Reduced-Tip Loading Tools for Drug-Coated Device Valve Passage
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Solution Overview
Problem
Existing medical devices face challenges in passing through hemostasis valves without damaging the drug coating or deforming the resilient seal, leading to potential loss of therapeutic coatings and seal integrity during intracorporeal procedures.
Innovation Solution
A loading tool with a reduced distal tip and axially-extending slots is used to minimize the force exerted by the resilient seal, allowing the medical device to pass through while preserving the drug coating and maintaining seal integrity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a standard loading tool is used to pass the medical device through the hemostasis valve, then the device can be delivered, but the resilient seal member may deform or the drug coating may be damaged due to excessive force
Solution Approach 1:
The loading tool features a reduced distal tip with a smaller cross-sectional area at its distal end compared to the rest of the tool body. This local geometric modification allows the distal tip to pass through the resilient seal member's opening with reduced contact area and force, preventing seal deformation and drug coating damage while the larger proximal portion remains outside the valve
Solution Approach 2:
The loading tool is effectively divided into two functional segments: a reduced distal tip portion that interacts with the resilient seal member and a larger proximal body that provides structural support and holds the medical device. This segmentation allows the interaction zone to be optimized for minimal force application while maintaining overall tool functionality
2Productivity
If the resilient seal member is compressed to allow device passage, then the device can be delivered, but the drug coating on the device may be damaged or lost
Solution Approach 1:
The reduced distal tip creates a localized low-force passage zone that minimizes contact and compressive forces on the medical device surface, thereby preserving the drug coating during the critical passage through the hemostasis valve while still enabling device delivery
3Reliability
If the opening in the resilient seal member is small to maintain seal integrity, then sealing is improved, but it becomes difficult to pass the medical device through without excessive force
Solution Approach 1:
The resilient seal member maintains its small opening size for optimal sealing, while the loading tool's reduced distal tip provides a locally optimized geometry that fits through this small opening with minimal force, thereby maintaining both seal integrity and ease of operation
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 loading tool effectively reduces the risk of coating loss and seal deformation, ensuring the drug coating remains adhered and the seal recovers properly, enhancing the efficacy of intracorporeal device delivery.
Implementation Method 1
the reduced distal tip having a structure with a reduced dimension that allows the reduced distal tip to be passed into a proximal end of the hemostasis valve in such a way to reduce displacement of the resilient seal member
Implementation Method 2
ensuring the drug coating remains adhered and the seal recovers properly
Data Source
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AI summary
Loading tools for use with medical devices are disclosed. An example loading tool may be suitable for use with a drug-coated expandable medical device. The loading tool may include a tubular sleeve having a distal end region, a proximal end region, and a lumen extending therethrough. The distal end region may include a reduced distal tip designed to interact with a hemostasis valve having a resilient seal member.