Rotatable Tether Valve Implant for Suture-Free Percutaneous Delivery
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Solution Overview
Problem
Existing heart valve replacement procedures, such as those for tricuspid regurgitation, are invasive and risky, requiring open-heart surgery and significant recovery time, and current percutaneous methods are complex and require sewing the replacement valve into place.
Innovation Solution
A valve implant with a rotatable tether strut mechanism and a delivery system that includes a stent and a valve leaflet prosthesis, allowing percutaneous deployment without sewing, using a delivery device with an outer sheath and inner catheter to expand and anchor the valve in place.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If percutaneous transluminal valve replacement is used, then surgical risk and recovery time are reduced, but the procedure becomes complex and requires sewing the replacement valve into place
Solution Approach 1:
The patent extracts the sewing step from the valve replacement procedure by providing a self-anchoring valve design that secures itself to the heart valve annulus through integrated anchoring elements, eliminating the need for separate surgical suturing operations
Solution Approach 2:
The replacement valve is designed with self-anchoring capabilities where the valve frame includes anchoring elements that automatically secure the valve to the annulus upon deployment, allowing the device to service itself without requiring external sewing intervention
2Reliability
If mechanical replacement valves are used, then valve function is restored, but the procedure requires sizing and securing the valve with sewing
Solution Approach 1:
The patent removes the sewing operation from the valve replacement process by integrating self-anchoring elements directly into the valve frame structure, allowing the valve to secure itself to the annulus through mechanical interlocking rather than surgical suturing
Solution Approach 2:
The patent replaces the surgical sewing mechanism with a mechanical self-anchoring system where the valve frame includes expansion elements and anchoring structures that mechanically interlock with the annulus, substituting complex surgical operations with simpler mechanical deployment
3Reliability
If open-heart surgery is used, then complete valve replacement is achieved, but the procedure is highly invasive with significant recovery time
Solution Approach 1:
The patent extracts the invasive aspects of open-heart surgery by enabling percutaneous delivery of the valve through catheter-based techniques, removing the need for sternotomy, cardiopulmonary bypass, and general anesthesia while achieving complete valve replacement
Solution Approach 2:
The patent introduces a delivery catheter as an intermediary device that carries the compressed valve through the vascular system to the heart, allowing the valve to be delivered percutaneously rather than requiring direct surgical access to the heart chambers
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
Facilitates less invasive heart valve replacement with improved operational movement and anchoring, reducing surgical risks and recovery time by using a tethered valve leaflet prosthesis that replicates native valve movement and expands to secure itself.
Implementation Method 1
a flexible extended stent strut extending longitudinally from the first end portion
Implementation Method 2
The valve implant may include a stent having a first end portion and a second end portion along a longitudinal stent axis, and a flexible extended stent strut extending longitudinally from the first end portion
Data Source
AI summary
A valve implant includes a valve leaflet prosthesis having a wire frame, a leaflet blade panel attached to the wire frame, and one or more tether struts extending from the wire frame, and a stent having a first end portion and a second end portion along a longitudinal stent axis, and a flexible extended stent strut extending longitudinally from the first end portion, wherein the one or more tether struts of the valve leaflet prosthesis is rotatably coupled to the flexible extended stent strut in a manner such that the one or more tether struts are rotatable about a rotational axis which is parallel to the one or more tether struts and which extends transverse to the longitudinal stent axis. A delivery system for the valve implant and a method of preparing the delivery system are also disclosed.