Tissue Anchor Eyelet Geometry for Wire Sliding and Secure Anchoring
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Solution Overview
Problem
Existing tissue anchor technologies face challenges in facilitating medical procedures like annuloplasty, especially when there is no line-of-sight to the target, and in ensuring secure anchoring and smooth sliding of anchors along wires or sutures during transcatheter delivery and post-implantation.
Innovation Solution
The development of tissue anchors with helical-shaped tissue-engaging elements and eyelets that allow for smooth sliding both parallel and orthogonal to the wire, along with spacers for stable spacing and conformational changes visible via imaging for successful anchoring, and systems for locking and covering excess contracting members.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the anchor is designed to be slidable along the wire in both aligned and orthogonal orientations, then the ease of operation is improved, but the device complexity increases
Solution Approach 1:
The eyelet is designed with a curved, rounded geometry rather than sharp edges or angular features. This curvature allows the wire to slide smoothly through the eyelet regardless of whether the anchor is oriented parallel or perpendicular to the wire, eliminating the need for complex mechanical guidance features while maintaining ease of operation.
Solution Approach 2:
The eyelet has an asymmetric cross-sectional shape that is optimized for wire passage. The eyelet opening is positioned and shaped to accommodate the wire's path during both aligned and orthogonal configurations, allowing a single asymmetric design to replace what would otherwise require multiple symmetric variants or complex adjustment mechanisms.
2Reliability
If the helical tissue-engaging element is used to capture the wire, then the reliability of anchoring is improved, but the ease of operation during delivery is worsened
Solution Approach 1:
The helical tissue-engaging element is designed to be dynamic rather than static. During delivery, the helix remains in an open, relaxed state that allows easy passage through the delivery catheter. Upon deployment, the helix automatically transitions to a captured state where it secures the wire, providing reliable anchoring without requiring complex manual manipulation during the delivery phase.
Solution Approach 2:
The anchor is pre-configured with the helical element in a compressed or open state before delivery, allowing it to pass through the delivery system easily. The wire capture function is prepared in advance but remains inactive during delivery, activating only after the anchor is positioned, thus separating the delivery simplicity from the anchoring reliability functions.
3Adaptability or versatility
If the eyelet is positioned laterally from the central axis, then the adaptability for different wire orientations is improved, but the manufacturing precision requirements increase
Solution Approach 1:
The eyelet is positioned at a specific lateral location on the anchor body rather than being centrally located or distributed throughout. This localized positioning is optimized for the specific function of wire passage during both aligned and orthogonal orientations. The eyelet's local geometry and position are precisely engineered to accommodate the wire's path, allowing the rest of the anchor to be manufactured with standard tolerances while maintaining high adaptability.
Data Source
Figure 1A~1C
Figure 2A~2B
Figure 3A~3B
AI summary
A system (500) includes a wire (512), and first and second anchors (520). Each of the first and second anchor can be configured to include (i) a tissue-engaging element (530) having a sharpened distal tip, and configured to be driven into tissue of a subject; and (ii) a head (580) coupled to a proximal end of the tissue-engaging element. The head can include a driver interface (582), configured to be reversibly engaged by an anchor driver (560). A flexible sheet (540) defines a hole (542) through which an anchor extends and an eyelet (546) through which the wire is threaded.