Remote Navigation System for Multi-Device Medical Steering
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Solution Overview
Problem
Current remote navigation systems for minimally invasive medical procedures lack the ability to effectively control and optimize the contact of multiple medical devices with the endocardial surface, particularly in accessing difficult-to-reach locations within the subject anatomy.
Innovation Solution
A method and apparatus that utilize a remote navigation system to steer and configure a deflectable sheath device, which is actuated mechanically or magnetically, to position an ablation catheter optimally for good contact with the endocardial surface by determining an optimal configuration that aims the sheath's distal tip at a target location while maintaining a pre-defined distance, allowing for precise placement and minimal catheter length for effective RF energy delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a single remote navigation system controls multiple medical devices, then the complexity of the control system is reduced and ease of operation is improved, but the ability to optimize contact of each device with the endocardial surface is compromised
Solution Approach 1:
The system segments the control of multiple devices by assigning device-specific parameters and control modes to each medical device while maintaining a unified remote navigation interface. Each device can be independently optimized for contact with the endocardial surface through device-specific parameter settings, even though they share the same navigation system.
Solution Approach 2:
The remote navigation system is designed with multi-functionality to handle multiple types of medical devices simultaneously. It provides universal navigation capabilities while accommodating device-specific requirements through configurable parameters and modes, allowing a single system to optimize contact for different device types without requiring separate control systems.
2Length of moving object
If the sheath is positioned close to the target location, then the catheter length is minimized for effective RF energy delivery, but the risk of damaging the endocardial surface increases
Solution Approach 1:
The deflectable sheath serves as an intermediary device that positions the ablation catheter near the target location while maintaining a safe distance from the endocardial surface. The sheath's distal tip is positioned at an optimal distance that allows the catheter to extend through it and contact the endocardium for RF energy delivery, while the sheath itself remains positioned to avoid direct contact and potential damage to the tissue.
3Adaptability or versatility
If manual steering of multiple devices is performed, then flexibility in adjusting device positions is maintained, but procedure time increases significantly
Solution Approach 1:
The system implements automated navigation with feedback control that continuously monitors the positions of multiple medical devices and automatically adjusts them to achieve optimal contact with the endocardial surface. This automated feedback-driven approach maintains the flexibility to adapt to anatomical variations while significantly reducing procedure time compared to manual steering.
Solution Approach 2:
The system performs preliminary automated navigation to position the deflectable sheath and ablation catheter near their target locations before manual fine-tuning is required. This preliminary automated positioning reduces the time and effort needed for manual adjustment, maintaining flexibility while minimizing overall procedure time.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach enables efficient and automated navigation of multiple medical devices for optimal contact with the endocardial surface, reducing procedure time, X-ray exposure, and improving the accuracy and effectiveness of ablation procedures by ensuring good contact force and minimal catheter length, thus enhancing the precision and safety of interventional cardiac electrophysiology procedures.
Implementation Method 1
a first medical device in the form of a remotely steered deflectable sheath... steered by the same remote navigation system... Niobe© magnetic navigation system manufactured by Stereotaxis, Inc.
Implementation Method 2
The deflectable sheath can itself be steered mechanically or magnetically
Implementation Method 3
The ablation energy is delivered by means of Radio Frequency (RF) power... ablation catheter... to ablate and isolate regions of the endocardial surface
Implementation Method 4
catheter-based ablation procedure... to ablate and isolate regions of the endocardial surface that function as sources of abnormal electrical activity
Data Source
AI summary
Methods are provided for automatically actuating and positioning a first medical device in a subject anatomy with a remote medical navigation system together with a localized second medical device that passes through the first device and is also actuated by the remote navigation system to access a desired target location. After an initial calibration step, an exemplary method comprises:(a) determining configurational variables for the first medical device based on a computational model of device deformation and a set of geometrical constraints, and(b) automatically steering the first medical device with the remote navigation system to the computationally determined configuration.