Segmented Balloon for TAVR Pre-Expansion
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Solution Overview
Problem
In transcatheter aortic valve replacement (TAVR) surgeries, the balloon often slips or fails to effectively expand due to hard anatomical tissues, leading to irregular valve stent expansion and potential perivalvular leakage, which can shorten the life of the artificial heart valve.
Innovation Solution
An auxiliary balloon structure with a conical front and rear parts made of semi-compliant polyamide polymer material and a non-compliant cylindrical middle part, featuring a mastoid structure and hydrophilic coating, is designed to prevent slipping and ensure accurate positioning during expansion, using a catheter with connectors for pressure and guide wire insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a conventional balloon is used for pre-expansion, then the procedure is simple, but the balloon slips during expansion due to hard anatomical tissues
Solution Approach 1:
The balloon is divided into three distinct segments: a front conical part, a rear conical part, and a cylindrical middle part. Each segment serves a specific function - the conical parts engage with the anatomical structures to prevent slipping, while the cylindrical middle part provides the expansion surface. This segmentation allows the balloon to maintain simplicity of use while improving positioning stability through specialized geometric features.
Solution Approach 2:
The balloon employs asymmetric conical shapes at both ends rather than symmetric cylindrical forms. The conical geometry creates mechanical engagement with the aortic annulus and other anatomical structures, preventing the balloon from slipping during inflation. This asymmetric design maintains ease of operation while significantly improving reliability by anchoring the balloon in place.
2Productivity
If a balloon expands in hard anatomical tissues, then the procedure can be completed, but the balloon fails to effectively expand and causes irregular valve stent expansion
Solution Approach 1:
Different segments of the balloon are designed with different geometric qualities suited to their specific functions. The conical parts are designed for engagement and anchoring in hard tissues, while the cylindrical middle part is optimized for uniform expansion. This local differentiation of geometric properties allows effective expansion in challenging anatomical conditions while maintaining overall procedure efficiency.
Solution Approach 2:
The conical parts of the balloon perform preliminary anchoring action before the main expansion occurs. By engaging with the anatomical structures first, the balloon establishes a stable foundation that prevents slipping during the subsequent expansion phase, ensuring both procedure completion and expansion uniformity.
3Ease of operation
If the valve stent is not effectively pre-expanded, then the surgery can proceed, but perivalvular leakage occurs affecting heart valve function
Solution Approach 1:
The segmented balloon design with conical anchoring parts and cylindrical expansion part enables reliable pre-expansion that ensures proper valve fit. The conical segments prevent slipping to guarantee adequate expansion, while maintaining ease of surgical procedure through the balloon's overall simple structure and delivery mechanism.
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 balloon structure effectively pre-expands the valve, reducing the risk of perivalvular leakage and improving the success rate of TAVR surgeries by maintaining the shape and functionality of the artificial valve, thus prolonging its service life.
Implementation Method 1
The front and rear conical parts are made of a semi-compliant material, while the cylindrical middle part is made of a non-compliant material
Implementation Method 2
a hydrophilic coating layer is applied outside the catheter
Data Source
AI summary
The invention discloses an auxiliary balloon structure for transcatheter aortic valve replacement (TAVR), which comprises a balloon head and a balloon body. When unexpanded, the balloon body has two conical ends and a cylindrical middle part. The conical ends are defined as a front and a rear conical part. The cylindrical middle part is provided with a mastoid structure. The front and rear conical parts are made of a semi-compliant material, while the cylindrical middle part is made of a non-compliant material.