Segmented Reentry Catheter Tip for Subintimal Crossing
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Solution Overview
Problem
Current medical devices face challenges in stabilizing and controlling the distal tip during reentry into the vessel lumen, leading to potential dissection or injury, and require significant force to cross the subintimal layer, which can result in limb amputation or other serious health risks due to inadequate blood flow restoration in cases of occlusions.
Innovation Solution
A method and apparatus involving a catheter system with a proximal end, distal end, lateral port, and lumens that allow for the advancement of wires and cannulas to reenter the true vessel lumen from a subintimal space, utilizing a rotating reentry cutter and split distal tip for improved stability and control, reducing the need for long rigid elements and minimizing reentry forces.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If a long rigid element is used at the distal tip to support reentry forces, then reentry force capability is improved, but device size and tracking ability worsen
Solution Approach 1:
The catheter shaft is divided into multiple segments with varying degrees of rigidity. The distal portion has higher rigidity to support reentry forces, while proximal portions are more flexible for tracking through tortuous anatomy. This segmentation allows the device to have localized force-bearing capability without requiring a long rigid element throughout the entire shaft.
Solution Approach 2:
The catheter incorporates a dynamic tip support mechanism that can be deployed or activated only when needed for reentry. This allows the device to maintain flexibility during navigation and only engage rigid support structures when force is required for penetrating the subintimal layer, avoiding the need for a permanently long rigid element.
2Stability of the object's composition
If the distal tip is made rigid to prevent backing out during reentry, then stability is improved, but tracking ability through tortuous anatomy worsens
Solution Approach 1:
The catheter is segmented into a flexible proximal shaft for tracking and a more rigid distal portion for stability during reentry. This allows each segment to optimize its function - the proximal portion conforms to tortuous anatomy while the distal portion resists backing out during the reentry procedure.
Solution Approach 2:
Different portions of the catheter have different mechanical properties tailored to their specific functions. The distal tip and shaft sections have locally optimized rigidity and flexibility characteristics to provide tracking ability where needed while maintaining stability at the reentry site.
3Force
If significant force is applied to cross the subintimal layer, then reentry capability is improved, but risk of dissection or vessel injury worsens
Solution Approach 1:
The distal tip of the catheter features a localized sharp penetrating element or enhanced tip geometry concentrated at a specific point. This allows the reentry force to be focused on a small area to efficiently penetrate the subintimal layer with minimal overall force application, reducing the risk of dissection or vessel injury while maintaining effective reentry capability.
Data Source
AI summary
Embodiments of the invention are directed towards a rapid exchange catheter configured for insertion into a subintimal space and crossing an occlusion in a subintimal space. The catheter includes a proximal end, a distal end, a first lumen configured to receive a first wire, the first lumen extending longitudinally through a least a lateral port of the catheter, and a second lumen having at least a portion distal of the lateral port and extending through at least the distal end of the catheter. The catheter also includes an exchange port, arranged on an exterior portion of the catheter configured to receive a second wire and second rapid exchange port in communication with the second lumen. Moreover, other embodiments of the invention are directed towards methods for using the rapid exchange catheter to cross an obstruction in a vessel, e.g., a total or partial occlusion, in a subintimal space.