Robotic Steerable Access System for Mechanical Septal Crossing
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Solution Overview
Problem
Current methods for left atrial access, such as using a Brockenbrough needle, pose risks of myocardial burning, thromboembolic events, and increased scarring due to radiofrequency ablation, and lack the precision and safety of steerable access systems.
Innovation Solution
Development of steerable endoluminal punches and robotic control systems that allow for precise, safe access to the interatrial septum through a steerable access system (SAS) with features like articulation, torqueability, and feedback mechanisms, enabling robotic delivery and minimizing tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If radiofrequency ablation is used to perforate the atrial wall, then tissue penetration is achieved, but myocardial burning, thromboembolic events, and increased scarring occur
Solution Approach 1:
The patent replaces radiofrequency ablation (thermal energy-based system) with a steerable mechanical punch system that uses controlled mechanical force to penetrate the interatrial septum. The punch mechanism delivers precise mechanical impact through a catheter to create an access hole, eliminating the need for thermal ablation and its associated harmful effects of myocardial burning and scarring.
Solution Approach 2:
The invention changes the fundamental parameter of tissue penetration from thermal energy (radiofrequency ablation) to mechanical energy (steerable punch). This parameter change allows for controlled, localized penetration without the widespread thermal damage and burning characteristic of RF ablation methods.
2Ease of operation
If a straight, unbent dilator is used, then passage of the steerable access system is facilitated with minimal skiving, but the dilator cannot assume optimal curvature configuration
Solution Approach 1:
The patent applies preliminary action by pre-configuring the sheath (not the dilator) with the optimal curvature needed for accessing target regions. The straight dilator is used first to facilitate easy passage and minimize skiving, then removed to allow the pre-curved sheath to be positioned, which subsequently assumes its native curved configuration for optimal access.
Solution Approach 2:
The introducer system is segmented into separate components: a straight dilator for initial passage and a curvable sheath for final positioning. This segmentation allows each component to perform its specific function optimally - the dilator provides easy passage without curvature constraints, while the sheath provides the necessary curvature for target access after the dilator is removed.
3Manufacturing precision
If the outer diameter of the devices is reduced to 0.030-0.050 inches, then access precision is improved, but column strength and torqueability are compromised
Solution Approach 1:
The patent employs composite construction for the punch system, combining materials with different properties to achieve both small diameter and sufficient strength. The outer tube and inner tube are made from materials selected to provide optimal strength-to-diameter ratio, allowing the device to maintain column strength and torqueability despite the reduced 0.030-0.050 inch outer diameter required for precise access.
Solution Approach 2:
The patent applies local quality by varying the wall thickness and material properties at different sections of the punch device. The distal tip region may have different structural characteristics than the proximal region, allowing optimized strength distribution that maintains adequate column strength and torqueability while keeping the overall outer diameter small for precise access.
Data Source
AI summary
An endoluminal traversing system and tissue crossing system are described wherein the access systems are controlled by actuators that allow for robotic control of system functions. The robotic system can be configured for full manual control over the actuators, full computerized control, or a combination of human and computer (AI, neural net, rule set) guidance.