Two-Stage Prosthetic Heart Valve Anchoring and Deployment
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Solution Overview
Problem
Prosthetic heart valves designed for less invasive approaches face challenges in achieving a strong structure with multiple layers while maintaining a small diameter for delivery, leading to trade-offs in valve performance.
Innovation Solution
A two-step deployment system featuring a collapsible/expandable anchoring platform and valve with integrated leaflets, where the anchoring platform is implanted first, followed by the valve, allowing for secure interlocking and reduced profile without compromising performance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a strong structure with multiple concentric layers is used to securely hold the prosthetic valve in place, then the valve strength and reliability are improved, but the valve diameter increases making less invasive delivery difficult
Solution Approach 1:
The prosthetic valve system is divided into multiple independent concentric layers including an inner frame structure, leaflet assembly, and outer frame structure. Each layer performs specific functions and can be collapsed independently during delivery, allowing the entire assembly to be compressed to a small diameter while maintaining structural integrity at the implant site
Solution Approach 2:
The valve components are nested within each other in a concentric arrangement where the leaflet assembly is positioned inside the inner frame, which is in turn positioned inside the outer frame structure. This nested configuration allows all components to be collapsed together into a compact delivery profile while providing multiple structural layers for strength and support when expanded
2Reliability
If multiple concentric layers of material are added to protect leaflets and promote tissue ingrowth, then valve reliability and biocompatibility are improved, but device complexity and delivery profile are worsened
Solution Approach 1:
The outer frame structure serves multiple functions simultaneously: it provides structural support for the entire assembly during delivery, acts as a protective layer for the leaflets, promotes tissue ingrowth through its porous structure, and facilitates anchoring to the native annulus. This multi-functionality reduces the need for separate dedicated components for each function
3Ease of operation
If the valve is designed with a small diameter for less invasive delivery, then ease of delivery is improved, but valve strength and anchoring capability are worsened
Solution Approach 1:
The frame structures are designed with dynamic collapse and expansion capabilities, transitioning from a compressed low-profile state during delivery to a fully expanded high-strength state at the implant site. The elastic properties of the frame materials allow them to store energy during compression and release it during expansion, providing strong anchoring forces without requiring a large delivery profile
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 approach enables a lower profile for the delivery system without performance trade-offs, providing a secure and durable prosthetic heart valve implantation with reduced stress on components.
Implementation Method 1
a collapsible/expandable anchoring platform (frame) and a collapsible/expandable valve
Implementation Method 2
When such a valve reaches the implant site in the patient, the valve circumferentially re-expands and becomes an operating valve implant in the patient
Data Source
AI summary
Prosthetic heart valve apparatus is adapted for delivery into a patient in a circumferentially collapsed condition, followed by circumferential re-expansion at the implant site in the patient. The apparatus includes an annular anchoring structure that can be implanted in the patient first. The apparatus further includes an annular valve support structure, which supports a flexible leaflet structure of the valve. The support and leaflet structures are initially separate from the anchoring structure, but they can be implanted in the patient by interengagement of the support structure with the already-implanted anchoring structure.