Drug-Coated Balloon Catheter Protective Sheath Assembly
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Solution Overview
Problem
The challenge is to prevent cross contamination when arranging a protective sheath on a drug-coated balloon catheter, which requires complex and costly machine processing to ensure cleanliness.
Innovation Solution
A process involving a machine-produced relative motion between the balloon catheter and the protective sheath, using at least one first and one second flexible film to prevent contact between the drug-coated area and the guide, ensuring the drug-coated area is protected from contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If machine processing is used to arrange the protective sheath, then productivity is improved, but cross contamination risk increases
Solution Approach 1:
The patent introduces a guide element as an intermediary component between the machine processing system and the drug-coated balloon catheter. This guide includes a contact element that interfaces with the catheter, allowing machine-driven relative motion while preventing direct contact between the drug-coated area and potentially contaminating surfaces. The guide acts as a mediator that enables automated positioning without compromising sterility.
Solution Approach 2:
The protective sheath is segmented into distinct functional zones: a drug-coated area that remains protected, a guide section that interfaces with the processing machine, and a distal area that can be manipulated. This segmentation allows the machine to process the catheter through the guide structure without the drug-coated portion contacting contaminating surfaces, thus maintaining both automation and contamination prevention.
2Ease of operation
If components contact the drug-coated area, then ease of operation is improved, but cross contamination occurs requiring cleaning or exchange
Solution Approach 1:
The guide element serves as a permanent intermediary structure that allows handling and positioning operations to be performed on the catheter without components directly contacting the drug-coated area. The contact element of the guide provides a designated interface point that mediates between the need for mechanical handling and the requirement to prevent contamination.
Solution Approach 2:
The patent describes that the guide or its contact elements can be designed as disposable components that are exchanged after each product. This allows easy cleanup of contamination risk by simply replacing the guide rather than cleaning or exchanging the expensive drug-coated catheter, thus maintaining ease of operation while preventing cross contamination.
3Ease of operation
If the guide contacts the drug-coated area, then ease of operation is improved, but device complexity increases to prevent contamination
Solution Approach 1:
The guide element is designed as a relatively simple intermediary structure with a contact element that provides guiding capability. Rather than complex contamination prevention systems, the solution uses this straightforward guide structure to mediate between the handling requirements and contamination prevention needs, keeping the overall device complexity low.
Solution Approach 2:
The guide element serves multiple functions: it provides mechanical guidance for positioning, acts as a contamination barrier, and can serve as a reference for the relative motion between the protective sheath and catheter. This multi-functionality reduces the need for separate components, thereby reducing overall device complexity while maintaining ease of operation.
Data Source
Figure 1A~1B
Figure 2A~2B
Figure 2C~3A
AI summary
A process for arranging a protective sheath (2) on a drug-coated balloon catheter (3), the protective sheath (2) having a wall (20) circling in a peripheral direction (U), this wall surrounding an interior (21) of the protective sheath (2), the process having at least the following step: - Arranging the protective sheath (2) on a drug-coated area (30a) of the balloon catheter (3) by machine production of a relative motion between the balloon catheter (3) and the protective sheath (2), wherein - the drug-coated area (30a) of the balloon catheter (3) is protected, by at least one first and one second flexible film (5, 6), against coming in contact with a guide (4) for the balloon catheter (3) during the relative motion, or - the balloon catheter (3) is held away from the drug-coated area (30a) during the relative motion.