Support Spine for Flexible Medical Device Navigation
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Solution Overview
Problem
Existing medical devices face challenges in navigating tortuous body lumens due to rigidity and flexibility issues, which can lead to stress concentration and potential damage during bending, and they often obstruct fluid flow with support structures.
Innovation Solution
A medical device featuring a flexible elongate member with a support spine that is not attached to the lumen surface, allowing for unobstructed fluid flow and distributing bending stress along the length of the device, while maintaining the ability to bend and curve for navigation through body vessels.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a support structure is added to the elongate member to provide rigidity and prevent damage during bending, then the strength and reliability are improved, but the support structure obstructs fluid flow through the lumen
Solution Approach 1:
The support spine is extracted from the lumen space and repositioned to the outer surface of the elongate member. This extraction eliminates the obstruction of fluid flow while maintaining the support function. The spine is affixed to the outer surface at its proximal end, allowing it to provide structural reinforcement without compromising the luminal patency.
Solution Approach 2:
The support structure is moved from a three-dimensional occupation within the lumen to a two-dimensional configuration on the outer surface. By positioning the spine on the external surface rather than inside the lumen, the design achieves structural support without intruding into the fluid flow pathway.
2Ease of operation
If the elongate member is made more flexible to navigate tortuous body lumens, then the ease of operation is improved, but the risk of stress concentration and damage increases
Solution Approach 1:
The support spine is positioned beforehand on the outer surface of the elongate member to act as a stress-distributing element during bending. This pre-positioned support structure prevents stress concentration at any single point, thereby reducing the risk of damage while allowing the member to remain flexible for navigation.
Solution Approach 2:
The support spine is made from a material with different mechanical properties than the elongate member, creating a composite structure. The spine's higher stiffness contrasts with the flexible member, allowing the combination to achieve both flexibility for navigation and strength for stress distribution.
3Strength
If a support spine is attached to the lumen surface to distribute bending stress, then the strength is improved, but the fluid flow is obstructed
Solution Approach 1:
The support spine is extracted from the lumen interior and repositioned to the outer surface of the elongate member. This extraction maintains the stress distribution function while eliminating the obstruction of fluid flow, as the spine no longer occupies the luminal space.
Solution Approach 2:
The support spine acts as an intermediary element that transfers and distributes bending stresses along the elongate member without directly contacting the fluid flow path. By serving as a structural mediator on the outer surface, it protects the member from stress concentration while leaving the lumen clear for fluid passage.
Data Source
AI summary
Embodiments of medical devices and methods are disclosed. The medical devices typically comprise a flexible elongate member defining a lumen, and a support spine affixed to the distal end and extending proximally therefrom within the elongate member lumen. In some embodiments, the support spine is configured to support at least a portion of the elongate member when the elongate member is bent or curved. Some embodiments include apertures at or near the distal end for enabling fluid communication between the lumen and the outside environment. In some embodiments, the support wire extends proximally from the distal end within a distal portion of the lumen such that a proximal portion of the lumen is substantially unobstructed, thereby reducing turbulence of fluid flowing through the lumen.