Braided Mitral Valve Docking Assembly for Regurgitation Sealing
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Solution Overview
Problem
Existing treatments for mitral regurgitation, such as stitching native mitral valve leaflets or using body implants, are inadequate, necessitating improved devices and methods to seal the native heart valves and prevent or reduce regurgitation.
Innovation Solution
Prosthetic devices with a body and fastener are implanted to extend the length and/or width of native leaflets, anchoring to the leaflets to create a more effective seal, using materials like ePTFE, silicone, or polymeric materials, and deploying via catheters to expand radially or laterally, securing with suture clips.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If stitching native mitral valve leaflets or using body implants is used to treat mitral regurgitation, then the valve sealing function is improved, but the treatment effectiveness is inadequate and the device complexity increases
Solution Approach 1:
The prosthetic device employs a nested structure where the docking assembly is positioned within the mitral valve annulus, and the leaflet extension is attached to and extends from the docking assembly. This nested configuration allows multiple functional components to be integrated in a compact manner, improving valve sealing effectiveness while managing device complexity through hierarchical organization of components.
Solution Approach 2:
The prosthetic device is divided into distinct functional segments: a docking assembly that anchors to the mitral valve annulus and a separate leaflet extension portion that attaches to the native leaflet. This segmentation allows each component to be optimized independently for its specific function (anchoring vs. sealing extension), thereby improving overall treatment effectiveness while maintaining manageable device complexity through modular design.
2Reliability
If prosthetic devices are implanted to extend leaflet length and width, then leaflet coaptation is enhanced and regurgitation is reduced, but the device structure becomes more complex
Solution Approach 1:
The leaflet extension is designed to provide localized reinforcement at specific regions where coaptation deficiency occurs. The extension can be configured with varying thicknesses, material properties, and geometric shapes tailored to the specific anatomical defect, allowing enhanced coaptation precisely where needed without unnecessarily complicating the overall device structure with uniform complex components throughout.
Solution Approach 2:
The prosthetic leaflet extension is designed to be dynamic rather than static, allowing it to move and deform with the native leaflet during cardiac cycle. The material and structural design enable the extension to flex, stretch, and adapt to physiological movements, maintaining effective coaptation throughout heart motion while avoiding rigid complex mechanical structures that would impede natural valve function.
3Stability of the object's composition
If suture clips are used to secure the prosthetic device to native leaflets, then anchorage stability is improved, but the implantation procedure becomes more complex
Solution Approach 1:
The suture clip mechanism is designed to self-secure upon deployment, where the clip automatically engages and locks the prosthetic device to the native leaflet without requiring additional manual fastening steps. This self-service anchoring mechanism provides stable fixation while simplifying the implantation procedure by eliminating complex multi-step securing processes, allowing the device to anchor itself through the inherent mechanical action of the clip closure.
Data Source
AI summary
Embodiments of the present disclosure include an implantable assembly for a native heart valve that includes a prosthetic heart valve and a braided support structure. The prosthetic valve includes a frame and prosthetic leaflets. The braided support structure has an inner braided layer and an outer braided layer. The outer braided layer is disposed over the inner braided layer. The outer braided layer is less porous to blood than the inner braided layer. The braided support structure defines a plurality of arms that are angularly spaced around the prosthetic heart valve such that each arm extends radially outwardly from the prosthetic heart valve. Other embodiments are also described.