Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient
Inventors
Straubinger, Helmut • Jung, Johannes
Assignees
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Publication Number
US-11564794-B2
Publication Date
2023-01-31
Expiration Date
Abstract
The present invention relates to a stent (10) for the positioning and anchoring of a valvular prosthesis (100) in an implantation site in the heart of a patient. Specifically, the present invention relates to an expandable stent for an endoprosthesis used in the treatment of a narrowing of a cardiac valve and/or a cardiac valve insufficiency. So as to ensure that no longitudinal displacement of a valvular prosthesis (100) fastened to a stent (10) will occur relative the stent (10) in the implanted state of the stent (10), even given the peristaltic motion of the heart, the stent (10) according to the invention comprises at least one fastening portion (11) via which the valvular prosthesis (100) is connectable to the stent (10). The stent (10) further comprises positioning arches (15) and retaining arches (16), whereby at least one positioning arch (15) is connected to at least one retaining arch (16) via a first connecting land (17). The stent (10) moreover comprises at least one auxiliary retaining arch (18) which connects the respective arms (16′,16″) of the at least one retaining arch (16) connected to the at least one positioning arch (15).
Core Innovation
An expandable self-expanding cardiac valve stent for an endoprosthesis is disclosed for positioning and anchoring a valvular prosthesis while minimizing longitudinal displacement caused by heart peristalsis. The stent includes positioning arches and retaining arches connected by first connecting webs, and auxiliary retaining arches that interconnect retaining-arch arms to generate a radially-acting contact/tensioning force for secure anchoring and sealing. The stent is configured as an integrally cut one-piece tubular construction with U-shaped/V-shaped arch geometries and a concave tapering expanded configuration, with positioning arches engaging pockets in the native cardiac valve.
The endoprosthesis further includes longitudinal fastening portions with distributed fastening holes to affix the valvular prosthesis with minimal play. The fastening holes enable attachment using threads/wires, and the longitudinal fastening portions are arranged to reduce chafing and wear of the valvular prosthesis. Optional structural features include reference markers, eyelets, and catheter retaining means.
Methods for treating a native heart valve are disclosed with the endoprosthesis introduced while in a collapsed configuration and positioned proximate the native heart valve under catheter control with fluoroscopic/echo guidance. The disclosed sequence expands the plurality of positioning arches while maintaining the plurality of retaining arches and the valvular prosthesis in the collapsed configuration, positioning the apex of each positioning arch within a respective pocket and positioning retaining arches and interconnecting structures radially inward of leaflets. Expanding a remainder of the endoprosthesis expands the valvular prosthesis such that each leaflet is positioned radially between portions of the positioning arches and portions of the retaining arches.
Claims Coverage
The independent claims cover staged expansion and spatial positioning of a collapsed endoprosthesis with exactly three first arches and additional second arches and interconnecting structures, so that valve leaflets are positioned radially between first-arch portions and second-arch portions. Across the independent claims, the core inventive features include the collapsed delivery and selective staged expansion, the pocket-based placement of first-arch apexes, and radially inward/outward placement coordination between arch sets and leaflets.
Collapsed endoprosthesis with staged expansion
Introducing an endoprosthesis into a patient's vasculature or via a femoral artery through a blood vessel while the endoprosthesis is in a collapsed configuration, positioning it proximate a native heart valve, expanding the plurality of first arches while maintaining the plurality of second arches, the plurality of interconnecting structures, and the valvular prosthesis in the collapsed configuration, and expanding a remainder of the endoprosthesis such that the valvular prosthesis expands.
Three positioning arches with apex placement in pockets
The plurality of first arches includes exactly three first arches, positioning the apex of each first arch within a respective pocket of the native heart valve, and positioning the apex of each first arch radially outward of a respective leaflet of the native heart valve where applicable.
Radially inward second arches and interconnecting structures relative to leaflets
Positioning the plurality of second arches and the plurality of interconnecting structures radially inward of leaflets of the native heart valve.
Leaflets radially between first-arch portions and second-arch portions
Expanding the plurality of second arches and the plurality of interconnecting structures, or expanding a remainder of the endoprosthesis, wherein each leaflet of the native heart valve is positioned radially between at least a portion of the plurality of first arches and at least a portion of the plurality of second arches.
Overall, the independent claims define treating a native heart valve by positioning a collapsed endoprosthesis near the valve and performing staged expansion where the first arches (exactly three) are expanded into pocket- and leaflet-relative positions while second arches and interconnecting structures remain collapsed initially and are then expanded so that each leaflet is positioned radially between first-arch portions and second-arch portions.
Stated Advantages
Minimizing longitudinal displacement from heart peristalsis.
Generating secure anchoring and sealing via a radially-acting contact/tensioning force.
Reducing chafing and wear of the valvular prosthesis by providing fastening with minimal play.
Documented Applications
Treating a native heart valve by introducing a collapsed endoprosthesis, positioning it proximate the native heart valve, and expanding positioning arches and retaining arches/interconnecting structures so the valvular prosthesis expands and leaflets are positioned radially between arch portions.
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