Tapered Balloon Catheter with Multi-Material Blow Molding
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Solution Overview
Problem
Existing balloon catheters with tapered designs face challenges in maintaining consistent radial growth and deliverability due to varying balloon wall thickness along the length, leading to inconsistent expansion and less-than-optimal distal deliverability.
Innovation Solution
The development of tapered balloon catheters formed using balloon tubes with varying materials and wall thickness gradients, where the balloon tube is blow-molded within a tapered mold to achieve a consistent hoop ratio and controlled radial growth, and the use of multi-material or multi-layer balloon tubes to vary compliance characteristics along the length.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a tapered balloon design is used to treat long vessel sections with varying diameters, then the adaptability to different vessel sizes is improved, but the balloon wall thickness becomes inconsistent leading to variable radial compliance
Solution Approach 1:
The balloon is designed with varying wall thickness along its length, with the distal portion having a thinner wall than the proximal portion. This local variation in structural properties allows the balloon to adapt to different vessel diameters while maintaining appropriate compliance characteristics in each region.
Solution Approach 2:
The balloon exhibits asymmetric geometry with a tapered configuration where the distal end has a smaller diameter and thinner wall compared to the proximal end. This asymmetric design enables the balloon to better conform to the natural tapering of blood vessels while maintaining consistent hoop stress distribution.
2Ease of operation
If the balloon tube decreases in outer diameter from proximal to distal end, then the deliverability through narrow vessels is improved, but the radial expansion consistency deteriorates
Solution Approach 1:
The balloon tube is manufactured with specifically controlled parameter variations, including outer diameter, inner diameter, and wall thickness along its length. These parameter changes are precisely engineered to ensure that when inflated, the balloon achieves consistent radial expansion and hoop stress distribution despite the tapered geometry.
3Adaptability or versatility
If multi-material balloon tubes are used to vary compliance characteristics, then the radial compliance control is improved, but the device complexity increases
Solution Approach 1:
The balloon tube is constructed from multiple materials with different compliance characteristics. The first material is used in the proximal portion where higher compliance is desired, while the second material is used in the distal portion for different mechanical properties. This composite construction allows precise control over radial compliance in different regions of the balloon.
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
This approach results in a balloon catheter with consistent radial compliance and improved deliverability, as the balloon maintains consistent hoop stress and radial expansion along its length, enhancing treatment efficacy while ensuring easier navigation through variable vessel diameters.
Implementation Method 1
blow molding the tapered balloon tube within the balloon mold to form a balloon
Implementation Method 2
the balloon maintains consistent hoop stress and radial expansion along its length
Data Source
AI summary
Balloon catheters having a tapered balloon design and methods for manufacturing tapered balloons. An illustrative method for forming a tapered balloon for use in a medical device may comprise forming a balloon tube, the balloon tube may be formed from a first material and a second material different from the first material, positioning the balloon tube within a balloon mold, and blow molding the tapered balloon tube within the balloon mold to form a balloon.