Expandable Annuloplasty Ring for Aortic Root Repair
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Solution Overview
Problem
Current aortic valve surgery lacks effective methods for repairing aortic valves while preserving native leaflets and maintaining normal valve physiology, due to the lack of suitable annuloplasty rings and holder assemblies that can dynamically adjust to the cardiac cycle, leading to complications such as valve insufficiency and the need for valve replacement.
Innovation Solution
An expandable annuloplasty ring and holder assembly that allows for resizing of the aortic root, featuring elastic core members and a textile sheath, which can adjust between diastolic and systolic configurations in response to cardiac pressures, and a holder assembly with a ball-and-socket mechanism for secure and versatile mounting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a non-rigid or flexible ring is used to resize the annulus, then the ring can passively comply to the desired shape during surgical repair, but the ring is not elastic and cannot expand as a function of varying cardiac cycle parameters
Solution Approach 1:
The annuloplasty ring changes its physical state from a compressed non-elastic state during implantation to an elastic expanded state during cardiac cycle operation. The ring is implanted in a compressed state for ease of insertion, then expands automatically in response to cardiac pressures to become elastic and adaptable to varying cardiac cycle parameters.
Solution Approach 2:
The annuloplasty ring transitions from a static non-rigid structure during implantation to a dynamic elastic structure during cardiac operation. The ring dynamically adjusts its elasticity and expansion based on real-time cardiac cycle conditions, allowing it to adapt to varying hemodynamic demands.
2Stability of the object's composition
If a rigid ring is used to resize the mitral or tricuspid valve annulus, then the ring provides stable structural support, but the ring cannot adapt to varying cardiac cycle parameters and ventricular mechanics
Solution Approach 1:
The ring's mechanical properties change from rigid during implantation to elastic during cardiac operation. This parameter change allows the ring to provide stable structural support during insertion, then automatically adapt to cardiac cycle variations through elastic expansion driven by cardiac pressures.
Solution Approach 2:
The annuloplasty ring transitions from a static rigid structure to a dynamic elastic structure that responds to cardiac cycle variations. The ring maintains structural stability when needed but becomes adaptable to cardiac dynamics through pressure-driven expansion.
3Reliability
If current aortic valve repair procedures are performed without specialized apparatus, then surgeons can perform valve sparing procedures, but the procedures are technically demanding and outcomes are surgeon-dependent
Solution Approach 1:
The expandable annuloplasty ring performs the resizing function automatically through its elastic expansion in response to cardiac pressures, eliminating the need for complex manual manipulation and adjustment during surgery. The ring self-adjusts to the correct size and shape based on cardiac dynamics.
Solution Approach 2:
The ring automatically changes its dimensional parameters (size and shape) in response to cardiac pressure changes, eliminating the need for manual adjustment during surgery. This automatic parameter change simplifies the surgical procedure while improving reliability of valve sparing procedures.
4Strength
If a non-expandable annuloplasty ring is used in the aortic root, then the ring provides immediate structural support, but the ring cannot accommodate the dynamic expansion of the aortic root between diastolic and systolic phases
Solution Approach 1:
The annuloplasty ring transitions from a static non-expanding structure to a dynamic expanding structure that accommodates aortic root motion. The ring remains structurally supportive during implantation then automatically expands with cardiac cycle-driven aortic root expansion.
Solution Approach 2:
The ring's dimensional parameters change dynamically to match aortic root expansion. The ring maintains its structural support function while automatically adjusting its size to accommodate the aortic root's diastolic-systolic expansion through elastic deformation.
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 expandable annuloplasty ring dynamically controls the aortic valve annulus, preserving native leaflet coaption and valve competence, reducing stress on leaflets, and improving blood flow, while the holder assembly enables rapid changeovers and secure orientations, simplifying surgical procedures.
Implementation Method 1
a first elastic core member and a second elastic core member, the first and second elastic core members held in general register and in a spaced apart relationship to each other by a sheath member
Implementation Method 2
the first and second elastic core members held in general register and in a spaced apart relationship to each other by a sheath member, the sheath member at least partially encapsulating a portion of each of said first and second core members
Data Source
AI summary
Devices and methods are provided for surgical repair of dilated aortic root to restore aortic valve competence while preserving native leaflets. In one aspect of the invention an expandable annuloplasty ring is provided for external placement at the base of a dilated aortic root. The expandable ring is capable of elastically expanding between a first diastolic diameter and a larger second systolic diameter to provide a physiologically representative surgical repair of the aortic root. In a further aspect of the invention, is provided a holder assembly for aortic annuloplasty ring and suitable for other cardiac valve prosthesis. The holder assembly consists of a holder body pivotingly coupled to a handle member through a ball-and-socket arrangement.