FOR REPLACING THE TRICUSPID ATRIO-VENTRICULAR VALVE |
EP4309628A3 (en) | 2015-12-03 | 2024-04-10 | Tendyne Holdings, Inc. | Frame features for prosthetic mitral valves |
WO2017100211A1 (en) | 2015-12-07 | 2017-06-15 | Micro Interventional Devices, Inc. | Affixing a prosthesis to tissue |
US10954540B2 (en) | 2015-12-11 | 2021-03-23 | University Of Iowa Research Foundation | Methods of producing biosynthetic bacterial cellulose membranes |
US10500046B2 (en) | 2015-12-14 | 2019-12-10 | Medtronic, Inc. | Delivery system having retractable wires as a coupling mechanism and a deployment mechanism for a self-expanding prosthesis |
CN108430392B (en) | 2015-12-14 | 2020-08-21 | 美敦力瓦斯科尔勒公司 | Devices and methods for transcatheter valve loading and implantation |
US10159568B2 (en) | 2015-12-14 | 2018-12-25 | Medtronic, Inc. | Delivery system having retractable wires as a coupling mechanism and a deployment mechanism for a self-expanding prosthesis |
EP3389557B1 (en) | 2015-12-15 | 2022-07-13 | Neovasc Tiara Inc. | Transseptal delivery system |
US11172921B2 (en) | 2015-12-18 | 2021-11-16 | Boston Scientific Scimed, Inc. | Heart tissue anchors |
US10617509B2 (en) | 2015-12-29 | 2020-04-14 | Emboline, Inc. | Multi-access intraprocedural embolic protection device |
US20190015232A1 (en) | 2015-12-30 | 2019-01-17 | Nuheart As | Transcatheter insertion system |
WO2017117388A1 (en) | 2015-12-30 | 2017-07-06 | Caisson Interventional, LLC | Systems and methods for heart valve therapy |
CN106943207B (en) | 2016-01-07 | 2018-11-06 | 上海市同济医院 | A kind of atrioventricular valve valve bracket and its transport system for puncturing merging |
JP6896742B2 (en) | 2016-01-07 | 2021-06-30 | メドトロニック ヴァスキュラー インコーポレイテッド | Artificial valve with guide |
CN105496606A (en) | 2016-01-11 | 2016-04-20 | 北京迈迪顶峰医疗科技有限公司 | Aortic valve membrane device conveyed through catheter |
CN105496607A (en) | 2016-01-11 | 2016-04-20 | 北京迈迪顶峰医疗科技有限公司 | Aortic valve device conveyed by catheter |
CN105476731A (en) | 2016-01-11 | 2016-04-13 | 北京迈迪顶峰医疗科技有限公司 | Aortic valve device conveyed by catheter |
WO2017123802A1 (en) | 2016-01-13 | 2017-07-20 | Medtronic Inc. | Delivery device for a stented prosthetic heart valve |
EP3406224B1 (en) | 2016-01-18 | 2020-07-01 | Asahi Kasei Kabushiki Kaisha | Medical fabric |
US9918838B2 (en) | 2016-01-25 | 2018-03-20 | Michael Ring | Integrated catheter guide wire control device |
CN105520792B (en) | 2016-02-02 | 2019-01-04 | 上海纽脉医疗科技有限公司 | A kind of D-shaped insertion type artificial cardiac valve |
CN108601655B (en) | 2016-02-04 | 2020-06-09 | 波士顿科学国际有限公司 | Mitral valve transition prosthesis |
US10363130B2 (en) | 2016-02-05 | 2019-07-30 | Edwards Lifesciences Corporation | Devices and systems for docking a heart valve |
US10179043B2 (en) | 2016-02-12 | 2019-01-15 | Edwards Lifesciences Corporation | Prosthetic heart valve having multi-level sealing member |
WO2017151292A1 (en) | 2016-02-29 | 2017-09-08 | The United States Of America, As Represented By The Secretary, Department Of Health And Human Services | Transcatheter coronary sinus mitral valve annuloplasty procedure and coronary artery and myocardial protection device |
CN108697498B (en) | 2016-03-02 | 2021-01-29 | 巴德股份有限公司 | Plug protective basket device |
CN109069273B (en) | 2016-03-08 | 2021-06-29 | 舒恰医疗公司 | Cardiac valve leaflet replacement system and method |
US10779941B2 (en) | 2016-03-08 | 2020-09-22 | Edwards Lifesciences Corporation | Delivery cylinder for prosthetic implant |
US10667904B2 (en) | 2016-03-08 | 2020-06-02 | Edwards Lifesciences Corporation | Valve implant with integrated sensor and transmitter |
WO2017153587A1 (en) | 2016-03-10 | 2017-09-14 | Keystone Heart Ltd. | Intra-aortic device |
US10278852B2 (en) | 2016-03-10 | 2019-05-07 | Medtronic Vascular, Inc. | Steerable catheter with multiple bending radii via a steering mechanism with telescoping tubular components |
WO2017156352A1 (en) | 2016-03-11 | 2017-09-14 | Medtronic Vascular Inc. | Delivery device for prosthetic heart valve with capsule adjustment device |
US10398549B2 (en) | 2016-03-15 | 2019-09-03 | Abbott Cardiovascular Systems Inc. | System and method for transcatheter heart valve platform |
WO2017161204A1 (en) | 2016-03-16 | 2017-09-21 | Calture Vascular, Inc. | Device and method of thrombus retrieval |
US9974649B2 (en) | 2016-03-24 | 2018-05-22 | Medtronic Vascular, Inc. | Stented prosthetic heart valve having wrap and methods of delivery and deployment |
CR20180410A (en) | 2016-03-24 | 2019-04-01 | Edwards Lifesciences Corp | Delivery system for prosthetic heart valve |
WO2019143775A1 (en) | 2018-01-17 | 2019-07-25 | Project Moray, Inc. | Fluid-actuated displacement for catheters, continuum manipulators, and other uses |
WO2017165810A1 (en) | 2016-03-25 | 2017-09-28 | Phillip Laby | Fluid-actuated sheath displacement and articulation behavior improving systems, devices, and methods for catheters, continuum manipulators, and other uses |
US10517711B2 (en) | 2016-04-25 | 2019-12-31 | Medtronic Vascular, Inc. | Dissection prosthesis system and method |
WO2017193123A1 (en) | 2016-05-06 | 2017-11-09 | Nasser Rafiee | Annuloplasty procedures, related devices and methods |
US11039923B2 (en) | 2016-05-06 | 2021-06-22 | Transmural Systems Llc | Annuloplasty procedures, related devices and methods |
US20190240022A1 (en) | 2016-05-06 | 2019-08-08 | Transmural Systems Llc | Annuloplasty procedures, related devices and methods |
WO2017197050A1 (en) | 2016-05-10 | 2017-11-16 | Yale University | Aortic arch embolic protection device |
US10172710B2 (en) | 2016-05-10 | 2019-01-08 | William Joseph Drasler | Two component mitral valve |
US10299921B2 (en) | 2016-05-12 | 2019-05-28 | St. Jude Medical, Cardiology Division, Inc. | Mitral heart valve replacement |
US10456245B2 (en) | 2016-05-16 | 2019-10-29 | Edwards Lifesciences Corporation | System and method for applying material to a stent |
RU2018145775A (en) | 2016-05-16 | 2019-02-18 | Вэлв Медикал Лтд. | TURN VALVE INVERTER SHELL |
CA3020238A1 (en) | 2016-05-16 | 2017-11-23 | Edwards Lifesciences Corporation | System and method for applying material to a stent |
GB2565028B (en) | 2016-05-17 | 2021-09-15 | Monarch Biosciences Inc | Thin-film transcatheter heart valve |
CN107432980A (en) | 2016-05-25 | 2017-12-05 | 孙英贤 | The foley's tube of flexible joint is provided between a kind of head end and sacculus |
WO2017210434A1 (en) | 2016-06-01 | 2017-12-07 | On-X Life Technologies, Inc. | Pull-through chordae tendineae system |
EP3463192B1 (en) | 2016-06-02 | 2020-08-19 | Medtronic Vascular Inc. | Transcatheter valve delivery system with septum hole closure tip assembly |
US10765513B2 (en) | 2016-06-06 | 2020-09-08 | Medtronic Vascular, Inc. | Transcatheter prosthetic heart valve delivery system with lateral offset control |
WO2017217932A1 (en) | 2016-06-13 | 2017-12-21 | Singapore Health Services Pte. Ltd. | Device for cardiac valve repair and method of implanting the same |
EP3468480B1 (en) | 2016-06-13 | 2023-01-11 | Tendyne Holdings, Inc. | Sequential delivery of two-part prosthetic mitral valve |
US20170360558A1 (en) | 2016-06-16 | 2017-12-21 | Jianlu Ma | Method and design for a mitral regurgitation treatment device |
US10588745B2 (en) | 2016-06-20 | 2020-03-17 | Medtronic Vascular, Inc. | Modular valve prosthesis, delivery system, and method of delivering and deploying a modular valve prosthesis |
CN109640887B (en) | 2016-06-30 | 2021-03-16 | 坦迪尼控股股份有限公司 | Prosthetic heart valve and apparatus and method for delivering same |
WO2018008019A2 (en) | 2016-07-03 | 2018-01-11 | Tel Hashomer Medical Research, Infrastructure And Services Ltd. | Apparatus for delivering electrical signals to the heart |
EP3484411A1 (en) | 2016-07-12 | 2019-05-22 | Tendyne Holdings, Inc. | Apparatus and methods for trans-septal retrieval of prosthetic heart valves |
US10058426B2 (en) | 2016-07-20 | 2018-08-28 | Abbott Cardiovascular Systems Inc. | System for tricuspid valve repair |
US11096781B2 (en) | 2016-08-01 | 2021-08-24 | Edwards Lifesciences Corporation | Prosthetic heart valve |
WO2018026904A1 (en) | 2016-08-03 | 2018-02-08 | Spence Paul A | Devices, systems and methods to improve placement and prevent heart block with percutaneous aortic valve replacement |
US20180035971A1 (en) | 2016-08-03 | 2018-02-08 | Pi-Harvest Holding Ag | System And Method For Non-Invasive Measurement Of Pressure Inside A Body Including Intravascular Blood Pressure |
US10945842B2 (en) | 2016-08-04 | 2021-03-16 | Evalve, Inc. | Annular augmentation device for cardiac valve repair |
WO2018035156A1 (en) | 2016-08-15 | 2018-02-22 | Advanced Cardiology Engineering Solutions, LLC | Expandable sheath and methods of usage |
CN107753153B (en) | 2016-08-15 | 2022-05-31 | 沃卡尔有限公司 | Device and method for treating heart valve insufficiency |
JP7199344B2 (en) | 2016-08-15 | 2023-01-05 | ザ クリーヴランド クリニック ファウンデーション | Apparatus and method for at least partially supporting heart valve leaflets with regurgitation |
BR112019003113A2 (en) | 2016-08-17 | 2019-05-21 | Neuravi Limited | clot removal system to remove occlusive clot from a blood vessel |
US10646340B2 (en) | 2016-08-19 | 2020-05-12 | Edwards Lifesciences Corporation | Steerable delivery system for replacement mitral valve |
ES2810401T3 (en) | 2016-08-24 | 2021-03-08 | Gore & Ass | Expandable Medical Device Sleeves |
US10722359B2 (en) | 2016-08-26 | 2020-07-28 | Edwards Lifesciences Corporation | Heart valve docking devices and systems |
CR20190069A (en) | 2016-08-26 | 2019-05-14 | Edwards Lifesciences Corp | Heart valve docking coils and systems |
US10456252B2 (en) | 2016-08-31 | 2019-10-29 | Medtronic Vascular, Inc. | Transcatheter guidewire delivery systems, catheter assemblies for guidewire delivery, and methods for percutaneous guidewire delivery across heart valves |
WO2018045156A2 (en) | 2016-08-31 | 2018-03-08 | Medtronic Vascular Inc. | Transcatheter guidewire delivery systems, catheter assemblies for guidewire delivery, and methods for percutaneous guidewire delivery across heart valves |
CN106175987A (en) | 2016-08-31 | 2016-12-07 | 上海纽脉医疗科技有限公司 | Cardiac valve prosthesis |
WO2018042439A1 (en) | 2016-08-31 | 2018-03-08 | Corassist Cardiovascular Ltd. | Transcatheter mechanical aortic valve prosthesis |
US20180056045A1 (en) | 2016-08-31 | 2018-03-01 | Medtronic Vascular, Inc. | Transcatheter guidewire delivery systems, catheter assemblies for guidewire delivery, and methods for percutaneous guidewire delivery across heart valves |
US10575946B2 (en) | 2016-09-01 | 2020-03-03 | Medtronic Vascular, Inc. | Heart valve prosthesis and separate support flange for attachment thereto |
US10357361B2 (en) | 2016-09-15 | 2019-07-23 | Edwards Lifesciences Corporation | Heart valve pinch devices and delivery systems |
US10575944B2 (en) | 2016-09-22 | 2020-03-03 | Edwards Lifesciences Corporation | Prosthetic heart valve with reduced stitching |
US10849745B2 (en) | 2016-09-23 | 2020-12-01 | Medtronic Vascular, Inc. | Balloon catheter including braided portions forming perfusion openings |
US10814102B2 (en) | 2016-09-28 | 2020-10-27 | Project Moray, Inc. | Base station, charging station, and/or server for robotic catheter systems and other uses, and improved articulated devices and systems |
US20180099124A1 (en) | 2016-10-06 | 2018-04-12 | Medtronic Vascular, Inc. | System and method for crossing a native heart valve with a guidewire |
WO2018071417A1 (en) | 2016-10-10 | 2018-04-19 | Peca Labs, Inc. | Transcatheter stent and valve assembly |
US11426276B2 (en) | 2016-10-12 | 2022-08-30 | Medtronic Vascular, Inc. | Stented prosthetic heart valve delivery system having an expandable bumper |
CA3041455A1 (en) | 2016-10-19 | 2018-05-03 | Piotr Chodor | Stent of aortic valve implanted transcatheterly |
PL419173A1 (en) | 2016-10-19 | 2018-04-23 | Chodór Piotr | Aortic valve stent implanted through a catheter |
CN106344213B (en) | 2016-10-24 | 2020-04-17 | 宁波健世生物科技有限公司 | Asymmetric heart valve prosthesis |
CN106420114B (en) | 2016-10-24 | 2018-06-08 | 宁波健世生物科技有限公司 | A kind of heart valve prosthesis |
EA201892397A1 (en) | 2016-10-28 | 2019-09-30 | Фолдэкс, Инк. | PROSTETIC HEART VALVES WITH ELASTIC SUPPORT STRUCTURES AND RELATED METHODS |
WO2018083493A1 (en) | 2016-11-04 | 2018-05-11 | Cambridge Enterprise Limited | Annuloplasty prosthesis and related methods |
US10492907B2 (en) | 2016-11-07 | 2019-12-03 | Medtronic Vascular, Inc. | Valve delivery system |
US10368988B2 (en) | 2016-11-09 | 2019-08-06 | Medtronic Vascular, Inc. | Valve delivery system having an integral displacement component for managing chordae tendineae in situ and methods of use thereof |
US10869991B2 (en) | 2016-11-09 | 2020-12-22 | Medtronic Vascular, Inc. | Telescoping catheter |
US10493248B2 (en) | 2016-11-09 | 2019-12-03 | Medtronic Vascular, Inc. | Chordae tendineae management devices for use with a valve prosthesis delivery system and methods of use thereof |
FR3058631B1 (en) | 2016-11-14 | 2019-01-25 | Laboratoires Invalv | IMPLANT FOR TREATING A BIOLOGICAL VALVE |
CN108066047B (en) | 2016-11-15 | 2020-06-30 | 先健科技(深圳)有限公司 | Flow-blocking membrane and implanted medical instrument |
US20180133006A1 (en) | 2016-11-15 | 2018-05-17 | Medtronic Vascular, Inc. | Stabilization and advancement system for direct aortic transcatheter aortic valve implantation |
US10973631B2 (en) | 2016-11-17 | 2021-04-13 | Edwards Lifesciences Corporation | Crimping accessory device for a prosthetic valve |
CN113893064A (en) | 2016-11-21 | 2022-01-07 | 内奥瓦斯克迪亚拉公司 | Methods and systems for rapid retrieval of transcatheter heart valve delivery systems |
WO2018098032A1 (en) | 2016-11-23 | 2018-05-31 | St. Jude Medical, Cardiology Division, Inc. | Tissue heart valve (thv) humidor packaging system |
US11197750B2 (en) | 2016-11-29 | 2021-12-14 | Lake Region Manufacturing, Inc. | Embolic protection device |
US10716666B2 (en) | 2016-12-05 | 2020-07-21 | Medtronic Vascular, Inc. | Prosthetic heart valve delivery system with controlled expansion |
US10603165B2 (en) | 2016-12-06 | 2020-03-31 | Edwards Lifesciences Corporation | Mechanically expanding heart valve and delivery apparatus therefor |
JP7440263B2 (en) | 2016-12-16 | 2024-02-28 | エドワーズ ライフサイエンシーズ コーポレイション | Deployment systems, tools, and methods for delivering anchoring devices for prosthetic valves |
EP3558164A1 (en) | 2016-12-21 | 2019-10-30 | Triflo Cardiovascular Inc. | Heart valve support device and methods for making and using the same |
EP3558166A4 (en) | 2016-12-22 | 2021-03-31 | Heart Repair Technologies, Inc. | Percutaneous delivery systems for anchoring an implant in a cardiac valve annulus |
US20180214141A1 (en) | 2016-12-22 | 2018-08-02 | TransCaval Solutions, Inc. | Systems, Apparatuses, and Methods for Vessel Crossing and Closure |
US9877833B1 (en) | 2016-12-30 | 2018-01-30 | Pipeline Medical Technologies, Inc. | Method and apparatus for transvascular implantation of neo chordae tendinae |
US10925731B2 (en) | 2016-12-30 | 2021-02-23 | Pipeline Medical Technologies, Inc. | Method and apparatus for transvascular implantation of neo chordae tendinae |
RU177405U1 (en) | 2017-01-09 | 2018-02-21 | Леонид Семенович Барбараш | AORTIC VALVE PROSTHESIS |
US10653523B2 (en) * | 2017-01-19 | 2020-05-19 | 4C Medical Technologies, Inc. | Systems, methods and devices for delivery systems, methods and devices for implanting prosthetic heart valves |
WO2019144036A1 (en) | 2018-01-19 | 2019-07-25 | Edwards Lifesciences Corporation | Covered prosthetic heart valve |
US11185406B2 (en) | 2017-01-23 | 2021-11-30 | Edwards Lifesciences Corporation | Covered prosthetic heart valve |
US11013600B2 (en) | 2017-01-23 | 2021-05-25 | Edwards Lifesciences Corporation | Covered prosthetic heart valve |
US11197754B2 (en) | 2017-01-27 | 2021-12-14 | Jenavalve Technology, Inc. | Heart valve mimicry |
US11376112B2 (en) | 2017-01-31 | 2022-07-05 | W. L. Gore & Associates, Inc. | Pre-strained stent elements |
US10869758B2 (en) | 2017-02-06 | 2020-12-22 | Caisson Interventional Llc | Systems and methods for heart valve therapy |
US10624738B2 (en) | 2017-02-23 | 2020-04-21 | Edwards Lifesciences Corporation | Heart valve manufacturing devices and methods |
US10842631B2 (en) | 2017-02-23 | 2020-11-24 | The Cleveland Clinic Foundation | Transcatheter cardiac de-airing system |
US10149685B2 (en) | 2017-02-28 | 2018-12-11 | Abbott Cardiovascular Systems Inc. | System and method for mitral valve function |
US11291807B2 (en) | 2017-03-03 | 2022-04-05 | V-Wave Ltd. | Asymmetric shunt for redistributing atrial blood volume |
CA3054891A1 (en) | 2017-03-03 | 2018-09-07 | V-Wave Ltd. | Shunt for redistributing atrial blood volume |
WO2018160790A1 (en) | 2017-03-03 | 2018-09-07 | St. Jude Medical, Cardiology Division, Inc. | Transcatheter mitral valve design |
EP3372198B1 (en) | 2017-03-06 | 2019-06-19 | AVVie GmbH | Implant for improving coaptation of an atrioventricular valve |
CA3055567C (en) | 2017-03-08 | 2021-11-23 | W. L. Gore & Associates, Inc. | Steering wire attach for angulation |
EP3372199A1 (en) | 2017-03-08 | 2018-09-12 | Epygon | Delivery system for transcatheter prosthetic heart valves |
WO2018165356A1 (en) | 2017-03-10 | 2018-09-13 | St. Jude Medical, Cardiology Division, Inc. | Transseptal mitral valve delivery system |
CN114587711A (en) | 2017-03-13 | 2022-06-07 | 宝来瑞斯医疗有限公司 | Devices, systems, and methods for transcatheter treatment of valve regurgitation |
US10653524B2 (en) | 2017-03-13 | 2020-05-19 | Polares Medical Inc. | Device, system, and method for transcatheter treatment of valvular regurgitation |
US10478303B2 (en) | 2017-03-13 | 2019-11-19 | Polares Medical Inc. | Device, system, and method for transcatheter treatment of valvular regurgitation |
WO2018170149A1 (en) | 2017-03-14 | 2018-09-20 | Shape Memory Medical, Inc. | Shape memory polymer foams to seal space around valves |
CN108618871A (en) | 2017-03-17 | 2018-10-09 | 沃卡尔有限公司 | Bicuspid valve with multi-direction anchor portion or tricuspid valve repair system |
WO2018175220A1 (en) | 2017-03-20 | 2018-09-27 | Medtronic Vascular, Inc. | Delivery systems and methods for transseptal access to a left atrium |
EP3600159B1 (en) | 2017-03-22 | 2022-04-06 | Edwards Lifesciences Corporation | System for implanting and securing a bioprosthetic device to wet tissue |
US11458017B2 (en) | 2017-03-27 | 2022-10-04 | Vvital Biomed Ltd. | Device and method for transcatheter mitral and tricuspid valve repair |
JP7194445B2 (en) | 2017-03-27 | 2022-12-22 | トランスバース メディカル インコーポレイテッド | Filter device and method |
DE102017002976B4 (en) | 2017-03-28 | 2021-08-26 | Immanuel Albertinen Diakonie Ggmbh | Minimally invasive implantable device for eliminating mitral valve insufficiency in the beating heart and mitral valve implant system |
US10806898B2 (en) | 2017-03-30 | 2020-10-20 | University Of Hawaii | Steerable surgical devices with shape memory alloy wires |
US10667934B2 (en) | 2017-04-04 | 2020-06-02 | Medtronic Vascular, Inc. | System for loading a transcatheter valve prosthesis into a delivery catheter |
US11103351B2 (en) | 2017-04-05 | 2021-08-31 | Opus Medical Therapies, LLC | Transcatheter atrial sealing skirt and related method |
US10820992B2 (en) | 2017-04-05 | 2020-11-03 | Opus Medical Therapies, LLC | Transcatheter atrial sealing skirt, anchor, and tether and methods of implantation |
BR112019020867B1 (en) | 2017-04-05 | 2021-08-31 | Opus Medical Therapies, Llc. | MEDICAL ASSEMBLY TO MINIMALLY INVASIVELY IMPLEMENT A VALVE IN THE HEART |
WO2018187753A1 (en) | 2017-04-06 | 2018-10-11 | Harpoon Medical, Inc. | Distal anchor apparatus and methods for mitral valve repair |
US11395734B2 (en) | 2017-04-07 | 2022-07-26 | Shanghai Joy Medical Devices Co., Ltd. | Prosthetic valve and prosthetic valve implanting method |
CN109414322B (en) | 2017-04-07 | 2021-05-11 | 上海甲悦医疗器械有限公司 | Artificial valve |
EP3609434A4 (en) | 2017-04-13 | 2020-11-25 | OrbusNeich Medical Pte. Ltd. | Medical devices coated with polydopamine and antibodies |
CN106890035A (en) | 2017-04-17 | 2017-06-27 | 乐普(北京)医疗器械股份有限公司 | One kind is through conduit implanted aorta petal film device |
US10702378B2 (en) | 2017-04-18 | 2020-07-07 | Twelve, Inc. | Prosthetic heart valve device and associated systems and methods |
KR20230121168A (en) | 2017-04-18 | 2023-08-17 | 에드워즈 라이프사이언시스 코포레이션 | Heart valve sealing devices and delivery devices therefor |
US20180303488A1 (en) | 2017-04-20 | 2018-10-25 | Medtronic, Inc. | Stabilization of a transseptal delivery device |
US10973634B2 (en) | 2017-04-26 | 2021-04-13 | Edwards Lifesciences Corporation | Delivery apparatus for a prosthetic heart valve |
WO2018200942A2 (en) | 2017-04-27 | 2018-11-01 | Medtronic Inc. | Transcatheter stented prosthesis tensioning and locking systems and devices |
US10799312B2 (en) | 2017-04-28 | 2020-10-13 | Edwards Lifesciences Corporation | Medical device stabilizing apparatus and method of use |
US11672883B2 (en) | 2017-04-28 | 2023-06-13 | Medtronic, Inc. | Shape memory articles and methods for controlling properties |
EP3628273A4 (en) | 2017-05-02 | 2021-08-18 | Braile Biomédica Indústria, Comércio e Representações SA | Device for releasing a valvular endoprosthesis and valvular endoprosthesis |
US10925756B2 (en) | 2017-05-03 | 2021-02-23 | St. Jude Medical, Cardiology Division, Inc. | Collapsible medical device having an open lumen |
CN107115161A (en) | 2017-05-04 | 2017-09-01 | 杭州启明医疗器械有限公司 | One kind is with markd foley's tube and processing and localization method |
US10327895B2 (en) | 2017-05-05 | 2019-06-25 | Vdyne, Llc | Pressure differential actuated prosthetic medical device |
WO2018204736A1 (en) | 2017-05-05 | 2018-11-08 | St. Jude Medical, Cardiology Division, Inc. | Introducer sheath having expandable portions |
US10076433B1 (en) | 2017-05-08 | 2018-09-18 | Vadim Bernshtein | Intravascular bifurication zone implants and crimping and deployment methods thereof |
EP3621529A1 (en) | 2017-05-12 | 2020-03-18 | Evalve, Inc. | Long arm valve repair clip |
US10842619B2 (en) | 2017-05-12 | 2020-11-24 | Edwards Lifesciences Corporation | Prosthetic heart valve docking assembly |
EP3400901A1 (en) | 2017-05-12 | 2018-11-14 | Keystone Heart Ltd. | A device for filtering embolic material in a vascular system |
US20200078167A1 (en) | 2017-05-14 | 2020-03-12 | Navigate Cardiac Structures, Inc. | Valved stent for orthotopic replacement of dysfunctional cardiac valve and delivery system |
US11135056B2 (en) | 2017-05-15 | 2021-10-05 | Edwards Lifesciences Corporation | Devices and methods of commissure formation for prosthetic heart valve |
CN110650711B (en) | 2017-05-22 | 2022-04-01 | 爱德华兹生命科学公司 | Valve anchors and methods of installation |
WO2018217338A1 (en) | 2017-05-26 | 2018-11-29 | Caisson Interventional, LLC | Systems and methods for heart valve therapy |
KR20200003424A (en) | 2017-05-31 | 2020-01-09 | 에드워즈 라이프사이언시스 코포레이션 | Sealing member for artificial heart valve |
US10869759B2 (en) | 2017-06-05 | 2020-12-22 | Edwards Lifesciences Corporation | Mechanically expandable heart valve |
US11026785B2 (en) | 2017-06-05 | 2021-06-08 | Edwards Lifesciences Corporation | Mechanically expandable heart valve |
US10952842B2 (en) | 2017-06-07 | 2021-03-23 | W. L. Gore & Associates, Inc. | Prosthetic valve with improved washout |
US10463482B2 (en) | 2017-06-14 | 2019-11-05 | William Joseph Drasler | Free edge supported mitral valve |
EP3641699B1 (en) | 2017-06-19 | 2023-08-30 | Harpoon Medical, Inc. | Apparatus for cardiac procedures |
CA3069991C (en) | 2017-06-29 | 2022-05-31 | Open Stent Solution | Intraluminal support structure and prosthetic valve from the same |
JP7240338B2 (en) | 2017-06-30 | 2023-03-15 | オハイオ ステート イノベーション ファンデーション | A heart valve prosthesis with three leaflet designs for use in percutaneous valve replacement procedures |
US10813757B2 (en) | 2017-07-06 | 2020-10-27 | Edwards Lifesciences Corporation | Steerable rail delivery system |
CN111093561A (en) | 2017-07-07 | 2020-05-01 | 恩朵罗杰克斯股份有限公司 | Endovascular graft system and method for deployment in main and branch arteries |
CN107260366B (en) | 2017-07-12 | 2019-10-18 | 宁波健世生物科技有限公司 | A kind of artificial valve prosthese |
WO2019014473A1 (en) | 2017-07-13 | 2019-01-17 | Tendyne Holdings, Inc. | Prosthetic heart valves and apparatus and methods for delivery of same |
US10918473B2 (en) | 2017-07-18 | 2021-02-16 | Edwards Lifesciences Corporation | Transcatheter heart valve storage container and crimping mechanism |
WO2019018319A1 (en) | 2017-07-18 | 2019-01-24 | St. Jude Medical, Cardiology Division, Inc. | Flushable loading base |
EP3431040A1 (en) | 2017-07-20 | 2019-01-23 | The Provost, Fellows, Foundation Scholars, and The Other Members of Board, of The College of The Holy and Undivided Trinity of Queen Elizabeth | A stented valve |
CN111093564B (en) | 2017-07-25 | 2022-06-14 | 科菲瓣膜技术有限公司 | System and method for positioning a heart valve |
US10575948B2 (en) | 2017-08-03 | 2020-03-03 | Cardiovalve Ltd. | Prosthetic heart valve |
US10537426B2 (en) | 2017-08-03 | 2020-01-21 | Cardiovalve Ltd. | Prosthetic heart valve |
US10888421B2 (en) | 2017-09-19 | 2021-01-12 | Cardiovalve Ltd. | Prosthetic heart valve with pouch |
WO2019026059A1 (en) | 2017-08-03 | 2019-02-07 | Cardiovalve Ltd. | Prosthetic heart valve |
DE202017104793U1 (en) | 2017-08-09 | 2018-11-14 | Nvt Ag | Charging system for heart valve prostheses |
EP3664749B1 (en) | 2017-08-11 | 2023-07-26 | Edwards Lifesciences Corporation | Sealing element for prosthetic heart valve |
US10932903B2 (en) | 2017-08-15 | 2021-03-02 | Edwards Lifesciences Corporation | Skirt assembly for implantable prosthetic valve |
US10898319B2 (en) | 2017-08-17 | 2021-01-26 | Edwards Lifesciences Corporation | Sealing member for prosthetic heart valve |
US10973628B2 (en) | 2017-08-18 | 2021-04-13 | Edwards Lifesciences Corporation | Pericardial sealing member for prosthetic heart valve |
US10856971B2 (en) | 2017-08-18 | 2020-12-08 | Edwards Lifesciences Corporation | Sealing members for prosthetic heart valve |
WO2019040357A1 (en) | 2017-08-21 | 2019-02-28 | St. Jude Medical, Cardiology Division, Inc. | Apparatus and methods for improved loading of a transcatheter heart valve |
US10722353B2 (en) | 2017-08-21 | 2020-07-28 | Edwards Lifesciences Corporation | Sealing member for prosthetic heart valve |
CN109419571A (en) | 2017-08-25 | 2019-03-05 | 上海微创心通医疗科技有限公司 | The conveying device of self-expanding prosthese and the conveying device of self-expanding heart valve prosthesis |
EP3672530A4 (en) | 2017-08-25 | 2021-04-14 | Neovasc Tiara Inc. | Sequentially deployed transcatheter mitral valve prosthesis |
EP3672532B1 (en) | 2017-08-26 | 2022-08-03 | Transmural Systems LLC | Implantable cardiac pacing system |
WO2019046099A1 (en) | 2017-08-28 | 2019-03-07 | Tendyne Holdings, Inc. | Prosthetic heart valves with tether coupling features |
US11051939B2 (en) | 2017-08-31 | 2021-07-06 | Edwards Lifesciences Corporation | Active introducer sheath system |
EP3679891A4 (en) | 2017-09-04 | 2021-08-18 | Venus MedTech (HangZhou) Inc. | Stent device having skirt for peripheral leakage prevention and processing method thereof, skirt folding method, and heart valve |
US11051940B2 (en) | 2017-09-07 | 2021-07-06 | Edwards Lifesciences Corporation | Prosthetic spacer device for heart valve |
US11147667B2 (en) | 2017-09-08 | 2021-10-19 | Edwards Lifesciences Corporation | Sealing member for prosthetic heart valve |
WO2019051476A1 (en) | 2017-09-11 | 2019-03-14 | Incubar, LLC | Conduit vascular implant sealing device for reducing endoleak |
US11534301B2 (en) | 2017-09-12 | 2022-12-27 | Asim Cheema | Apparatus and system for changing mitral valve annulus geometry |
WO2019055577A1 (en) | 2017-09-12 | 2019-03-21 | W. L. Gore & Associates, Inc. | Leaflet frame attachment for prosthetic valves |
WO2019058178A1 (en) | 2017-09-25 | 2019-03-28 | Mitracore Technologies Inc. | Apparatuses and methods for cutting a tissue bridge and/or removing a heart valve clip or suture |
AU2018342223B2 (en) | 2017-09-27 | 2021-04-01 | Edwards Lifesciences Corporation | Prosthetic valves with mechanically coupled leaflets |
EP3687451B1 (en) | 2017-09-27 | 2023-12-13 | Edwards Lifesciences Corporation | Prosthetic valve with expandable frame |
US10828158B2 (en) | 2017-09-29 | 2020-11-10 | St. Jude Medical, Cardiology Division, Inc. | Catheter shaft construction for TAVR delivery systems |
US10426473B2 (en) | 2017-10-19 | 2019-10-01 | Abbott Cardiovascular Systems Inc. | System and method for plicating a heart valve |
CN111511313B (en) | 2017-10-23 | 2023-02-21 | 心脏成功有限公司 | Adjustable self-locking mastoid muscle strip |
WO2019081453A1 (en) | 2017-10-23 | 2019-05-02 | Symetis Sa | Prosthetic valve leaflet |
US11382751B2 (en) | 2017-10-24 | 2022-07-12 | St. Jude Medical, Cardiology Division, Inc. | Self-expandable filler for mitigating paravalvular leak |
CR20200141A (en) | 2017-10-24 | 2020-08-27 | Univ Maryland | Method and apparatus for cardiac procedures |
JP2019076526A (en) | 2017-10-25 | 2019-05-23 | テルモ株式会社 | Treatment method |
EP3476365A1 (en) | 2017-10-27 | 2019-05-01 | Keystone Heart Ltd. | A dome shaped filtering device and method of manufacturing the same |
US10646343B2 (en) | 2017-10-27 | 2020-05-12 | Abbott Cardiovascular Systems Inc. | System and method for valve activation |
WO2019086958A1 (en) | 2017-10-30 | 2019-05-09 | Endoluminal Sciences Pty Ltd | Expandable sealing skirt technology for leak-proof endovascular prostheses |
WO2019089821A1 (en) | 2017-10-31 | 2019-05-09 | Miami Medtech Llc | Embolic protection devices and methods of embolic protection |
JP2019080875A (en) | 2017-10-31 | 2019-05-30 | テルモ株式会社 | Treatment method |
CN111295158A (en) | 2017-10-31 | 2020-06-16 | W.L.戈尔及同仁股份有限公司 | Medical valve and valve leaflet for promoting tissue ingrowth |
US20210177568A1 (en) | 2017-11-10 | 2021-06-17 | Asahi Kasei Kabushiki Kaisha | Medical Fabric |
US10959843B2 (en) | 2017-11-12 | 2021-03-30 | William Joseph Drasler | Straddle annular mitral valve |
CA3021877C (en) | 2017-11-14 | 2019-04-09 | Three Rivers Cardiovascular Systems Inc. | Dual sensor system for continuous blood pressure monitoring during transcatheter heart valve therapies |
US10993807B2 (en) | 2017-11-16 | 2021-05-04 | Medtronic Vascular, Inc. | Systems and methods for percutaneously supporting and manipulating a septal wall |
CN109793596A (en) | 2017-11-17 | 2019-05-24 | 上海微创心通医疗科技有限公司 | Valve bracket, valve prosthesis and conveying device |
US10792396B2 (en) | 2017-11-21 | 2020-10-06 | The Regents Of The University Of California | Methods for development of hybrid tissue engineered valve with polyurethane core |
US11083581B2 (en) | 2017-12-04 | 2021-08-10 | Edwards Lifesciences Corporation | Expandable heart valve coaptation device |
US10722349B2 (en) | 2017-12-07 | 2020-07-28 | Medtronic Vascular, Inc. | Adjustable prosthetic heart valve |
US20190175339A1 (en) | 2017-12-12 | 2019-06-13 | Vdyne, Llc | Septomarginal trabecula attachment for heart valve repair |
WO2019116322A1 (en) | 2017-12-14 | 2019-06-20 | Meacor Sal | Helical anchor driving system |
US20190183639A1 (en) | 2017-12-19 | 2019-06-20 | St. Jude Medical, Cardiology Division, Inc. | Transcatheter Mitral Valve: Off-Center Valve Design |
US11109856B2 (en) | 2017-12-20 | 2021-09-07 | W. L. Gore & Associates, Inc. | Sutures and related medical devices |
CN107890382A (en) | 2017-12-20 | 2018-04-10 | 乐普(北京)医疗器械股份有限公司 | It can position recyclable through conduit implanted aorta petal film device |
US11376127B2 (en) | 2017-12-20 | 2022-07-05 | W. L. Gore & Associates, Inc. | Artificial chordae tendineae repair devices and delivery thereof |
CN111417362A (en) | 2017-12-28 | 2020-07-14 | 旭化成株式会社 | Medical fabric |
US20190240017A1 (en) | 2018-01-03 | 2019-08-08 | Ergosuture Corp. | Threading devices, elongated members, and methods of manufacture and use thereof |
US10980635B2 (en) | 2018-01-07 | 2021-04-20 | William Joseph Drasler | Annuloplasty device and methods |
CN110013356B (en) | 2018-01-07 | 2023-08-01 | 苏州杰成医疗科技有限公司 | Heart valve prosthesis delivery system |
CA3081357A1 (en) | 2018-01-07 | 2019-07-11 | Suzhou Jiecheng Medical Technology Co., Ltd. | Prosthetic heart valve delivery system |
US10543083B2 (en) | 2018-01-08 | 2020-01-28 | Rainbow Medical Ltd. | Prosthetic aortic valve pacing system |
SG11202006045QA (en) | 2018-01-12 | 2020-07-29 | Edwards Lifesciences Corp | Automated heart valve sewing |
WO2019147585A1 (en) | 2018-01-23 | 2019-08-01 | Edwards Lifesciences Corporation | Method for pre-stretching implantable biocompatible materials, and materials and devices produced thereby |
WO2019165213A1 (en) | 2018-02-22 | 2019-08-29 | Medtronic Vascular, Inc. | Prosthetic heart valve delivery systems and methods |
US11051934B2 (en) | 2018-02-28 | 2021-07-06 | Edwards Lifesciences Corporation | Prosthetic mitral valve with improved anchors and seal |
WO2019173385A1 (en) | 2018-03-05 | 2019-09-12 | Harmony Development Group, Inc. | A force transducting implant system for the mitigation of atrioventricular pressure gradient loss and the restoration of healthy ventricular geometry |
KR20200130351A (en) | 2018-03-07 | 2020-11-18 | 이너베이티브 카디오배스큘러 솔류션스, 엘엘씨 | Embolic protection device |
US11071626B2 (en) | 2018-03-16 | 2021-07-27 | W. L. Gore & Associates, Inc. | Diametric expansion features for prosthetic valves |
WO2019191102A1 (en) | 2018-03-27 | 2019-10-03 | Medtronic Inc. | Devices and methods for aortic valve preparation prior to transcatheter prosthetic valve procedures |
US11123208B2 (en) | 2018-03-29 | 2021-09-21 | Medtronic Vascular, Inc. | Prosthesis delivery system with tip travel limiter and method of use |
CA3094248A1 (en) | 2018-04-09 | 2019-10-17 | Edwards Lifesciences Corporation | Expandable sheath |
CN109124829A (en) | 2018-06-29 | 2019-01-04 | 金仕生物科技(常熟)有限公司 | It is a kind of through conduit aortic valve and preparation method thereof |
US10321995B1 (en) | 2018-09-20 | 2019-06-18 | Vdyne, Llc | Orthogonally delivered transcatheter heart valve replacement |
CN109199641B (en) | 2018-10-24 | 2021-04-23 | 宁波健世生物科技有限公司 | Artificial valve prosthesis with fixing piece |
CN109567991B (en) | 2018-12-05 | 2021-02-19 | 东莞市先健医疗有限公司 | Conveying sheath |
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