Prosthetic heart valve and transcatheter delivered endoprosthesis comprising a prosthetic heart valve and a stent
Inventors
Girard, Michael J. • Lane, Randy • Mayer, Arnulf
Assignees
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Publication Number
US-11589981-B2
Publication Date
2023-02-28
Expiration Date
Abstract
The invention relates to a prosthetic heart valve (100) for an endoprosthesis (1) used in the treatment of a stenotic cardiac valve and/or a cardiac valve insufficiency. The prosthetic heart valve (100) comprises of a plurality of leaflets (102), which consist of a natural and/or synthetic material and have a first opened position for opening the heart chamber and a second closed position for closing the heart chamber, the leaflets (102) being able to switch between their first and second position in response to the blood flow through the heart. In addition, the prosthetic heart valve (100) comprises a leaflet support portion (103), consisting of biological and/or synthetic material for mounting of the prosthetic heart valve (100) to a stent (10), and a bendable transition area (104) which forms a junction between the leaflets (102) and the leaflet support portion (103), the transition area (104) progressing essentially in a U-shaped manner similar to a cusp shape of a natural aortic or pulmonary heart valve for reducing tissue stresses during opening and closing motion of the leaflets (102). The invention further relates to an endoprosthesis (1) comprising a prosthetic heart valve (100) and a stent (10).
Core Innovation
The invention relates to an endoprosthesis for implantation at a patient's native heart valve, comprising a stent, prosthetic leaflets, and lattice cells disposed to enable prosthetic leaflets to transition from an open position to a closed position. The stent includes a proximal portion and a distal portion and includes arches around the circumference configured to contact and clip native leaflet(s) therebetween.
Adjacent prosthetic leaflets join together and are configured to be coupled to an apex of an arch or to a through hole of the stent. A transition area is described as a bendable U-shaped or cusp-like transition area between leaflets and a skirt portion for mounting to a self-expandable stent. Leaflet-to-stent attachment is addressed through fastening holes and/or fastening notches and through coupling arrangements at a commissure region.
Durability and reduced stress concentration are emphasized by integrally formed one-piece tissue or multi-piece pericardial tissue for the prosthetic tissue structure, intended to reduce seam-related stress concentration and calcification. Additional reinforcement elements are described, including inner cushion, wire rail, inner attachment rail, and outer wrapping element(s) with rounded edges to reduce abrasion and wear.
Claims Coverage
The document includes two independent claims. Across them, the inventive coverage centers on a stent architecture with arches that clip native leaflets and/or provide leaflet-contact features, lattice cells extending between arches, and prosthetic leaflets that transition open-to-closed while adjacent leaflets join and are coupled at an apex of an arch or at a through hole of the stent.
Prosthetic valve endoprosthesis with paired arches clipping native leaflets and arch-apex leaflet coupling
An endoprosthesis comprising a stent with a proximal portion and a distal portion, wherein the proximal portion comprises a first plurality of arches and a second plurality of arches corresponding to the first plurality such that each corresponding pair of arches is configured to clip a native leaflet therebetween; lattice cells extending between the second plurality of arches; and prosthetic leaflets disposed within the stent configured to transition from an open position to a closed position, wherein at least a portion of adjacent prosthetic leaflets join together and are configured to be coupled to an apex of an arch of the first plurality of arches.
Stent with through hole(s) and arches contacting native leaflet, enabling through-hole leaflet coupling
An endoprosthesis comprising a stent with a proximal portion and a distal portion, wherein the proximal portion comprises at least one through hole and a first plurality of arches around the circumference configured to contact a native leaflet; lattice cells extending between and connecting each one of the first plurality of arches; and prosthetic leaflets disposed within the stent configured to transition from an open position to a closed position, wherein at least a portion of adjacent prosthetic leaflets join together and are configured to be coupled to the stent at the at least one through hole of the stent.
Taken together, the independent claim coverage requires prosthetic leaflets transitioning between open and closed positions and adjacent leaflets joining, supported by a stent architecture that uses arches and lattice cells. Coupling of the joined adjacent leaflets is specifically to either an apex of an arch or to a through hole of the stent.
Stated Advantages
Reduces seam-related stress concentration and calcification.
Reduces stress and wear through reinforcement elements with rounded edges to prevent abrasion.
Improves leaflet-to-stent attachment using fastening holes/notches.
Reduces device migration and paravalvular leakage using leaflet guard arches and attachment/collar and support structures as described.
Documented Applications
Transcatheter prosthetic heart valve endoprosthesis for implantation at a patient's native heart valve using catheter delivery/collapsibility as described.
Native leaflet protection and mitigation of paravalvular leakage and prevention of device migration via optional leaflet guard arches and described valve structures.
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