Adjustable Annuloplasty Ring Reshapes Valve Annulus
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Solution Overview
Problem
Traditional heart valve repair methods require open-heart surgery, which comes with significant risks, expenses, and extended recovery times, and fail to maintain the natural inter-trigonal distance during mitral valve repair, potentially leading to complications like left ventricular outflow obstruction and valvular insufficiency.
Innovation Solution
A catheter-based annuloplasty system featuring a delivery catheter with a self-expanding stent and an adjustable annuloplasty ring that can be deployed minimally invasively, allowing for the adjustment and anchoring of the ring to the valve annulus using tissue attachment members, thereby reshaping the valve annulus to ensure proper leaflet coaptation and prevent dilation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart surgery with cardiopulmonary bypass is used for heart valve repair, then complete valve repair can be achieved, but the patient faces significant risks including thrombosis, stroke, infarction, and extended recovery time
Solution Approach 1:
The patent replaces the mechanical open-heart surgical system with a catheter-based delivery system that can be inserted through blood vessels. The annuloplasty ring is delivered via catheter to the heart valve site, eliminating the need for sternotomy, cardiopulmonary bypass, and direct surgical manipulation of the heart, thereby substituting a minimally invasive mechanical system for the traditional high-risk surgical system
Solution Approach 2:
The patent introduces a catheter as an intermediary device to deliver the annuloplasty ring to the target site. The catheter serves as a mediator that transports the repair device through the bloodstream to the heart valve, allowing the repair to be performed without direct surgical access to the heart chambers and eliminating the need for cardiopulmonary bypass
2Reliability
If a prosthetic ring or band is implanted to constrict the annulus, then valve competence is improved, but the inter-trigonal distance may be reduced causing left ventricular outflow obstruction
Solution Approach 1:
The patent applies local quality by designing the annuloplasty ring with varying degrees of constriction at different locations. The ring can be customized to provide greater constriction in areas needing support while maintaining adequate inter-trigonal distance in critical regions, allowing localized adaptation to the patient's specific anatomy and pathology
Solution Approach 2:
The patent introduces dynamics by making the annuloplasty ring adjustable after implantation. The ring size and shape can be modified post-deployment to optimize both valve competence and inter-trigonal distance, allowing real-time adjustments to prevent left ventricular outflow obstruction while maintaining valve function
3Ease of manufacture
If traditional surgical methods are used for mitral valve repair, then the valve can be repaired, but the natural inter-trigonal distance is not maintained potentially leading to valvular insufficiency and stenosis
Solution Approach 1:
The patent incorporates feedback mechanisms where the annuloplasty ring's effect on the valve geometry can be assessed and adjusted. The adjustable design allows clinicians to evaluate the outcome of annulus constriction and make modifications to maintain the natural inter-trigonal distance, using feedback from imaging and hemodynamic assessment to optimize the repair
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, off-pump repair of heart valves during a beating heart, reducing the risk of complications and recovery time, while maintaining the natural inter-trigonal distance to prevent valvular insufficiency and stenosis, thus providing a safer and more effective alternative to traditional surgical methods.
Implementation Method 1
an expandable stent disposed on the distal end of the catheter. An adjustable annuloplasty ring is disposed on the expandable stent and is configured to expand and contract in response to expansion and contraction of the stent
Data Source
Figure 1
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AI summary
A catheter-based annuloplasty system ( 200 ) for use in repairing a heart valve having leaflets and a valve annulus, includes a delivery catheter ( 204 ) having proximal end and a distal end, and an expandable stent ( 202 ) disposed on the distal end of the catheter. An adjustable annuloplasty ring ( 206 ) is disposed the expandable stent and is configured to expand and contract in response to expansion and contraction of the stent.