Laminated Valve Sealing Cuff for Suture-Free Frame Encapsulation
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Solution Overview
Problem
The production of prosthetic valves is hindered by the time-consuming and costly process of securing inner and outer skirts to the frame through manual suturing.
Innovation Solution
A laminated sealing member is introduced, comprising encapsulating layers that secure the fabric layer to the frame without suturing, using a monolithic laminate structure formed by fusing non-fabric inner and outer layers, with a fabric layer optionally included for reinforcement, to encapsulate the frame and reduce paravalvular leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If manual suturing is used to secure skirts to the frame, then the prosthetic valve can be assembled, but the production time and cost increase significantly
Solution Approach 1:
The patent merges the inner skirt and outer skirt into a single integrated sealing member that is pre-secured to the frame as one unit. This eliminates the need for separate manual suturing operations for each skirt, thereby reducing production time and labor costs while maintaining the sealing function.
Solution Approach 2:
The sealing member is prepared in advance with the skirts already attached to the frame in a factory setting using automated processes. This preliminary assembly allows complex suturing work to be done during manufacturing rather than during final assembly, significantly reducing production time and enabling automation.
2Ease of manufacture
If manual suturing is used to secure skirts to the frame, then the prosthetic valve can be assembled, but the production cost increases
Solution Approach 1:
By combining multiple skirts and their attachment processes into a single integrated sealing member, the patent reduces the number of separate components and assembly steps. This simplification directly reduces production complexity and enables more efficient manufacturing processes.
3Reliability
If traditional sealing members are used, then the frame is covered, but paravalvular leakage may occur
Solution Approach 1:
The patent applies different material properties to different regions of the sealing member. The inner skirt uses a first material optimized for contact with blood flow, while the outer skirt uses a second material optimized for tissue integration and sealing against the annulus. This local differentiation of material properties enhances sealing effectiveness and prevents paravalvular leakage.
Solution Approach 2:
The sealing member is constructed as a composite structure with an inner skirt made of one material and an outer skirt made of a different material. This composite construction allows each layer to perform its specific function optimally, with the inner layer providing hemocompatibility and the outer layer providing sealing against surrounding tissue, thereby preventing leakage.
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
This method reduces assembly time and cost, enhances durability, minimizes paravalvular leakage, and allows for a more predictable and even crimping process, protecting the leaflets from damage during deployment.
Implementation Method 1
The non-fabric inner and outer layers are fused to one another such that the fabric layer and at least a portion of the frame are encapsulated therebetween
Data Source
AI summary
A prosthetic heart valve has a radially expandable and collapsible annular frame, the frame having an inflow end and an outflow end and defining a longitudinal axis along a lumen of the prosthetic heart valve when it is in the expanded configuration. A leaflet structure is positioned within the frame and secured thereto. The prosthetic heart valve also has a laminate sealing member including a plurality of layers heat-bonded together to encapsulate at least a portion of the frame. The laminate sealing member extends along the longitudinal axis in an upstream direction and doubles back toward the outflow end of the frame at a fold line to form a cuff, and an edge portion of the laminate sealing member is secured to a main portion of the laminate sealing member downstream of the fold line such that the cuff forms an inflow end of the laminate sealing member.