Steerable Transseptal Punch With Articulating Stylet
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Solution Overview
Problem
Current methods for left atrial access, such as using a Brockenbrough needle with a Mullins catheter, face challenges in precision and flexibility during procedures, leading to potential complications like embolic effects and difficulty in aligning the puncture site accurately.
Innovation Solution
A steerable transseptal punch system with an inner core wire, inner tube, and outer tube, featuring a flexible region with slots and control rods, allows for articulation and precise alignment of the puncture site, minimizing tissue damage and embolic risks by enabling controlled curvature and steering within the cardiovascular system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a Brockenbrough needle with Mullins catheter is used for left atrial access, then the procedure can be performed with simple equipment, but precision and flexibility during the procedure are insufficient leading to potential complications
Solution Approach 1:
The punch device is divided into multiple functional segments: a stylet for initial puncture, an inner tube for guiding, and an outer tube for support. This segmentation allows each component to perform its specific function optimally while maintaining overall precision and control during the procedure.
Solution Approach 2:
The device incorporates a flexible region that allows dynamic bending and articulation during insertion and positioning. This dynamic capability enables the device to navigate complex anatomical paths and achieve precise puncture site alignment while adapting to patient-specific anatomical variations.
2Adaptability or versatility
If a rigid punch device is used, then column strength is maintained, but flexibility and ability to align puncture site accurately are reduced
Solution Approach 1:
Different regions of the device have different mechanical properties: the proximal and distal ends maintain rigidity for strength and support, while the intermediate flexible region provides bending capability. This local differentiation of mechanical properties allows the device to simultaneously achieve both strength and flexibility where needed.
Solution Approach 2:
The device combines materials with different mechanical characteristics - rigid materials (such as stainless steel or nitinol) for the stylet and tube ends to provide column strength, and flexible materials for the intermediate section to enable articulation and adaptation to anatomical pathways.
3Measurement precision
If the punch device is made flexible for steering, then puncture site alignment is improved, but tissue scraping and embolic risks increase
Solution Approach 1:
The stylet is advanced first to create the initial puncture path through the tissue, followed by sequential advancement of the inner tube and then the outer tube. This preliminary action by the stylet establishes a clean trajectory before the larger tubes are inserted, minimizing tissue scraping and embolic risks while maintaining precise alignment.
Solution Approach 2:
The stylet acts as an intermediary element that facilitates the insertion of the inner and outer tubes by first creating the puncture path. This intermediary action allows the subsequent tubes to follow the established path without causing additional tissue damage or generating embolic debris.
4Reliability
If a single-use punch device is used, then contamination issues are avoided, but cost and resource waste increase
Solution Approach 1:
The device is designed as a disposable single-use item that can be safely discarded after one use, eliminating contamination risks. The design incorporates features that ensure sterility and prevent cross-contamination while being manufactured at a cost that makes single-use economically acceptable.
Data Source
AI summary
A transseptal needle or punch is described wherein the distal end of the transseptal needle is able to articulate laterally out of the longitudinal axis of the steerable transseptal needle. The transseptal needle includes a blunted distal end configuration that is minimally traumatic. Under control by the user or a computer, the transseptal needle can be articulated to generate various curves with high bending force. The transseptal needle is configured for use with an introducer which can also include side windows.