Steerable Transseptal Needle with Segmented Flexibility
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Solution Overview
Problem
The existing Brockenbrough needle system is pre-curved and rigid, causing material to be carved from the guiding catheter during insertion, potentially leading to emboli and damage to cardiovascular structures.
Innovation Solution
A steerable transseptal needle system that is initially straight and can be curved under user control after insertion into the guiding catheter, featuring a concentrically arranged inner and outer tube with slots for flexibility and control rods for articulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If the Brockenbrough needle is made rigid and pre-curved to maintain structural stability during insertion, then the needle can withstand insertion forces, but it carves material from the guiding catheter and generates emboli
Solution Approach 1:
The needle is divided into a proximal rigid section and a distal flexible section. The proximal portion maintains structural integrity for insertion, while the distal portion is made flexible to conform to the guiding catheter interior without carving material. This segmentation allows the needle to have different mechanical properties in different regions, resolving the contradiction between needing rigidity for structural stability and flexibility to avoid generating emboli.
2Stability of the object's composition
If the Brockenbrough needle is made rigid to maintain shape during insertion, then it can be advanced through the catheter, but it is difficult to advance through the cardiovascular system and may damage vessel walls
Solution Approach 1:
The needle comprises a proximal rigid portion that maintains shape stability and a distal flexible portion that can bend and conform to the cardiovascular system's natural curves. This allows the needle to be easily advanced through the body lumen while maintaining overall structural integrity during insertion.
Solution Approach 2:
The needle's flexibility parameter is varied along its length, with the distal portion having higher flexibility to navigate cardiovascular structures easily, while the proximal portion maintains lower flexibility for shape stability during insertion. This gradient in flexibility parameters resolves the contradiction between shape stability and ease of advancement.
3Adaptability or versatility
If the Brockenbrough needle is pre-curved to reach the target site, then insertion path is established, but it causes damage to cardiovascular structures during advancement
Solution Approach 1:
The needle is segmented into a proximal portion that provides structural support and a distal flexible portion that can adapt to the cardiovascular system's natural anatomy. The flexible distal section allows the needle to reach target sites by conforming to existing vascular paths rather than forcing a pre-curved path, thereby avoiding damage to cardiovascular structures.
4Ease of operation
If the needle is made straight for easy insertion into the guiding catheter, then insertion is facilitated, but it cannot be steered or articulated once inside the vasculature
Solution Approach 1:
The needle has a straight proximal portion for easy insertion into the guiding catheter and a flexible distal portion that can be articulated and steered once inside the vasculature. This segmentation allows the needle to provide both ease of insertion and in-situ articulation capability.
Solution Approach 2:
The needle transitions from a static straight configuration during insertion to a dynamic flexible configuration inside the vasculature, allowing articulation and steering. The flexible distal portion can be actively manipulated to change its shape and orientation, providing adaptability while maintaining ease of insertion.
Data Source
AI summary
A transseptal needle or punch. The transseptal punch includes a stylet with a tube with a side window and a cutting wire disposed within the tube, with a sharp cutting segment disposed proximate the window. The sharp cutting segment can be expanded radially outwardly from the window by translation of the cutting wire proximal end within the tube.