Steerable Endoluminal Punch for Transseptal Access
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Solution Overview
Problem
The Brockenbrough needle system is pre-curved and rigid, causing it to carve material from the guiding catheter, potentially leading to emboli and difficulty in advancing through the cardiovascular system, which can result in serious clinical sequelae.
Innovation Solution
A steerable transseptal needle with a straight configuration that becomes curved under user control, featuring concentrically arranged inner and outer tubes with controlled articulation, allowing for adjustable curvature within the vasculature to minimize debris release and facilitate easier advancement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If the Brockenbrough needle is made pre-curved and rigid to maintain its structural integrity, then it can be operated effectively for tissue punching, but it carves material from the guiding catheter causing emboli and difficulty in advancement
Solution Approach 1:
The needle transitions from a static pre-curved configuration to a dynamic steerable configuration. The distal tip is made articulating through a mechanism involving an inner tube that can translate relative to an outer tube, allowing the needle to change its curvature from pre-set to user-controlled during the procedure. This resolves the contradiction by enabling the needle to be straight during insertion (avoiding catheter material carving) and then curved at the tip for effective tissue punching.
Solution Approach 2:
The needle shaft is divided into concentric tubes (inner and outer tubes) that can move independently relative to each other. The inner tube can translate along the longitudinal axis within the outer tube, creating articulation at the distal tip. This segmentation allows different portions of the needle to have different configurations - straight proximal portion for easy insertion and curved distal tip for tissue engagement.
2Strength
If the Brockenbrough needle is made pre-curved and rigid to maintain structural integrity, then it can perform tissue punching effectively, but it damages the vessel wall and cardiovascular structures during advancement
Solution Approach 1:
The needle allows dynamic adjustment of its curvature through the articulating mechanism at the distal tip. During advancement, the needle maintains a straight configuration to minimize vessel wall trauma, and only curves at the distal tip when tissue punching is required, thereby reducing damage to cardiovascular structures.
Solution Approach 2:
The curvature is localized only at the distal tip through the articulating mechanism, while the proximal portion remains straight. This local quality change allows the needle to be straight during insertion (avoiding vessel damage) and then develop curvature only where needed for tissue engagement, resolving the contradiction between structural integrity and vessel wall protection.
3Object-generated harmful factors
If the Brockenbrough needle is made straight for easier insertion, then it reduces debris release, but it becomes difficult to articulate and steer within the vasculature
Solution Approach 1:
The needle incorporates a dynamic articulation mechanism where the inner tube can translate relative to the outer tube, allowing the distal tip to be steered and articulated within the vasculature after insertion. This resolves the contradiction by maintaining a straight configuration during insertion (minimizing debris) while providing controlled articulation capability when needed for procedural maneuvers.
Data Source
AI summary
An endoluminal needle or punch is describes wherein the distal end of the endoluminal needle is able to articulate laterally out of the longitudinal axis of the steerable endoluminal needle. The endoluminal needle further comprise a blunted distal end configuration that is minimally traumatic. Under control by the user, at the proximal end of the endoluminal needle, a sharp stylet can be advanced to punch tissue and then be retracted to maximize safety. The endoluminal needle is configured for use within an introducer.