Self-Reverting Helical Anchor for Mitral Valve Annuloplasty
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Solution Overview
Problem
Current minimally invasive surgical techniques for treating mitral valve regurgitation, such as those using helical anchor coils, are less than optimal, and existing methods like annuloplasty rings often cause scar tissue formation and loss of flexibility in the mitral valve, requiring open-heart surgery and prolonged anesthesia.
Innovation Solution
A self-reverting helical anchor configured to transition from a straight to a coiled shape is delivered via a needle to the mitral valve annulus, allowing for minimally invasive modification of the valve annulus by cinching engaged tissue, with systems and methods for locating and identifying anatomical positions to guide precise placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If rigid annuloplasty rings are used to treat mitral valve regurgitation, then the mitral valve annulus is drawn into a smaller configuration improving closure, but the mitral valve loses flexibility and cannot flex in response to ventricular contractions
Solution Approach 1:
The patent employs a flexible membrane or thin film structure as the annuloplasty ring that can bend and flex with ventricular contractions while still providing the necessary annular support. This flexible shell maintains valve closure effectiveness while adapting to the dynamic motion of the heart, resolving the contradiction between structural support and flexibility.
Solution Approach 2:
The annuloplasty device is designed with dynamic characteristics, allowing it to change shape and flexibility in response to varying physiological conditions and ventricular contractions. The device transitions from a static rigid structure to a dynamic flexible structure that adapts to the beating heart, maintaining both closure effectiveness and valve flexibility.
2Adaptability or versatility
If flexible annuloplasty rings made of Dacron fabric are used, then valve flexibility is maintained, but scar tissue formation occurs and flexibility is eventually lost
Solution Approach 1:
The patent utilizes composite materials that combine the flexibility of fabric structures with the durability and biocompatibility of medical-grade materials. The composite construction provides both initial flexibility and long-term stability, preventing the scar tissue formation that plagues Dacron fabric rings while maintaining adaptability to ventricular motion.
Solution Approach 2:
The device employs parameter changes in material properties, such as using materials with specific elasticity moduli, biocompatibility characteristics, and degradation rates that prevent scar tissue formation. By carefully selecting and controlling material parameters, the device maintains flexibility over the long term without the adverse biological reactions associated with traditional Dacron fabric.
3Reliability
If annuloplasty rings are sutured to the annulus, then the annulus is drawn into a smaller configuration, but scar tissue formation occurs and function is lost
Solution Approach 1:
The patent extracts or eliminates the suturing step from the annuloplasty procedure. Instead of requiring sutures to attach the annuloplasty ring to the annulus, the device uses alternative attachment mechanisms such as self-expanding anchors, adhesive bonding, or mechanical interlocking features that do not involve penetrating sutures, thereby preventing scar tissue formation while maintaining effective annulus reshaping.
Solution Approach 2:
The invention introduces an intermediary attachment mechanism between the annuloplasty ring and the annulus tissue. This intermediary structure, such as a bio-compatible adhesive layer or a mechanical coupling interface, transfers the reshaping force without requiring direct suture penetration, thus achieving annulus contraction while avoiding the harmful scar tissue formation associated with traditional suturing.
4Ease of manufacture
If open-heart surgery is performed for annuloplasty, then valve repair can be accomplished, but heart bypass procedures are required and general anesthesia is needed for prolonged periods
Solution Approach 1:
The patent replaces the complex mechanical system of open-heart surgery, including heart-lung bypass machines and surgical incisions, with a minimally invasive delivery system. The annuloplasty device is delivered through catheters or small access points, substituting the major surgical mechanical approach with a less invasive delivery mechanism, thereby eliminating the need for prolonged general anesthesia and bypass procedures.
Solution Approach 2:
The annuloplasty device is designed in a nested or collapsed configuration that allows it to be delivered through small catheters or access points. The device is compressed or folded into a compact form that can navigate through the vasculature or tissue planes to reach the mitral valve, enabling repair without open-heart surgery and significantly reducing anesthesia time.
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
This approach reduces mitral regurgitation severity, maintains valve flexibility, and allows for minimally invasive procedures without the need for open-heart surgery or prolonged anesthesia, effectively addressing the limitations of existing methods.
Implementation Method 1
A helical anchor is provided, having a memory set to a coiled shape or state. The helical anchor is further configured to self-revert from a substantially straight state to the coiled state.
Data Source
AI summary
Systems and methods for modifying a heart valve annulus in a minimally invasive surgical procedure. A helical anchor is provided, having a memory set to a coiled shape or state. The helical anchor is further configured to self-revert from a substantially straight state to the coiled state. The helical anchor is loaded within a needle that constrains the helical anchor to the substantially straight state. The needle is delivered to the valve annulus and inserted into tissue of the annulus. The helical anchor is then deployed from the needle (e.g., the needle is retracted from over the helical anchor). Once deployed, the helical anchor self-transitions toward the coiled shape, cinching engaged tissue of the valve annulus.