Braided Helical Valve Replacement Frame to Prevent Migration
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Solution Overview
Problem
Existing heart valve replacements face issues such as migration, improper directional blood flow, inflexibility causing trauma, and difficulty in secure delivery and removal, especially with laser-cut nitinol frames, which do not conform to the heart's dynamic movements.
Innovation Solution
A braided wire frame design with a helical spiral configuration that mimics the heart's natural movements, allowing for flexible anchoring and secure positioning, featuring a tubular frame with a flange and stabilizers for anchoring, and a collapsible structure for delivery via catheters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a laser-cut nitinol frame is used for valve replacement, then the valve can be manufactured with precise geometry, but the frame does not conform to dynamic heart movements causing trauma and potential damage
Solution Approach 1:
The patent changes the structural parameters of the frame from rigid laser-cut nitinol to flexible braided wire construction. This parameter change allows the frame to dynamically adapt to heart movements while maintaining manufacturing precision through controlled braiding patterns and material selection.
Solution Approach 2:
The patent employs composite material construction by combining braided wire elements with valve leaflets and anchoring structures. This composite approach integrates the flexibility of braided wires with the precision of manufactured valve components, resolving the contradiction between geometric precision and adaptability.
2Strength
If a rigid valve frame is used to ensure structural strength, then the valve maintains its shape, but it causes trauma to surrounding tissue during delivery and implantation
Solution Approach 1:
The patent replaces rigid frame structures with flexible braided wire constructions that can bend and conform during delivery. This allows the valve to maintain structural strength while avoiding trauma to surrounding tissue by adapting its shape during implantation.
Solution Approach 2:
The patent introduces dynamic flexibility to the valve frame through braided wire construction, allowing the frame to change its configuration during delivery and implantation. This dynamic adaptability eliminates the need for rigid structures, thereby preventing tissue trauma while maintaining necessary structural integrity.
3Adaptability or versatility
If a floating valve design is used to allow heart movement, then the valve conforms to cardiac cycles, but the valve may migrate or be dislodged from position
Solution Approach 1:
The patent divides the valve system into separate functional segments: a floating valve body that conforms to cardiac movements and discrete anchoring structures that prevent migration. This segmentation allows the valve to simultaneously achieve adaptability to heart movements and positional stability through the coordinated action of its parts.
Solution Approach 2:
The patent introduces anchoring structures as intermediary elements between the floating valve body and the heart tissue. These intermediaries transmit forces appropriately, allowing the valve to conform to cardiac cycles while preventing dislodgement through secure attachment points.
4Reliability
If a complex anchoring system is implemented to prevent valve migration, then the valve remains securely in position, but the delivery and implantation process becomes more difficult
Solution Approach 1:
The patent incorporates anchoring structures that are pre-positioned and pre-configured within the valve assembly before delivery. This preliminary preparation allows the anchoring system to be deployed automatically during implantation, maintaining position stability while simplifying the delivery process.
Solution Approach 2:
The patent merges the anchoring functions into an integrated valve assembly where the braided wire frame simultaneously provides structural support, enables flexibility, and incorporates anchoring elements. This consolidation reduces the complexity of delivery by eliminating separate anchoring deployment steps while maintaining secure positioning.
Data Source
AI summary
Disclosed are valve replacement devices, systems, and methods. Valve replacement devices may comprise one- or two-piece systems comprising a receiver body (also called an adapter) and a valve assembly with replacement leaflets attached to and located within the receiver body. In two-piece systems, the valve assembly may be removable from the receiver body such that both can be delivered together or separately, and the receiver body may remain implanted while the valve assembly may be removed and replaced. Also described are devices, systems, and methods related to delivering, removing, and replacing a 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.