Radiopaque Insert Balloon for Precise Working Surface Location
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Solution Overview
Problem
Current medical balloons used for angioplasty face challenges in precise location identification during procedures, misalignment issues due to tolerance stack-ups and bending of the catheter shaft, and prolonged inflation/deflation times, which can lead to geographic misses and inefficient procedures.
Innovation Solution
Incorporating radiopaque inserts and markers within the balloon that are independent of the catheter shaft, allowing for precise identification of the working surface and reducing the risk of misalignment, while also minimizing interference with balloon inflation and deflation processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If marker bands are attached to the catheter shaft to identify the working surface location, then the working surface position can be located, but misalignment occurs due to tolerance stack-ups and shaft bending
Solution Approach 1:
The radiopaque marker is extracted from the catheter shaft and embedded directly into the balloon structure. This separation eliminates the dependency on shaft-marker alignment and prevents misalignment caused by tolerance stack-ups and shaft bending during inflation.
Solution Approach 2:
The radiopaque marker is nested within the balloon wall structure itself, making the marker an integral part of the balloon rather than a separate component on the shaft. This ensures the marker moves with the balloon and maintains accurate positioning regardless of shaft flexing.
2Illumination intensity
If X-ray contrast agent is used to inflate the balloon for visibility, then radiographic visibility is improved, but inflation and deflation times are prolonged
Solution Approach 1:
The radiopaque marker function is extracted from the inflation fluid (contrast agent) and implemented as a solid marker embedded in the balloon structure. This eliminates the need to use contrast agent for visibility, allowing inflation with plain saline or other non-viscous fluids that enable rapid inflation and deflation.
Solution Approach 2:
The physical state of the radiopaque substance is changed from liquid (contrast agent in inflation fluid) to solid (embedded marker). This parameter change allows the balloon to be inflated and deflated rapidly without the viscosity and retention issues of liquid contrast agents.
3Stress or pressure
If high pressure is applied to compact calcified plaque, then the blockage is resolved, but the balloon requires complex technology to maintain low profile
Solution Approach 1:
The balloon incorporates a localized radiopaque marker only at the working surface region, rather than making the entire balloon structure complex or radiopaque. This provides the necessary identification function with minimal added complexity to the overall balloon design.
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
Enhances procedural efficiency by ensuring accurate positioning of the balloon's working surface, reducing the risk of geographic misses, and shortening inflation/deflation times without increasing cost or complexity, applicable to various existing catheter technologies.
Implementation Method 1
at least one radiopaque insert within the balloon and separate from the shaft
Data Source
AI summary
A balloon catheter adapted for use with a guidewire includes an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end. An inflatable balloon is supported along the distal end of the shaft, the balloon when inflated including first and second spaced ends and a working surface between the ends. An insert located within the interior compartment of the balloon includes at least a radiopaque portion separate from the shaft. Related methods are also disclosed.