Annuloplasty Ring Structure for Secure Commissure Fixation
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Solution Overview
Problem
Existing annuloplasty implants face challenges in achieving correct positioning and secure fixation at the heart valve, leading to insufficient suturing strength, time-consuming procedures, and increased patient risk due to traumatic effects from inadequate fixation structures.
Innovation Solution
An annuloplasty device with first and second support rings arranged as a coil around a central axis, positioned on opposite sides of native heart valve leaflets, featuring a transition section at the commissure, and retention units to anchor the device securely, utilizing shape-memory materials for improved accommodation and fixation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If suturing devices are used for annuloplasty implant positioning, then the implant can be fixedated at the heart valve, but the procedure becomes very time-consuming and suturing strength is insufficient
Solution Approach 1:
The patent replaces the mechanical suturing system with a self-expanding frame structure that achieves fixation through radial expansion force. The frame expands from a compressed delivery state to a deployed state, where the radial force presses the frame against the annulus tissue, creating secure fixation without requiring sutures or clips.
Solution Approach 2:
The annuloplasty frame performs self-fixation through its own structural design. The self-expanding mechanism automatically generates the necessary fixation force when deployed, eliminating the need for separate fixation devices or time-consuming surgical procedures. The frame's geometry and material properties enable it to self-anchor in the annulus tissue.
2Reliability
If clips are used for positioning annuloplasty implants, then fixation can be achieved, but traumatic effects occur and long-term stability is compromised
Solution Approach 1:
The patent replaces the clipping mechanism with a distributed radial pressure system. Instead of concentrated forces from clips that can damage tissue, the frame distributes fixation force uniformly across the annulus tissue through its expanded structure, reducing localized trauma while maintaining long-term stability.
Solution Approach 2:
The frame incorporates flexible struts and connection elements that can conform to the natural curvature and movement of the heart annulus. This flexibility allows the frame to move with the heart's physiological motions without causing stress concentration or tissue damage, ensuring long-term stability without traumatic effects.
3Manufacturing precision
If traditional annuloplasty implants are used, then valve repair can be performed, but correct positioning and fixation are difficult to achieve
Solution Approach 1:
The annuloplasty frame is designed with a nested structure where the expanded frame contains compressed delivery catheters and positioning tools. This nesting allows the complex device to be delivered through a relatively simple catheter-based approach, simplifying the implantation procedure while maintaining precise positioning capability through the structured expansion sequence.
Solution Approach 2:
The frame is pre-shaped and pre-sized during manufacturing to match the target annulus geometry. The delivery system is pre-configured with the frame in a compressed state, and the deployment sequence is designed to automatically position the frame at the correct location before expansion. This preliminary preparation eliminates the need for complex intra-procedural adjustments.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Facilitates secure, long-term fixation of the annuloplasty device with reduced risk of anatomical damage, enabling a less complex and time-efficient implantation procedure with enhanced retention force and accommodation to heart valve anatomy.
Implementation Method 1
The transition section bends at least partly along the central axis so that the first coil plane is separated a distance (d1) from the second coil plane along the central axis at the transition section
Implementation Method 2
utilizing shape-memory materials for improved accommodation and fixation
Data Source
AI summary
An annuloplasty device is disclosed comprising first and second support rings having a coiled configuration, and respective first and second retention units, the first support ring transitions to the second support ring over a transition section, the transition section is adapted to be arranged at a commissure of the heart valve leaflets, the first and second support rings extend in respective first and second coil planes being essentially perpendicular to the central axis, the transition section bends at least partly along the central axis so that the first coil plane is separated a distance from the second coil plane along the central axis at the transition section.