Heart valve prosthesis
Inventors
Zhang, Ji • Walsh, Brandon G. • Yang, Cheng Yong • Zhu, Jinhua • McMahon, Dennis
Assignees
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Publication Number
US-11083577-B2
Publication Date
2021-08-10
Expiration Date
Abstract
The present disclosure relates to heart valve prostheses, delivery devices, actuation handles, and other improved devices and methods that facilitate delivery of a heart valve prosthesis to a defective native valve structure in a patient, such as the aortic valve.
Core Innovation
The document describes a valve prosthesis for transcatheter deployment in which a valve anchor includes at least one U-shaped member extending about a longitudinal axis. The U-shaped member has a peak portion and a base portion, and the peak portion defines an engagement area formed by coupled peak portions of adjacent U-shaped members. The valve anchor is expandable from a compressed configuration for engaging a native valve structure.
An expandable valve frame has a compressed configuration and an expanded configuration and is configured to expand within the valve anchor at the native valve structure. A link mechanism interconnects the valve anchor and the valve frame, is coupled to the valve frame, and is slidably coupled to the U-shaped member. When the link mechanism is moved from the base portion to be captured within the peak portion engagement area, it limits axial movement of the valve frame relative to the valve anchor.
In further implementations, a suture interconnects the valve anchor with the valve frame and is coupled to the valve frame and slidably coupled to the valve anchor. The suture includes a weave pattern extending from circumferential positions on the valve frame to legs of first and second U-shaped members and back to a circumferential position on the valve frame. The suture is slidable along each U-shaped member from the base portion to be captured within the peak portion engagement area, thereby limiting axial movement of the valve frame relative to the valve anchor.
Claims Coverage
The partial content includes four independent claims. Across them, inventive features are directed to a valve anchor with U-shaped members and peak-portion engagement areas, an expandable valve frame configured to expand within the anchor, and a link mechanism that is captured in the engagement area to limit relative axial movement; one claim further specifies a suture weave pattern and another adds a delivery method using sheath or carrier restraint and link capture.
Valve anchor with coupled peak portion engagement areas and expandable valve frame
A valve prosthesis comprising a valve anchor having at least one U-shaped member with a peak portion and a base portion, the peak portion having an engagement area formed by coupled peak portions of adjacent U-shaped members, an expandable valve frame configured to expand within the valve anchor at the native valve structure, and a link mechanism interconnecting the valve anchor with the valve frame and being slidably coupled to the U-shaped member so that it is captured within the peak portion engagement area to limit axial movement of the valve frame relative to the valve anchor.
Delivery method using compressed restraint, link capture, and sequential expansion
A method for delivering a prosthetic heart valve prosthesis including introducing the prosthesis, permitting expansion of the base portion of the valve anchor, distally urging the base portion of the valve anchor into engagement with a native valve structure, proximally retracting the valve frame relative to the valve anchor to slide the link mechanism proximally toward an engagement area of the peak portion to urge the link mechanism into the engagement area and capture it to restrict movement of the valve frame relative to the valve anchor, releasing the peak portion of the valve anchor to permit expansion against the native valve structure, and permitting expansion of the valve frame within a lumen of the valve anchor.
U-shaped peak portion engagement area limiting axial movement of a coupled link
A valve prosthesis comprising a valve anchor having at least one U-shaped member extending about a longitudinal axis, the U-shaped member having a peak portion and a base portion where the peak portion defines an engagement area for capturing a link mechanism that limits axial movement of the link mechanism coupled thereby to the valve anchor and limits movement of the link mechanism along the U-shaped member, the valve anchor being expandable from a compressed configuration for engaging a native valve structure.
Suture weave pattern for sliding capture along interconnected U-shaped members
A valve prosthesis comprising a valve anchor with first and second interconnected U-shaped members each having a peak portion and a base portion, an expandable valve frame configured to expand within the valve anchor at the native valve structure, and a suture interconnecting the valve anchor with the valve frame where the suture is coupled to the valve frame and slidably coupled to the valve anchor and has a weave pattern extending from a first circumferential position at the valve frame to the first leg of the first U-shaped member, then to the second leg of the second U-shaped member, and then to a first or second circumferential position at the valve frame, with the suture slidable along each U-shaped member from the base portion to be captured within the peak portion engagement area to limit axial movement of the valve frame relative to the valve anchor.
Taken together, the independent claims focus on capturing a slidably coupled link mechanism, including a suture weave pattern in one case, within a peak-portion engagement area formed by coupled U-shaped members, while an expandable valve frame expands within the anchor at a native valve structure. In the method claim, the link is captured by proximally retracting the valve frame relative to the valve anchor while the anchor and frame are restrained in compressed states, followed by expansion against the native valve structure.
Stated Advantages
Reduced cross-sectional passing profile.
Improved maneuverability.
Controlled deployment sequence.
Minimized snagging.
Improved positioning, migration, and reduction of paravalvular leakage outcomes, including potential benefits for aortic regurgitation.
Documented Applications
Prosthetic heart valve delivery to a native valve structure of a patient at an implantation site, including transcatheter delivery of a prosthetic heart valve to a native valve structure.
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