Medical device for treating a heart valve insufficiency
Inventors
Guyenot, Volker • Peschel, Thomas • Damm, Christoph • Figulla, Hans-Reiner • Ferrari, Markus • Jung, Johannes
Assignees
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Publication Number
US-11357624-B2
Publication Date
2022-06-14
Expiration Date
Abstract
A medical device for treating a heart valve insufficiency, with an endoprosthesis which can be introduced into a patient's body and expanded to secure a heart valve prosthesis in the patient's aorta. In an embodiment, the endoprosthesis has a plurality of positioning arches configured to be positioned with respect to a patient's aorta and a plurality of retaining arches to support a heart valve prosthesis. The endoprosthesis includes a first collapsed mode during the process of introducing it into the patient's body and a second expanded mode when it is implanted.
Core Innovation
The disclosed endoprosthesis is configured for heart valve insufficiency and includes an integral metal-tube structure with a first mode for catheter delivery and a second mode for implantation in the aorta. The structure has a first set of positioning arches positioned within pockets of a native heart valve on a first side of native valve leaflets, and a second set of arches positioned on a second side of the native valve leaflets.
When implanted, the native valve leaflets are positioned radially inward of at least a portion of the first arches and radially outward of at least a portion of the second arches. A prosthetic heart valve prosthesis is attached to the plurality of second arches such that at least part of the prosthetic valve extends transversely across an interior of the endoprosthesis, and the first arches are self-expandable independently of the second arches.
The integral metal-tube structure includes connecting webs/arms and distal fixing eyes with barbs and/or anchoring supports, with optional slots/elongate holes and reinforcing portions to configure the endoprosthesis. Embodiments also describe a heat-shaping to a concave tapering profile, with a larger distal diameter than proximal, and shape-memory actuation using shape-memory material such as Nitinol with a switching temperature near body temperature.
Claims Coverage
The independent claims are clm-00001, clm-00010, and clm-00017. Across the independent claims, the inventive coverage centers on an endoprosthesis having separately self-expandable first and second arch sets arranged on opposite sides of native valve leaflets, with a prosthetic valve attached to the second arches and extending transversely across the interior, optionally with additional structural constraints such as shape memory material and connecting webs.
First and second arches arranged across native valve leaflets
An endoprosthesis comprising a plurality of first arches configured to be respectively positioned within a plurality of pockets of a native heart valve on a first side of a plurality of native valve leaflets; a plurality of second arches configured to be positioned on a second side of the plurality of native valve leaflets such that the plurality of native valve leaflets are positioned radially inward of at least a portion of the plurality of first arches and radially outward of at least a portion of the plurality of second arches when the endoprosthesis is implanted; and a prosthetic valve attached to the plurality of second arches such that at least part of the prosthetic valve extends from the plurality of second arches transversely across an interior of the endoprosthesis.
Independent self-expansion of first and second arch sets
The plurality of first arches are self-expandable independently of the plurality of second arches.
Shape-memory material for both arch sets with independent self-expansion
The plurality of first arches and the plurality of second arches each comprise a shape memory material, the plurality of first arches being self-expandable independently of the plurality of second arches.
Three connecting webs connecting first and second arches
The plurality of first arches is connected to the plurality of second arches by three connecting webs.
The independent claims collectively cover an endoprosthesis architecture with first arches positioned in native valve pockets on one side of native valve leaflets and second arches on the opposite side, with leaflet positioning radially between the arch sets. A prosthetic valve is attached to the second arches and extends transversely across the interior. The claims further require that the first arches self-expand independently of the second arches, with additional coverage for shape memory material and three connecting webs.
Stated Advantages
Automatic rotational and axial positioning by engagement of positioning arches with valve pockets.
Supporting and sealing of the heart valve prosthesis using retaining arches/retaining segment.
Enhanced anchoring and sealing under peristalsis using a concave tapering profile, with larger distal diameter than proximal.
Documented Applications
Implantation in the aorta for a self-expanding endoprosthesis addressing heart valve insufficiency, with catheter delivery using a first collapsed mode and implantation using a second expanded mode.
Explanting/removal capability using catheter engagement of distal fixing means.
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