Toroidal Brachytherapy Balloon with Retention Ring
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Solution Overview
Problem
Current HDR brachytherapy methods face challenges due to air pockets and improper applicator positioning, leading to inadequate dose delivery and increased toxicity, as existing solutions like gauze packing and non-conforming balloons fail to provide consistent and comfortable positioning within body cavities.
Innovation Solution
A universal brachytherapy balloon with a toroidal shape that accommodates existing applicators, featuring a hollow core for the applicator and a retention ring to prevent displacement, allowing for consistent and reproducible positioning by eliminating air pockets and adapting to patient anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If gauze packing is used to position the applicator, then it is simple to implement, but it fails to provide consistent positioning and is uncomfortable for patients
Solution Approach 1:
The patent employs a flexible balloon made of thin film material that can be inflated to conform to the body cavity walls. This flexible shell structure provides consistent positioning of the applicator while adapting to patient anatomy, resolving the contradiction between ease of implementation and positioning consistency.
2Ease of manufacture
If non-conforming balloons are used, then they are easier to manufacture, but they do not hold their shape when squeezed and allow considerable slop in treatment margins
Solution Approach 1:
The patent changes the material parameters of the balloon by using a specific thin film material with appropriate elasticity and strength properties. This allows the balloon to maintain its shape when squeezed while still being manufacturable, achieving both ease of manufacture and shape consistency.
3Reliability
If a larger diameter applicator is selected to eliminate air gaps, then close mucosal apposition is achieved, but patient comfort is reduced and applicator positioning becomes more difficult
Solution Approach 1:
The flexible balloon can be inflated to different sizes to accommodate various applicator diameters while maintaining close mucosal apposition. This allows the use of smaller, easier-to-position applicators without compromising the elimination of air gaps, as the balloon fills the remaining space.
4Productivity
If HDR brachytherapy is performed with high dose delivery, then treatment time is reduced and convenience is improved, but positioning errors have more serious side effects
Solution Approach 1:
The balloon system is self-adjusting and self-positioning. When inflated, it automatically conforms to the body cavity walls and secures the applicator in the optimal position without requiring complex external fixation devices. This self-service mechanism ensures high positioning accuracy that is critical for safe HDR brachytherapy.
Data Source
AI summary
A brachytherapy balloon system, including a brachytherapy applicator and a brachytherapy balloon, is described. The brachytherapy balloon is shaped and sized to fit a vagina, a rectum or an esophagus and is made of elastomeric polymer and has a cylindrical inner surface defining an interior hollow of diameter D with at least one open end into which a brachytherapy applicator of diameter x<D can fit, and an outer surface. The inner and outer surfaces of the brachytherapy balloon together define an inflatable elongated toroidal shape having a distal and a proximal end. The distal end has a diameter less than x, a valve for inflating the balloon, and a retention ring that prevents the brachytherapy applicator from protruding beyond the retention ring and reproducibly positioning the applicator on every use.