Pleated Balloon Cover Structure for Uniform Stent-Graft Deployment
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Solution Overview
Problem
Existing inflatable medical balloons and covers face challenges in achieving uniform deployment of expandable implants with lower inflation pressures, leading to inefficiencies in interventional medical procedures.
Innovation Solution
A medical balloon and cover system featuring a continuously wrapped sheet with an innermost porous polymer layer and a composite layer imbued with an elastomeric component, incorporating pleats along the longitudinal axis, and a method of forming the cover by imbibing a porous polymeric sheet with an elastomer, wrapping it around a mandrel, and pleating it to conform to the balloon's surface.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional inflatable balloons and covers are used, then the structure is simple and easy to manufacture, but the deployment uniformity is poor and high inflation pressure is required
Solution Approach 1:
The cover is divided into multiple pleats that can independently unfold during inflation. Each pleat acts as a separate segment that progresses from a compressed state to an expanded state, enabling controlled and uniform deployment across the entire cover surface while reducing the peak inflation pressure required
Solution Approach 2:
The cover transitions from a static compressed configuration during delivery to a dynamic expanding configuration during deployment. The pleated structure allows the cover to progressively change shape and volume as inflation proceeds, optimizing the deployment process and reducing the force required at any given moment
2Stress or pressure
If the cover material is made more compliant to reduce inflation pressure, then the inflation pressure requirement decreases, but the structural support capability deteriorates
Solution Approach 1:
Different regions of the cover have different properties: the pleated regions provide compliance and low inflation pressure requirements, while the reinforced zones maintain structural integrity. The material composition or structural density varies locally to optimize both compliance where needed and strength where required
Solution Approach 2:
The cover employs composite construction combining materials with different mechanical properties. This allows the cover to exhibit both compliant behavior for easy inflation and sufficient structural strength to maintain its shape and provide support during the procedure
3Strength
If the cover is made thicker to improve structural support, then the strength increases, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
Rather than uniformly thickening the entire cover, the structure is segmented into pleats and reinforced zones. This segmentation allows strength to be concentrated where needed while keeping other areas thin and simple, avoiding the complexity of a uniformly thick design
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 system enhances uniform deployment and reduces inflation pressure requirements, improving the operational characteristics of the balloon and cover, facilitating more precise and efficient placement of expandable implants.
Implementation Method 1
a composite layer comprising a porous polymer imbibed with an elastomeric component
Data Source
AI summary
The present disclosure describes implantable medical devices comprising covers, such as a balloon cover. Such devices can comprise a first layer of a porous polymeric material, such as ePTFE, surrounded by layers of a porous polymeric material having an imbibed elastomer, such as polyurethane. The cover can be used to assist in deployment of an expandable implant, such as a stent-graft, within the body of the patient.