Epicardial Anchor Locking Pin Mechanism for Valve Sealing
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Solution Overview
Problem
Existing devices for anchoring prosthetic heart valves struggle with large profiles, difficulty in percutaneous delivery, and inefficient sealing of cardiac puncture sites, which can lead to hemodynamic issues and complications.
Innovation Solution
The described apparatus includes a tether attachment member with a base member and a locking pin channel, allowing for secure anchoring of prosthetic heart valves by engaging tethers and providing a mechanism to close cardiac puncture sites effectively.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If staples or fasteners are used to secure tethers, then anchoring strength is improved, but device profile increases and percutaneous delivery becomes difficult
Solution Approach 1:
The locking pin is nested within the locking pin channel, allowing it to be compact during delivery and expand only when needed for securing the tether. This nested configuration enables the device to maintain a small profile for percutaneous delivery while providing sufficient anchoring strength when deployed.
Solution Approach 2:
The tether attachment member is divided into separate functional components: the base member with the locking pin channel, and the movable locking pin itself. This segmentation allows each component to be optimized independently - the channel provides structural support while the pin provides the securing function, reducing overall device complexity and profile.
2Strength
If suturing methods are used to secure tethers, then anchoring strength is improved, but ease of operation deteriorates due to difficulty in maneuvering and securing with desired tension
Solution Approach 1:
The complex manual suturing process is replaced with a simplified mechanical locking system. The locking pin moves along a predefined channel and secures the tether through a straightforward engagement mechanism, eliminating the need for manual knot-tying and tension adjustment while maintaining secure anchoring.
Solution Approach 2:
The locking pin is designed to be movable along the locking pin channel, allowing dynamic adjustment during the securing process. This mobility enables the operator to easily position and secure the tether with the desired tension, then lock the pin in place for stable anchoring.
3Ease of operation
If direct puncture into ventricular wall is made, then percutaneous delivery is enabled, but sealing efficacy deteriorates due to high outward pressure at the puncture site
Solution Approach 1:
The tether attachment member is positioned and secured at the puncture site before attempting to seal the puncture. By establishing the anchoring structure first, the device creates a stable foundation that can then be used to deploy sealing components effectively counteract the high outward pressure at the ventricular puncture site.
Solution Approach 2:
The anchoring function and sealing function are merged into a single integrated device - the tether attachment member. This combination ensures that the anchoring structure and sealing mechanism work together synergistically to address both the delivery access requirement and the sealing challenge at the high-pressure ventricular puncture site.
Data Source
AI summary
Apparatus and methods are described herein for anchoring a prosthetic heart valve. In some embodiments, an apparatus includes a tether attachment member that includes a base member that defines at least a portion of a tether passageway through which a portion of a tether extending from a prosthetic heart valve can be received therethrough. The base member defines a locking pin channel that intersects the tether passageway. A locking pin is disposable within the locking pin channel and movable between a first position in which the locking pin is at a spaced distance from the tether passageway, and a second position in which the locking pin intersects the tether passageway and can engage the portion of a tether disposed therein to secure the tether to the tether attachment member.