Radiopaque Scaffold Marker Rivets for Crimping Retention
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Solution Overview
Problem
Existing bioresorbable scaffolds face challenges in securely attaching radiopaque markers, particularly during crimping and balloon expansion, due to significant plastic deformation, which can lead to marker dislodgment.
Innovation Solution
The use of reshaped markers, such as rivet-shaped markers, and reshaped holes in the scaffold structure to enhance marker retention, combined with a process of cold-forming platinum beads into rivet shapes and swaging them into place, ensures secure attachment even under deformation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If radiopaque markers are attached to bioresorbable scaffolds using conventional methods, then the scaffold can be delivered and deployed, but the markers may dislodge during crimping and balloon expansion due to significant plastic deformation
Solution Approach 1:
The marker is pre-formed with a rivet shape including a head and a body portion designed to be inserted through the scaffold strut. This preliminary configuration allows the marker to be properly positioned and secured before the scaffold undergoes crimping and deployment, ensuring reliable retention despite subsequent plastic deformation
Solution Approach 2:
The rivet-shaped marker acts as an intermediary element between the scaffold strut and the radiopaque material. The marker's body portion passes through the strut while the head remains outside, creating a mechanical connection that secures the marker to the scaffold structure and prevents dislodgment during deformation
2Reliability
If the scaffold structure is modified to securely retain markers, then marker retention improves, but the scaffold profile increases which may increase thrombogenicity
Solution Approach 1:
The marker retention structure is localized to specific regions of the scaffold where markers are needed, rather than modifying the entire scaffold structure. The rivet-shaped marker with its head and body portion provides secure retention only at the marker attachment sites, maintaining the overall low profile of the scaffold in non-critical regions
Solution Approach 2:
The marker retention mechanism utilizes the third dimension by extending the marker body portion through the strut thickness. The marker's head remains on one side of the strut while the body passes through to the other side, creating a three-dimensional securement that does not require increased scaffold dimensions
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 approach significantly improves the reliability of radiopaque marker securement, reducing the risk of marker dislodgment during scaffold deployment and expansion, while maintaining a low profile to minimize thrombogenicity.
Implementation Method 1
a process of cold-forming platinum beads into rivet shapes
Implementation Method 2
significant plastic deformation
Implementation Method 3
swaging them into place
Data Source
AI summary
A scaffold includes a radiopaque marker connected to a strut. The marker is retained within the strut by a head at one or both ends. The marker is attached to the strut by a process that includes forming a rivet from a radiopaque bead and attaching the rivet to the marker including deforming the rivet to enhance resistance to dislodgement during crimping or balloon expansion. The strut has a thickness of about 100 microns.