Percutaneous Valve with Nested Leaflet Transition for Low Profile Delivery
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Solution Overview
Problem
Damaged or diseased valves in the vascular system, such as the aortic valve, can lead to significant health issues due to disrupted blood flow, with existing solutions lacking effective percutaneous replacement or augmentation methods.
Innovation Solution
A percutaneous valve system comprising a valve frame with frame members defining a lumen and a valve leaflet coupled to the frame, where the leaflet extends outside the frame for flexibility and low profile delivery, allowing for balloon deployment and transition within the lumen, using shape-memory materials and radiopaque markers for positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If a percutaneous valve is designed with a low profile for delivery, then the valve can be delivered through small access points, but the valve leaflet flexibility and functional performance may be compromised
Solution Approach 1:
The valve frame transitions from a compressed delivery configuration to an expanded functional configuration. The frame members are designed to be flexible during delivery but rigid when expanded, allowing the valve to achieve both low profile delivery and adequate leaflet flexibility when deployed. The leaflets are attached to the expanded frame where they gain structural support while maintaining natural movement capability.
Solution Approach 2:
The valve components are nested within each other during delivery, with the leaflets positioned inside the frame structure. This nesting allows the entire valve assembly to be compressed to a low profile for percutaneous delivery through the catheter, while the nested arrangement preserves the ability of leaflets to extend and function properly when the valve is deployed.
2Ease of operation
If the valve leaflet extends outside the frame for flexibility, then the valve can be delivered with low profile, but the leaflet positioning and sealing within the lumen may be compromised
Solution Approach 1:
The valve is delivered in a pre-compressed state within the catheter with leaflets positioned inside the frame. This preliminary compressed configuration allows easy delivery through the access point. Once deployed, the frame expands and automatically positions the leaflets in their functional configuration, ensuring proper sealing surfaces are aligned and contact the lumen wall at the correct locations.
Solution Approach 2:
The valve frame undergoes a parameter change from a compressed state during delivery to an expanded state during deployment. This parameter change transforms the valve from a low-profile deliverable form to a functional form where the leaflets are properly positioned and secured within the lumen, achieving both ease of delivery and sealing reliability.
3Reliability
If the valve frame is expanded to secure the valve in position, then the valve can be anchored in the lumen, but the profile size increases making delivery difficult
Solution Approach 1:
The valve frame is designed with dynamic structural properties that allow it to transition between compressed and expanded states. During delivery, the frame is compressed to a small profile that can pass through the catheter and access point. Upon deployment, the frame expands to provide stable anchoring in the lumen through its increased radial profile and engagement with the lumen wall.
Solution Approach 2:
The valve frame is divided into multiple frame members that can be independently compressed during delivery and then expanded upon deployment. This segmentation allows the frame to be collapsed into a compact configuration for delivery while enabling reliable expansion to secure the valve in position within the lumen.
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
Enables flexible and minimally invasive replacement or augmentation of valves, ensuring unidirectional blood flow and secure positioning within the body lumen, accommodating changes in diameter and reducing retrograde flow.
Implementation Method 1
the valve frame and the leaflet transition member are formed from a shape-memory material
Data Source
AI summary
Apparatus, systems, and methods for percutaneous valve replacement and/or augmentation are provided. The apparatus includes a valve having a valve frame, a valve leaflet coupled to the valve frame, and a leaflet transition member coupled to the valve leaflet. The valve leaflet and leaflet transition member can transition from a first position where the valve leaflet and leaflet frame are at least partially outside a lumen of the valve frame to a second position where the valve leaflet and the leaflet transition member are within the lumen of the valve frame.