Heart valve prosthesis
Inventors
Zhang, Ji • Walsh, Brandon G. • Yang, Cheng Yong • Zhu, Jinhua
Assignees
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Publication Number
US-12059349-B2
Publication Date
2024-08-13
Expiration Date
Abstract
A valve prosthesis can be manufactured by aligning a membrane along a support frame and attaching the membrane to the support frame. The membrane can have a plurality of first fibers arranged in a warp direction and a plurality of second fibers arranged in a weft direction that is transverse relative to the warp direction. The plurality of first fibers and the plurality of second fibers can be woven together. The warp and weft directions can be oriented oblique relative to a longitudinal axis of the support frame.
Core Innovation
The invention relates to manufacturing a valve prosthesis by aligning a woven membrane along a support frame having a longitudinal axis. The membrane includes a plurality of first fibers arranged in a warp direction and a plurality of second fibers arranged in a weft direction transverse relative to the warp direction, where the warp and weft directions are oblique relative to the longitudinal axis of the support frame. The first fibers and the second fibers are woven together before attachment.
The invention further provides for attaching the woven membrane to the support frame. In particular configurations, the membrane includes major peak portions and at least one minor peak portion, and these peak portions are aligned with corresponding bottom-edge and peak portions of the support frame having major peak portions and minor peak features. Attachment can include wrapping membrane peak portions around corresponding peak portions of the support frame to cover parts of inner and outer surfaces at those peak portions.
The invention also supports coupling of the woven membrane to the support frame in a way that is consistent with the prosthesis geometry and operation. In some configurations, attaching includes a plurality of sutures and coupling allows membrane movement relative to the support frame after attachment. In related configurations, the warp and weft fibers are aligned in oblique directions relative to the longitudinal axis and are further aligned with expandable elements of the support frame that transition between a compressed configuration and an expanded configuration.
Claims Coverage
The provided independent claims cover a method of manufacturing a valve or heart valve prosthesis by coupling a woven membrane to a support frame while aligning fiber directions oblique to the support-frame longitudinal axis, with attachment of the membrane to the support frame. The claim set includes 7 inventive features.
Woven membrane fiber alignment oblique to the longitudinal axis
Aligning a membrane along a support frame having a longitudinal axis, wherein the membrane comprises a plurality of first fibers arranged in a warp direction and a plurality of second fibers arranged in a weft direction transverse relative to the warp direction, the first and second fibers being woven together, and the warp and weft directions being oblique relative to the longitudinal axis of the support frame.
Attaching the membrane to the support frame
Attaching the membrane to the support frame after the membrane is aligned along the support frame having a longitudinal axis.
Coupling a woven membrane with warp and weft fibers oblique to the longitudinal axis
Coupling a woven membrane to a support frame of the heart valve prosthesis, and aligning warp and weft fibers of the membrane in warp and weft directions that are oblique relative to a longitudinal axis of the support frame.
Coupling with a plurality of sutures permitting membrane movement
Attaching the membrane to the support frame with a plurality of sutures that allow the membrane to move relative to the support frame after attachment.
Attaching to a wire support frame by wrapping sutures
Passing a plurality of sutures through the membrane and wrapping the sutures around portions of a wire structure of the support frame.
Geometric correspondence of frame peak/base and membrane peak/base
Characterized in that the support frame has peak portions and base portions, and the membrane has corresponding membrane peak portions and membrane base portions matching the support frame portions.
Cylindrical membrane shape matching the support frame shape
Forming the membrane into a cylindrical shape by joining one lateral end of the membrane to the other, where the cylindrical shape matches the support frame’s shape.
Across the independent claims, the core claim coverage centers on manufacturing by coupling a woven membrane whose warp and weft fiber directions are oblique relative to the support-frame longitudinal axis, followed by attaching the membrane to the support frame. Dependent features further specify suture-based coupling that permits membrane movement, attachment to a wire support frame via wrapped sutures, geometric correspondence between frame peak/base portions and membrane peak/base portions, and forming a cylindrical membrane shape matching the support frame.
Stated Advantages
Improved coronary ostia access due to minor peak geometry.
Reduced reliance on radial retention via sandwiching native leaflets.
Reduced membrane stress/bunching during compression to facilitate tandem operation of the membrane and expandable frame.
Documented Applications
Transcatheter heart valve prosthesis (TAVI/TAVR) delivery/device context with membrane coupled to a support frame and expandable frame behavior during compression/expansion.
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