Hinged Compliance Fiber Braid Balloon Design
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Solution Overview
Problem
Medical balloons used in applications such as vascular dilatation and stent delivery require high strength and pressure resistance, especially for treating calcified stenoses in large vessels, but existing balloons struggle to maintain compliance at high pressures and large diameters.
Innovation Solution
The development of fiber-reinforced laminate composite balloons, where a polymer underlayer is expanded, coated with a fiber web, and encased in a matrix material, with an optional overlayer balloon, to achieve a hinged compliance curve that maintains strength and trackability at varying pressures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If high strength polymeric materials are used to increase pressure resistance, then strength is improved, but compliance and softness deteriorate
Solution Approach 1:
The balloon employs a composite structure combining a polymer underlayer with a fiber web (aramid, UHMWPE, or liquid crystal polymer) and matrix material. This composite construction provides high strength and pressure resistance while the polymer underlayer maintains compliance and softness for trackability.
Solution Approach 2:
The fiber web is applied selectively to specific regions of the balloon, such as the cone portions or body portion, rather than uniformly across the entire surface. This localized reinforcement provides strength where needed while preserving compliance in other areas.
2Adaptability or versatility
If balloon diameter is increased to treat large vessels, then adaptability is improved, but pressure resistance deteriorates
Solution Approach 1:
The composite structure with fiber web and matrix material provides the necessary strength to maintain pressure resistance even as balloon diameter increases to accommodate large vessels and stenoses.
Solution Approach 2:
The fiber web is applied to specific segments or regions of the balloon (cone portions, body portion) rather than uniformly, allowing optimization of strength distribution across different diameter regions.
3Strength
If fiber web is applied to increase strength, then pressure resistance is improved, but manufacturing complexity increases
Solution Approach 1:
The fiber web is applied to the balloon while it is in an expanded state, which simplifies the application process and ensures proper coverage and orientation of the fibers on the balloon surface.
Solution Approach 2:
A friction-enhancing material is applied as an intermediary layer between the polymer underlayer and the fiber web, facilitating proper adhesion and positioning of the fiber web during the manufacturing process.
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 balloons exhibit a hinged compliance curve, providing high strength and pressure resistance, with wall strengths exceeding 15,000 psi and diameters up to 14 mm, suitable for demanding medical procedures like balloon angioplasty and stent delivery.
Implementation Method 1
expanding the preformed underlayer balloon by pressurizing the underlayer balloon to a predetermined pressure above ambient
Implementation Method 2
The fiber web is bonded to the underlayer balloon with a suitable adhesive
Data Source
AI summary
Composite fiber reinforced balloons for medical devices are prepared by applying a web of fibers to the exterior of a preformed underlayer balloon which has been pressurized and expanded to a predetermined pressure or above ambient size, encasing the web with a matrix material to form an assembly with the fiber web bonded to the underlayer balloon. The assembly may have an outer layer formed by inserting the assembly into a preformed outer layer balloon. The overlayer balloon can be bonded to the assembly during a heat set step.