Nested Balloon Resistive Ablation Device
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Solution Overview
Problem
Existing medical devices for treating menorrhagia, such as those using endometrium ablation, often require user manipulation that can lead to tissue perforation, user discomfort, prolonged procedures, and fatigue, and may involve fluid circulation risks if the balloon leaks.
Innovation Solution
A medical device featuring an expandable member with a fluid cavity and a heating element, where the expandable member is connected to an introducer and can be inflated with fluid from a source, and the heating element is powered to generate heat for ablation, minimizing the need for user manipulation and reducing fluid circulation risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single-walled balloon is used for fluid circulation, then the device structure is simple, but there is a risk of fluid entering the body cavity if the balloon breaks or leaks
Solution Approach 1:
The patent employs a nested balloon structure where an inner balloon is placed inside an outer balloon. The inner balloon contains the therapeutic fluid while the outer balloon provides an additional containment barrier. This nested configuration prevents fluid leakage into the body cavity even if one balloon layer fails, thereby maintaining structural simplicity while significantly improving reliability.
2Productivity
If an electrode array is inserted into the body cavity, then ablation coverage is improved, but tissue perforation risk increases
Solution Approach 1:
The patent replaces the mechanical insertion of electrode arrays with a non-contact thermal ablation system. A balloon is inflated within the body cavity and heated through resistive heating or induction heating mechanisms. This eliminates the need for physical electrode insertion, thereby maintaining comprehensive ablation coverage while removing the risk of tissue perforation associated with mechanical electrode placement.
3Productivity
If user manipulation is required to spread the ablation, then ablation distribution is improved, but user fatigue and procedure time increase
Solution Approach 1:
The patent implements a self-expanding balloon mechanism that automatically distributes the ablation field when inflated. The balloon expands to conform to the body cavity geometry, and the heating element distributes thermal energy uniformly across the entire balloon surface. This eliminates the need for manual manipulation to achieve proper ablation distribution, reducing user fatigue and procedure time while maintaining effective ablation coverage.
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 effectively treats anatomical features like the endometrium with reduced risk of tissue perforation and user discomfort, while maintaining fluid containment within the expandable member, enhancing procedural efficiency and safety.
Implementation Method 1
heating element is powered to generate heat for ablation
Data Source
AI summary
A medical device that includes an expandable member, a fluid lumen, and a heating element. The expandable member has an inner expandable member and an outer expandable member. The fluid lumen is between the inner expandable member and the outer expandable member. The heating element is located inside of the fluid lumen.