Balloon Catheter Radiopaque Markers for Precise Working Surface Alignment
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing balloon catheters face challenges in accurately locating the working surface during angioplasty procedures due to misalignment of marker bands on the catheter shaft, leading to potential geographic misplacement and prolonged procedures, especially when delivering payloads like drugs or stents.
Innovation Solution
The balloon catheter features at least three radiopaque markings along its longitudinal axis, with varying distances between them, allowing for precise alignment of the working surface with the treatment area by accounting for balloon expansion, and optionally includes external markers on the shaft for enhanced visibility and measurement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional marker bands are attached to the catheter shaft, then the working surface location can be indicated, but misalignment occurs due to tolerance stack-ups, balloon growth, and shaft flexing
Solution Approach 1:
The patent replaces mechanical marker bands attached to the catheter shaft with radiopaque markers integrated directly into the balloon structure. This substitution eliminates the mechanical connection issues between separate components (marker bands and shaft) that cause misalignment due to tolerance stack-ups and shaft flexing. The radiopaque markers are embedded in the balloon wall itself, ensuring they move with the balloon and accurately indicate the working surface location regardless of shaft movement.
Solution Approach 2:
The patent incorporates radiopaque markers into the balloon during manufacturing, before the balloon is assembled to the catheter shaft. This preliminary action ensures the markers are permanently fixed to the balloon structure and will maintain their relative positions to the working surface during inflation and deployment, eliminating alignment issues that arise from post-assembly attachment methods.
2Measurement precision
If contrast agent is used to fill the balloon for visibility, then the balloon can be located under X-ray imaging, but inflation and deflation times are prolonged
Solution Approach 1:
The patent extracts the radiopacity function from the inflation medium (contrast agent) and assigns it to the balloon structure itself through integrated radiopaque markers. This allows the balloon to be filled with non-contrast media like saline or carbon dioxide, eliminating the need for contrast agent while maintaining X-ray visibility. The markers provide continuous visibility during inflation and deflation without delaying the procedure.
Solution Approach 2:
The radiopaque markers serve as a disposable, integrated visibility solution that is used only during the procedure. Unlike contrast agent which must be carefully selected and managed for patient safety (iodine sensitivity risks), the embedded markers provide safe, repeatable visibility without the need for contrast media, allowing rapid inflation and deflation with standard saline or CO2.
3Measurement precision
If the balloon is designed to deliver payload or working element to specified location, then treatment can be targeted, but geographic misplacement occurs due to marker misalignment
Solution Approach 1:
The patent replaces the mechanical marker band system with radiopaque markers integrated into the balloon wall. This substitution ensures the markers remain fixed relative to the balloon's working surface regardless of manufacturing tolerances in balloon-to-shaft attachment. The markers move with the balloon, providing accurate real-time location indication for payload delivery to the specified treatment site.
Solution Approach 2:
The patent applies radiopaque material specifically at the locations corresponding to the balloon's working surface boundaries and center. This localized application of radiopacity ensures that the markers accurately define the treatment zone without requiring precision across the entire catheter assembly. The markers are positioned with high precision relative to the balloon structure itself, ensuring accurate geographic placement of the payload delivery zone.
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
This design ensures accurate positioning of the balloon's working surface, reducing the risk of geographic misalignment and enabling efficient delivery of treatments by minimizing the need for redeployment or additional catheters, thus enhancing procedural efficiency.
Implementation Method 1
at least three radiopaque markings or markers spaced along a longitudinal axis of the catheter within the interior of the balloon
Data Source
Figure 1~2
Figure 3~4
Figure 5
AI summary
A balloon catheter for insertion in a vessel includes a catheter shaft (24) and an inflatable balloon (12) attached to the catheter shaft; the balloon including a working surface having a midpoint (B) in an inflated condition; at least one first radiopaque marker (39) correspoonding to the location of at least one end of the working surface in the inflated state; at least one secondradiopaque marking (30) corresponding to the location of at the midpoint of the working surface in the inflated condition.