Stent Anchoring via V-Shaped Wires for Heart Valve Fixation
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Solution Overview
Problem
Current percutaneous heart valve replacement techniques are invasive and carry risks such as infection, stroke, and adverse effects from heart-lung machine use, with a need for minimally invasive designs that effectively anchor and seal prosthetic valves without conventional sewing to native tissue.
Innovation Solution
The development of stents with various docking and anchoring structures that are compressible for delivery and expandable via self-expanding or balloon mechanisms, allowing for rotatable and repositionable prosthetic heart valves that can be securely implanted using antegrade or retrograde approaches, with features like commissure attachment posts and V-shaped wire structures for tissue attachment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional open-heart surgery is used for valve replacement, then the valve can be securely implanted with sutures, but the patient is exposed to serious risks including infection, stroke, and adverse effects from heart-lung machine use
Solution Approach 1:
The patent replaces the conventional surgical suture system with a mechanical anchoring system. The stent features barbs, hooks, and radial expansion mechanisms that mechanically anchor the valve to the annulus without requiring sutures. This substitution eliminates the need for open-heart surgery and heart-lung machine support, thereby reducing patient exposure to serious surgical risks while maintaining secure valve implantation.
Solution Approach 2:
The patent introduces a stent as an intermediary component between the valve and the annulus. The stent serves as a mediator that provides mechanical support and anchoring features (barbs, hooks, radial expansion) to secure the valve in place without direct suture attachment to native tissue. This intermediary structure enables percutaneous delivery while achieving reliable valve fixation.
2Ease of operation
If percutaneous delivery is used to minimize invasiveness, then the procedure is less invasive, but the valve requires complex compressible and expandable stent structures for delivery and deployment
Solution Approach 1:
The patent employs dynamic stent structures that can transition between compressed and expanded states. The stent is designed to be compressed for percutaneous delivery through the catheter and then expanded at the implantation site via balloon inflation or self-expansion mechanisms. This dynamic transformation enables minimally invasive delivery while achieving the required structural support and anchoring capabilities.
Solution Approach 2:
The patent implements a nested structure where the valve is mounted within the stent, which in turn is compressed within the delivery catheter. The valve leaflets are positioned inside the stent framework, and the entire assembly is nested within the delivery system for percutaneous insertion. This nested configuration enables compact delivery while maintaining the functional integrity of the valve-stent assembly.
3Ease of manufacture
If frictional engagement is used to anchor the stent, then conventional sewing is not necessary, but the anchoring strength may be insufficient compared to suture attachment
Solution Approach 1:
The patent applies local quality by incorporating discrete anchoring features (barbs, hooks, and radial expansion elements) at specific locations on the stent rather than relying on uniform frictional engagement. These localized anchoring structures concentrate the attachment force at critical points, providing superior anchoring strength compared to diffuse frictional engagement while still eliminating the need for conventional sewing.
Solution Approach 2:
The patent employs composite anchoring mechanisms that combine frictional engagement with mechanical interlocking features. The stent structure integrates radial expansion capabilities with barb and hook elements, creating a composite anchoring system that leverages both friction and mechanical interlocking to achieve strong, suture-free attachment to the annulus.
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 minimally invasive and effective implantation of prosthetic heart valves with reduced risk, allowing for secure anchoring and sealing without conventional sewing, facilitating easier positioning and reduced risk of complications like infection and stroke.
Implementation Method 1
The stents of the invention include a wide variety of structures and features that can be used alone or in combination with features of other stents of the invention. In particular, these stents provide a number of different docking and/or anchoring structures that are conducive to percutaneous delivery thereof. Many of the structures are thus compressible to a relatively small diameter for percutaneous delivery to the heart of the patient, and then are expandable either via removal of external compressive forces (e.g., self-expanding stents), or through application of an outward radial force (e.g., balloon expandable stents).
Data Source
AI summary
A stented valve including a stent structure including a generally tubular body portion having a first end, a second end, an interior area, a longitudinal axis, and a plurality of vertical wires extending generally parallel to the longitudinal axis around a periphery of the body portion, wherein the plurality of vertical wires includes multiple commissure wires and at least one structural wire positioned between adjacent commissure wires, and a plurality of V-shaped wire structures having a first end, a second end, and a peak between the first and second ends, wherein a first end of each V-shaped structure extends from a first vertical wire and a second end of each V-shaped structure extends from a second vertical wire that is adjacent to the first vertical wire, wherein each V-shaped structure is oriented so that its peak is facing in the same direction relative to the first and second ends of the body portion, and a valve structure including a plurality of leaflets attached to the stent structure within the tubular body portion.