Dual Modulus Balloon for Adaptive Lumen Sizing
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Solution Overview
Problem
Current intraluminal catheters require multiple sizes of balloons to accommodate varying lumen diameters, leading to increased costs and procedural time due to the need for inventory management and potential misselection of balloon sizes during procedures.
Innovation Solution
A single balloon with distinct regions of different elasticities, where one part is non-distensible and the other is elastomeric, allowing for selective inflation to various sizes by adjusting pressure or volume, enabling the balloon to expand asymmetrically and accommodate different lumen diameters and depths.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple sizes of balloons are used to accommodate varying lumen diameters, then the balloon can fit different lumen sizes, but inventory costs and procedural time increase
Solution Approach 1:
The balloon is designed with regions of different elastic moduli that allow dynamic adjustment of its expansion characteristics. By controlling inflation pressure and volume, the balloon can adapt to different lumen diameters within a single device, eliminating the need for multiple pre-sized balloons and reducing procedural time for size selection.
Solution Approach 2:
The invention changes the physical parameters of the balloon by incorporating regions with different material moduli. This allows the balloon to exhibit variable compliance during inflation, enabling it to accommodate a range of lumen sizes through controlled pressure and volume adjustments rather than requiring multiple fixed-size balloons.
2Adaptability or versatility
If multiple sizes of balloons are used to accommodate varying lumen diameters, then the balloon can fit different lumen sizes, but inventory costs increase
Solution Approach 1:
The balloon is designed as a universal device that can serve multiple functions across different lumen sizes. By incorporating regions of different elastic moduli, a single balloon type can be used for various lumen diameters, reducing the quantity of different balloon sizes needed in inventory while maintaining adaptability to different anatomical variations.
Solution Approach 2:
The variable compliance regions allow the balloon to change its effective size parameters during inflation based on the lumen diameter encountered. This parameter adaptability enables one balloon design to replace multiple pre-sized options, reducing inventory requirements.
3Productivity
If a single balloon with different modulus regions is used, then inventory costs and procedural time are reduced, but the balloon structure becomes more complex
Solution Approach 1:
The balloon incorporates regions with different material properties (moduli) at specific locations along its length. This local differentiation allows the balloon to exhibit varied compliance characteristics in different zones, enabling adaptation to different lumen sizes while maintaining a relatively simple overall structure that can be manufactured as a single integrated component.
4Reliability
If regions of different moduli are used in the balloon, then apposition to luminal structures is improved, but manufacturing complexity increases
Solution Approach 1:
The balloon is constructed with regions of different material moduli positioned at specific locations to optimize apposition to luminal structures. These localized material variations can be integrated into the balloon manufacturing process using techniques such as co-extrusion or layering, allowing improved apposition quality while maintaining reasonable manufacturing complexity through established fabrication methods.
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 solution allows for efficient apposition of tools against luminal structures with a single catheter, reducing inventory costs and procedural time by enabling the balloon to adapt to various lumen sizes and depths through controlled inflation, enhancing the precision and efficiency of medical interventions.
Implementation Method 1
A material with lower modulus than the involuted balloon material, such that the lower modulus material may expand at a different rate and create an anchoring or opposing force to the working component
Data Source
AI summary
A device for interventional surgical or medical procedures is presented. The device is generally in the form of a balloon and is used to position itself or other working elements up against or through lumen walls in the body. The balloon is comprised of at least two materials of different elastic modulus, which allows for a flexible but relatively non-distensible, unfolding component of the balloon as well as an elastomeric, inflatable component of the balloon. The elastomeric component is fixedly attached to the flexible but relatively non-distensible component and together they form a pressure vessel that can be inflated within the lumens of the body.