Implant Delivery System Axial Ridges Maintain Orientation
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Solution Overview
Problem
Rapid exchange stent delivery systems face challenges in maintaining proper orientation between the guidewire lumen and the deployable device, leading to potential friction, entanglement, and difficulties in tracking and deploying the stent due to tortuous pathways and torqueing during advancement.
Innovation Solution
A medical implant delivery system with a tubular inner and outer shaft member configuration, featuring a contact surface with axial ridges on the outer shaft member to maintain rotational alignment and communication between the guidewire lumen and the rapid-exchange port, ensuring proper orientation and preventing stent rotation during deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a rapid exchange stent delivery system is used, then procedural efficiency is improved and guidewire handling is simplified, but maintaining proper orientation between the guidewire lumen and rapid-exchange port becomes difficult due to torqueing and tortuous pathways
Solution Approach 1:
The delivery system is divided into distinct segments: an inner member containing the guidewire lumen and an outer member containing the rapid-exchange port. These segments can rotate independently but are connected through a friction fit that allows controlled relative movement while maintaining overall alignment, resolving the orientation stability issue while preserving procedural efficiency
Solution Approach 2:
The system is pre-assembled with the guidewire lumen and rapid-exchange port in proper relative orientation during manufacturing. This preliminary alignment is maintained through the friction fit connection between inner and outer members, eliminating the need for complex realignment procedures during the actual stent deployment and thus maintaining both efficiency and orientation stability
2Ease of operation
If the delivery system components are not properly aligned, then friction and entanglement with the guidewire occur, but achieving and maintaining proper alignment is difficult during advancement through tortuous pathways
Solution Approach 1:
The friction fit connection between the inner and outer members provides localized rotational constraint at the interface where alignment is critical, while allowing the distal end of the delivery system to navigate tortuous pathways freely. This localized control prevents guidewire entanglement without compromising the ease of tracking through complex vasculature
3Reliability
If the guidewire lumen and rapid-exchange port become misoriented, then stent deployment is prevented or delayed, but the system lacks mechanisms to maintain orientation during torqueing
Solution Approach 1:
The friction fit connection between the inner member and outer member automatically maintains the relative orientation of the guidewire lumen and rapid-exchange port during normal operation. The system self-adjusts to maintain alignment without requiring additional active control mechanisms, thus ensuring reliable stent deployment while avoiding excessive device complexity
Data Source
Figure 1A~2A
Figure 2B~2C
Figure 3
AI summary
A medical implant delivery system maintains an orientation between a guidewire lumen of an inner member of the system and a rapid-exchange port in an outer member. The medical device is disposed intermediate the inner and outer members and in friction or pressure-fit contact with the outer member. Once the guidewire lumen of the inner member and the rapid exchange port of the outer member are oriented, the friction or pressure-fit operates to maintain the orientation until deployment of the medical implant. Orientation is further maintained by a telescoping coupling of the guide wire lumen with the rapid exchange port.