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Publication Number
US-11510769-B2
Publication Date
2022-11-29
Expiration Date
Abstract
Devices and methods for providing 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 document describes a valve prosthesis with embolic protection that includes a support frame radially expandable between a compact configuration during delivery to a native valve and an expanded configuration during placement at the native valve. The support frame defines a central orifice about a longitudinal axis along an inflow-outflow direction, and the support frame comprises a plurality of flexible prosthetic leaflets to provide a one-way valve in the orifice when the support frame is in the expanded configuration.
A valve clasper is coupled to and movable relative to the support frame along the longitudinal axis between a nesting position during delivery and an engagement position during placement at the native valve. The valve clasper comprises U-shaped members and leg members extending along the longitudinal axis, where the leg members extend longitudinally between adjacent U-shaped members and are engageable to permit manipulation of a position of the valve clasper.
In the disclosed arrangement, the filter sheet is coupled to the support frame and the valve clasper. The filter sheet is configured to permit blood flow and prevent passage of debris therethrough.
The system further connects the embolic protection function with implantation of a sutureless cardiac valve prosthesis, where the support frame and valve clasper interact to secure a native leaflet while the filter sheet blocks passage of debris. This integration is intended to seal a native leaflet while preventing debris passage through the filter sheet.
Claims Coverage
The document includes three independent claims that share a core architecture: a radially expandable support frame with flexible prosthetic leaflets forming a one-way valve, a movable valve clasper having U-shaped members and leg members that transition between a nesting position and an engagement position, and a filter sheet coupled to the support frame and valve clasper to permit blood flow while preventing passage of debris. Across the independent claims, the distinctive inventive features are the combined valve prosthesis and embolic-protection structure and its implantation/delivery interaction using positional nesting and engagement along a longitudinal axis.
Radially expandable support frame with flexible prosthetic leaflets forming a one-way valve
A support frame defining a central orifice about a longitudinal axis along an inflow-outflow direction, the support frame being radially expandable between a compact configuration during delivery to a native valve and an expanded configuration during placement at the native valve, the support frame comprising a plurality of flexible prosthetic leaflets to provide a one-way valve in the orifice when the support frame is in the expanded configuration.
Movable valve clasper with U-shaped members and leg members transitioning between nesting and engagement positions
A valve clasper coupled to and movable relative to the support frame and along the longitudinal axis between a nesting position during delivery and an engagement position during placement at the native valve, the clasper comprising U-shaped members and leg members extending along the longitudinal axis, each of the leg members extending longitudinally between adjacent U-shaped members and being engageable to permit manipulation of a position of the valve clasper.
Filter sheet coupled to support frame and valve clasper to permit blood flow and prevent debris passage
A filter sheet coupled to the support frame and the valve clasper, wherein the filter sheet is configured to permit blood flow and prevent passage of debris therethrough.
Valve prosthesis for engaging native valve leaflet and valve annulus with clasper deployable to secure native leaflet
A valve prosthesis with embolic protection device for engagement with at least one native valve leaflet and a valve annulus of a native valve, wherein during placement of the valve clasper at the native valve, the support frame is deployable to secure the at least one native valve leaflet between the support frame and the valve clasper.
Valve clasper geometry with three U-shaped members and three leg members movable along the longitudinal axis
A valve clasper coupled to and movably attached to the support frame, the valve clasper comprising three U-shaped members and three leg members, the U-shaped members each comprising a peak portion and a valley portion, each U-shaped member being coupled to an adjacent U-shaped member at the peak portions thereof, each of the leg members being positioned circumferentially intermediate respective U-shaped members at the peak portions thereof, the U-shaped members and the leg members being movable relative to the support frame along the longitudinal axis between a nesting position during delivery and an engagement position during placement at the native valve, the leg members being engageable to permit manipulation of a position of the valve clasper.
Method implanting a valve prosthesis by advancing in compact configuration, positioning engagement, expanding support frame to secure leaflet, and restricting debris passage with filter sheet
A method to implant a valve prosthesis in a patient, the method comprising advancing the valve prosthesis in a compact configuration through a vessel of the patient, permitting expansion of the valve clasper, moving the valve clasper into an engagement position via engagement with the leg members, positioning the support frame within a lumen of the valve clasper, permitting expansion of the valve support frame within the valve clasper to sandwich a native valve leaflet between an external surface of the support frame and the valve clasper to secure the valve prosthesis within a native valve annulus, and permitting blood flow through a filter sheet coupled to the support frame and the valve clasper for restricting passage of debris through the filter sheet.
Across the independent claims, the document covers a valve prosthesis with embolic protection that combines a radially expandable support frame that carries flexible prosthetic leaflets to provide a one-way valve, a movable valve clasper with U-shaped members and leg members that transitions between a nesting position during delivery and an engagement position during placement, and a filter sheet coupled to the support frame and valve clasper configured to permit blood flow and prevent or restrict passage of debris. One claim further specifies a valve-annulus and leaflet engagement context and a three-U-shaped-member clasper geometry, and another recites an implantation sequence centered on positional offset, engagement, support-frame expansion to sandwich a native leaflet, and filter-sheet debris restriction.
Stated Advantages
Permits blood flow while preventing passage of debris through the filter sheet.
Restricts passage of debris through the filter sheet during implantation.
Provides a one-way valve in the orifice when the support frame is in the expanded configuration.
Secures the valve prosthesis within a native valve annulus by sandwiching a native valve leaflet between the external surface of the support frame and the valve clasper.
Documented Applications
No documented applications found
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