Offset Balloon Instrument Port for Stable Epicardial Ablation
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Solution Overview
Problem
Existing epicardial ablation procedures face challenges in accurately visualizing coronary vessels, scar tissue, and the phrenic nerve due to limitations in current visualization methods, and existing ablation catheters lack control over force application, risking damage to the pericardium and phrenic nerve.
Innovation Solution
An instrument port with a steerable tip, bendable shaft, and an offset balloon that can be asymmetrically inflated to create space for customizable angles and stable contact with heart tissue, allowing precise ablation while avoiding the pericardium and phrenic nerve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If ablation catheter is inserted tangentially through the pericardium to lay flat against the heart surface, then the catheter can emit energy to create lesions in the heart tissue, but this orientation may damage the phrenic nerve located on the pericardium's external surface and provides little control over the force applied
Solution Approach 1:
The balloon is designed with asymmetric inflation characteristics where one side of the balloon inflates more than the other when subjected to pressure. This asymmetric inflation creates a focal point of contact with the heart tissue, allowing the catheter to apply controlled force at a specific location rather than uniformly across the pericardium, thereby reducing the risk of phrenic nerve damage while maintaining ablation effectiveness.
Solution Approach 2:
The system allows dynamic adjustment of the balloon inflation state to control the contact force between the catheter and heart tissue. By varying the inflation pressure and volume, the operator can adjust the force applied during ablation procedures, enabling real-time control to prevent damage to critical structures like the phrenic nerve while maintaining effective tissue contact for lesion creation.
2Measurement precision
If existing visualization methods (fluoroscopy and 3D electro-anatomical voltage mapping) are used during epicardial ablation, then the ablation catheter and heart tissue can be visualized, but it is difficult or impossible to identify coronary vessels, scar tissue, fat pads, and the phrenic nerve
Solution Approach 1:
The patent introduces an intermediary substance or method that enhances the visibility of critical structures. This could involve the use of contrast agents, optical indicators, or advanced imaging techniques that act as intermediaries between the existing visualization methods and the target structures (coronary vessels, scar tissue, fat pads, phrenic nerve), enabling their identification without requiring complete redesign of the visualization system.
Solution Approach 2:
The system may utilize color changes or optical property modifications to enhance the visibility of different tissue types and structures. By applying contrast agents or using tissues with different optical properties, the visualization system can distinguish between coronary vessels, scar tissue, fat pads, and phrenic nerve, transforming previously invisible or indistinct structures into clearly identifiable targets.
3Ease of operation
If the ablation catheter is inserted through the pericardium, then access to the heart tissue is achieved, but the catheter lacks control over the force applied, leading to unstable heart tissue contact
Solution Approach 1:
The balloon is inflated prior to ablation procedures to establish stable contact between the catheter and heart tissue. This preliminary inflation action creates a consistent contact interface that maintains stable force application during the ablation process, ensuring reliable tissue contact while simplifying the overall operation of the catheter system.
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
Enhances visualization and control during epicardial ablation, enabling deeper lesions and protecting critical structures like the phrenic nerve by providing stable, precise contact and improved imaging.
Implementation Method 1
the offset balloon is radially asymmetrically inflated with respect to the shaft axis
Data Source
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AI summary
An instrument port includes an elongated shaft, a steerable tip, an offset balloon, and a working tube. The elongated shaft has proximal and distal ends and extending along a shaft axis, the elongated shaft having a fluid port defined in an external surface at the distal end of the elongated shaft. The steerable tip is attached to the distal end of the shaft. The offset balloon is attached to the external surface of the elongated shaft, the offset balloon having an internal volume in fluid communication with the fluid port, the offset balloon having an inflated state and a deflated state, wherein in the inflated state the offset balloon is radially asymmetrically inflated with respect to the shaft axis. The working tube is disposed in the elongated shaft, the working tube forming a working channel to receive a medical instrument.