Steerable Endoluminal Punch for Transseptal Access
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Solution Overview
Problem
The existing Brockenbrough needle system is pre-curved and rigid, which causes it to carve material from the guiding catheter during insertion, potentially leading to emboli and damage to cardiovascular structures, making it difficult to advance and increasing the risk of severe clinical sequelae.
Innovation Solution
A transvascularly or endovascularly placed tissue punch with internal deflectability, allowing it to articulate away from its longitudinal axis, comprising a straight configuration for insertion and curvature for target alignment, featuring a central stylet, inner and outer tubes, and control mechanisms for precise steering and alignment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If the Brockenbrough needle is pre-curved and rigid, then it can maintain structural stability for punching, but it carves material from the guiding catheter during insertion, potentially causing emboli and damage to cardiovascular structures
Solution Approach 1:
The needle assembly transitions from a straight configuration during insertion to a curved configuration during punching. The inner tube can be rotated relative to the outer tube to change the curvature of the distal end, allowing the needle to adapt its shape dynamically based on the procedural phase, thereby avoiding material carving during insertion while maintaining structural stability during punching.
Solution Approach 2:
The curvature parameter of the needle is changed from zero (straight) during insertion to a predetermined curve during punching. By controlling the relative rotation between inner and outer tubes, the curvature radius and angle are adjusted to optimize performance for each procedural stage, eliminating the harmful effect of material carving while preserving punching effectiveness.
2Measurement precision
If the Brockenbrough needle is pre-curved, then it can align with the atrial septum target, but it is difficult to advance through the guiding catheter and cardiovascular structures
Solution Approach 1:
The needle assembly allows dynamic adjustment of curvature by rotating the inner tube within the outer tube. During advancement, the needle is kept straight (zero curvature) to facilitate easy passage through the guiding catheter and cardiovascular structures. Once positioned, the inner tube is rotated to create the necessary curve for precise alignment with the atrial septum target, thereby resolving the conflict between ease of advancement and target alignment.
Solution Approach 2:
The needle is inserted in a straight configuration to avoid advancement difficulties, and the curvature is applied only after the needle has been successfully advanced to the target region. This preliminary straight configuration eliminates resistance during insertion, and the curvature is activated only when needed for precise positioning, optimizing both advancement ease and target alignment.
3Strength
If the Brockenbrough needle is rigid, then it can provide sufficient force for punching through the atrial septum, but it increases the risk of damage to adjacent cardiovascular structures
Solution Approach 1:
The needle assembly provides rigidity and punching force only at the distal end where the punch is located, while the proximal portion remains more flexible. The inner tube can be rotated to align the curved section precisely at the target site, concentrating the rigid punching action only where needed through the atrial septum, thereby minimizing the risk of damage to adjacent cardiovascular structures while maintaining sufficient punching force.
Data Source
AI summary
A transseptal punch with a steering mechanism within the punch, such that punch can be steered and deflected within a guide catheter during delivery, to avoid skiving of the guide catheter inner wall by passage of the punch tip through the guide catheter. The punch can be advanced through a body lumen in its straight configuration and then be selectively articulated or curved to permit negotiation of tortuous curvature or to permit optimal approach or access to a puncture site. The punch is able to create holes in the atrial septum of the heart or other structures and is easier to use than punches that are pre-curved near their distal tip since it is easier to advance through accessory catheters.