Inflatable Balloon Fold Pattern for Prosthetic Heart Valve Rotation Control
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Solution Overview
Problem
Existing collapsible and expandable prosthetic heart valves face challenges in achieving precise alignment and minimizing rotation during balloon inflation, which can affect the accuracy of valve deployment and commissural alignment.
Innovation Solution
The use of a delivery device with an inflatable balloon featuring a specific pattern of primary and secondary folds, which are wrapped around the outer diameter in opposite directions, helps to minimize valve rotation during inflation. This design allows for controlled expansion and reduces the likelihood of valve misalignment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a conventional balloon is used for valve deployment, then the valve can be expanded, but the valve rotates during inflation causing misalignment
Solution Approach 1:
The balloon is divided into multiple folded segments or pleats that can unfold in a controlled manner during inflation. This segmentation allows the balloon to expand while maintaining a more predictable and controlled orientation, reducing unwanted rotation of the deployed valve.
Solution Approach 2:
The balloon is pre-formed with specific fold patterns and geometric configurations before deployment. These pre-established folds create inherent structural guidance that directs the unfolding process, ensuring the valve expands in the intended orientation without significant rotation.
2Productivity
If the balloon is inflated quickly to deploy the valve, then the procedure is faster, but the valve alignment becomes less precise
Solution Approach 1:
The balloon inflation is performed in periodic stages rather than as a single continuous action. The balloon unfolds through predetermined phases where different segments expand at different times, allowing controlled progression that maintains alignment precision even during relatively quick deployment.
Solution Approach 2:
The balloon structure is designed with dynamic fold patterns that adapt during inflation. The folds are engineered to unfold in a specific sequence and manner that maintains geometric control throughout the expansion process, enabling both speed and precision.
Data Source
AI summary
In some examples, a method of delivering a prosthetic heart valve includes providing a delivery device having a catheter and an inflatable balloon coupled to the catheter, the inflatable balloon having a plurality of primary folds wrapped around an outer diameter of the inflatable balloon in a first direction, placing a prosthetic heart valve around the inflatable balloon, advancing the delivery device to a native aortic valve of a patient while the prosthetic heart valve is disposed about the inflatable balloon, partially inflating the inflatable balloon, and pausing after partially inflating the inflatable balloon and allowing the user to rotate the balloon prior to full inflation.