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Publication Number
US-12440324-B2
Publication Date
2025-10-14
Expiration Date
Abstract
Devices and methods are discussed herein for protection from embolisms and microembolisms in a subject undergoing catheter-based intravascular procedures. The embolic protection devices have an expandable support frame comprising U-shaped members and leg members which facilitate proper placements in a defective valve annulus. The filtering devices expand in the vessels and allow blood flow to continue through the vessels, thereby catching and removing debris of the flowing blood. Also disclosed are embolic protection devices for use with a sutureless valve prosthesis which is implanted via catheter-based methods.
Core Innovation
The invention relates to a valve prosthesis with embolic protection in which a valve clasper is coupled to a support frame via a filter sheet positioned therebetween. The valve clasper is movable relative to the support frame along a longitudinal axis between a nesting configuration during delivery and an engagement configuration during placement at a native valve. The filter sheet is configured to permit blood flow and prevent passage of debris therethrough.
In the engagement configuration, the support frame is deployed to sandwich a native valve leaflet between an external surface of the support frame and a U-shaped member of the valve clasper to secure the prosthesis within a native valve annulus. The nesting configuration enables series positioning of the valve clasper and the support frame along the longitudinal axis so that both components provide a diameter that can readily fit within a sheath or tube advanced through vessel walls with minimal or no damage.
The invention also includes a method to implant the valve prosthesis in a patient, advancing the valve prosthesis through a vessel in a compact configuration while the valve clasper is movable and coupled to the support frame via the filter sheet. The method permits expansion of the valve clasper and permits expansion of the support frame within the valve clasper, while blood flow is permitted through the filter sheet to restrict passage of debris through the filter sheet.
Claims Coverage
The partial content includes two independent claims: a valve prosthesis with embolic protection and a method to implant the valve prosthesis. Across these independent claims, there are three main inventive aspects.
Filter sheet coupled, longitudinally movable valve clasper and support frame
A valve prosthesis comprising a support frame; a valve clasper coupled to the support frame via a filter sheet positioned therebetween, the valve clasper being movable relative to the support frame along a longitudinal axis between a nesting configuration during delivery and an engagement configuration during placement at a native valve.
Filter sheet permits blood flow and prevents debris passage
A valve prosthesis wherein the filter sheet is configured to permit blood flow and prevent passage of debris therethrough.
Implantation via compact advancement with expandable support and clasper
A method to implant a valve prosthesis in a patient, comprising advancing the valve prosthesis in a compact configuration through a vessel of the patient, the valve prosthesis having a support frame and a valve clasper movably coupled to the support frame via a filter sheet; permitting expansion of the valve clasper; and permitting expansion of the support frame within the valve clasper.
Overall, the independent claims center on a valve prosthesis where the valve clasper and support frame are coupled through a filter sheet and are configured to move between nesting and engagement configurations. The filter sheet enables blood flow while restricting debris passage, and the method claim emphasizes compact advancement followed by expansion of the valve clasper and the support frame to provide the desired embolic-protective function during implantation.
Stated Advantages
Permit blood flow while preventing passage of debris through the filter sheet.
Restrict passage of debris through the filter sheet during implantation.
Documented Applications
Implanting a valve prosthesis in a patient by advancing the valve prosthesis through a vessel in a compact configuration.
Providing embolic protection for valve placement at a native valve by using the filter sheet configured to permit blood flow and prevent passage of debris therethrough.
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