Braided Helical Heart Valve Frame for Cardiac Adaptability
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Solution Overview
Problem
Current heart valve replacement technologies face challenges such as degradation of leaflets, frame breakage, undesirable size changes in the native valve annulus, and inflexibility, leading to issues like valve migration, improper blood flow, and difficulty in retrieval or replacement, especially with laser-cut nitinol frames.
Innovation Solution
A braided wire design for the heart valve frame that is collapsible and adaptable, allowing for secure anchoring, flexible movement with the heart, and easy delivery via catheter, featuring a two-piece system with a separable valve assembly and adapter body for precise positioning and repositioning, and a helical braided structure that mimics the heart's natural movement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If laser-cut nitinol frames are used for valve replacement, then structural strength is improved, but flexibility and adaptability to heart movement deteriorate
Solution Approach 1:
The patent employs a braided wire frame structure that inherently provides flexibility while maintaining strength. The braided construction allows the frame to bend and deform elastically, enabling it to adapt to the dynamic movements of the heart during contraction and relaxation, while still providing sufficient structural support for valve replacement.
Solution Approach 2:
The frame is designed with dynamic characteristics to match the physiological dynamics of the heart. The braided wire construction allows the frame to change its shape and stiffness properties in response to cardiac cycles, transitioning from a rigid structure during diastole to a more compliant structure during systole, thereby adapting to heart movement while maintaining necessary strength.
2Stability of the object's composition
If rigid frames are used to ensure structural integrity, then valve stability is improved, but ease of delivery through catheter deteriorates
Solution Approach 1:
The braided wire frame exhibits dynamic mechanical properties that allow it to be compressed to a small profile for catheter delivery, then expand to its full functional size upon deployment. The helical braid structure enables the frame to collapse axially while maintaining radial integrity when expanded, facilitating both easy delivery and stable positioning.
Solution Approach 2:
The frame is designed to be collapsible into a compact configuration that can be nested within a catheter for delivery, then expanded to its full functional diameter at the target location. This nesting capability allows the rigid yet flexible braided frame to be transported through narrow vascular passages while maintaining structural integrity when deployed.
3Device complexity
If a one-piece valve system is used, then device simplicity is improved, but ease of repair and replacement deteriorates
Solution Approach 1:
The valve replacement system is divided into separable components including the braided wire frame, valve leaflets, and anchoring structures. This segmentation allows individual components to be replaced or repaired independently, with the frame serving as a reusable scaffold that can be modified or replaced without removing the entire valve assembly from the heart.
Solution Approach 2:
The system is designed to allow selective replacement of degraded components such as valve leaflets while retaining the intact braided wire frame. The frame acts as a permanent or semi-permanent scaffold that can be recovered and reused, while only the failing valve tissue components are discarded and replaced.
4Adaptability or versatility
If helical braided wire design is used, then flexibility and adaptability are improved, but manufacturing complexity deteriorates
Solution Approach 1:
The braided wire frame allows for customization of manufacturing parameters such as wire diameter, braid density, and helical pitch to optimize both flexibility and strength. By adjusting these parameters during the braiding process, the frame can be tailored to specific valve sizes and patient anatomies while using standardized manufacturing techniques.
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
The solution provides a durable, flexible, and self-adapting valve replacement that minimizes trauma to the heart, ensures proper blood flow, and allows for easy retrieval or replacement, addressing the limitations of existing technologies by enhancing long-term health outcomes and procedural safety.
Implementation Method 1
a helical braided structure that mimics the heart's natural movement
Implementation Method 2
The frame may be made from a helical braided wire architecture that is configured to flex and move with a natural helical contraction and relaxation of a heart
Data Source
AI summary
Disclosed are valve replacement devices, systems, and methods. valve replacement devices may comprise one- or two-piece systems comprising an adapter body and a valve assembly with leaflets positioned within the adapter body. In two-piece systems, the valve assembly may be removable from the adapter body such that both can be delivered together or separately, and the adapter body may remain implanted while the valve assembly may be removed and replaced (i.e., “revalved”). Also described are devices (such as a delivery catheter device), systems, and methods related to such delivering and revalving the valve replacement. Such delivery methods may include transseptal insertion of a new minimum leaflet structure, and securement of the valve replacement using several securement type (e.g., supra-annular, sub-annular, radial, leaflet securement, etc.). Also described is a braided helical design that mimics the heart's natural movement, and a flange structure for assisting the functioning of the valve replacement.