Radiopaque Medical Balloon with Intermediate Foil Layer
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Solution Overview
Problem
Angioplasty balloons require high pressure to dislodge calcified plaque, need to be resistant to puncture and scratch, and must have reduced inflation and deflation times without using X-ray contrast agents, which are costly and pose iodine exposure risks, and lack inherent radiopacity for accurate positioning during procedures.
Innovation Solution
A radiopaque medical balloon with a multi-layered structure including an inner and outer layer sandwiching a discrete intermediate layer with a radiopaque film or foil, comprising metals like silver, platinum, or bismuth, providing radiopacity throughout the balloon, especially in the absence of inflation fluid, and allowing for differential radiographic qualities in different sections for improved visibility during imaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a multi-layered balloon structure with intermediate radiopaque layer is used, then radiopacity and visibility under X-ray are improved, but device complexity and manufacturing cost increase
Solution Approach 1:
The radiopaque material is embedded within the multi-layered balloon wall structure, with the intermediate layer containing radiopaque particles or foil positioned between the inner and outer balloon layers. This nesting approach integrates radiopacity functionality within the existing balloon structure rather than adding separate external components.
Solution Approach 2:
The balloon employs a composite multi-layered construction where the intermediate layer combines radiopaque materials (such as barium sulfate, zinc oxide, or metal foils) with polymer matrices to create a structurally integrated radiopaque component that maintains flexibility while providing X-ray visibility.
2Measurement precision
If marker bands are attached to the catheter shaft for positioning, then positioning accuracy is improved, but device complexity and manufacturing cost increase
Solution Approach 1:
The radiopaque function is merged directly into the balloon wall structure itself, eliminating the need for separate marker bands on the catheter shaft. The intermediate radiopaque layer serves dual purposes: providing structural integrity to the balloon wall and enabling X-ray visualization for positioning.
Solution Approach 2:
The intermediate radiopaque layer performs multiple functions simultaneously: it provides structural support as part of the balloon wall, enables X-ray imaging for positioning accuracy, and maintains flexibility for inflation/deflation operations, replacing the need for dedicated positioning markers.
3Measurement precision
If X-ray contrast agent is used for balloon inflation, then visibility during procedure is improved, but procedural time and patient risk increase
Solution Approach 1:
The radiopaque functionality is extracted from the inflation fluid (contrast agent) and transferred to the balloon wall structure itself through the intermediate radiopaque layer, eliminating the need to use iodine-based contrast agents for visualization during the procedure.
Solution Approach 2:
The balloon structure itself provides the radiopacity needed for imaging through its intermediate layer, making the balloon self-visible under X-ray without requiring external contrast agents, thereby reducing patient exposure risks and procedural delays.
4Force
If high pressure is applied to dislodge calcified plaque, then blockage removal is improved, but balloon puncture resistance requirements increase
Solution Approach 1:
The multi-layered construction with intermediate radiopaque layer creates a composite structure that combines the flexibility needed for high-pressure expansion with enhanced strength and puncture resistance, allowing the balloon to withstand both the forces required for plaque dislodgement and the stresses of repeated inflation/deflation cycles.
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 balloon achieves improved visibility under X-ray without contrast agents, reduces procedural costs, and enhances the ability to accurately position and track the balloon during angioplasty, while maintaining flexibility and ease of inflation/deflation, thus enhancing the safety and efficiency of the procedure.
Implementation Method 1
The intermediate layer includes a film comprising a radiopaque material or a radiopaque foil
Data Source
Figure 1~2
Figure 3~3a
Figure 4A~4B
AI summary
A medical balloon is made radiographic, such as by incorporating a radiopaque foil 36 or film layer 35. The radiopaque foil or film layer may be placed between an inner layer 32 and an outer layer 30 of a non-compliant balloon wall. The foil or film may provide the balloon with a radiographic quality from a first end to a second end in the absence of an inflation fluid. The balloon may be provided with the foil or film in a manner that provides a first section, such as the barrel 16, with a first radiographic quality, and a second section, such as the cone 18, 20, with a second radiographic quality. The film may also be applied as a decal or appliqué to the external surface of a balloon-shaped body.