Heat-Bonded Laminate Cuff for Prosthetic Heart Valve Assembly
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
The manual suturing process for securing inner and outer skirts to the frame of prosthetic valves is time-consuming and costly, necessitating improvements in prosthetic valve skirt assembly.
Innovation Solution
A laminated sealing member comprising encapsulating layers that encapsulate the frame and fabric layer, eliminating the need for manual suturing by securing the fabric layer to the frame through fused non-fabric inner and outer layers, which are bonded together to form a monolithic laminate sealing member with a folded end portion forming a cuff.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual suturing is used to secure inner and outer skirts to the frame, then the fabric layer can be attached to the frame, but the assembly process becomes time-consuming and costly
Solution Approach 1:
The patent replaces the manual mechanical suturing system with a thermal bonding system. The fabric layer is treated with a heat-activatable adhesive coating that bonds the fabric to the frame through controlled heating, eliminating the need for manual needle and thread operations while maintaining secure attachment.
Solution Approach 2:
The patent changes the bonding mechanism from mechanical (suturing) to thermal (heat-activatable adhesive). By applying heat to activate the adhesive coating on the fabric layer, the bonding process becomes automated and faster while maintaining reliable attachment security.
2Reliability
If manual suturing is used to secure skirts to the frame, then the fabric layer can be attached to the frame, but the manufacturing cost increases
Solution Approach 1:
The patent replaces the manual mechanical suturing system with an automated thermal bonding process. The heat-activatable adhesive coating allows for automated application and bonding, reducing labor costs and manufacturing complexity while maintaining secure attachment.
Solution Approach 2:
The fabric layer is pre-coated with heat-activatable adhesive in the manufacturing process, allowing it to bond to the frame automatically when exposed to controlled heating during assembly. This self-bonding capability eliminates the need for manual intervention and reduces manufacturing costs.
3Ease of operation
If additional protective layers are added to enable crimping, then the valve can be crimped for delivery, but the device complexity and size increase
Solution Approach 1:
The fabric layer serves multiple functions: it provides structural support, enables crimping through its inherent flexibility, and bonds to the frame through heat-activatable adhesive. This multi-functionality eliminates the need for separate protective layers, reducing device complexity while maintaining crimping capability.
Solution Approach 2:
The patent merges the protective layer function with the fabric layer by using the fabric itself as the protective and crimping-enabling element. The heat-activatable adhesive coating on the fabric layer provides both bonding and protective functions, eliminating the need for additional separate layers.
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 while enhancing durability and reducing paravalvular leakage, allowing for a smaller crimped profile and predictable crimping without additional protective layers, and providing a secure attachment of the fabric layer to the frame.
Implementation Method 1
fusing the first and second layers to form a monolithic laminate sealing member
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.