Medical Balloon Strengthening Rods and Reinforcing Layers
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Solution Overview
Problem
Medical balloons used in procedures like angioplasty face challenges in controlling dimensions during inflation, as they can overinflate and rupture, leading to complications, and they often fail due to friction and abrasion during insertion.
Innovation Solution
A non-compliant medical balloon design featuring a woven fabric layer with angled fibers and reinforcing layers, including inelastic fibers and textile fabric materials, which maintains its dimensions and resists expansion when fully inflated, and is integrated with strengthening rods for enhanced stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If pressure is increased to inflate the medical balloon to the proper size, then the balloon expands to the required dimensions, but the balloon may overinflate and rupture causing stress on the body and serious complications
Solution Approach 1:
The patent changes the physical parameters of the balloon material by incorporating reinforcing layers with fibers having specific tensile strengths and elastic moduli. The base layer uses compliant material while reinforcing layers use materials with progressively higher stiffness, allowing the balloon to reach target dimensions without overinflating or rupturing.
Solution Approach 2:
The patent creates a composite structure combining a compliant base layer with multiple reinforcing layers containing fibers of different orientations and properties. This composite construction allows the balloon to exhibit both flexibility for inflation and strength to prevent rupture, resolving the contradiction between dimension control and reliability.
2Ease of operation
If compliant material is used to allow balloon expansion, then the balloon can be inflated, but the balloon lacks dimensional stability and may overexpand under pressure
Solution Approach 1:
The patent applies local quality by making different regions of the balloon wall have different properties. The base layer provides compliance for inflation, while strategically placed reinforcing layers with specific fiber orientations provide localized stiffness to maintain dimensional stability in critical areas during inflation.
Solution Approach 2:
The patent creates a dynamic structure where the balloon transitions from a compliant state during insertion to a stabilized state during inflation. The reinforcing layers remain inactive during deflated insertion but become active constraints when pressure is applied, allowing the balloon to expand to the proper size without overexpanding.
3Measurement precision
If the balloon is made to close tolerances for predictable inflation pressure, then the inflation pressure becomes predictable, but material variations cause the balloon to under-inflate or overinflate
Solution Approach 1:
The patent changes the material parameters by using fibers with controlled tensile strength, elastic modulus, and orientation angles. This allows the balloon to compensate for material variations and maintain consistent dimensional output despite variations in base layer material properties.
Solution Approach 2:
The patent uses composite construction where the reinforcing layers with controlled fiber properties compensate for variations in the compliant base layer. The combination creates a more predictable overall structure that maintains dimensional consistency across production batches.
4Ease of operation
If the balloon catheter is inserted through the vessel, then the procedure can be performed, but friction causes abrasion and puncture failure of the balloon
Solution Approach 1:
The patent applies local quality by providing enhanced protection at the outer surface of the balloon where abrasion occurs during insertion. The reinforcing layers, particularly those with circumferential or angled fiber orientations, create a more resistant surface layer that protects against friction and puncture while maintaining balloon flexibility.
Data Source
AI summary
A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing the internal pressure within the balloon. The balloon comprises a balloon layer having an outer surface, the balloon layer including a base layer, a first reinforcing layer and a second reinforcing layer. The base layer is formed of a polymer material. The first reinforcing layer is one of either a plurality of discrete inelastic fibers oriented substantially parallel to the long axis of the balloon and a first layer of textile fabric material, the textile fabric material being one of a woven, knitted, braided and non-woven fabric. The second reinforcing layer is one of either at least one inelastic fiber wrapped around the circumference of the balloon substantially transverse to the long axis of the balloon and a second layer of textile fabric material, the textile fabric material being one of a woven, knitted, braided and non-woven fabric. At least one of the first and second reinforcing layers is a layer of textile fabric material. At least one strengthening rod is connected to the outer surface of the balloon layer.