Transluminal Anchor Delivery Tool for Mitral Valve Repair
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Solution Overview
Problem
Ischemic heart disease leads to mitral regurgitation due to papillary muscle dysfunction and left ventricle dilation, causing the mitral valve annulus to dilate and prevent proper coaptation of valve leaflets, resulting in decreased cardiac output and ventricle weakening.
Innovation Solution
An adjustable partial annuloplasty ring with a flexible sleeve and deployable anchors is used to anchor the ring around the valve annulus, allowing for contraction to tighten the annulus and improve valve coaptation, employing a steerable anchor deployment manipulator to position and screw anchors into cardiac tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional annuloplasty devices are used to tighten the valve annulus, then valve coaptation is improved, but the risk of tissue damage and blood flow interference increases
Solution Approach 1:
The delivery catheter is nested within a larger access catheter, and the anchors are nested within the delivery catheter. This multi-level nesting allows the entire system to be delivered through a single vascular access point, minimizing tissue disruption and avoiding interference with normal blood flow paths while maintaining effective annulus tightening capability
Solution Approach 2:
The delivery catheter acts as an intermediary device that guides and positions the anchors precisely at the valve annulus without requiring direct surgical access to the heart. This intermediary approach allows minimally invasive delivery of the anchors, reducing tissue damage while achieving reliable valve coaptation through precise positioning
2Strength
If multiple anchors are deployed to secure the annuloplasty device, then anchoring strength is improved, but device complexity and procedural time increase
Solution Approach 1:
Multiple anchors are combined into a single integrated annuloplasty device that is delivered through one catheter system. The anchors work together as a unified system to distribute anchoring forces around the valve annulus, achieving strong securement without requiring separate deployment procedures for each anchor, thus reducing overall procedural complexity
Solution Approach 2:
The anchors are pre-loaded into the delivery catheter in a prepared configuration before patient insertion. This preliminary preparation allows for rapid sequential deployment of multiple anchors once the catheter is positioned, reducing procedural time and simplifying the deployment process while maintaining strong anchoring capability
3Reliability
If anchors are deployed at steep angles to achieve secure fixation, then anchoring reliability is improved, but tissue damage increases
Solution Approach 1:
The delivery catheter incorporates steerable capabilities that allow dynamic adjustment of the anchor deployment angle during the procedure. This dynamic control enables the operator to optimize the deployment angle for each specific anatomical location, achieving reliable anchoring while minimizing tissue damage by avoiding excessively steep angles that would cause unnecessary trauma
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 solution effectively reduces mitral regurgitation by tightening the valve annulus, enhancing cardiac output and preventing further ventricle weakening, while minimizing tissue damage and blood flow interference.
Implementation Method 1
a rotating deployment element, which is configured to directly engage the anchors in the anchor storage area one at a time, advance each of the anchors while engaged in a distal direction, and deploy each of the anchors through the distal tube end and into tissue of a subject
Data Source
AI summary
A tube and a set of anchors, are transluminally advanced toward a heart of a subject. Tabs are distributed axially along an anchor storage area of the tube, each of the tabs protruding medially from a circumferential wall of the tube. The anchors are disposed in the anchor storage area, a first anchor engaged and restrained by a first tab at a first axial location of the tube, and a second anchor engaged and restrained by a second tab at a second axial location of the tube proximal from the first axial location. The first anchor is engaged by the driver at the first axial location, advanced to a distal end of the tube, and anchored to tissue of the heart. Subsequently, the second anchor is engaged by the driver at the second axial location, advanced to the distal end of the tube, and anchored to the tissue.