Dual-Layer Medical Balloon Resolving Strength and Flexibility Trade-Off
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Solution Overview
Problem
Current angioplasty balloons made from high-strength polymers lack the desired flexibility and trackability required for navigating small, tortuous vessels while maintaining high burst strength, and the use of plasticizers to enhance flexibility limits their biocompatibility.
Innovation Solution
A dual-layer dilatation balloon with an inner layer containing a plasticizer and a polyamide, and an outer layer made of maleated ethylene-propylene rubber, providing a hoop strength of 10,000 psi to 60,000 psi, which improves flexibility and trackability while preventing plasticizer migration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If high-strength polymers are used to increase burst strength, then the balloon exhibits high strength, but the balloon exhibits less flexibility and trackability
Solution Approach 1:
The balloon is divided into multiple layers with distinct functions: an inner layer containing plasticizer for flexibility and an outer layer of polyamide for strength. This segmentation allows each layer to optimize its specific property without compromising the other, resolving the contradiction between strength and flexibility.
Solution Approach 2:
The invention uses composite material structure combining plasticizer-containing polymer and polyamide in a multi-layer configuration. This composite approach enables the balloon to simultaneously achieve high burst strength from the polyamide outer layer and high flexibility from the plasticizer-containing inner layer.
2Ease of operation
If plasticizer is added to increase flexibility, then the balloon exhibits increased softness and flexibility, but the balloon's biocompatibility is limited
Solution Approach 1:
The plasticizer is segregated into a dedicated inner layer rather than being dispersed throughout the entire balloon structure. This segmentation contains the potentially harmful plasticizer away from direct contact with blood vessels, improving biocompatibility while maintaining flexibility where needed.
Solution Approach 2:
The polyamide outer layer acts as an intermediary barrier between the plasticizer-containing inner layer and the biological environment. This intermediate layer prevents direct interaction between the plasticizer and bodily tissues, mitigating biocompatibility concerns while allowing the inner layer to provide necessary flexibility.
Data Source
AI summary
A dual-layer dilatation balloon, and a process of making such balloon, which includes an inner layer that includes a plasticizer and a polymer selected from the group consisting of a polyamide, a copolymer thereof, and a combination thereof, and an outer layer that includes an ethylene-propylene rubber. The dual-layer balloon optionally further includes a stent disposed on the balloon. The stent is optionally a drug-eluting stent.