Steerable Septal Puncture Device for Left Atrium Access
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Solution Overview
Problem
Minimally-invasive access to the left side of the heart for therapeutic and diagnostic procedures is challenging and risky due to the complexity of navigating the atrial septum without causing trauma or damage.
Innovation Solution
A septum puncture device with a steerable platform between the inferior and superior vena cava, featuring a side catheter guide and guide stabilizer/actuator, allows for precise and stable puncture of the septal tissue, enabling guidewire delivery and therapeutic device access into the left atrium, with optional assistance in maneuvering the device within the left atrium.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional catheter-based approach is used to access the left side of the heart, then the procedure can be performed percutaneously, but the risk of trauma and damage to the atrial septum increases
Solution Approach 1:
The device performs preliminary actions by first delivering a guidewire through the septum before attempting to deliver the therapeutic device. The guidewire is advanced through the deflectable catheter to create a safe initial puncture path, allowing subsequent devices to follow the established trajectory and reducing the risk of uncontrolled trauma
Solution Approach 2:
The deflectable catheter serves as an intermediary device between the operator and the atrial septum. It provides a controlled platform that can be precisely positioned and oriented, allowing the operator to deliver guidewires and subsequent therapeutic devices through a stabilized intermediate structure rather than direct manipulation, thereby reducing trauma risk
2Stability of the object's composition
If a rigid shaft is used to provide stability for catheter manipulation, then axial and rotational adjustment is enabled, but the ability to independently adjust deflection angle is limited
Solution Approach 1:
The catheter is segmented into distinct functional zones: a rigid shaft portion that provides stability and support, and a deflectable tip portion that enables independent angle adjustment. This segmentation allows the rigid and flexible portions to perform their respective functions simultaneously without compromising either stability or adaptability
Solution Approach 2:
The catheter incorporates dynamic elements including a deflectable tip that can be actively controlled to change its angle relative to the rigid shaft. This dynamic capability allows the operator to adjust the deflection angle independently while maintaining the stability provided by the rigid shaft, enabling precise positioning for septal puncture
3Productivity
If the puncture device is withdrawn after guidewire delivery, then the guidewire can guide therapeutic device delivery, but the device capabilities for maneuvering within the left atrium are lost
Solution Approach 1:
The deflectable catheter is designed to perform multiple functions: it can deliver guidewires through the septum, serve as a delivery sheath for therapeutic devices, and provide maneuvering capabilities within the left atrium. This multi-functionality eliminates the need to withdraw the device after guidewire delivery, as it continues to assist with therapeutic device delivery and maneuvering throughout the procedure
4Object-affected harmful factors
If minimal access techniques are used to reduce invasiveness, then patient trauma is reduced, but the complexity of navigating the atrial septum increases
Solution Approach 1:
The deflectable catheter incorporates self-positioning and self-stabilization capabilities through its design features including the rigid shaft that maintains position and the deflectable tip that can be actively controlled. The device essentially guides itself through the complex navigation required for septal puncture, reducing the operational complexity for the operator while maintaining minimal access benefits
Data Source
AI summary
In some embodiments, an apparatus includes a shaft, and a guide coupled and angularly deflectable relative to the shaft via a guide coupler to be transitioned between a delivery configuration and a deployed configuration in which a distal end of the guide points away from a centerline of the shaft. The apparatus further includes an elongate member removably and slidably disposable within a lumen of the guide and extendable distally relative to the distal end of the guide. The apparatus further includes a puncture member slidably disposable within a lumen of the elongate member and extendable distally relative to a distal end of the elongate member. The guide is configured to have the elongate member and the puncture member removed from the lumen of the guide and to receive in the lumen of the guide a therapeutic device, and to be angularly deflected while holding the therapeutic.