Catheter with Inflatable Members for Controlled Thermal Ablation
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Solution Overview
Problem
Current radiofrequency ablation technologies face issues such as incomplete ablation, lack of visualization during catheter insertion, potential for tissue charring, and risk of organ or lumen damage due to their invasive and uncontrolled energy delivery methods.
Innovation Solution
A therapeutic device utilizing a catheter with inflatable/expandable members and optional pressure sensing elements to deliver heated fluids or gases in a controlled manner, allowing for precise temperature management between 50-100 degrees Celsius, and the option to use chilled fluids for rapid treatment termination, enabling controlled tissue damage and minimizing risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If radiofrequency ablation is used to deliver thermal energy to tissue, then tissue heating and ablation can be achieved, but incomplete ablation and charring of tissues occur due to excessive energy delivery
Solution Approach 1:
The patent replaces radiofrequency electromagnetic energy delivery with a mechanical fluid circulation system. A catheter delivers heated fluid (e.g., saline) directly to the treatment site, and a separate suction catheter removes the fluid. This mechanical substitution allows precise control of thermal energy delivery through adjustable flow rate, temperature, and contact time, eliminating the charring problem associated with RF ablation while achieving complete ablation.
Solution Approach 2:
The patent introduces heated fluid as an intermediary medium between the heat source and the target tissue. Instead of directly applying RF energy to tissue, the heated fluid circulates through the treatment area, transferring thermal energy in a controlled manner. This intermediary approach prevents excessive localized heating and charring while ensuring uniform ablation across the treatment zone.
2Productivity
If radiofrequency electrodes are used for ablation, then thermal energy can be delivered to tissue, but frequent debridement and additional energy doses are required
Solution Approach 1:
The patent implements continuous fluid circulation during the ablation process. The heated fluid continuously flows through the treatment area, maintaining consistent thermal energy delivery throughout the procedure. This continuous action ensures uniform and complete ablation in a single pass, eliminating the need for repeated debridement and additional energy doses required by intermittent RF ablation methods.
3Ease of operation
If RF ablation is performed without visualization, then the procedure can be performed, but lack of visualization during catheter insertion increases risk
Solution Approach 1:
The patent integrates multiple functions into a single system: the catheter serves both as a delivery vehicle for heated fluid and as a visualization guide. The system can be used with or without concurrent endoscopic visualization, providing flexibility. When visualization is available, it enhances safety; when not available, the standardized catheter design maintains procedural simplicity and acceptable safety levels.
4Power
If rigid RF electrodes are used for ablation, then energy delivery can be achieved, but perforation of body cavity or lumen may occur
Solution Approach 1:
The patent replaces rigid RF electrodes with a flexible catheter system. The catheter can be advanced through body cavities and lumens in a flexible, controllable manner, reducing the risk of perforation. The flexible design allows the catheter to conform to anatomical structures while delivering thermal energy through fluid circulation, maintaining power delivery capability without the mechanical hazards of rigid components.
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 device provides consistent, controlled thermal energy delivery, reducing tissue damage and post-operative pain, while allowing for adjustable treatment parameters and modular components for versatile application in various body cavities, with the ability to combine thermal therapy with active agents for enhanced treatment efficacy.
Implementation Method 1
a source for a heated fluid and/or gas, e.g., hot water/steam, one or more pumps to deliver said hot water/steam... The heated fluid and/or gas may then be delivered to the area contained by the inflatable/expandable members
Implementation Method 2
Optionally, a chilled or room temperature fluid such as water may then be used to rapidly terminate the treatment session
Data Source
AI summary
Methods and apparatus for the treatment of a body cavity or lumen are described where a heated fluid and/or gas may be introduced through a catheter and into treatment area within the body contained between one or more inflatable/expandable members. The catheter may also have optional pressure sensing elements which may allow for control of the pressure within the treatment zone and also prevent the pressure from exceeding a pressure of the inflatable/expandable members to thereby contain the treatment area between these inflatable/expandable members. Optionally, a chilled or room temperature fluid such as water may then be used to rapidly terminate the treatment session.