Texturized Yarn Sealing Member for Prosthetic Valve Retention
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Solution Overview
Problem
Prosthetic heart valves cause damage to native heart tissue due to relative motion, leading to malfunction and the need for improved retention and sealing mechanisms to prevent dislodgment and leakage.
Innovation Solution
An implantable prosthetic device with a radially compressible and expandable frame, featuring a sealing member with a cushioning layer of texturized yarns and a base layer, designed to promote thrombus formation and inhibit inward thrombus formation, enhancing tissue integration and sealing efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the prosthetic heart valve is made larger than the native valve annulus diameter to ensure retention, then the valve can prevent dislodgment, but it causes increased damage to the surrounding tissue due to relative motion
Solution Approach 1:
A sealing member is introduced as an intermediary component between the prosthetic valve frame and the native annulus tissue. This sealing member includes a cushioning layer that acts as a mediator to reduce direct contact and relative motion between the rigid frame and the tissue, thereby reducing tissue damage while maintaining retention through the sealing action.
2Reliability
If the prosthetic heart valve is expanded to its functional size immediately after implantation, then the valve becomes functional, but it causes paravalvular leakage and tissue damage
Solution Approach 1:
The sealing member is deployed and sealed against the annulus tissue before the valve frame is fully expanded to its functional size. This preliminary sealing action prevents paravalvular leakage from occurring when the valve is subsequently expanded, as the sealing member is already in place to prevent fluid passage during the expansion process.
3Ease of manufacture
If a simple sealing member is used to reduce complexity, then the device is easier to manufacture, but it cannot effectively prevent tissue damage or leakage
Solution Approach 1:
The sealing member is constructed as a composite structure combining a base layer and a cushioning layer. The base layer provides structural support and sealing function, while the cushioning layer (comprising soft, compliant material) provides tissue protection. This composite construction achieves effective sealing and tissue protection while remaining manufacturable through standard layering and assembly processes.
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 effectively reduces tissue damage and leakage by promoting outward thrombus formation, improving the retention of the prosthetic valve and minimizing paravalvular leakage, thus enhancing the durability and functionality of the implant.
Implementation Method 1
a first layer configured to promote radially outward thrombus formation between the implantable prosthetic device and a selected implantation site
Implementation Method 2
a second layer disposed between the first layer and the frame, the second layer configured to inhibit radially inward thrombus formation
Data Source
AI summary
An implantable prosthetic device can include a frame movable between a radially compressed and a radially expanded configuration and a sealing member. The frame can include an inflow end portion, an outflow end portion, and a plurality of struts. The sealing member can be disposed around the frame and can include a cushioning layer comprising a plurality of texturized yarns extending along the longitudinal axis of the frame, and a base layer disposed between the cushioning layer and the frame.


