Medical Balloon with Embedded Radiopaque Particles for Positioning
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Solution Overview
Problem
Medical balloons used in procedures like angioplasty and vascular dilatation are difficult to visualize and position accurately due to their smooth, slippery surface and the use of radiopaque inflating fluids, which can be viscous and biocompatibility issues.
Innovation Solution
A medical balloon with a first polymeric layer for strength and a second layer containing embedded round or cuboidal particles for a roughened, radiopaque/echogenic outer surface, which enhances visibility and positioning without compromising strength or pliability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the balloon is made with a thin-walled material to ensure it can be wrapped to a very small profile and optimise flexibility, then the balloon profile is reduced and flexibility is improved, but the balloon becomes very difficult to see by conventional imaging techniques
Solution Approach 1:
The patent applies radiopaque particles to the outer surface of the balloon to change its radiological properties, making it visible on conventional imaging techniques while maintaining the thin-walled flexible structure. The particles provide contrast against surrounding tissues, allowing real-time visualization during procedures.
Solution Approach 2:
The patent creates a composite structure by embedding radiopaque particles within the thin polymeric wall of the balloon. This composite approach allows the balloon to maintain its thin, flexible nature while gaining radiopacity for improved visibility during imaging.
2Difficulty of detecting and measuring
If radiopaque materials are used to make the balloon visible, then the balloon becomes detectable by imaging techniques, but the materials are relatively viscous resulting in greater inflating and deflation times
Solution Approach 1:
The patent applies radiopaque particles only to the outer surface layer of the balloon rather than filling the entire balloon volume with radiopaque fluid. This localized approach provides sufficient visibility while minimizing the overall viscosity and allowing for faster inflation and deflation cycles.
3Difficulty of detecting and measuring
If radiopaque fluids are used to inflate the balloon, then the balloon becomes visible, but the fluids tend not to be particularly biocompatible leading to potential difficulties should the balloon burst
Solution Approach 1:
The patent extracts the radiopacity function from the inflation fluid and transfers it to the balloon wall structure itself. By embedding radiopaque particles in the balloon wall, the inflation fluid can be standard biocompatible saline without needing to provide radiopacity, thereby maintaining biocompatibility while achieving visibility.
4Ease of operation
If the outer surface of the balloon is made smooth to maintain flexibility, then the balloon is easier to wrap and position, but the balloon becomes slippery making it difficult to position accurately and hold in position
Solution Approach 1:
The patent uses radiopaque particles not only for visibility but also to create a roughened surface texture that provides friction for accurate positioning. The particles embedded in the outer layer create micro-irregularities that prevent slipping while maintaining overall flexibility.
Solution Approach 2:
The patent creates a composite outer layer combining polymeric material with embedded radiopaque particles, where the particles provide both radiopacity for visibility and surface roughness for positioning stability, while the polymeric matrix maintains flexibility and elongation capability.
Data Source
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AI summary
A balloon catheter (10) includes a balloon (16) having a plurality of layers (34, 36). The inner layer (34) acts as a support layer to the outer layer (36). Embedded within the outer layer (36) is a plurality of particles or pellets (38) which in one embodiment provide roughening of the outer surface (40) of the balloon (16). The particles or pellets (38), particularly in conjunction with an inner support layer (34), ensure maintenance of the roughened outer surface of the balloon (16) during inflation of the balloon (16). In another embodiment, the particles or pellets (38) may be radiopaque and/or echogenic with or without creating surface roughening of the balloon.