Porous Elastomer-Composite Balloon Cover for Lower Inflation Pressure
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Solution Overview
Problem
Existing inflatable balloons and covers used in medical procedures face challenges with high inflation pressure and non-uniform deployment of expandable implants, such as stents, which can lead to suboptimal treatment outcomes.
Innovation Solution
A medical balloon and cover system featuring a continuously wrapped outer cover with a porous polymer layer imbibed with an elastomeric component and pleats along the longitudinal axis, allowing for improved inflation characteristics and uniform deployment of expandable implants.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stress or pressure
If conventional inflatable balloons and covers are used, then the deployment of expandable implants can be achieved, but high inflation pressure is required and deployment uniformity is poor
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 unfolded state, allowing controlled and uniform deployment of the expandable implant across different radial positions. This segmentation enables the cover to expand in a more uniform manner compared to conventional smooth covers.
Solution Approach 2:
The patent changes the geometric parameters of the cover by introducing pleats with specific dimensions (depth, width, spacing). These parameter changes allow the cover to transform from a smooth configuration to a pleated configuration, which fundamentally alters the inflation characteristics and enables lower pressure operation with improved deployment uniformity.
2Force
If high inflation pressure is applied to deploy expandable implants, then deployment can be achieved, but treatment effectiveness is reduced due to non-uniform deployment
Solution Approach 1:
The pleated cover introduces dynamic behavior to the deployment process. As inflation pressure increases, the pleats progressively unfold in a controlled sequence, transforming the static cover structure into a dynamic expanding structure. This dynamic unfolding process distributes the deployment force more evenly across the implant, improving treatment effectiveness.
Solution Approach 2:
The cover is designed as a flexible thin-walled structure with pleats that can easily deform and unfold during inflation. This flexibility allows the cover to adapt to the expansion of the implant while maintaining uniform contact and force distribution, thereby improving deployment uniformity and treatment reliability.
3Device complexity
If conventional smooth covers are used, then the structure is simple, but inflation characteristics are poor with higher pressure requirements
Solution Approach 1:
The introduction of pleats creates curved surfaces and three-dimensional geometry in the cover structure. The pleated configuration with its multiple curves and folds fundamentally changes the inflation characteristics compared to a smooth cylindrical cover, enabling more efficient expansion at lower pressures despite increased structural complexity.
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 reduces inflation pressure and enhances the uniformity of expandable implant deployment, providing more effective treatment by conforming to the treatment area with lower force, thus improving clinical outcomes.
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.