Self-Tensioning Anchors for Mitral Prosthetic Valve Fixation
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Solution Overview
Problem
Existing percutaneous heart valve replacement technologies face challenges in securing prosthetic valves to the mitral valve due to structural inconsistencies and the need for invasive surgeries, as aortic valve designs fail to reliably anchor in the mitral valve due to differences in tissue rigidity and consistency, and existing anchoring technologies risk damaging nearby cardiac structures.
Innovation Solution
A proprietary anchoring technology using TCAT anchors with a tension component that self-tensions upon deployment, ensuring constant contact with fluctuating heart tissues and minimizing invasiveness, combined with a compliant prosthetic valve design that adapts to native tissue shape and provides improved sealing and support.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If aortic valve prosthesis designs are used for mitral valve replacement, then the procedure can be performed, but the prosthesis fails to reliably anchor due to tissue rigidity differences
Solution Approach 1:
The anchor device incorporates a tension component with specific mechanical properties tailored for mitral valve tissue. The tension component includes a tension member that can be adjusted to provide appropriate tension forces, and an anchor body with barb structures designed to engage with the specific tissue characteristics of the mitral valve, creating local adaptation to tissue rigidity differences.
Solution Approach 2:
The device allows for parameter adjustment including the tension level in the tension member, the depth of anchor deployment into tissue, and the configuration of barb structures. These parameters can be modified to match the specific tissue conditions at the mitral valve site, enabling reliable anchoring despite tissue rigidity variations.
2Reliability
If existing anchoring technologies are used, then the prosthesis can be secured, but nearby cardiac structures may be damaged
Solution Approach 1:
The anchor device is deployed in a controlled manner with pre-planned tension application. The tension component is gradually engaged to secure the prosthesis before final anchoring is completed, allowing for monitoring and adjustment to prevent damage to surrounding cardiac structures while ensuring reliable prosthesis securing.
Solution Approach 2:
The deployment system incorporates feedback mechanisms to monitor the anchoring process in real-time. This allows the operator to adjust tension levels and deployment depth based on tissue response, preventing excessive force that could damage nearby cardiac structures while maintaining secure prosthesis anchoring.
3Ease of operation
If invasive surgical techniques are used for percutaneous valve replacement, then the procedure can be completed, but recovery time increases and health risks increase
Solution Approach 1:
The anchor device incorporates a self-tensioning mechanism where the tension component automatically engages and secures the prosthesis to the mitral valve tissue without requiring extensive manual manipulation or complex surgical techniques. This self-service capability reduces the invasiveness of the procedure and accelerates patient recovery while maintaining complete procedural effectiveness.
4Reliability
If the prosthetic valve is made compliant to adapt to native tissue shape, then sealing improves, but structural support may be reduced
Solution Approach 1:
The prosthetic valve is divided into segments with different mechanical properties. The valve frame provides rigid structural support where needed, while the valve leaflets and sealing elements are made compliant to adapt to the native mitral valve shape. This segmentation allows simultaneous achievement of strong structural support and effective sealing through appropriate material selection in different valve regions.
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
The solution allows for minimally invasive heart valve replacement surgeries with faster recovery times and reduced health risks by securely anchoring prosthetic valves to the mitral valve, adapting to irregular shapes, and minimizing gaps and damage to surrounding tissues.
Implementation Method 1
a tension component configured to exert a force on the proximal head when the distal end is anchored into the tissue
Data Source
AI summary
Systems and methods recited herein provide for affixation of a prosthetic valve to surrounding tissue, by at least one anchor and an anchor deployment device. The surgical anchor includes a distal end tapered to a distal tip configured to pierce and anchor into tissue; a proximal head; and a tension component integrally connected with the distal end and the proximal head; wherein the tension component is configured to exert a force on the proximal head when the distal end is anchored into the tissue.