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-12232957-B2
Publication Date
2025-02-25
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
The invention relates to an endoprosthesis for implantation at a native heart valve, where an expandable stent positions and retains a valvular prosthesis while limiting longitudinal displacement during peristaltic motion. The expandable stent includes retaining arches and positioning arches that are coupled to each other by connecting struts configured to offset the arches relative to each other. The sequential expansion of the retaining arches and the positioning arches causes the arches to clip at least one native leaflet of the native heart valve.
Auxiliary arches are uniformly distributed around a lower end of the expandable stent and are configured to press against a vascular wall. The auxiliary arches and the retaining arches are configured to form a seal with the vascular wall. In this way, the endoprosthesis anchors against the vascular wall while also enabling positioning in pockets of the native heart valve and subsequently clipping native leaflet tissue between retaining arches and positioning arches.
Deployment of the endoprosthesis includes delivering the endoprosthesis to the native heart valve in a compressed state, causing the positioning arches to at least partially expand, and positioning the positioning arches into pockets of the native heart valve. After positioning, the retaining arches are caused to at least partially expand to clip at least one native leaflet of the native heart valve between at least one retaining arch and at least one positioning arch. The expandable stent is formed as a self-expandable (shape-memory) structure, and dependent aspects describe coupling with a valve prosthesis with prosthetic leaflets and coupling options using fastening holes and sutures.
Claims Coverage
The document includes two independent claims that cover an endoprosthesis for implantation at a native heart valve and a method for implanting such an endoprosthesis, centered on sequential expansion of positioning and retaining arches, auxiliary arches for sealing and pressing against a vascular wall, and connecting struts that offset the arches. In total, the independent claim set emphasizes four main inventive features: sequential arch expansion for leaflet clipping, auxiliary arches for sealing/pressing, connecting struts that offset arches, and pocket positioning of native valve tissue before leaflet clipping.
Sequential expansion positioning and retaining arches to clip native leaflet
The retaining arches and the positioning arches are configured to be sequentially expanded to cause the plurality of retaining arches and the plurality of positioning arches to clip at least one native leaflet of the native heart valve.
Auxiliary arches press and seal with vascular wall
The plurality of auxiliary arches uniformly distributed around a lower end of the expandable stent and configured to press against a vascular wall, wherein the plurality of auxiliary arches and the plurality of retaining arches are configured to form a seal with the vascular wall.
Offset by connecting struts between positioning and retaining arches
A plurality of connecting struts, each connecting strut coupled at a first end of each connecting strut to at least one positioning arch of the plurality of positioning arches and coupled at a second end of each connecting strut to at least one retaining arch of the plurality of retaining arches, the plurality of connecting struts configured to offset the plurality of retaining arches from the plurality of positioning arches.
Method sequence: expand positioning arches into pockets before expanding retaining arches to clip
Causing the plurality of positioning arches to at least partially expand; positioning, after causing the plurality of positioning arches to at least partially expand, the plurality of positioning arches into pockets of the native heart valve; and causing, after positioning the positioning arches into pockets of the native heart valve, the plurality of retaining arches to at least partially expand, thereby clipping at least one native leaflet of the native heart valve between at least one of the plurality of retaining arches and at least one of the plurality of positioning arches.
Across the independent claims, the coverage is directed to an expandable-stent endoprosthesis with auxiliary arches that press against and seal the vascular wall, and a sequential deployment in which positioning arches expand into pockets prior to retaining arches expanding to clip native leaflet tissue between retaining and positioning arches, with connecting struts offsetting the arch structures.
Stated Advantages
Substantially prevents longitudinal displacement during peristaltic motion.
Forms a seal with the vascular wall.
Clips at least one native leaflet of the native heart valve.
Documented Applications
Minimally invasive treatment of valve stenosis and/or insufficiency at a native heart valve.
Implantation of an endoprosthesis at a native heart valve via transarterial and/or transapical delivery with a compressed state and catheter tip release.
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