Dual-Frame Prosthetic Heart Valve Collapsible Waist Design
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Solution Overview
Problem
Current prosthetic heart valves face limitations in collapsibility and expandability, which restricts their size reduction for minimally invasive delivery and increases periprocedural complications due to material volume, strength, and shape constraints.
Innovation Solution
A collapsible and expandable prosthetic heart valve design featuring a dual-frame structure with a radially inward positioned inner frame and an outer frame that includes atrial and ventricular portions, coupled by arms, allowing for a narrowed waist and diamond-shaped cells for anchoring and tissue engagement, enabling self-expansion and reduced strain during deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If the implant is collapsed to a smaller size for minimally invasive delivery, then the access site size is minimized and periprocedural complications are reduced, but the implant cannot be collapsed sufficiently due to material volume, strength, and shape constraints
Solution Approach 1:
The implant is divided into multiple segments including an outer frame with coupling arms and an inner frame with cells. This segmentation allows each component to be optimized independently for collapsibility while maintaining overall structural strength during delivery and deployment
Solution Approach 2:
The inner frame is nested within the outer frame, with the inner frame's cells providing structural support during collapse. This nested configuration enables the implant to be compressed to a smaller delivery size while the outer frame protects and maintains the integrity of the inner components
2Volume of moving object
If the implant is collapsed to a smaller size, then the delivery system size is reduced, but the implant cannot be collapsed sufficiently due to material volume constraints
Solution Approach 1:
The coupling arms are designed to be dynamic and flexible, allowing them to bend and compress during delivery while maintaining their functional configuration during deployment. This dynamic design enables the implant to adapt its volume for minimally invasive delivery without sacrificing the necessary material volume for proper function
Solution Approach 2:
The implant utilizes materials and structures that can change their physical parameters between delivery and deployed states. The coupling arms and cellular structures are designed to transition from a compressed, low-volume delivery configuration to an expanded, high-volume functional configuration
3Device complexity
If the coupling arms are positioned only at the atrial and ventricular portions, then the frame structure is simpler, but the frame cannot provide adequate support and anchoring during deployment
Solution Approach 1:
Different portions of the frame are given different local qualities and functions. The outer frame's coupling arms are positioned at specific locations to provide anchoring, while the inner frame's cellular structure provides distributed support. This local differentiation of structure and function enhances overall reliability without requiring uniform complexity throughout the entire device
4Ease of manufacture
If the inner frame coupling arms are positioned at the inflow end only, then the manufacturing is simpler, but the strain distribution during expansion is uneven causing potential failure
Solution Approach 1:
The coupling arms are positioned asymmetrically at specific locations along the inner frame rather than uniformly distributed. This asymmetric positioning is strategically designed to create balanced strain distribution during expansion, with arms placed to counteract differential forces and prevent localized stress concentrations that could lead to failure
Data Source
AI summary
A prosthetic heart valve includes an outer frame having an atrial portion, a ventricle portion, a narrowed waist portion between the atrial portion and the ventricle portion, and a plurality of outer coupling arms having a first end coupled to the outer frame and a second free end. An inner frame is positioned radially inward of the outer frame and includes a plurality of inner coupling arms having a first end coupled to the inner frame and a second free end, the first ends of the inner coupling arms coupled to the inner frame at a location substantially equidistant between an inflow end of the inner frame and an outflow end of the inner frame. The second free ends of the outer coupling arms are coupled to the second free ends of the inner coupling arms to couple the outer frame to the inner frame.