TAVI Balloon Catheter Segmentation for Deployment Accuracy
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Solution Overview
Problem
Existing collapsible/expandable prosthetic heart valves face challenges in achieving accurate deployment within the native valve annulus, leading to potential issues with hemodynamics, paravalvular leakage, and the need for pacemaker implantation.
Innovation Solution
A delivery device featuring a balloon catheter with a unique balloon design, including proximal and distal bulges and an intermediate section, which allows for controlled expansion and minimizes axial foreshortening, ensuring precise placement of the prosthetic heart valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a conventional balloon catheter with uniform diameter is used for prosthetic heart valve deployment, then the valve can be delivered through the catheter, but axial foreshortening occurs during expansion leading to inaccurate placement
Solution Approach 1:
The balloon is divided into three distinct segments: a proximal bulge section, a distal bulge section, and an intermediate section with smaller diameter. This segmentation allows each section to expand independently and controllably, with the intermediate section acting as a spacer that maintains axial length while the bulge sections provide expansion force for valve deployment.
Solution Approach 2:
Different sections of the balloon are given different diameters and expansion characteristics. The proximal and distal bulge sections have larger diameters to provide expansion force, while the intermediate section has a smaller diameter to maintain axial spacing. This local differentiation of properties prevents uniform expansion that causes foreshortening.
2Productivity
If rapid balloon inflation is used to deploy the valve quickly, then productivity is improved, but deployment precision deteriorates due to uncontrollable expansion
Solution Approach 1:
The balloon is pre-formed with proximal and distal bulge sections and an intermediate section before delivery. This preliminary configuration ensures that when inflation occurs, the expansion follows a predetermined pattern where the bulge sections expand first to push the valve into position, while the intermediate section maintains axial spacing, thereby controlling the deployment sequence and accuracy.
3Shape
If the balloon expands uniformly in all directions, then the valve achieves radial expansion, but axial position shifts occur reducing placement accuracy
Solution Approach 1:
The balloon design introduces asymmetry in the axial direction with proximal and distal bulge sections of potentially different dimensions, separated by an intermediate section. This asymmetric configuration creates different expansion characteristics at the proximal and distal ends, allowing control over axial positioning while maintaining radial expansion of the valve.
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 enhances the accuracy of prosthetic heart valve placement, reducing the risk of paravalvular leakage and improving hemodynamic performance by maintaining the desired alignment and position of the valve during expansion.
Implementation Method 1
the balloon may include a proximal bulge, a distal bulge, and an intermediate section between the proximal bulge and the distal bulge
Data Source
AI summary
A delivery device for delivering a prosthetic heart valve may include a balloon catheter shaft having a distal end, an inner shaft extending through the balloon catheter in a proximal-to-distal direction, an atraumatic distal tip positioned at a distal end of the inner shaft, and a balloon positioned between the distal end of the balloon catheter shaft and the atraumatic distal tip. In an uninflated condition of the balloon, the balloon may include a proximal bulge, a distal bulge, and an intermediate section having a diameter that is smaller than a diameter of the proximal bulge and smaller than a diameter of the distal bulge. The distal bulge may extend a first length in the proximal-to-distal direction, and the proximal bulge may extend a second length in the proximal-to-distal direction, the first length being different than the second length.