Inflatable Catheter Barrier for Esophageal Protection
Solution Overview
Problem
During cardiac ablation procedures, there is a risk of damaging the esophagus due to its proximity to the heart, as heat from the ablation can penetrate through tissue and cause infection, leading to a high mortality rate from fistula formation.
Innovation Solution
A catheter with a protective shield, featuring an inflatable barrier member that can expand to create a physical barrier between the esophagus and the heart, made of bio-compatible materials, and equipped with shape-memory elements for easy deployment and retrieval, along with radiopaque materials for visualization and temperature sensors for monitoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If catheter ablation procedures are performed to treat atrial fibrillation, then cardiac arrhythmias can be treated effectively, but the esophagus may be damaged due to heat penetration and proximity to the ablation site
Solution Approach 1:
An inflatable barrier member is introduced as an intermediary element positioned between the ablation catheter and the esophagus. This barrier member physically separates the heat source (ablation catheter) from the vulnerable organ (esophagus), allowing the ablation procedure to proceed effectively while preventing thermal damage to the esophagus.
Solution Approach 2:
The barrier member is inflated before or during the ablation procedure to create a protective cushion between the ablation site and the esophagus. This pre-established protective layer prevents heat penetration and potential esophageal injury before the harmful effect can occur.
2Object-affected harmful factors
If a protective barrier is introduced between the esophagus and heart during ablation, then esophageal damage is prevented, but device complexity increases
Solution Approach 1:
The barrier member is integrated into the existing catheter system architecture, serving both as a protective shield and as a component of the overall catheter assembly. This integration allows the barrier function to be added without requiring a completely separate device system, thereby limiting the increase in overall complexity.
Solution Approach 2:
The barrier member is constructed as a flexible, inflatable structure that can be collapsed for insertion and then expanded to provide protection. This flexible shell design allows the protective barrier to be introduced through standard catheter access routes without requiring complex deployment mechanisms or large-bore access.
3Object-affected harmful factors
If the barrier member is inflated to provide protection, then esophageal shielding is effective, but the procedure time increases due to inflation and deflation steps
Solution Approach 1:
The barrier member is inflated to its protective configuration before the ablation procedure begins or as part of the initial catheter positioning steps. By establishing the protective barrier in advance, the actual ablation procedure can proceed without interruption for barrier deployment, minimizing the time penalty.
Solution Approach 2:
The barrier member remains inflated throughout the entire ablation procedure, providing continuous protection without requiring repeated inflation or deflation cycles. This continuous protective state eliminates the need for multiple deployment and retrieval operations, reducing the overall time loss associated with barrier management.
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
The catheter effectively shields the esophagus from extreme temperatures and physical trauma during ablation procedures, reducing the risk of esophageal damage and associated complications, thereby improving patient safety.
Implementation Method 1
a balloon member (15) mounted on a distal portion of the intermediate section (14)... the balloon member can assume a deployed configuration when inflated with a fluid... to shield the esophagus
Implementation Method 2
equipped with shape-memory elements for easy deployment and retrieval
Implementation Method 3
along with radiopaque materials for visualization and temperature sensors for monitoring
Implementation Method 4
temperature sensors for monitoring
Data Source
AI summary
A device that shields internal organs and tissues from medical procedures performed within a patient's body, especially in the chest cavity where ablation and related procedures are performed in or near the heart, includes a catheter body, a distal section, and a barrier member that can be inflated with fluid to act as a barrier to extreme temperatures and physical trauma, and be deflated to a smaller size to facilitate entry and removal from the patient's chest cavity. In a more detailed embodiment, the barrier member is a balloon that can protect the esophagus, which can be provided with folds and shape memory elements so that the balloon expands and collapses into predetermined configurations. Fluid is fed to and drawn from the barrier member via an irrigation tubing that extends along a catheter shaft and is in communication with a lumen of a deflectable tubing section that extends through an interior cavity of the barrier member. The catheter can be adapted for uni- or bi-directional deflection.