Rotating Catheter Support for Stent Crimping Coating Protection
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Solution Overview
Problem
Current crimping methods for medical devices, particularly stents with drug-polymer coatings, often result in damage to the coating due to torque and shear stress applied during the crimping process, leading to potential contamination and reduced drug release effectiveness.
Innovation Solution
A crimping process and apparatus that allows the balloon catheter to rotate during crimping, reducing torque and shear stress on the stent or scaffold, thereby minimizing damage to the coating. This is achieved through the use of a crimping device with a rotating catheter support and motor-assisted rotation to counteract torque, ensuring minimal gravity-induced torque and free rotation about the Y-axis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Shape
If a crimping apparatus is used to crimp a stent with drug-polymer coating, then the stent can be compressed to the desired diameter for delivery, but the coating is damaged due to torque and shear stress
Solution Approach 1:
The catheter support is made rotatable rather than fixed, allowing the catheter to rotate during crimping. This dynamic adjustment enables the crimping surface to remain tangential to the stent surface throughout the compression process, eliminating torque application to the stent and preventing coating damage while still achieving the desired crimped diameter.
2Ease of operation
If the catheter is held fixed during crimping, then the crimping process is simple to control, but torque is applied to the stent surface causing coating damage
Solution Approach 1:
The catheter support transitions from a fixed position to a rotatable mechanism, allowing the catheter to rotate during crimping. This dynamic adjustment enables the crimping surface to remain tangential to the stent surface throughout the compression process, eliminating torque application to the stent and preventing coating damage while still achieving the desired crimped diameter.
3Productivity
If traditional crimping methods are used, then the process is quick and straightforward, but shear stress damages the drug-polymer coating reducing drug release effectiveness
Solution Approach 1:
The rotatable catheter support allows the catheter to rotate during crimping, maintaining a tangential crimping surface that eliminates shear stress application to the stent coating. This preserves the integrity and uniformity of the drug-polymer layer, ensuring reliable drug release effectiveness while maintaining crimping efficiency through the streamlined rotational mechanism.
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 reduced torque and shear stress result in less damage to the coating, maintaining the integrity and uniformity of the drug-polymer layer, enhancing the drug release characteristics and reducing thrombogenicity of the stent when deployed.
Implementation Method 1
The channel is supported by a bearing for rotation about a Y-axis
Data Source
AI summary
A medical device includes a balloon expanded scaffold crimped to a balloon catheter. The scaffold has a network of rings formed by struts connected at crowns and links connecting adjacent rings. The scaffold has a polymer coating and is crimped to the balloon. The scaffold is rotated, or allowed to rotate during crimping to improve results from crimping, such as reduced damage to the coating.