Annuloplasty Device Self-Expanding Frame Fixation
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Solution Overview
Problem
Existing annuloplasty devices face challenges in achieving correct positioning and reliable fixation at the heart valve, leading to insufficient suturing strength, time-consuming procedures, and increased patient risk due to inadequate fixation, particularly in catheter-based procedures.
Innovation Solution
The annuloplasty device comprises first and second support rings configured as a coil around the heart valve leaflets with an interior channel for a stiffening unit, which increases stiffness, and a delivery device with a locking structure for secure positioning and fixation, facilitating easier implantation and long-term stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If suturing devices are used for annuloplasty implant fixation, then the implant can be positioned at the heart valve, but the procedure becomes very time-consuming and suturing strength is insufficient
Solution Approach 1:
The patent replaces the traditional mechanical suturing system with a self-expanding frame structure that achieves fixation through radial expansion and tissue engagement. The frame expands from a compressed delivery state to a deployed state, mechanically interlocking with the annular tissue to provide secure fixation without requiring sutures or clips.
Solution Approach 2:
The frame is pre-configured in a compressed state within the delivery device, allowing it to be delivered to the target site in advance. Upon deployment, the frame automatically expands to its functional configuration, performing the fixation action immediately without requiring time-consuming manual suturing or clipping procedures.
2Reliability
If clips are used for positioning annuloplasty implants, then fixation can be achieved, but fixation reliability is insufficient particularly for helix rings on either side of the heart valve
Solution Approach 1:
The patent merges the positioning and fixation functions into a single integrated frame structure. The frame simultaneously achieves positioning at the annulus and secure fixation through its self-expanding mechanism, eliminating the need for separate clips or complex fixation structures on either side of the heart valve.
Solution Approach 2:
The frame is designed as a segmented or articulated structure that can expand and conform to the annular geometry. This segmentation allows the frame to adapt to the specific anatomical configuration, providing reliable fixation whether positioned on one side or both sides of the heart valve without requiring additional complex fixation elements.
3Manufacturing precision
If traditional annuloplasty implants are used, then valve repair can be performed, but correct positioning is difficult to achieve
Solution Approach 1:
The patent introduces a delivery device as an intermediary that holds the frame in a compressed, pre-positioned state during navigation to the target site. The delivery device facilitates precise positioning by controlling the frame's deployment location and orientation, after which the frame expands to its final configuration at the correct position.
Solution Approach 2:
The frame transitions from a static compressed state in the delivery device to a dynamic expanded state at the target site. This dynamic transformation allows the frame to adapt to the anatomical geometry upon deployment, achieving correct positioning through its ability to expand and conform to the annular structure rather than requiring precise manual positioning of a rigid structure.
4Duration of action of stationary object
If fixation structures are made more complex to ensure correct position over time, then long-term stability improves, but anatomical damage risk increases
Solution Approach 1:
The patent changes the physical parameters of the fixation structure by using a self-expanding frame that transitions from a compressed to an expanded state. This parameter change allows the structure to achieve long-term stability through its expanded configuration that distributes forces across a larger area of the annulus, reducing the risk of anatomical damage compared to concentrated fixation points.
Solution Approach 2:
The frame's expansion force, which could potentially cause tissue damage, is converted into a beneficial anchoring mechanism. As the frame expands, it gently engages with the annular tissue, using the tissue's own elasticity and geometry to provide fixation. The expansion force distributes pressure across a broader area, converting what could be a harmful concentrated force into a beneficial distributed anchoring effect that ensures long-term stability without increasing anatomical damage risk.
Data Source
AI summary
An annuloplasty device is disclosed comprising first and second support rings being configured to be arranged as a coil in a first configuration around an axial direction, wherein the first and second support rings are configured to be arranged on opposite sides of native heart valve leaflets of a heart valve, a stiffening unit, wherein at least part of the first and second support rings comprises an interior channel configured to receive the stiffening unit, wherein insertion of the stiffening unit into the interior channel increases the stiffness of the first and/or second support rings. A method of repairing a defective heart valve is also disclosed.