Cryogenic Ablation Balloon for Esophageal Tissue Treatment
Solution Overview
Problem
Current techniques for treating Barrett's Esophagus, such as photodynamic therapy, mechanical resection, argon plasma coagulation, and radio-frequency ablation, face usability drawbacks including high procedural complication rates, limited area treatment, operator dependency, and the need for precise catheter sizing and additional equipment.
Innovation Solution
A medical device comprising a catheter with a refrigerant delivery system that uses a balloon to cool esophageal target tissue through a refrigerant delivery lumen, allowing for controlled cryogenic ablation with adjustable balloon sizes and refrigerant flow to effectively treat esophageal tissues while minimizing procedural complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Temperature
If direct spray of liquid nitrogen is used for cryogenic ablation, then cooling effect is achieved, but operator dependency and procedural complexity increase
Solution Approach 1:
The patent introduces a balloon as an intermediary medium between the liquid nitrogen and the esophageal tissue. The balloon is inflated with liquid nitrogen, which cools the balloon wall, and the cooled balloon wall then contacts and cools the target tissue. This intermediary approach eliminates the need for direct spray operation, reducing operator dependency while maintaining effective cryogenic ablation.
2Object-generated harmful factors
If argon plasma coagulation or radio-frequency ablation is used, then tissue ablation is achieved, but limited treatment area and need for precise catheter sizing occur
Solution Approach 1:
The patent employs an inflatable balloon that can be adjusted to different sizes by controlling the amount of liquid nitrogen introduced. This dynamic adjustment allows the treatment area to be adapted to different esophageal diameters and lesion extents, eliminating the need for precise pre-sizing and enabling versatile treatment area coverage while maintaining effective cryogenic ablation.
3Object-generated harmful factors
If conventional ablation techniques are used, then tissue removal is achieved, but procedural complication rates increase
Solution Approach 1:
The patent utilizes phase change of liquid nitrogen (from liquid to gas) as the cooling mechanism, which provides controlled and uniform temperature reduction across the target tissue. This parameter change approach enables precise control of the ablation process, achieving effective tissue removal while minimizing procedural complications such as perforation or excessive damage to surrounding healthy tissue.
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 effective cryogenic ablation of esophageal tissues with controlled depth and uniform surface treatment, reducing procedural complications and the need for additional equipment, while being less operator-dependent and more efficient than existing methods.
Implementation Method 1
A refrigerant is deliverable through the refrigerant delivery lumen, into the chamber, through the distribution passageway, through the refrigerant delivery opening and into the balloon interior so to place the balloon into an expanded, cooled state so that the balloon can press against and cool esophageal target tissue
Data Source
AI summary
A device for treating esophageal target tissue comprises a catheter, a balloon and a refrigerant delivery device. The catheter has a distal portion and a refrigerant delivery lumen. The balloon is mounted to and the refrigerant delivery device is coupled to the distal portion. The refrigerant delivery device comprises a chamber with the refrigerant delivery lumen opening into the chamber, a refrigerant delivery opening fluidly coupled to the balloon interior, and a distribution passageway fluidly coupling the chamber and the refrigerant delivery opening. A refrigerant is deliverable through the refrigerant delivery lumen, into the chamber, through the distribution passageway, through the refrigerant delivery opening and into the balloon interior so to place the balloon into an expanded, cooled state so that the balloon can press against and cool esophageal target tissue. The medical device may include means for sensing a leak in the balloon.