Esophageal Ablation System with Balloon Sizing
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Solution Overview
Problem
Current medical systems for treating and determining physiologic characteristics of body lumens, such as the esophagus, face challenges in accurately measuring lumen size and controlling energy delivery to prevent damage and ensure uniform treatment, particularly in cases like Barrett's esophagus where precise depth penetration is crucial to avoid perforation, stricture, or incomplete treatment.
Innovation Solution
A system that includes a sizing member to measure the inner diameter of the esophagus using an inflatable balloon with a mass flow sensor, allowing for controlled expansion and energy delivery with a generator that adjusts energy based on measured diameter, impedance, or temperature to ensure precise ablation depth and uniform treatment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If energy is applied to treat Barrett's esophagus without precise control of penetration depth, then treatment energy can be delivered to the tissue, but the energy may penetrate too deeply into the esophageal wall beyond the mucosa and submucosal layers into the muscularis externa, causing esophageal perforation, stricture or bleeding
Solution Approach 1:
The system performs preliminary measurement of esophageal lumen dimensions and tissue characteristics before energy delivery. The catheter measures the inner diameter of the esophagus and determines the compliance of the lumen by measuring cross section at two or more pressure values, allowing the system to pre-calculate luminal dimensions and select appropriate treatment parameters to prevent over-penetration
Solution Approach 2:
The system incorporates real-time feedback mechanisms during energy delivery. The controller monitors treatment parameters and adjusts energy delivery based on measured lumen size and tissue response, ensuring energy penetration remains within the desired depth range and preventing perforation or stricture formation
2Length of moving object
If an expandable catheter is used to treat Barrett's esophagus, then the catheter profile can be kept small for ease of delivery, but the catheter may not expand sufficiently to achieve complete treatment coverage
Solution Approach 1:
The catheter is designed with expandable elements that can dynamically change size. The catheter profile is kept small for delivery, then expands within the esophagus to achieve adequate treatment coverage. The controller regulates the expansion to ensure uniform treatment while preventing over-distension of the organ
Solution Approach 2:
The system changes physical parameters of the catheter during the procedure. The catheter transitions from a compressed delivery state to an expanded treatment state, with the controller managing the expansion parameters to achieve optimal treatment coverage based on measured esophageal dimensions
3Manufacturing precision
If the catheter is over-distended during treatment, then treatment coverage may be maximized, but harm to the esophageal organ occurs
Solution Approach 1:
The controller monitors catheter expansion parameters and tissue response in real-time, adjusting expansion force to achieve adequate treatment coverage without exceeding safe limits that would cause esophageal injury
Solution Approach 2:
The system performs preliminary measurement of esophageal compliance and dimensions before treatment, using this information to pre-determine safe expansion parameters that maximize treatment coverage while preventing tissue damage
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
Enables accurate measurement and controlled treatment of esophageal lumens, reducing the risk of complications like perforation and ensuring effective ablation of abnormal tissue while preserving deeper tissue structures, thereby improving treatment efficacy and safety.
Implementation Method 1
monitoring a mass of the expansion medium inside the balloon
Implementation Method 2
inflating the balloon inside the body lumen using an expansion medium
Implementation Method 3
delivering energy to the electrodes for treatment of the luminal tissue
Implementation Method 4
controlling the depth of ablated tissue by monitoring a change in tissue impedance
Implementation Method 5
controlling the depth of ablated tissue by monitoring a change in the tissue temperature
Data Source
Figure 1
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AI summary
A method and apparatus for treating abnormal mucosa in the esophagus is disclosed, such that the depth of the treated tissue is controlled. The depth of ablation is controlled by monitoring the tissue impedance and/or the tissue temperature. A desired ablation depth is also achieved by controlling the energy density or power density, and the amount of time required for energy delivery. A method and apparatus is disclosed for measuring an inner diameter of a body lumen, where a balloon is inflated inside the body lumen at a fixed pressure.